cyrilzakka/clinical-trials huggingface dataset:
One-stage Adjustable Strabismus Surgery Under AIVOC

The purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl)

Adjustable surgery is a surgical treatment technique for strabismus and oculomotor paralysis well known and widely used around the world. The adjustable surgery is done in 2 steps. The first step, performed under general anesthesia, is practically the same as "classic" strabismus surgery however one or more muscles are fixed by temporary sutures. In a second time once the patient is awake and after a new clinical examination the sutures are adjusted and definitively fixed. The adjustment is sometimes made the same day but more often the day after the first intervention because it requires a state of consciousness close to normal.

Anesthesia type Intravenous Intensity Concentration Anesthesia (AIVOC) allows the realization of a surgery under anesthesia general deep (choice of a cerebral or plasma anesthetic target suitable for surgery) but allows a programmed awakening, very fast in full consciousness, condition of an immediate reliable adjustment practically upon stopping the infusion of the anesthetic agent.

The goal is to present an adjustable surgery technique simplified from a logistical point of view since performed in a single step thanks to the contribution of Intravenous Anesthesia with Concentration Objective (AIVOC) and to show that its results are equivalent to a second deferred time.

Eligibility Criteria:
Inclusion Criteria:

* Patient with medical insurance
* Major patient requiring a strabismus surgery
* Patient who received information about study and not having expressed their opposition to participate in the study

Exclusion Criteria:

* Minor patient
* Patient participation in another interventional study
* Patient having expressed their opposition to participate in the study
* Patient for whom it is impossible to give informed information
* Patient under the protection of justice, under curatorship ou under tutorship
Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Introduction: Although inflating tracheal cuff using lidocaine is effective for cough suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during anesthesia emergence is not determined yet. Objective: the objectives of this study are to determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during extubation by sex and age group.

Ideal patient weight in kg will be considered.

Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on the incidence of emergence cough in the previous patient of the same group:

* It will increase if coughed in a probability of 95%
* It will decrease if not coughed in a probability of 5%.
* It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.

Patients groups will be determined by sex and age group (18-60 or \>60 years old), therefore, four independent groups will be studied:

* Female 18 to 60 years old
* Male 18 to 60 years old
* Female \> 60 years old
* Male \> 60 years old

Eligibility Criteria:
Inclusion Criteria:

* Understands study risks and benefits, signs informed consent.
* Not pregnant.
* Not an airway surgery
* No acute or chronic respiratory disease.
* Non smoker
* No chronic cough

Exclusion Criteria:

* Any protocol violation.
A Randomized Trial of Recruitment Strategies for Research Participation

In a multicenter, randomized clinical trial of attitudes towards research participation, we will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment strategies for research participation in a mobility trial among hospitalized patients and a smoking cessation trial among patients with depression.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible for parent RCT
2. 18 years or older
3. No prior knowledge of recruitment strategies used for this trial
4. Speaks English

Exclusion Criteria:

1)Prior knowledge of recruitment strategies used for this trial
Study of CVN424 in Healthy Subjects

This is a phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose ascending study in healthy subjects.

Part 1: Single-Dose Regimen and Fasted-Fed Crossover - For the single-dose regimen, approximately 40 healthy male and female subjects will be enrolled in 1 of 5 single dose cohorts (designated as S1 through S5, respectively) in an ascending fashion.

Part 2: Multiple-Dose Regimen

- For the multiple-dose regimen, approximately 24 healthy male and female subjects age 18 to 50 years old will be enrolled in 1 of the 3 multiple-dose cohorts (designated as M1 through M3, respectively) in an ascending fashion.

Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
* The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
* Subject is a healthy male or female adult who is 18 to 50 years of age inclusive at the time of ICF and study drug dosing.
* Subject weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 30.0 kg/m2, inclusive at Screening.
* A male subject who is nonsterilized and sexually active with a female partner of childbearing potential\* agrees to use adequate contraception\* from signing of the ICF throughout the duration of the study and for 12 weeks after last dose.
* A female subject with no childbearing potential, defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH\>40 IU/L).

Exclusion Criteria:

* Subjects have a known hypersensitivity to any component of the formulation of CVN424.
* Subjects have evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, psychiatric disorder, or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
* There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.
Evaluation of The Effectiveness of m-DAKBAS on Foot Care

Aim: To develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) related to foot care for diabetic individuals and to evaluate its effectiveness.

Method: The study involved 88 patients who applied to the Diabetes Polyclinic (intervention=44; control=44). While the intervention group used m-DAKBAS (for 6 months), the control group was provided with a verbal foot care training once, as a standardized procedure of the hospital. Data were collected using the "Socio-demographic Form", "Diabetic Foot Knowledge Form - DFKF", "Foot Self Care Behaviours Scale -FSCBS", "Diabetic Foot Care Self Efficacy Scale - DFCSES", and "m-DAKBAS Assessment Form".

Diabetic foot, one of the important complications of diabetes, is a health problem that affects quality of life in a negative way, that has high treatment and care costs and mortality rates, long hospitalization duration and thus with all these aspects a psychological, physical, social and economic priority. Despite all these, diabetic foot complications and amputations could be decreased with the help of a good foot care, education and a multidisciplinary team work. Mobile technologies have been continuously increasing worldwide for the management of diabetes, and the use of these technologies is recommended by international institutions as well.

Therefore, the purpose of this study is to develop a Turkish mobile application that would increase patients' knowledge levels about foot health and care, improve their behaviours and self-efficacy, and evaluate its effectiveness so that it could be possible to prevent foot ulcer and the related amputations in individuals with diabetes. The Mobile Diabetic Foot Personal Care System (m-DAKBAS) developed for this purpose enables to increase individuals' self-confidence, improve communication with the health personnel, involve patients in their own care in an interactive way, and take responsibility.

The usability of the application was indicated by the patients' feedback, and in line with the purpose of the mobile application, improvements in the patients' knowledge, behaviours and self-efficacy about foot care in diabetes.

Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis history of \>1 year;
* having Type 1 or Type 2 diabetes;
* having a mobile phone with Android or IOS operating system;

Exclusion Criteria:

* having visual impairment,
* hand skill problem, difficulty in communication, or mental insufficiency;
* currently having foot ulcer.
Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass

Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 65 years old.
* Have had a gastric bypass in Y more than 2 years ago
* Have a weight regain of more than 10% of the lowest weight after the first intervention.
* Have benefited from a multidisciplinary medico-psychological reassessment.
* Understand the interest of the study and agree to long-term follow-up.
* Agree to be included in the study and have signed a consent form in a free and informed manner.
* Be affiliated with health insurance.
* For female patients of childbearing potential, have an effective method of contraception

Exclusion Criteria:

* Presence of a disease unrelated to obesity that is life-threatening.
* Pregnancy or wish to become pregnant within the year.
* "Breastfeeding" patients
* Female patients of childbearing age and unable or unwilling to use an effective method of contraception
* Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
* Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
* Patient not understanding French or unable to give consent.
* Patient already included in a study or in conflict of interest with this study.
Effect of Tablet-Based Games on Executive Functions in Older Adults With Mild Cognitive Impairment

The primary objective of this study is to investigate whether a tablet-based role-playing game is more effective than tablet-based word or image puzzles at improving executive functions in older adults with mild cognitive impairment. The secondary objective of this study is to investigate whether a tablet-based role-playing game will show higher levels of engagement (measured by time played) in older adults with mild cognitive impairment than tablet-based word or image puzzles.

The purpose of this study is to examine the use of tablet-based (iPad or android) video games as a means of improving executive functions in older adults with mild cognitive impairment (Petersen, Smith, Waring, et al., 1999). The worldwide rising average age of the population and increasing incidence of dementia has created an urgent need for the development of effective and engaging therapies to mitigate age- and dementia-related cognitive decline. Much evidence supports the use of cognitive therapies as a means of improving general cognition in older adults. Video games may offer benefits over traditional cognitive therapies as they are challenging and fun, provide frequent feedback which motivates and encourages user engagement, and are widely available at low cost on tablet devices. This study will be implemented as a single blinded randomized control trial structured as a 2 x 2 mixed design with one repeated factor (time: pre-training, post-training) and one between-subject factor (group: treatment, active control). Forty-two older adults with mild cognitive impairment will be randomly assigned to play either a role-playing game, or a selection of word or image puzzles, for 5 or more hours a week for a period of 8 weeks. Participants can have a study partner assist them in the study. A study partner can help the participant with using the tablet and navigating menu in the game, but cannot play the game along with the participant. Participants will be assessed pre and post training with the Cambridge Brain Sciences (www.cambridgebrainsciences.com) online battery of 12 cognitive tasks. These tasks are "based on well-established paradigms from the cognitive neuroscience literature, to measure planning, reasoning, attention, and working memory abilities" (Hampshire, Highfield, Parkin, et al., 2012, p. 1236).

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* fluent in English
* diagnosis of mild cognitive impairment
* normal or corrected hearing and vision
* can operate the touch screen on an iPad
* access to a tablet (iPad or android) for 8 weeks of the study

Exclusion Criteria:

* have started taking memory medication in the last 3 months
* have experience in any of the tablet-based games included in the study
HeartMate PHP™ CE Mark Clinical Investigation Plan

The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Patient presents with a non-emergent need for complex PCI with:

  1. an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
  2. the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
* Written, signed, and dated informed consent

Exclusion Criteria:

* Emergent PCI
* ST elevation myocardial infarction within 7 days of procedure
* Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
* Hemodynamic support with the HeartMate PHP post-PCI is anticipated
* Cardiogenic shock (SBP \<90 mmHg for \>1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index \<2.2 L/min/m2)
* Mural thrombus in the left ventricle
* History of aortic valve replacement
* Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
* Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
* Severe peripheral vascular disease
* Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
* Planned use of rotablator or atherectomy during the procedure
* Serum creatinine \> 3.5mg/dL within 7 days of procedure
* Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2
* Uncorrectable abnormal coagulation parameters
* Active systemic infection requiring treatment with antibiotics
* Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
* Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
* History of heparin induced thrombocytopenia
* Patient is pregnant or planning to become pregnant during the study period
* Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-
Hypernet- Hypertension Screening

Identify untreated, asymptomatic hypertension in ER patients

this was a prospective study done with no intervention- the study has since been completed

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic hypertension

Exclusion Criteria:

* cardiac symptoms
Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)

In this study patients with

1. chronicle liver diseases

   * primary biliary cirrhosis
   * primary sclerosing cholangitis
   * alcoholic liver cirrhosis
   * hepatitis b or C
   * Wilson's disease
   * cryptogenic cirrhosis
2. Septic Inflammatory Response Syndrome (SIRS)

   * sepsis
   * septic shock
3. patients after lysis

should be included

Blood samples will be gathered from the patients to measure fibrinogen with 5 different methods.

The methods are:

* Clauss fibrinogen
* PT-Derived fibrinogen
* immunoturbidimetric method
* heat-precipitated fibrinogen
* Schulz fibrinogen

The result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* SIRS
* sepsis
* septic shock
* chronicle liver disease (MELD-Score \>10)
* patient after lysis
* patient agrees

Exclusion Criteria:

* no agreement
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.

This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.

Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus

Exclusion Criteria:

* patients not willing to participate data or undergo screening for gastroesophageal reflux disease
Efficacy of tDCS on Pain in Multiple Sclerosis

Pain is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception;
* lack of MS worsening in the three months just before the intervention period;
* cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30.

Exclusion Criteria:

* worsening of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
* rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study;
* intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current;
* severe cardiopulmonary, renal, and hepatic diseases;
* pregnancy.