cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion Criteria:

* Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
* Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects.

In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.

The intervention will be carried out for 4 weeks, with 1 weekly session of 10 minutes duration. The patient will go to the intervention room where the treatment procedure will be explained in detail. He will be explained verbally and with a visual demonstration of what the technique consists of and how it is going to be performed, the position that he has to adopt during and how long the intervention will last.

The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.

The patient will be asked to focus on their own breathing and the contact that the therapist will apply.

In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy people
* no spinal pathology
* no respiratory pathology

Exclusion Criteria:

* have suffered spinal pathologies in the last 3 months
* have suffered respiratory diseases in the last 3 months
Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training

The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist, Escape (SERE) school at Camp Lejeune, North Carolina.

SERE school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in Warfighters. Our laboratory has recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which probably included lean body mass. The effects of severe operational stress induced by SERE, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. Under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. Further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated.

Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial. Using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of SERE and the efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will be assessed.

We hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress.


Eligibility Criteria:
Inclusion Criteria:

* US Marines at least 18 years old, enrolled in US Marine SERE school

Exclusion Criteria:

* Self-reported allergies to dairy products
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus

The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
2. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
3. Ostial lesions;
4. Bifurcations;
5. Target vessel diameter of both lesions must be \>=2.25mm and \<=3.0mm in diameter (visual estimate);
6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
7. Target lesion stenosis for both lesions is \>50% and \<100% (visual estimate).

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald A I-II-III;
3. Any of the lesions is an unprotected left main coronary disease with \>=50% stenosis;
4. Angiographic evidence of thrombus within target lesion;
5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
6. Documented left ventricular ejection fraction \<=25%;

8. Totally occluded vessel (TIMI 0 level) (applies to both lesions);

9. Prior stent within 10mm of target lesion (applies to both lesions).
Evaluation of Dentists Burnout in Turkey

The aim of this study is to determine the level of burnout in Turkish dentists. The Copenhagen Burnout Inventory of 19 questions will be used to assess burnout; and 4 more about; gender, occupational age, institution and title. All surveys will be conducted online and we plan to reach approximately 400 participants. After the burnout levels are determined, it will be statistically investigated whether there is a difference between the groups according to gender, occupational age, institution and title.


Eligibility Criteria:
Inclusion Criteria:

* Being a dentist who is still working
* Accepted electronically to participate in our study
* Completed and submitted our electronic questionnaires successfully

Exclusion Criteria:

* Did not answer all questions of survey
12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder

The overarching goal of this project is to evaluate the longer-term effects of implementing DBT for adolescents with BD in a subspecialty clinic. In collaboration with the University of Pittsburgh and continuing from the parent study (042-2018), this study will measure the longer-term effects of DBT in additional the the longer-term effects of DBT training on study therapist knowledge and performance.

This is an extension study related to an ongoing implementation study of dialectical behavior therapy (DBT) for adolescents with bipolar disorder, in collaboration with investigators at the University of Pittsburgh. During the conduct of that initial study (the DITO study; REB PIN 042-2018), compelling questions have been raised by the investigators, study therapists, and participants/patients about what will happen following participation in the initial study: Which DBT outcomes are sustained over time? Will patients request and/or require additional booster sessions? Will study therapists remain adherent to the treatment model? There is sparse knowledge regarding what happens after a course of DBT is completed, and this study seeks to advance our understanding of what happens in the year after DBT by addressing these questions. This study provides a unique opportunity to examine the frequency, dose, and indications for ongoing DBT treatment for participants who have completed one year of DBT at the Centre for Youth Bipolar Disorder (CYBD). In the spirit of the original dissemination and implementation study, this study is focused on "real-world" issues routinely faced by study therapists and patients, and anticipated findings will inform future randomized controlled trials on this topic.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 14 years, 0 months to 21 years, 11 months
* Meet diagnostic criteria for BD by KSADS-PL
* Followed by a CAMH or Sunnybrook psychiatrist who provides ongoing care
* If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium
* Has completed participation in the DITO study (REB PIN 042-2018)
* Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

* Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
* A life-threatening medical condition requiring immediate treatment
* Current victim of sexual or physical abuse.
Nosocomial Influenza Surveillance of 2022 - 2027 Seasonal Period

Hospital-Acquired Influenza (HAI) is closely linked to the intensity of influenza in the community. HAI is associated with significant morbidity, mortality and extra costs due to prolonged hospital stay. The incidence of laboratory confirmed HAI has been reported rarely. The proportion of HAI among influenza cases was 11.38% (95% Confidence Interval: 5.19%-19.55%) in a meta-analysis of 14 studies. In France, a prospective surveillance study of adults with Influenza-Like Illness (ILI) over 11 years, reported that 35.6% of the influenza cases diagnosed at hospital were hospital-acquired.

HAI is transmitted via respiratory droplets and by hand contacts. The spread is facilitated by Health Care Professionals (HCPs), patients and visitors.

Prevention and control of HAI is of upmost importance to preserve patient safety and limit the related economic costs. While vaccination of HCPs has been shown to contribute to the reduction of HAI, less is known on the impact of patient vaccination on the risk of HAI during hospitalization.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital.


Eligibility Criteria:
Inclusion Criteria:

* Any volunteer adult patient (≥ 18 years of age) hospitalized for at least 24 hours on a study unit, who had a nasopharyngeal swab taken as part of care for the purpose of diagnosing influenza by PCR testing and who had an influenza-like illness meeting the following definition:
* Fever greater than 37.8°C in the absence of antipyretics; And/or
* Cough or pharyngeal pain.

Exclusion Criteria:

* Any person who does not meet the above definition or who has expressed opposition.
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.

Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Women of childbearing potential must be willing to consistently use a highly effective method of birth control

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Any previous HBV infection
* Previous vaccination (1 or more doses) with any HBV vaccine
* Any previous autoimmune diseases
* Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
* Received any blood products or antibodies within 3 months prior to study entry
* Ever received an injection with DNA plasmids or oligonucleotides
* Received any vaccines within 4 weeks prior to study entry
* Received any other investigational medicinal agent within 4 weeks prior to study entry
Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma

Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.

In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.


Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis of classical HL
* Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
* Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
* Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
* Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.

Exclusion Criteria:

- radiotherapy in the treatment after anti-PD1
Evaluation of Touch Massage on Anxiety in Critically Ill Patients

Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age≥18 years) hospitalized in Intensive Care Unit \> 24 h
* Requiring mechanical ventilation or not
* Securité Sociale affiliated
* Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back)
* No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment

Exclusion Criteria:

* Pregnant
* Legal guardianship
* Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,
* Patient with upper limbs neuromuscular disorders
* Cutaneous lesion (zone of touch massage)
* Temperature ≥ 38,5°C
* A positive score of CAM ICU scale
* Patient refuse to participate
Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study

This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively.


Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old
* Proficient in Chinese
* Not dyslexic
* Scoring at least 5 on the PHQ-9 or GAD-7
* Not having a serious physical or diagnosed mental illness

Exclusion Criteria:

* Unwilling to continue to participate in the study
* Insufficient clocking in
The Microcirculation in Acute Myocardial Infarction (Micro-AMI)

This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Cardiac symptoms of \> 20 mins chest pain or equivalent.
* ECG criteria consistent with STEMI (STEMI)
* Proceeding with percutaneous angioplasty
* Assent/ consent to the study

Exclusion Criteria:

* Known allergy to adenosine or gadolinium
* Chronic atrial fibrillation
* Renal impairment with eGFR \<30
* Contraindication to angiography
* Contraindication to CMR (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
* Cardiogenic shock
* Patients with special communication needs or altered consciousness.
* Patients who do not give assent/consent to the study
Dose-Response of Adenosine for Perioperative Pain

Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Female gender; age 18 to 65 years;
* American Society of Anesthesiology (ASA) physical classification I to III;
* scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;

Exclusion Criteria:

* ASA physical classification of IV or V;
* documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);
* history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;
* history of gout;
Cohort Study on People Who Inject Drugs in Senegal

The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar, Senegal.

THE UNODC estimated the number of consumers of injectable drugs at 1,02 millions in 2012 in Africa among which 12,1 % lived with HIV. Prevalences of HIV, chronic hepatitis C and B among people who inject drugs remain little documented in Sub-Saharan Africa. The transmission of HCV in Africa is mainly hospital-borne, bound to a precarious transfusional and therapeutic safety. However, the transmission by intravenous drug use emerges as a new stake in public health in urban areas. The report of a strong HIV prevalence in the population of PWID in the sub-region ( for example, In 2007, in the Cape Verde, prevalence of the HIV was 14 % in emprisoned PWID against 0,8 % in the general population) contributed to assert the reality of the use of intravenous drugs in the region and the vulnerability of this population. Senegal, a country with an concentrated HIV epidemic \[0,5 % prevalence in 2012, WHO source\] is the first country of western Africa to have measured prevalence of HIV (5,2 %), HBV (7,9 %) and HCV (23,3 %) in PWID (Study ANRS 12243). In view of these results, the Senegalese authorities introduced from October, 2011 in Dakar, activities of harm reduction by means of a mobile team of social workers and mediators allowing individual and collective activities of prevention, needle exchange program, references for care and follow-up, as well as a opioid substitution program in a methadone center (CEPIAD) located in Dakar, first of its kind in Western Africa. The objective of the present research project thus is to estimate the impact of a strategy of " test and treat " of HIV and harm reduction initiatives on the prevalence and incidence of HIV, HBV and HCV infections in an population of injectable drug consumers followed in the methadone center ( CEPIAD) of Dakar, Senegal

Eligibility Criteria:
Inclusion Criteria:

* being aged greater than or equal to 18 years or emancipated minor,
* Being or have been an injecting drug user and followed at the CEPIAD (methadone program)
* Living in the Dakar region for at least three months,
* Consenting to the study after individual information.

Exclusion Criteria:

* Mental impairment making it difficult or impossible to consent to the study.