cyrilzakka/clinical-trials huggingface dataset:
The Study of Warfarin Maintenance Dose in Chinese Patients

1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
2. Drug: Warfarin
3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
4. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.

* For the patients who need to use warfarin, detect the "Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype.
* Record the demographic information: gender, age, height, and weight.
* Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
* Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.

Eligibility Criteria:
Inclusion Criteria:

* Chinese patients
* Age \>18y
* target INR 1.5\~3.0
* Patients signed informed consent

Exclusion Criteria:

* Has hemorrhage disease, or tendency to significant bleeding
* Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease
* patients with pregnancy or lactation;
* with cognitive impairment.
Postoperative Neurocognitive Disorders

The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.

The investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)). This study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with MD measures and blood biomarkers.

On the day of surgery, standard of care procedures will take place. Hemodynamic vitals will be continuously monitored. As per the latest guidelines and recommendations from the American Society of Anesthesiologists (ASA), mean arterial pressure (MAP) will be targeted to \> 60 mmHg or within 20% of baseline values, and processed EEG-guided anesthesia will be monitored to maintain a patient state index between 20-50. Electronic medical records and intraoperative integrated physiologic waveform will be collected.

In summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (POD) and acute and long-lasting neurocognitive deficits in an at-risk population (OSA).

Eligibility Criteria:
Inclusion Criteria:

Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index \[AHI\]\>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures
Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

The purposes of this study are to evaluate the acceptance of the subcutaneous drug teriparatide over 6 months of therapy in patients with severe osteoporosis in Canada, and to evaluate how often such patients are actually able to use the injection; to obtain additional safety data (side effect data) that will supplement the existing database of adverse events that have been reported to-date in clinical trials by patients treated with teriparatide; to document the prior use of other osteoporosis therapies in this patient population, and ongoing use of other osteoporosis therapies during the study; and to describe the baseline demographics and disease state of these severely osteoporotic patients.The purposes of the study extension are to continue to assess the acceptance of the subcutaneous drug teriparatide over up to 18 months of therapy in patients with severe osteoporosis in Canada, and to continue to assess how often such patients are actually able to use the injection; to obtain additional safety data (side effects) that will supplement the existing database of adverse events that have been reported to date in clinical trials by patients treated with teriparatide.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman OR a man at least 30 years of age (who no longer have bone growth)
* In the opinion of the investigator:

  * The patient must have severe osteoporosis (defined as a low bone mass AND a fracture related to osteoporosis), and be at high risk for fracture despite currently available therapies
  * Patients should have failed or been shown to be intolerant to currently commercially available osteoporosis therapies. (Failure of therapy: fracture, or significant loss of bone mass)
  * There should be no other medical causes of the osteoporosis (called idiopathic osteoporosis) except for low estrogen (in women) or low testosterone (in men)
* In the opinion of the investigator, the patient can learn to use the pen type injection delivery system and will be able to use it either alone or with appropriate assistance
* Must be able to understand and sign an approved informed consent document
* Must be able to come in for follow-up visits for the duration of the study.

Exclusion Criteria:

* High blood calcium levels, high parathyroid hormone levels in the blood, high levels of a blood test called alkaline phosphatase that haven't been explained yet.
* Known or suspected bone diseases other than osteoporosis
* Any medical condition that might increase a patient's baseline risk for bone tumors (including prior radiation to the skeleton, Paget's disease, previous bone tumors).
* Recent or currently active kidney stone, OR major problems with kidney function
* Serious ongoing medical problems incompatible with the study (as assessed by the investigator)
The Effect of Etomidate on Outcomes of Trauma Patients

Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents.

Research Hypothesis: The investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction.

Specific Aims: The specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. The investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. The investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized.

Significance: If the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. Since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.


Eligibility Criteria:
Inclusion Criteria:

* All critically ill trauma patients (defined as patients over the age of 14 years requiring trauma team activation) who present to the ED in need of ventilatory support due to the severity of their illness and injuries.

Exclusion Criteria:

* Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ED.
Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)

The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD is more effective than a credible non-specific form of CBT for treating BDD and its delusional variant in adults aged 17 or over. This will be done in a single centre randomised controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks. The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1 month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. A secondary aim is to explore whether delusionality (insight) as measured by the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* BDD is the main psychological problem. We will use DSMIV criteria as BDD does not exist as a separate diagnosis in ICD10. They may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective.
* They must have a total of 24 or more on the twelve-item YBOCS modified for BDD (Phillips et al., 1997).
* They may be of either gender but must be 17 years or above.
* They are willing to travel to the treatment centre for weekly sessions.
* They are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning.
* They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose.

Exclusion Criteria:

* They have a current or past diagnosis of schizophrenia, bipolar affective disorder.
* They have current suicidal intent or severe self-neglect that requires hospitalisation.
* They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right.
* They are currently receiving any other form of psychotherapy,
* They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond.
* They cannot speak sufficient English for CBT. (Assistance will be provided for those who speak English but are unable to read questionnaires).
Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"

The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.


Eligibility Criteria:
Inclusion Criteria:

-- Adult chronic haemodialysis patients since al least 3 months

* Two needles puncture of the fistula,
* Low molecular weight heparinization during haemodialysis sessions,
* Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min),
* Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions.
* Patients capable to understand the design of the study and to follow the instructions
* Patients having the French social security system affiliation.

Non-inclusion criteria :

* C reactive protein \> 30 mg/L.
* Single needle puncture of the fistula
* Active documented haemorrhage,
* Haemoglobin \< 10 g/dl and/or need blood transfusion,
* Documented thrombophilia
* Patients waiting for renal graft
* Acute sepsis
* Fistula or catheter dysfunction
* Patients under anti-vitamine K
* Per dialytic hypotension requiring al least once a nurse intervention,
* Severe diseases (Dysglobulinemia, vascularitis, HIV...),
* Patients following another research protocol or have ended one less then one month before starting of this study.
* Pregnant or breast feeding patients,
* Minor patients or under law-protection
Establishing the Language Network With Independent Component Analysis of Resting State MRI

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Eligibility Criteria:
Inclusion Criteria:

* Persons major and minor.
* Having given their written consent, or whose parents have given their written consent for minors.
* Affiliated with the social security system
* All patients eligible adults in awake surgery
* Affiliated with the social security system
* patient given their written consent

Exclusion Criteria

* Contraindications to MRI
* Pregnant or breastfeeding women
The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform

Since aging is a systemic (not organ-specific) phenomenon, the main objective of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and IC evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.

This is a 10-year observational study. The study will be performed in Occitania Region. Once a year, a complete data collection will be performed in the Gerontopole of Toulouse, in participants' home and health centers by the Gerontopole mobile research team, and in selected Gerontopole's collaborating centers in Occitania.

Between yearly waves of data collection, participants will have their intrinsic capacity domains monitored (with or without the help of a caregiver) each 4-month through the use of either an app developed in collaboration with World Health Organization (WHO) or a web platform; or through a phone call by a clinical/research nurse. For the first self-monitoring of IC at four months, all participants will be contacted by a research/clinical nurse by phone; this call will inform about how participants measured their capacity and/or help them to do it. After this first 4-month phone call, participants capable of correctly self-monitoring their IC through the app will no longer be systematically contacted by phone. Once IC declines are confirmed, participants will have a thorough clinical assessment and blood sampling; such information will allow us to investigate the response of markers of aging at the time declines are detected. Those needing usual care, will be followed according to WHO framework recommendations proposed for Integrated Care for Older Adults (ICOPE).

Eligibility Criteria:
Inclusion Criteria:

* Aged 30 years-old or over;
* Both sexes
* Affiliated to a social security scheme

Exclusion Criteria:

* severe disease compromising life expectancy at 5 years;
* Deprived of their liberty by administrative or judicial decision, or under guardianship
Pilot Study Testing Feasibility of Health Screening at Farm Site

Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months

The investigators will be visiting farmers at the worksite monthly for six month and perform cardiovascular risk factors screening: blood pressure, blood glucose, glycosylated hemoglobin and cholesterol.

At the end of this intervention, the investigators will test the feasibility of this approach among this specific population through questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* agricultural workers and farm owners

Exclusion Criteria:

* None
Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Several observational studies have evaluated the comparative treatment costs associated with each agent, particularly those within the anti-TNF class, but few have evaluated the impact of therapy compliance, persistence, treatment patterns on patient reported outcomes, healthcare utilization and costs, using a provider database. This study is designed to fill in this information gap.

Cohort observational

Eligibility Criteria:
Inclusion Criteria:

* Adults with moderate to severe RA who are currently using a DMARD

Exclusion Criteria:

* Psoriatic Arthritis (PsA), Psoriasis (PsO), SSystemic Lupus Erythematosus (SLE), Non-Disease modifying anti-rheumatic disease (non-DMARD) use
Clinical Study to Test a New Drug to Treat Major Depression

In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.

The primary endpoint is the change from baseline associated with GW856553 versus placebo at Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be performed throughout the study to potentially adapt the study design by changing the randomization ratio and/ or reducing the total number of subjects to be randomized into the study. Exploratory analyses will be performed by associating changes in cytokine levels and selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive clinical and biological markers.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
* Males or Females who agree to use protocol specified contraception if of child bearing potential
* BMI 18.5-35.0 kg/m2
* Normal liver function tests

Key Exclusion Criteria:

* History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
* Elevated liver function tests on \>2 ocassions in the last 7 months
* Significant medical illness, autoimmune disease or infectious disease
* Pregnant or nursing females
* Excessive and regular alcohol consumption
* History of substance abuse or dependence in past 6 months or positive urine drug screen
* Significant suicidal or homicidal risk
* Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
* Psychoactive drugs within 1 week or 5 half lives of randomization visit
* Treatment resistant subjects