Kornimate/medical-research-clean huggingface dataset:
coach-cog intervention adaptation focus groups

Conditions: Focus Groups

Summary: to gather key stakeholder input for feedback on the adaption of the coach ga intervention (i.e., develop coach-cog) to enhance triadic communication among oncologists, care partners and patients with adrd.


Eligibility criteria:
inclusion/exclusion criteria: the inclusion and exclusion criteria for participants are that they must be able to consent for themselves and must speak english. for the medical oncologist focus group, participants must be a medical oncologist. for the clinicians with expertise in cognitive impairment and dementia focus group, participants must be a clinician that treats patients with cognitive impairment and dementia. for the older patients with cancer focus group, participants must be older than 65 years of age and have or had cancer. for the caregivers of patients with dementia focus group, participants must be caregivers of patients with dementia or cognitive impairment.
early luteal progesterone profile in ivf patients triggered with hcg

Conditions: Infertility

Summary: until now very little information exists regarding the early luteal serum progesterone profile after human chorionic gonadotropin (hcg) trigger. this pilot study will help characterize the serum progesterone, 17-hydroxyprogesterone profiles in ivf patients and correlate progesterone, 17-hydroxyprogesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

the early luteal phase after ivf treatment is only scarcely studied. during ivf treatment the early luteinizing hormone (lh) activity deficit induced after ovarian stimulation with exogenous gonadotropins will be partly covered by the bolus of hcg used for triggering of final oocyte maturation due to the long half-life of hcg. in addition, the luteal phase will be covered by exogenous progesterone supplementation. after successful implantation the embryo itself will provide the supportive lh activity, securing the function of the corpora lutea. however, during the early luteal phase and peri-implantation, recent data suggest that an early-mid-luteal hcg/lh deficiency exists after hcg trigger during which the corpus luteum lacks an optimal stimulation. furthermore, the early luteal progesterone profile in ivf differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. with this non-invasive trial, we wish to further explore the early luteal phase profiles of progesterone, 17-hydroxyprogesterone and hcg in order to optimize current luteal phase support policies in ivf and hopefully increase ongoing pregnancy rates.

Eligibility criteria:
inclusion criteria: * freeze all cycle after hcg trigger * age 18 - 38 * bmi \< 28kg/m2 * normal ovarian reserve, defined by anti-mullerian hormone (amh) \> 1.25 ng/ml or antral follicle count (afc) ≥ 6 measured within two months prior to stimulation start * receiving gonadotrophin releasing hormone (gnrh) antagonist co-treatment during ovarian stimulation * agreement to participate in the study, and to disclose any medical events to the investigator. the subject must be willing and able to comply with the protocol requirements for the duration of the study. * have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. exclusion criteria: * previous poor response (≤ 3 oocytes) after high dose follicle stimulating hormone (fsh) stimulation * hyper-response defined as \>20 follicles ≥ 14 mm * chronical medical conditions like diabetes, crohns disease, thyroid disease, hepatitis b and sexually transmitted diseases simultaneous participation in an interventional clinical trial.
expanded access of pimavanserin for patients with pd psychosis

Conditions: Parkinson's Disease Psychosis

Summary: the purpose of this program is to provide patients with pdp access to pimavanserin until the product receives marketing approval from the fda and is commercially available.


Eligibility criteria:
inclusion criteria: 1. patient meets one of the following criteria: 1. patient has participated in a previous study of pimavanserin for parkinson's disease psychosis (pdp) 2. new ("de novo") patients 2. a clinical diagnosis of parkinson's disease with a minimum duration of 1 year 3. female patients must be of non-childbearing potential 4. psychotic symptoms must have developed after parkinson's disease diagnosis was established 5. patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to study day 1 (baseline) and must remain stable during the trial 6. the patient or legally authorized representative (lar) is willing and able to provide consent 7. the patient or lar is willing and able to adequately communicate in english. exclusion criteria: 1. patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of parkinson's disease including, but not limited to, schizophrenia or bipolar disorder 2. patient has had dementia prior to or concurrently with their diagnosis of parkinson's disease that may be inconsistent with a parkinson's diagnosis 3. patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program 4. patient has had a myocardial infarction in last six months 5. patient has any surgery planned during the screening, treatment, or follow-up periods patients will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
the effect of bariatric surgery to central sensitization

Conditions: Bariatric Surgery; Central Sensitization

Summary: nowadays obesity is emerging as a very common health problem. it has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (oa). the aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

weight loss in patients with knee oa reduces pain and provides functional improvement. it has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function. neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. it has been reported that neuropathic pain is more frequently seen in patients with high body mass index. the hyperreactivity of the central nervous system (cns) plays an important role in the chronic pain of oa patients. it has been shown that cns becomes hypersensitive in people with chronic oa pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients. the aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

Eligibility criteria:
inclusion criteria: * patients decided to undergo bariatric surgery * patients with knee pain more than 3 months. exclusion criteria: * patients with mental impairment, * patients with inflammatory rheumatic disease, * patients who had previously undergone knee surgery

Keywords: bariatric surgery central sensitization knee pain function quality of life
efficacy and safety of liposomal bupivacaine in thoracic paravertebral nerve block

Conditions: Thoracic Paravertebral Block; Postoperative Analgesia; Thoracoscopic Lobectomy

Summary: i. research purpose 1.1 main objective: to investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block combined with drainage tube analgesia for postoperative analgesia after thoracoscopic lobectomy 1.2 secondary objective: to investigate the efficacy and safety of drainage tube analgesia after thoracoscopic lobectomy 1.3 exploratory objective: to investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine

group a: participants were treated with 0.5% bupivacaine 20ml thoracic paravertebral block combined with patient-controlled intravenous analgesia (pcia). group b: 0.5% bupivacaine 20ml thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with pcia; group c: 1.33% bupivacaine liposome 20ml thoracic paravertebral nerve block complex pcia; group d: 1.33% bupivacaine liposome 20ml thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with pcia. a mechanical intravenous analgesic pump (100 ml, jiangsu aipeng medical technology co., ltd., jiangsu, china) was used with no background dose, pca dose was 1ml, locking interval was 10 minutes, sufentanil 1ug/kg, nalbuphine 1mg/kg and ondansetron 16mg, and the postoperative analgesic management system was used to record the number of compressions. analgesia through the drainage tube was performed by inserting an epidural catheter through the lateral wall of the drainage tube. after the operation, 0.25% bupivacaine 10ml was injected through the epidural catheter. an external mechanical intravenous analgesic pump was installed, and the background dose was set to 5ml/h, without pca dose. if the nrs score is ≥4 points after 3 consecutive pca doses, additional rescue drugs are added without limiting the type

Eligibility criteria:
inclusion criteria: * 1) age ≥18 years old; 2) patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (tv or robot-assisted); 3) american society of anesthesiologists (asa) grade i - iii; 4) voluntarily participate in the study and sign the informed consent. exclusion criteria: * 1) pregnant or lactating women; 2) pulmonary wedge-shaped resection; 3) ≥2 thoracic drainage tubes; 4) abnormal liver function: alt and/or ast\>2×uln, or tbil≥1.5×uln; 5) renal function impairment (serum creatinine \>176μmol/l), or received dialysis treatment within 28 days before surgery; 6) participate in another research trial involving an investigational drug within 6 months; 7) a history of drug or alcohol abuse; 8) long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month); 9) history of allergy to local anesthetics or one of the investigational drugs; 10) uncontrolled mental or neurological symptoms.

Keywords: liposomal bupivacaine(lb) thoracic paravertebral nerve block postoperative analgesia thoracoscopic lobectomy
neisseria meningitidis burden of disease study

Conditions: Streptococcus Pneumoniae; Neisseria Meningitidis; Haemophilus Influenzae

Summary: this study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to n. meningitidis and the serogroup responsible in the philippines and vietnam.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * written informed consent obtained from the subject/from the parent(s)/lar of the subject. * a male or female subject who visits the hospital with suspected bacterial meningitis. * csf sample taken as part of routine practice. exclusion criteria: * child in care.
spl026 with or without ssris in participants with mdd

Conditions: Major Depressive Disorder

Summary: the main aim of the study is to test the safety and tolerability of single doses of spl026 (n,n-dimethyltryptamine \[dmt\] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (ssri) for their depression, but for whom the ssri is not fully relieving their depression.


Eligibility criteria:
inclusion criteria: * mdd diagnosis * previously tried at least one approved method of treatment for their depression * no monoamine oxidase-inhibitor class antidepressants for at least 3 months * deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, laboratory tests of blood and urine * no psychedelic drug use in the 6 months before dosing until the end of the study * willing to follow the contraception requirements of the trial * willing to be contacted by email and video call, and have online access * able to give fully informed written consent * test cohort only: currently on a stable dose of an unspecified single ssri alone and not in combination with any other psychiatric medications, for at least 6 weeks prior to screening with no intention of making any changes * control cohort only: no antidepressant medication for 6 months before dosing exclusion criteria: * substance use disorder * current or clinically relevant history of a psychotic disorder, or first-degree relatives with a clinically relevant history of a psychotic disorder * significant history of mania * significant risk of suicide * clinically relevant abnormal findings at the screening assessment * blood pressure, heart rate, or qtcf outside the acceptable ranges * acute or chronic illness (other than mdd) or infection * clinically relevant abnormal medical history or concurrent medical condition (other than mdd) * use of any serotonergic psychedelics within 6 months prior to dosing * patients of child-bearing potential who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception * history of a severe adverse reaction to any drug or sensitivity to serotonergic psychedelic drugs * use of over-the-counter or prescribed medication (excluding oral contraceptives, hormone replacement therapy and ssris \[test cohort only\]) within previous 28 day before dose of trial medication; or paracetamol or ibuprofen within 4 hours prior to dosing

Keywords: major depressive disorder mdd depression ssri n,n-dimethyltryptamine dmt
comparison of esophageal and central venous pressure for estimating transpulmonary pressure changes

Conditions: Mechanical Ventilation; Acute Respiratory Distress Syndrome

Summary: central venous pressure (cvp) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. the aim of the study is to compare the low-frequency component of cvp with the esophageal pressure (pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure (pl).

the investigators will enroll mechanically ventilated patients admitted to the intensive care unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric catheter and a central venous catheter for measuring pes and cvp, respectively. electrocardiogram trace, pes, cvp and airway pressure (paw) will be recorded at the end of inspiratory and expiratory pauses. the cvp waveforms will be analyzed off-line using a dedicated low-pass digital filter to obtain the low-frequency component of cvp (filtered cvp, fcvp). paw, pes and fcvp will be used to calculate pl using transpulmonary driving pressure formula (pl-pes and pl-fcvp, respectively). the pl values obtained with fcvp and pes will be compared to assess the correlation of the two methods.

Eligibility criteria:
inclusion criteria: * adult patients receiving invasive mechanical ventilation * diagnosis of acute respiratory failure (defined as the ratio of partial oxygen pressure and fraction of inspired oxygen below 200 mmhg) * esophageal balloon catheter * central venous catheter exclusion criteria: * age under 18 years old * hemodynamic instability * esophageal diseases (varices, stenosis..) * refusal of the patient * evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing chest tube....) * history of lung/abdominal surgery * pregnancy * severe coagulopathy

Keywords: esophageal pressure transpulmonary pressure central venous pressure acute respiratory failure
nighttime protein intake on overnight lipolysis and morning fat oxidation in obese men

Conditions: Obesity

Summary: single macronutrients will be consumed before sleep by obese men. overnight lipolysis will be measured with the microdialysis technique by measuring glycerol concentration and blood flow in abdominal adipose tissue. morning fat oxidation will be measured with indirect calorimetry. the investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis rate compared to casein protein and a non-caloric placebo. the investigators also hypothesize that casein and placebo will not be significantly different from each other in terms of overnight lipolysis.


Eligibility criteria:
inclusion criteria: * healthy, sedentary overweight or obese (bmi ≥25 kg/m\^2; body fat ≥ 25% ) men exclusion criteria: * men that have been exercising for more than 2 days per week for more than 45 minutes per session (within the past 6 months), have uncontrolled hypertension (blood pressure (bp)\>160/100 mmhg, diagnosed cardiovascular disease, stroke, diabetes, thyroid or kidney dysfunction, take cholesterol medication, or have any allergies to milk products will be excluded. smokers will also be excluded.

Keywords: nighttime eating protein obesity lipolysis metabolism
evaluation of antibody persistence following 4 menacwy vaccinations

Conditions: Infections, Meningococcal

Summary: this is phase iv, open label, multicenter study. subject's parents and/or legal guardian will be provided information about the trial. if interested and if eligible, they will then be asked to provide signed informed consent. the initial study visit can occur immediately after signed informed consent has been obtained. approximately 135 subjects will be enrolled to receive 4 doses of intramuscular menacwy vaccine at 2, 4, 6 and 12 months of age.


Eligibility criteria:
inclusion criteria: 1. healthy male and female 2 month-old infants (55 - 89 days) on the day of consent. 2. infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. infants whose parents or legal guardians can comply with study procedures including follow-up exclusion criteria: 1. previously received any meningococcal a, c, w and y vaccines. 2. previous confirmed or suspected disease caused by n. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed n. meningitidis infection at any time since birth. 3. progressive, unstable or uncontrolled clinical conditions. 4. a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy. 5. experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°c \[100.4°f\]) within the previous 3 days. 6. any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 7. received treatment with systemic administration corticosteroids (po/iv/im) for more than 14 consecutive days from birth 8. ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including hepatitis b immune globulin) at any time since birth and for the full length of the study. 9. any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw. 10. any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 11. received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study. 12. received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops). 13. relatives of site research staff working on this study.
brief multifamily psychoeducation for families of patients with chronic major depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning.

major depressive disorder (mdd) is a long-lasting illness with significant effects on the patient's family, social life, and work life. treatment failure results in a low recovery rate and frequent relapses. relatives of patients with mdd are fraught with heavy psychosocial burden and show increased rates of depression and anxiety. among relatives of patients with mdd, the patient's behavior and mood disturbance and relative's emotional distress were associated with the relatives' burden. family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. this intervention has been shown to reduce the rates of relapse and hospitalization among individuals with psychotic disorders and is recognized as an evidenced-based treatment for psychotic disorder. several randomized controlled trials have found that family psychoeducation is effective in enhancing the course of bipolar disorder. however, there are few studies on psychoeducation of families of patients with mdd. the purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning, in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: 1. meets the criteria for major depressive disorder (mdd) according to dsm-iv. 2. receives antidepressant therapy. 3. the patient had the first episode of mdd more than one year ago. 4. currently fulfills the diagnostic threshold for major depressive episode or partial remission. 5. the patient and their family member(s) are aged between 18 and 85 years. 6. the patient has lived with his/her family at the time of participating in this study and is expected to live with his/her family during the investigation period. exclusion criteria: 1. patients who undergo electroconvulsive therapy (ect) during the investigation period. 2. patients who are at serious suicidal risk.

Keywords: family psychoeducation major depressive disorder family burden
use of arterio-venous fistula as first choice for intravenous drug administration in kidney transplant recipients

Conditions: Evaluate the Risks of Using Arteriovenous Fistula as First Choise for Drug Administration

Summary: use of arteriovenous fistula for iv drug administration is controversial and often prohibited by nephrologists. however, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future. the aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.


Eligibility criteria:
inclusion criteria: * age \> 18 years, functional av fistula, new kidney transplant recipient exclusion criteria: * prothetic av fistula, very recent av fistula of less than 3 months