cyrilzakka/clinical-trials huggingface dataset:
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia

The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.

The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (PM101) compared to placebo.

The corresponding null hypothesis is that survival to hospital discharge is identically distributed when out-of-hospital VF/VT arrest is treated with PM101 or placebo.

The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of:

1. Lidocaine compared to placebo
2. PM101 compared to lidocaine The corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital VF/VT arrest is treated with lidocaine as compared with placebo, and with PM101 as compared with lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years or local age of consent
* Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability
* VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity)
* Incessant or recurrent VF/VT after receipt of ≥ 1 shocks
* Established vascular access

Exclusion Criteria:

* Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT
* Written advance directive to not attempt resuscitation (DNAR)
* Blunt, penetrating, or burn-related injury
* Exsanguination
* Protected populations (prisoners, pregnancy, children under local age of consent)
* Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers
* Prior receipt of open label lidocaine or amiodarone during resuscitation
Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.

Primary outcome:

• 24-hour analgesic consumption.

Secondary outcomes:

* Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
* Time to first rescue analgesia and total postoperative consumption of analgesia.
* Effect of the block on Hemodynamics.
* Adverse effects in the form of postoperative nausea and vomiting (PONV).
* Patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* All patients within the age range ≥ 21 to ≤ 70 years old.
* Body mass index (BMI) ≤ 35kg m2.
* ASA I, II of both sex

Exclusion Criteria:

* Refusal of the patient to the study.
* Infection at the site of injection.
* Previous known allergy to any drug used in the study by history.
* Renal disease \[Creatinine. \>3mg/dl.\].
* Hepatic disease. \[ALT\>50U/L, AST \>50U/L\].
* Un cooperative or psychological unstable patients.
* Coagulopathy or anticoagulant therapy.
* Pregnancy.
Blood Glucose Awareness Training for Parents

The purpose of this study is to test a training program for parents of children with T1DM.

Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based,pyschobehavioral intervention, Blood Glucose Awareness Training (BGAT) that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of this project is to correct the scientific neglect of the self-regulation in pediatric diabetes by adapting the conceptual and methodological tools used in adult studies to investigate the process of diabetes regulation by school-aged children (6-11 years) with T1DM and their parents and to develop and test an intervention to enhance the skills critical to this process.

Eligibility Criteria:
Inclusion Criteria:

* Parent/Guardian with primary responsibility for a child's diabetes management
* Child with T1DM between the ages 6 - 11 years.
* Duration of child's diabetes \> 1 year
* Routine self-testing of child's BG \> 2x day
* Intention to remain in the study's geographical region for the next 5 months
* Have a computer at home

Exclusion Criteria:

* Significant comorbidity in the child that could interfere with BG awareness or psychosocial status
* Medications taken by the child that interfere with symptom perception
* Psychiatric disorder in a parent or child
* Cognitive deficits/learning disabilities in the child that might preclude ability to complete the study protocol.
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.

The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥ Age 60 years (no upper age limit)
* Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
* Able to read English (required for CGA and other surveys administered)
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Signed, IRB-approved written informed consent

Exclusion Criteria:

* Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
* Already walking or engaging in other physical activity \>120 minutes per week as documented via subject self-report
* Unable to walk or engage in moderate-intensity physical activity
* One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children 12 to 18 months of age.

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine.
* Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
* Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
* History of seizures (convulsions)
* Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
* A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F \[37.5° C\]).
Exploratory Study on Global Reflexology in Sickle Cell Disease

Sickle cell disease (or sickle cell anemia) is the most common genetic disease in France with 586 children screened in 2019. This chronic disease is characterized by the presence of abnormal Hemoglobin (Hb) S and a deformation of the red blood cells which take the elongated shape of a sickle and become more rigid and more fragile. Sickle cell disease manifests itself among other things by very painful vaso-occlusive crises (VOC) and for some chronic pain.

Their management is an emergency and often requires hospitalization. Despite analgesic treatment, some patients have persistent pain.

In 2013, a childcare assistant trained in Canadian global reflexology EMC offered reflexology sessions to 12 sickle cell patients. She observed a relief in all patients with a decrease in the pain score in 8 of them. These sessions seem to show us a double interest: the reduction of the child\&amp;#39;s pain and the emergence of a technique that can be used by paramedics in the context of their own role.

The investgators hypothesize that global reflexology is an effective and acceptable complementary technique for pain management in addition to the usual analgesic management in sickle cell children under 18 years of age in CVO. In order to verify our hypothesis, the investigators propose to explore the practice of Canadian global reflexology as an innovative therapeutic option complementary to drug treatments in the hospital management of sickle cell children.


Eligibility Criteria:
Inclusion Criteria:

* Patient under 18 years of age
* Patient suffering from sickle cell disease
* Patient hospitalized in the UHCD or USC unit of the Women\&#39;s Mother and Child Hospital of the Hospices Civils de Lyon for the management of a CVO
* Informed consent signed by at least one holder of parental authority
* Collection of the patient\&#39;s assent as soon as his age allows it.

Exclusion Criteria:

* Patient with PCA (Patient Controlled Analgesia)
* Patient with NCA (Nurse Controlled Analgesia)
* Patient not affiliated to a social security scheme or beneficiaries of a similar scheme.
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients

Primary Objective:

To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).

Secondary Objective:

A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:

* Glycaemic parameters: 7 blood glucose profiles
* Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
* Change in lipid status


Eligibility Criteria:
Inclusion criteria:

* Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
* Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
* No pre-treatment with any insulin in the last 3 months before the study.
* Glycated Haemoglobin A1c (HbA1c) value between \> or = 7.0 and \> or = 9.5%
* Fasting Blood Glucose (FBG) \> or = 120 mg/dl (6.7 mmol/l).
* Body mass index \< 40 kg/m.
* Ability to read and understand German language.
* Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
* Women of childbearing potential who will take adequate contraceptive protection.

Exclusion criteria:

* Patients with type 1 diabetes mellitus.
* Any history of ketoacidosis.
* Pregnancy.
* Prior treatment with insulin.
* Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.
* History of drug or alcohol abuse.
* Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
* Following pancreatectomy.
* Impaired hepatic function.
* Impaired renal function.
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
* Inability to attend follow-up visits.
* Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).
* Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
* Systemic corticoids \> 7,5 mg prednisolon equivalent or \<or=7,5 mg prednisolon equivalent for less than 2 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors.

Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence.

Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* For the patients :

  * Woman.
  * Aged of more than 15 years and 3 months.
  * Followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for Restrictive Anorexia Nervosa (according to the diagnostic criteria of DSM-IV-TR).
  * French language mastered.
  * Having signed the consent if major and if not the legal representatives have signed the consent (for minors).
* For the volunteers :

  * Women.
  * Aged of more than 15 years and 3 months.
  * French language mastered.
  * Having signed the consent if major and if not the legal representatives have signed the consent (for minors).

Exclusion Criteria:

* For the patients :

  * Man
  * Age under 15 years and 3 months old
  * Current Renutrition by nasogastric tube
  * Personal history of:

    * Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    * Support for current or past cognitive remediation
  * Opposition of the patient and / or his legal representatives if minor
  * Subject under legal guardianship
  * Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  * French language not mastered
* For the volunteers :

  * Man
  * Age under 15 years and 3 months old
  * Current Renutrition by nasogastric tube
  * Personal history of:

    * Eating disorders
    * Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    * Support for current or past cognitive remediation
  * Opposition of the volunteer and / or his legal representatives if minor
  * Subject under legal guardianship
  * Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  * French language not mastered
Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy

The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.


Eligibility Criteria:
Inclusion Criteria:

* HCV patients with compensated cirrhosis (Child-Pugh A)
* HCV genotype 1
* non-responders to a previous course of interferon (IFN)/ribavirin
* receiving boceprevir or telaprevir

Exclusion Criteria:

-
Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis

To evaluate the efficacy of 3 different types of cervical disc prosthesis (Prodisc-C, Mobi-C and Prestige-LP) in the treatment of cervical spondylosis.

A cohort, retrospective analysis will be performed of 150 patients who were in implementation of artificial disc replacement in our department from 2008 to 2012 and accepted a regular postoperatively follow-up up to 5 years, the sample will be divided into 3 groups according to prosthesis and 50 people in each group. The outcome will be measured among 3 groups respectively on the operation (such as operation time, intraoperative bleeding.), postoperative complications (such as prosthesis sinking, displacement and prolapse, adjacent segments degeneration and heterotopic ossification), photographic indicators and functional efficacy analysis and then a comparison for self-contrast pre- and post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Patients was diagnosed as cervical spondylosis based on imaging and symptomology;
2. patients were purely underwent TDR within the three kinds of prosthesis;
3. the range of participants is from 20-65 years;
4. conservative treatment of 6 months is invalid;
5. never had cervical operations.

Exclusion Criteria:

1. Patients suffered from cervical trauma or congenital malformations;
2. non-artificial cervical disc replacement or hybrid surgery;
3. ones who refused to be followed up.
Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry

The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.

The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalized in intensive care unit
* Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)

Exclusion Criteria:

* Pregnant women
* Minors
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
* Patient who doesn't understand French language
Correlation Between Types of Lateral Pterygoid Muscle Attachment and Internal Derangement of the Temporomandibular Joint

the study aimed to evaluate the clinical and MRI finding of TMJ AND LPM with predication of the risk factors. Study design: this retrospective study included 1365 joints in 800 patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

the study aimed to evaluate the clinical and MRI finding of TMJ with LPM with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility Criteria:
Inclusion Criteria:

- study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.

Exclusion Criteria:

* Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.