Kornimate/medical-research-clean huggingface dataset:
gender related differences in the acute effects of delta-9-tetrahydrocannabinol in healthy humans: sub-study ii

Conditions: Cannabis

Summary: the purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

to characterize the acute effects of vaporized thc in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility criteria:
inclusion criteria: * at least one lifetime exposure to cannabis * good physical and mental health exclusion criteria: * cannabis naïve individuals * major current or recent stressors
observational program to assess routine use of add-back therapy in patients with endometriosis in russian federation, planned for 6-month course of lucrin depot® (leuprorelin)

Conditions: Genital Endometriosis

Summary: the purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the russian federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.

this was a non-interventional, observational program in which lucrin depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy). the rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the russian federation. further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the russian federation.

Eligibility criteria:
inclusion criteria: * age from 18 to 50 years * written patient consent for use/disclosure of data * diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis) * candidate for treatment with lucrin depot for 6-month course * patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded exclusion criteria: * contraindications to administration of lucrin depot (leuprorelin): * hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition * vaginal bleedings of unknown etiology * hysterectomy * pregnancy and lactation * menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program) * acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs * other contraindications that make the patients participation impossible (by investigator judgment) * previous enrollment in the present program * extra-genital endometriosis

Keywords: lucrin depot genital endometriosis 6 months therapy
high pressure non invasive ventilation in hypercapnic respiratory failure

Conditions: Acute Hypercapnic Respiratory Failure

Summary: high pressure niv is a pressure limited ventilation, stating ipap pressure at 20 cmh2o and gradually increasing pressure up to 30 cmh2o according to patient tolerance.

noninvasive ventilation (niv): refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube). nppv is well established in the management of acute on chronic hypercapnic respiratory failure secondary to acute exacerbation of copd (aecopd), obesity hypoventilation syndrome, and restrictive thoracic disorders. during the past years niv was applied by using low pressure inspiratory positive airway pressure (ipap), which means titrating inspiratory pressure starting at 10 cmh2o and increasing pressure gradually according to patient tolerance maximum up to 20 cm h2o. there is still about 15% failure rate while using conventional low pressure niv, this failure rate may be attributed to the following: 1. still in a number of patients with conventional low pressure niv, paco2, and ph worsen with subsequent deterioration and need for invasive ventilation. 2. despite lowering paco2 value with conventional niv ventilation but it is not normalized so with minimal derangement in clinical condition of the patient it worsens again. 3. also abnormally high level paco2 may have a negative impact on vital organs. 4. low pressure may be associated with patient intolerance , and discontinuation of niv. recently high pressure niv used aiming to improve outcome of niv. high pressure niv is a pressure limited ventilation, stating ipap pressure at 20 cmh2o and gradually increasing pressure up to 30 cmh2o according to patient tolerance. high pressure niv is expected to improve alveolar ventilation, decreasing dead space ventilation, and work of breathing, so it can improve the outcome result .

Eligibility criteria:
inclusion criteria: all patients admitted in assiut university hospital and assiut police hospital with acute hypercapnic respiratory failure due to copd and obesity hypoventilation syndrome (ohs) indicated for conventional niv. patients who failed on low pressure niv will be shifted to high pressure niv with any of these conditions: 1. ph \<7.30 or less than admission level. 2. rr \> 35b/m or more than admission level. 3. spo2 \< 88%. exclusion criteria: (4) 1. age \<18 years. 2. excessive amount of respiratory secretions or weak cough. 3. upper airway obstruction. 4. recent oral, facial or cranial trauma or surgery. 5. sever abdominal distension. 6. active upper gastrointestinal bleeding. 7. cardiac or respiratory arrest. 8. ph\<7.25. 9. arterial oxygen tension /fraction of inspired oxygen (pao2 / fio2) \<150mmhg.
prepare: remote nutrition education, ghana

Conditions: Health Literacy; Dietary Diversity; Infant Feeding Practices

Summary: in the wake of the pandemic, it is important to explore remote nutrition education programs during the pre- and postnatal period. this is the second phase of a bigger project, where a 6-week intensive remotely delivered nutrition and health education program called the prepare program will be piloted. prepare stands for "perinatal remote education for pandemic resilience", and it is a nutrition and health education program meant for pregnant and lactating women aimed at improving maternal and infant dietary diversity, maternal health literacy and increasing covid-19 awareness. one hundred women will be selected from a pool of 233 women who completed a baseline survey last year. fifty of them will receive the intervention and the other 50 will receive a delayed intervention.


Eligibility criteria:
inclusion criteria: * women currently enrolled on the preliminary phase of the prepare project who participated in our baseline survey are eligible. to have been part of the preliminary survey, women had to have had children between 6 and 15 months old during recruitment last year. * due to our primary outcome of infant dietary diversity, women from our preliminary survey whose children are currently between 6 months and 2 years will be included in the prepare pilot study. exclusion criteria: * in our preliminary survey, participants were excluded if they were non-ghanaian or currently pregnant. * besides women who had children less than 6 months at time of recruitment, there will be no other exclusion criteria for the prepare pilot.
fab block vs. placebo for hip arthroplasty patients

Conditions: Hip Arthroplasty; Anesthesia, Regional; Femoral Articular Branch Block

Summary: hip arthroplasty surgery can be associated with significant pain. a regional anesthesia technique, the femoral articular branch block (fab), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. the investigators aim to demonstrate the analgesic benefits of fab. the investigators hypothesize that fab will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroplasty. this is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. a comparison of pain will be made between both groups.

hip arthroplasty procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. these patients usually receive a spinal anesthetic as well. the ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet. the femoral articular branch block (fab) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. the investigators aim to demonstrate the analgesic benefits of fab.

Eligibility criteria:
inclusion criteria: * asa i-iii patients * ages 18-60yrs * bmi ≤ 35 kg/m2 exclusion criteria: * preexisting neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves * local infection * contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy * chronic pain disorders * history of use of over 30mg oxycodone or equivalent per day * contraindication to a component of multi-modal analgesia * allergy to local anesthetics * history of significant psychiatric conditions that may affect patient assessment * pregnancy * inability to provide informed consent * patient refusal of fab * revision arthroscopy surgeries
study of the efficacy and safety of sch 486757 in subjects with chronic cough (study p04887)

Conditions: Cough

Summary: this is a randomized, double-blind, placebo-controlled, crossover, single center study of sch 486757 in subjects with chronic cough. subjects will be randomized to receive sch 486757 or placebo for 14 days. after a 2-week washout period, subjects will be crossed over to the other treatment. the primary objective is to evaluate the effectiveness of sch 486757 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.


Eligibility criteria:
inclusion criteria: * male and female subjects, 18 to \ 6 months. * by history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor \[ppi\] given twice daily) with no clinical response in cough. * by history, if there are clinical signs and symptoms of postnasal drip, these signs and symptoms will have been treated with a combination of an antihistamine and decongestant for a minimum of 8 weeks with no clinical response in cough. * by history, if there are clinical signs and symptoms of asthma, these signs and symptoms will have been treated with a combination of an inhaled steroid and a short-acting beta-agonist for a minimum of 8 weeks with no clinical response in cough. exclusion criteria: * subjects with current evidence of clinically significant pulmonary (especially conditions that involve coughing), hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune, or other disease that precludes the subject's participation in the study. in particular, diabetics, uncontrolled hypertensives, and subjects with clinically significant cardiomyopathy, prostatic hypertrophy, glaucoma, seizure disorders, and psychiatric disorders are to be excluded from participation in this study. * subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids. * subjects receiving concurrent prohibited medications unless they observe the washout period prior to the baseline visit. these medications would include opioid- and non-opioid-containing cough suppressants and potent cyp3a inhibitors, such as ritonavir, ketoconazole, and clarithromycin. subjects receiving ace inhibitors or maois will be excluded from the study. * subjects with a history of allergies to more than two classes of medications. * current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history \>10 pack-years will be excluded. (pack-years is a way to measure the amount a person has smoked over a long period of time. it is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked, eg, a 10 pack-year history is equal to smoking 1 pack per day for 10 years or 2 packs per day for 5 years, etc.)
inhaled nitric oxide (ino) as an adjunct to neonatal resuscitation

Conditions: Respiratory Distress Syndrome in Premature Infants; Very Low Birth Weight Baby

Summary: this study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame. although the use of oxygen in management of breathing is an important part of supporting baby immediately after delivery, there is more evidence that too much exposure to oxygen may lead to potential problems for your baby later. oxygen exposure can be harmful to premature babies developing lungs.

current neonatal resuscitation program (nrp) guidelines suggest the use of supplemental oxygen up to fraction of inspired oxygen of 1.0 during neonatal resuscitation for both term and preterm newborns. exposure to supplemental oxygen in preterm babies has been shown to have significant toxicity. even minimal exposure in the first hours of life has been shown to be associated with morbidity including later onset of cancer. the transition from fetal circulation to neonatal circulation is a complex process requiring lung inflation and decrease in pulmonary vascular resistance. endogenous nitric oxide, along with oxygen, plays a major role in facilitating this transition by decreasing pulmonary vascular resistance. it is not known whether exogenous nitric oxide would facilitate this transition. in this study, we propose a novel approach to resuscitation of preterm infants where inhaled nitric oxide (ino) will be used as an adjunct to oxygen with the primary goal of reducing supplemental oxygen exposure. this study is designed to be a double-blind, randomized, -placebo- controlled pilot trial with strict monitoring of parameters during transition in the delivery room.

Eligibility criteria:
inclusion criteria: * infants that are 25 0/7 - 31 6/7 weeks gestation * infants who require continuous positive airway pressure (cpap) or positive pressure ventilation ( ppv) during delivery room resuscitation. exclusion criteria: * refusal of consent * known complex congenital anomalies of the heart or lungs * known major genetic defects * hydrops fetalis

Keywords: prematurity oxygen exposure nitric oxide
prophylactic negative pressure wound therapy for high risk laparotomy wounds. a randomized prospective clinical trial.

Conditions: Surgical Wound; Wound Dehiscence, Surgical; Surgical Site Infection; Dehiscence of Internal Surgical Wound

Summary: negative pressure wound closure technique (npwt) has been widely introduced in different clinical settings. most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. npwt as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness. in this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (cinpwt) with traditional, dry wound dressing at high infection risk laparotomy wounds.

the aim is to compare cinpwt (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds. control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress. experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (atrauman® ag - hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (vivanomed® white foam - hartmann) and sufficient-size sealant film (hydrofilm® - hartmann). a negative pressure of -90 hgmm will be administered in a continuous mode over 5 days postoperatively. surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Eligibility criteria:
inclusion criteria: * high risk laparotomy patients. ssi risk at least 3x higher than normal rate (6-8%) * surgical wound type iii or iv.. exclusion criteria: * patients not giving informed consent. * patients requiring open abdominal wound care. * patients with abdominal wall malignancy, * patients with peritoneal carcinomatosis, * patients who are planned for second look laparotomy within 5 days, * patients with less thank 3 month life expectancy. * patients who are operated with existing wound infection

Keywords: negative pressure wound closure surgical site infection cost effectiveness
the effect of 40 hz transcranial stimulation on the incidence of delirium after total hip replacement or total knee replacement arthroplasty in elderly patients.

Conditions: Postoperative Delirium; Anesthesia; Elderly

Summary: delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. exogenous 40 hz stimulation can improve cognitive functioning. therefore, the aim of this study was to investigate the effect of exogenous 40hz stimulation on the incidence of postoperative delirium in elderly patients undergoing hip and knee replacement.


Eligibility criteria:
inclusion criteria: 1.65-85 years old, gender not limited 2.general anesthesia unilateral total hip replacement surgery or unilateral total knee replacement 3.asa classification i-iii 4.no drugs for mental and central nervous system diseases were used before surgery 5.preoperative mmse score illiterate \> 17 points, primary \> 20 points, junior high school and above \> 24 points 6.obtaining informed consent exclusion criteria: 1. severe liver and kidney dysfunction 2. here were mental and nervous system diseases before operation 3. have a history of alcoholism, long-term use of sedative or analgesic 4. a history of a delirium and other reasons are reluctant to cooperate 5. massive blood loss and blood transfusion during operation, prolonged operation time
glycemic control and variability for congestive heart failure exacerbation

Conditions: Congestive Heart Failure; Diabetes Mellitus

Summary: high glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

high glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. glucose fluctuations have not been well-studied in patients with heart failure. in this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. we will enroll 80 patients with severe heart failure and divide them into 2 groups. we will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. we will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.

Eligibility criteria:
inclusion criteria: * age 18 and above * admitted (less than 48 hours) to the with worsening heart failure * hyperglycemia or diabetes. hyperglycemia is defined as blood glucose greater than 150 mg/dl on at least 2 occasions separated by at least 4 hours apart, insulin use, or hba1c \>6.5%. exclusion criteria: * type 1 diabetes * receiving comfort care measures only * hospital stay expected to be less than 2 days * pregnancy * prisoners * participation in the study on prior hospitalizations * acute myocardial infarction within 3 months * end stage renal or liver disease

Keywords: congestive heart failure diabetes mellitus hyperglycemia
comparison of different electroporation systems in the ablation treatment of atrial fibrillation

Conditions: AF; Ablation of Atrial Fibrillation

Summary: the participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (af) called electroporation systems. atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. the goal of this study is to determine which electroporation system is the most effective and safest for treating af. these systems work by using electrical energy to disrupt abnormal heart tissue, helping to restore a normal heart rhythm.

the investigators are testing three different electroporation systems: farapulse, pulseselect, and varipulse. each of these systems uses a similar approach to treat af, but they may work slightly differently. the investigators want to find out which one is best at permanently stopping the irregular heart rhythm, while also being the safest for patients. what will happen during the study? the patient will have two procedures: first procedure: this is the initial ablation, where the doctors will use one of the three electroporation systems to treat the atrial fibrillation. during this procedure, the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening. second procedure: after about 3 months, the participant will return for a re-mapping procedure. this will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back. if necessary, the investigator will perform another ablation to correct any remaining problems. is it safe? all procedures are performed by experienced doctors who specialize in treating af. like any medical procedure, there are some risks, such as small chances of blood clots, injury to nearby tissues, or complications from the anesthesia. however, the electroporation systems are designed to minimize these risks, and the study will closely monitor your loved one for any complications. what are the benefits of participating? the participant could benefit from receiving one of the latest treatments for atrial fibrillation. by participating, they will help doctors learn which system works best, which could help future patients with similar conditions. additionally, the participant heart rhythm will be closely monitored, and if any problems arise, they will receive immediate care. how long will it take? the study will last about 6 to 7 months, with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later.

Eligibility criteria:
patients with symptomatic paroxysmal or persistent atrial fibrillation. eligible for catheter ablation as per current guidelines. willing to undergo both an initial ablation procedure and a repeat mapping/ablation if required. exclusion criteria: patients with prior ablation procedures. contraindications for af ablation (e.g., severe coagulopathy, left atrial appendage thrombus). significant comorbidities impacting study outcomes.