cyrilzakka/clinical-trials huggingface dataset:
Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2

Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. The purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.

Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. This suggests that schizophrenic individuals may absorb higher doses of nicotine. The purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders.

This observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. Upon completing baseline assessments, participants will smoke a single cigarette. Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. An expired carbon monoxide reading will also be measured. This measurement correlates with the amount of smoke inhalation. Individual participant studies will be completed in 1 to 2 hour-long sessions.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder
* Stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder

Exclusion Criteria:

* At serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry
* Current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)
Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner.

The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this.

The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure.

\*\*Update August 2009\*\* Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.


Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 16 involved in blunt trauma.
* Patient is to undergo a CT of the head to evaluate suspected closed head injury
* Consent and ultrasound can be preformed within 1 hour before or after CT of the head

Exclusion Criteria:

* Penetrating trauma to the head or significant ocular trauma
* Patients not expected to survive transfer out of the emergency room department
* Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve
Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty

Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).

The investigators conducted a prospective randomized controlled study in 165 patients American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in 3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120 mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal anesthesia.

All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with intravenous (IV) Perfalgan and morphine on demand for the following 48 h.

The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS \> 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* weight (kilos) over 40 kg
* height (centimeters) over 155 cm
* non-anemic
* indication for primary TKA (total knee arthroplasty)

Exclusion Criteria:

* history of asthma
* peptic ulcer
* severe hepatic or renal dysfunction
* neuropathies
* bleeding disorders
* uncooperative
* drug abuse
* sensibility to etoricoxib
* paracetamol or morphine
* long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days preoperative
* cerebrovascular and peripheric vascular disease
* arterial hypertension (HTA) not adequately controlled
* congestive heart failure.
Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres

Retrospective secondary data collection observational chart review study. Data collection and analysis will be performed on a cohort of patients who have previously been enrolled on the BPAP. Approximately 300 patients taking part in the BPAP between April 2018 and November 2019 and who meet the eligibility criteria will be recruited to participate in the study.

Data for each participant in the study will be obtained retrospectively with a focus on obtaining data at baseline (12 months prior to first benralizumab dose or at first assessment in the severe asthma center if \<12 months), Index date (date of first benralizumab dose) and at least up to 24 months after index date.

Primary Objectives

* To describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients enrolled in the BPAP
* To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation

Secondary Objectives:

* To describe clinical outcomes after initiation of benralizumab therapy in severe eosinophilic asthma patients treated with benralizumab at 12 and 24 months
* To describe patients' adherence to benralizumab, persistence and discontinuation rates and reasons for discontinuation at 12 and 24 months


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled on the BPAP between April 2018 and November 2019
* Patients who have at least 1 benralizumab injection and with at least 3 months followup data from the time of enrolment into the BPAP
* Patients initiated on benralizumab outside of the BPAP by October 30, 2019.
* Where CRO employees conduct the data extraction, patients must be able and willing to give informed consent to participate in the study

Exclusion Criteria:

* Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
* Refusal or inability to provide informed consent where the CRO will be collecting the data
Cohort Primary Hyperparathyroidism

CoHPT is a prospective, monocentric, observational cohort including all patients diagnosed with primary hyperparathyroidism in Nantes University Hospital, aiming to study the outcomes associated with parathyroidectomy. Clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. A biocollection is collected. The main hypotheses are that parathyroidectomy could improve cardiovascular, renal, bone, and cardiovascular outcomes along with quality of life.

Primaty hyperparathyroidism is the third most frequent endocrine disorder, which only curative treatment is the parathyroidectomy (approximately 8000/year). However, evidences suggest that the mildest forms of PHPT could be safely monitored with simple surveillance. However, to define surgical indications is challenging because data regarding the impach of surgery on several outcomes (namely cardiovascular, bone, renal or quality of life) are controversial.

CoHPT is a prospective, monocentric, observational cohort including all consecutive patients diagnosed with sporadic primary hyperparathyroidism in Nantes University Hospital aiming to study the outcomes associated with parathyroidectomy. Patients are followed even if surgery is not performed.

A systematic clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. These informations include demographic and general medical data, pre-operative imaging exams, post-operative outcomes, histopathological analysis, evaluation of the impact of primary hyperparathyroidism and its surgery on target organs (bone, kidney, cardiovascular) and quality of life. Fasting blood samples are also collected to constitute a biocollection, in order to measure biomarkers related to the bone remodeling and the cardiovascular risk.

The objectives are:

* To know the long-term consequences of the primary hyperparathyroidism treatment or observation.
* To better define the surgical indications
* To better understand the mechanisms of the cardiovascular impairment by using the biocollection
* To study the medico-economics consequences of the surgical management versus simple surveillance

Eligibility Criteria:
Inclusion Criteria:

• Age \> 18

Exclusion Criteria:

* Age \< 18
* Pregnancy / lactation
* Adults underguardianship
* Secondary/tertiary hyperparathyroidism
* Multiple endocrine neoplasia
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.

Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before cisatracurium pretreatments, at intubating time, and 5 min after intubation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia;
* 20 - 65 years old;
* Without acid-base imbalance and electrolyte disturbance;
* With normal hepatic and renal function.

Exclusion Criteria:

* Patients with the contraindications associated with succinylcholine or cisatracurium;
* Patients taking drugs known to alter the action of neuromuscular blockers;
* Patients with a body mass index exceeding 30
An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.

The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan, Hong-Kong and Singapore.

If participants decide to participate in this study, participants will first be asked to sign and date this consent form. If participants sign the consent form, participants will go through a baseline/ procedure process. Information about participants and participants' health will be collected and participants will have a limited physical examination.

Participants will need to have the laboratory tests (including myocardial enzyme test before and post the index procedure, pregnancy test before the index procedure) and other assessments to find out if participants meet the requirements to be in the study and to ensure it is safe for participants to have the procedure. These tests and assessments are part of routine care and may be done even if participants do not join the study. If participants have had some of them recently, they may not need to be repeated.

Participants will be expected to follow the scheduled follow-ups which occur at 30 days, 6 and 12 months, and then annually through 3 years post the index procedure for all enrolled subjects. Angiographic follow-up will perform at 9 months post index procedure for all the subjects with small vessel lesions and the first 100 consecutively enrolled subjects with ISR lesions. Enrolled subjects with the failure of advancing Agent DCB across target lesion will be followed through hospital discharge following the initial attempted index procedure.

Participants' participation in the study will be completed after approximately 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Chinese subject at least 18 years of age(or meet age requirements per local law).
* Subject (or legal guardian) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Subject who has ischemic symptoms or evidence of myocardial ischemia and is clinically indicated for PCI and will be treated with Agent DCB.
* Subject is willing to comply with all protocol-required follow-up evaluation.
* In women with childbearing potential a negative pregnancy test is mandatory.
* Subject with no known intolerance to paclitaxel and no contraindications to antiplatelet regimen.

Exclusion Criteria:

- Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" study.
Characterizing Hypoxic Apnea Intra-individual Repeatability

Apneas (breath-holds) are increasingly being tested in human subjects to understand how the human body operates. Apneas decrease heart rate and increase blood pressure. These findings are driving current research into the effects of oxygen concentrations on the heart rate and blood pressure responses to apneas and the effect of breath-hold training on these responses. The interest in apnea research is three-fold:

1. Apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body;
2. Elite divers can use findings from research to better their training and performance; and
3. The scientific understanding of apneas may translate to a better understanding of sleep apnea.

Despite this interest, little is known about the repeatability (the consistency within a single day) and reproducibility (the consistency between days) in the heart rate and blood pressure responses to apneas. This uncertainty limits the scientific interpretations from previous results. This study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas. The goals of the study are:

1. To provide greater certainty to previous results; and
2. Inform best practices for future studies.

The study requires 20 healthy volunteers (10 females) and will measure heart rate, blood pressure, breathing parameters (expired gas concentrations, breathing volume and rate), and oxygen saturation. During the protocol, participants will complete two maximal voluntary apneas and five test apneas. The test apneas will all be the same length based on the longer of the two maximal voluntary apneas. Before each apnea, participants will also breathe low oxygen concentrations (hypoxia). Hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas (i.e., bigger signal-to-noise ratio). Participants will complete two identical test sessions on back-to-back days. The differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility. The investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18-70

Exclusion Criteria:

* Having known cardiovascular or nervous system disease
* Low or high blood pressure (\< 90/60 or \>139/85, respectively)
* Taking any prescribed medications (other than oral contraceptives) that may affect cardiovascular system function
* Females who may be pregnant (self-reported)
* Involved in other studies
Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)

AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.

1. To study which variable or variables (various clinical biological indicators) affect the prognosis of ischemic stroke patients;
2. To study the differences in variables (various clinical evaluations, biological indicators, etc.) among patients receiving different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
3. To study hemoglobin, mean erythrocyte volume, white blood cell count, neutrophil count, lymphocyte count, monocyte count, IL-2, IL-4, IL-6, IL-10, IFNγ, TNFα, C-reactive protein, serum iron and iron-related proteins (ferritin, transferrin, fibromodulin, ceruloplasmin), uric acid, amino acid, lipoprotein, homocysteine, vitamin D and other clinical indicators that correlated with acute ischemic stroke patients and different treatment groups were compared;
4. To study the relationship between blood pressure changes at multiple time points from admission to discharge and clinical manifestations and prognosis of stroke patients, and to make comparison between groups;
5. To study the relationship between ischemic stroke and other variables (clinical assessment, biological, genetic and neuroimaging) in different pathological types;
6. To study the correlation between neuroimaging indicators and clinical evaluation, biomolecular, genetic and other variables;
7. DNA and RNA were extracted from peripheral blood samples of patients with acute stroke for genetic related studies to explore the genetic susceptibility of young stroke and unexplained stroke;
8. To study the role of one-stop multimodal-MRI in the assessment and diagnosis of patients with acute ischemic stroke;
9. To study the adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
10. To study the effect of Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) on inflammation and the prognosis in ischemic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed informed consent.

Exclusion Criteria:

* A) patients with incomplete clinical information; B) hospitalization observation time less than 24 hours; C) recent trauma, severe inflammation, severe liver and kidney dysfunction, progressive malignance and other serious diseases; D) baseline mRS score\>2; E) informed consent is not signed.
The Influence of Tramadol on Opioid-induced Bowel Dysfunction

Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (assessed by a study-affiliated medical doctor.)
* Signed informed consent.
* Able to read and understand Danish.
* Male (to avoid influence of menstrual cycles)
* Northern European descent (to minimize genetic variance influences on drug metabolism).
* The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
* Opioid naïve\* (who have not taken prescription opioid for one week or longer and at least a year have passed since completion of a previous opioid study.)
* Between 20 and 40 years of age.
* A State Trait Anxiety Inventory (STAI) score in the range of 20-37 i.e., classified as "no or low anxiety" at inclusion.

Exclusion Criteria:

* Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
* Less than three spontaneous bowel movements per week.
* Participation in other studies within 14 days prior to first visit.
* Expected need of medical/surgical treatment during the study.
* Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn's, ulcerative colitis, and toxic mega colon).
* History of substance abuse (alcohol, tetrahydrocannabinol (THC), benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start). ¹
* History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.) ²
* Metal implants or pacemaker.
* Daily use of prescription only medicine
* Daily alcohol consumption
* Participation motivated by "wrongful" reasons such as poor economy, or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence.1
* Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period. If consumption takes place during the study the participant will be excluded.
* Use of any analgesic medication within 48 hours before start as well as for the duration of the study. If consumption takes place during the study the participant will be excluded.
* Nicotine use