Kornimate/medical-research-clean huggingface dataset:
revive: reducing exsanguination via in-vivo expandable foam

Conditions: Hemorrhagic Shock; Trauma; Exsanguinating Hemorrhage; Shock; Traumatic

Summary: the purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of resqfoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.


Eligibility criteria:
inclusion criteria: 1. estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown) 2. emergent, exsanguinating hemorrhage, from abdominal source as defined by: * class iii or iv hemorrhagic shock or * assessment of blood consumption (abc) score ≥ 2 3. confirmation of abdominal hemorrhage by: * direct visualization or * positive focused assessment with sonography in trauma (fast) or * diagnostic peritoneal aspiration (dpa) 4. no other known, uncontrolled active sources of hemorrhage 5. subject is intubated and sedated per local guidelines 6. decision to administer foam is made within 30 minutes of admission to the emergency department. 7. decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department. 8. definitive surgical care is expected to occur within three hours of foam deployment 9. subject must also be receiving concurrent transfusion of fluids or blood products. exclusion criteria: 10. known or suspected major diaphragm injury 11. known or suspected untreated pneumothorax 12. known or suspected untreated hemothorax 13. known or suspected blunt or penetrating cardiac or thoracic aortic trauma 14. traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam 15. received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting 16. patients with pulseless electrical activity 17. known allergy to isocyanate 18. known or suspected pregnancy 19. history of prior abdominal surgery or evidence of abdominal surgery (scars) 20. disrupted abdominal wall that, in the opinion of the investigator would preclude resqfoam from being adequately contained within the abdominal cavity 21. subject in whom the abdominal aortic junctional tourniquet (aajt) or resuscitative endovascular balloon occlusion of the aorta (reboa) techniques have been used 22. known prisoners 23. subjects with burns \> 20% of total body surface area 24. subject/legally authorized representative/subject family member purposefully opted out of participation in the study 25. known do not resuscitate order (dnr) or physician orders for life sustaining treatment (polst) 26. known enrollment in another randomized, interventional study
ltfu study of subjects who received grnopc1

Conditions: Spinal Cord Injuries

Summary: this is a ltfu study for thoracic sci subjects that were administered grnopc1 cells in the main study cp35a007.

study cp35a008 is a phase 1, multi-center long term follow-up (ltfu) study for five (5) subjects with complete thoracic sci that were administered 2 million grnopc1 cells in the main study cp35a007. the purpose of this study is to monitor long-term safety in subjects for 15 years post grnopc1 administration.

Eligibility criteria:
inclusion criteria: * subjects who received administration of grnopc1 under clinical study protocol cp35a007. exclusion criteria: * there are no exclusion criteria for this ltfu study.
effects of chocolate on motor symptoms of parkinson's disease

Conditions: Parkinson's Disease

Summary: chocolate consumption has long been associated with enjoyment and pleasure. popular claims confer on chocolate the properties of being a stimulant, relaxant, euphoriant and antidepressant. these possible pharmacological actions might be related to various biogenic amines, such as serotonin, dopamine, tyramine, histamine, phenylethylamine and cannabinoid-like substances. most amines are metabolized by monoamineoxidase-a (mao-a) and are therefore unable to pass the blood-brain-barrier. in contrast, phenylethylamine is a direct dopamine releasing ingredient and as a substrate of mao-b and due to its lipophilic structure even capable to pass the blood-brain-barrier. within this line, own clinical observations suggested an increased chocolate consumption in patients with parkinson's disease (pd) compared to healthy subjects and to their pre-disease state. in a previous study, we assessed the consumption of chocolate and non-chocolate sweets in pd patients and their partners (as household controls) using a self-questionnaire. consumption of chocolate was significantly higher in pd patients compared to controls, while consumption of non-chocolate sweets was similar in both groups. our study suggests that chocolate consumption is increased in pd independent of concomitant depressive symptoms measured by bdi-1. although reasons for increased chocolate consumption in pd remain elusive, it may hypothetically be a consequence of the high content of various biogenic amines as a content of cocoa influencing dopamine metabolism. therefore, in the present study we aim to study the effects of dark chocolate with high cocoa content (85%) compared to chocolate without any cocoa (white chocolate) on motor symptoms in pd patients as measured with updrs part iii (motor score). the principle design of the intervention is similar to the standard pharmacological challenge test for studying effects on motor symptoms in pd (e.g. levodopa challenge test).


Eligibility criteria:
inclusion criteria: * age of 18 years or older * idiopathic parkinson's disease, according to ukbb criteria * hoehn \& yahr score ii-iii * 16 points or more in updrs part iii scale * sufficient ability to follow the study procedure for at least 3 hours * ability to give informed consent * stable antiparkinsonian medication for at least 4 weeks prior to study inclusion exclusion criteria: * psychiatric conditions, severe enough to interfere with study procedures * motor or affective fluctuations or dyskinesias * treatment with comt and/or mao inhibitors * diabetes mellitus

Keywords: parkinson's disease neurodegenerative disorders biogenic amines chocolate cocoa
laboratory studies into the pathology of leukaemia

Conditions: Leukemia

Summary: ongoing laboratory work into the pathology of leukaemia:

the investigators will test aml samples sent to the diagnostic laboratory from participants with newly diagnosed or relapsed/refractory aml. samples will be sent from district general hospitals and teaching hospitals. results will be returned to referring clinicians in the same way investigators currently return results for samples sent for standard tests. the service will be advertised through the royal marsden website with visibility to both participants and hcps). the investigators will also inform all the clinicians involved in the aml working party (dr taussig is a member of the aml working group). in addition we are looking at diagnostic approaches to idh 1 and 2 mutation identification. an initial comparison of 50 samples by three analysis methods will be conducted. idh1 and idh2 variant discovery will first be performed using an established standard in house sop (sop: smd103) for ce-ssca

Eligibility criteria:
inclusion criteria: 18 \& over diagnosis of aml generic research consent given exclusion criteria: under 18 no generic research consent
effect of the aquaretic tolvaptan on nitric oxide system (tora)

Conditions: Cardiovascular Diseases; Nephropathy

Summary: the purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (pwv) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.

tolvaptan is a vasopressin antagonist (v2-antagonist) and is used in treatment of hyponatremia. animal studies have demonstrated that inhibition of v2 receptors in the renal principal cell increases renal free water clearance and renal sodium excretion. treatment with v2-receptor antagonists increases vasopressin concentration in plasma that stimulates v1-receptors in the vascular bed. this may change both central and peripheral hemodynamics and plasma concentration of vasoactive hormones. changes in hemodynamics and hormone concentration may consequently change renal sodium and water handling. the nitric oxide system plays a central role in both renal sodium and water handling and regulation of vascular tone and blood pressure. the effects of tolvaptan the circulation and kidneys is investigated by using measurements of biomarkers specific for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of tolvaptan and l-nmma infusion.

Eligibility criteria:
inclusion criteria: * men and women, age 18-40 years * body mass index (bmi) 18,5-30 kg/m2 exclusion criteria: * anamnestic or clinical signs of heart, lung, lever, kidney and brain disease * neoplastic disease * drug abuse * alcohol abuse * medical treatment except peroral anticontraceptive * pregnancy * smoking * abnormal blood and urine sample * abnormal ecg * blood donation within a month before examination * arterial hypertension (\>140 mmhg systolic and/or 90 mmhg diastolic)

Keywords: tolvaptan l-nmma healthy subjects nephrology cardiology
observational study conducted on patients receiving the esop 2 stem to confirm security and performance of the device

Conditions: Hip Disease; Hip Fractures

Summary: this study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the esop 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

the primary objective of this study is to evaluate the security of the esop 2 stem by calculating the survival rate up to 10 years of follow-up. the secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.

Eligibility criteria:
inclusion criteria: * subject implanted with esop 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture * subject who received an information form and is willing to participate in the study exclusion criteria: * contraindications described in the instructions for use * usual surgical contraindications * subject who is not able to express his/her non-opposition

Keywords: arthroplasty hip replacement
description of compliance with hydroxychloroquine treatment in patients with systemic lupus erythematosus

Conditions: Lupus Erythematosus

Summary: the project focuses on non-compliance in patients with systemic lupus erythematosus taking plaquenil. more than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them. the investigators want to use an already validated existing questionnaire in english, the morisky medication adherence scale 8 (mmas 8). these results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.


Eligibility criteria:
inclusion criteria: age \>18 years * patient with systemic lupus erythematosus * treatment with plaquenil for \> 6 months with dosage of hydroxychloroquinemia planned during the consultation.
a long-term observational study cohort in patients with advanced prostate cancer

Conditions: Advanced Prostate Cancer

Summary: the purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (adt) induction in a study cohort of patients with advanced disease.


Eligibility criteria:
inclusion criteria: * have participated and received study treatment in the triptocare study * be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent exclusion criteria: * absence of written informed consent from the patient
a study of pf-05175157 in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of pf-05175157 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 years (inclusive). * healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ecg and clinical laboratory tests. * in addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination. * body mass index (bmi) of 17.5 to 29.5 kg/m2; and a total body weight \> 50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies). * evidence or history of any chronic ongoing or current pulmonary disease. * history of smoking in the past 5 years or history or evidence of habitual use of other (non-smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day 0. * active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease. * evidence or history of 'dry eye-syndrome', meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.

Keywords: single ascending dose phase 1 safety and tolerability pk healthy subjects
pro-omega-3, reduction of inflammation and modulation of prematurity

Conditions: PPROM

Summary: the aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery. the main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with mag-dha or with the placebo.

this randomized controlled trial will be conducted in two hospitals in the province of quebec (chus, chuq- site mère-enfant soleil). patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes (pprom) who meet all inclusion and none of the exclusion criteria will be approached to participate. once they have signed the ifc, participants will be randomized and begin a supplementation with either mag-dha or the placebo until delivery or for up to 2 weeks (14 days). a total of 70 patients will be recruited. principal outcome: to compare the difference in duration between the start of treatment and delivery between the group receiving mag-dha and the group receiving placebo. secondary outcomes: 1) evaluate the difference in neonatal outcome between children in the mag-dha group and those in the placebo group. 2) determine the inflammatory status of the patients associated with the exposure to either mag-dha or the placebo. this regimen could potentially represent an innovative approach in the management of women with a diagnosis of pprom.

Eligibility criteria:
inclusion criteria: * pprom diagnosis, gestational age between 24 and 33 weeks of gestation. exclusion criteria: * multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations

Keywords: pro-omega-3 inflammation prematurity
combined systemic inflammatory indices and birth weight

Conditions: Systemic Inflammation Markers; Birth Weight; Combined Systemic Inflammatory Indices

Summary: the study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight

the research was structured as a prospective observational study. it was conducted at a second-level university hospital over the period from december 2019 to february 2021. participants: blood samples were collected at hospital admission. these samples were used for a complete blood count, focusing specifically on deriving systemic inflammatory indices. the primary inflammatory indices studied were neutrophil-to-lymphocyte ratio (nlr), platelet-to-lymphocyte ratio (plr), and monocyte-to-lymphocyte ratio (mlr). the birth weight was registered.

Eligibility criteria:
inclusion criteria: * physiological full-term pregnancies exclusion criteria: * gestational diabetes * pregestational diabetes * chronic hypertension * gestational hypertension * preeclampsia * eclampsia * intrauterine fetal growth restriction * preterm delivery * multiple pregnancies * fetal malformations
middle school matters study

Conditions: Depression

Summary: this study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.

this study involve two parts: part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (part 2). an "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, individual support program (isp) comparison group or a skills group program. research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. following completion of the intervention, all participants were followed for 12-months.

Eligibility criteria:
inclusion criteria: * 7th and 8th grade students at 4 participating middle schools * score 14 or above on the mood and feelings questionnaire at screening (approximately top 25%) * no imminent plans to move or change to non-participating school * at minimum 6th grade language skills * agree to participate in random assignment and research interviews * one parent/caregiver willing to complete research interviews exclusion criteria: * student with past or current major depressive disorder (mdd) or probable mdd * students with parents who do not speak english or spanish * students in concurrent treatment * students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member * parent not willing to complete research interviews

Keywords: depressive symptoms depression prevention adolescents school-based services health behavior
study 102: multiple ascending dose study of alln-346 (engineered urate oxidase)

Conditions: Hyperuricemia; Gout

Summary: the purpose of this phase i study is to evaluate the safety and tolerability of alln-346 in in normal healthy volunteers, in an ascending dose design. alln-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

this is a phase i, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered alln-346 in normal healthy volunteers. study will take place at a clinical pharmacology unit (cpu). two sequential cohorts will be dosed and followed for safety through day 28. the study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of alln-346.

Eligibility criteria:
inclusion criteria: * male or female, age 18 to 55 years * incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation * good general health as determined by medical history and physical examination * normal clinical laboratory test results and ecg exclusion criteria: * presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia * any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines * positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse, or positive covid-19 test * clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ecg) * positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) antibody * received treatment with or exposure to an investigational drug or device within 30 days prior to or during screening * prior dosing in alln-346 clinical study * per investigator judgment, is not an ideal clinical study candidate
safe and easy access technique for the first trocar in laparoscopic obesity surgery

Conditions: Obesity, Morbid

Summary: laparoscopic surgery has become very popular and standard in many indications after advancements of technique. various methods have been used in first entry to the abdomen. safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. there is no consensus yet on an optimal method has yet emerged. the investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen. to evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery. two methods are commonly used in surgical literature and in our center. the investigators have been used visible optical-entry technique in some patients for first entry and veress technique in some other patients. for this purpose, the investigators designed an observational study.

several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. these methods include the standard technique of insufflation after insertion of the veress needle, the open (hasson technique), the direct trocar insertion and optical trocar insertion. furthermore, it is more difficult to perform in the obese patient, especially if the first trocar is not umbilical, like obesity surgery. this is because obese patients have a very thick abdominal wall (particularly in women) as well as a thick peritoneum. very different complications, some even potentially fatal, i.e., injury to viscera or to major intra-abdominal and abdominal wall vessels, have been reported in surgical literature. complications of first entry develop in up to 1-2% of patients and more than half of all are fatal complications. major vascular and abdominal organ injury rates of 0.03-0.1% and 0.08-0.14%, respectively, have been reported. surprisingly, there has been little change in entry techniques since the dawn of laparoscopic surgery. some risk factors are defined for prediction of complications, such as obesity. laparoscopic obesity surgery has become very attractive and gaining popularity, recently, and however it possess many complications and challenges such as (it starts with) entry to the abdomen.

Eligibility criteria:
inclusion criteria: * patients with body mass index of \>40 exclusion criteria: * patients who have skin disease at operation area

Keywords: obesity, morbid