cyrilzakka/clinical-trials huggingface dataset:
Adaptive CRT Effect on Electrical Dyssynchrony

The purpose of this study is to better understand how adaptive cardiac resynchronization therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. aCRT has already been approved by the FDA and is being used in patients now, but it is not clear which patients it should be used in compared to normal CRT. This study will include patients who are already scheduled to get a CRT device. The investigators will then randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the investigators will assess the electrical activity of the patients' hearts. After this time, the patient and their doctors will be able to decide if they would like to change the type CRT they have been designated.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a standard class I or class II indications for CRT-P or CRT-D implantation in accordance with ACC/AHA/HRS guidelines (2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities)2.At least 18 years of age at the time of consent
* Is willing and able to comply with the protocol

Exclusion Criteria:

* Chronic atrial arrhythmias defined as: "Atrial fibrillation is permanent when it has resisted all attempts to restore sinus rhythm or when the physician and patient decide that no such attempt should be made."
* Patient has ever had a previous or has an existing CRT system, ICD, or pacemaker.
* GFR \<30ml/min
* Patient has had unstable angina, acute myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 30 days prior to study enrollment
* Patient has primary valvular disease and is indicated for valve repair or replacement
* Patient is enrolled in ≥1 concurrent studies that would confound the study results (any other interventional trial)
* Patient is pregnant or of childbearing potential and not on a reliable form of birth control. All women of child-bearing potential must undergo a pregnancy test.
* Patient status post heart transplant
* Patient has been classified as NYHA functional class IV within 3 months prior to study enrollment
* concomitant conditions other than cardiac diseases that were associated with a higher likelihood of death during 1 year after enrollment
* Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy

This study will examine the pharmacokinetics of the various, routinely given antibiotics, sedatives, and opioids in patients undergoing venous-venous extra-corporal oxygenation (ECMO). Little is known about the distribution and effectiveness of antibiotics in this particular patient population.

Patients with severe hypoxia that is refractory to traditional therapies are occasionally placed on venous-venous extracorporal membrane oxygenation (vv ECMO) to provide a bridge during the time when lungs alone cannot provide necessary support. This procedure is gaining prominence but it is largely unknown how medications, especially antibiotics, given to the patient on ECMO is distributed throughout the body as compared to patients without ECMO. Since the serum level of medication determines the biological activity of the drug, it is important to know if there is a difference in drug distribution between ECMO and non-ECMO patients. The investigator already collected well-established data on several antibiotics on non-ECMO as a part of FDA labeling. The study will help to determine if the concentration of currently prescribed are sufficient enough to reach their intended concentration in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with respiratory failure undergoing ECMO.

Exclusion Criteria:

* Lack of consent
* Age less than 18 years old
* Hematocrit lower than 7
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

* Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.
* Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
* Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight \[kg\]/height \[m\]2)

Exclusion Criteria:

* Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
* Any gastrointestinal surgery that could impact upon the absorption of study drug.
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.
Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence

The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with polypharmacy (5 or more medicines)
* That detects to them a problem of Therapeutic Adherence
* That agree to take part in the study

Exclusion Criteria:

* Immobilized patients or with an index of Barthel lower than 60 points
* Incapable to fulfill ABVD
* Patients with cognitive deterioration
* Patients with diagnosis of ictus in the last 6 months
* That has been admitted to hospital 2 or more times in the last year Institutionalized patients
Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography

This trial aims to compare the incidence of postoperative residual curarisation (PORC) and postoperative pulmonary complications (PPCs) in the SUG and NEO group by means of diaphragm ultrasonography and LUS, so as to conclude whether SUG can outperform NEO in preventing occurrence of PORC and PPCs.

The incidence of postoperative residual curarisation (PORC) is about 2%-64% worldwide, which may be an underling risk factor of postoperative pulmonary complications (PPCs), causing many undesirable effects on patients. Thus, reversal drugs of neuromuscular blocking agents (NMBAs) such as neostigmine (NEO) and sugammadex (SUG) have been administrated, and SUG maybe perform better in preventing PORC. Different supplementary methods to help identify PORC or PPCs have also been reported, such as adductor of pollicis acceleromyography and lung ultrasound (LUS). Recently, diaphragm ultrasonography has been used to evaluate PORC, as a novel approach.In this prospective, double-blind, randomized controlled trial, we will enroll 414 patients of American Society of Anesthesiologists physical status I-III, aged over 60 years, who will be scheduled to undergo arthroplasty surgery under general anesthesia. Participants will be randomized into NEO and SUG group receiving neostigmine and sugammadex as reversal drug respectively. The primary outcomes will be the incidence of PPCs in NEO and SUG group respectively. The secondary outcome is the incidence of PORC in the two groups.We hypothesize that: 1) the incidence of PPCs is lower after reversal with SUG than with NEO, 2) using the method of diaphragm ultrasonography, the incidence PORC is lower after reversal with SUG than with NEO, 3) the incidence of PPCs can be predicted by LUS and by evaluating whether there is PORC through diaphragmatic ultrasound.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I-III
2. Aged over 60 years
3. Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
4. Scheduled to undertake joint surgery
5. Signed the informed consent form

Exclusion Criteria:

1. Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system
2. Those with diaphragm insufficiency or massive pleural effusion
3. Women who are pregnant or nursing
4. Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
5. Declined to participate
Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy

Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

Background: Fiberoptic intubation is the preferred method of intubation in patients with acute symptoms or signs of cervical myelopathy. This approach minimizes cervical spine movements to prevent new neurologic deficits or further neurologic injury, and is the safer method to secure the airways in patients with foreseen difficult intubation. In these patients anaesthesia induction is aimed to prevent cervical spine movements and to maintain hemodynamic stability. The most commonly reported technique for anaesthesia induction in patients with cervical myelopathy is based on local anaesthesia and propofol administration. Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

Methods: This randomized controlled trial is designed to prove equivalence. A series of 116 patients aged between 18 and 75 years, with cervical myelopathy will be enrolled. In all patients topical anaesthesia will be accomplished before anaesthesia induction. Patients will be randomly assigned to one of two anaesthesia induction strategies (sevoflurane + O2 + air or propofol + O2 + air). When loss of consciousness occurs (indicated by Bispectral index values between 40 and 50), oral or nasal fiberoptic intubation will be performed. The hemodynamic effects of the anaesthesia induction strategies will be assessed measuring mean arterial pressure at 4 time points: before anaesthesia induction (T1: baseline), at the end of anaesthesia induction when an adequate sedation level, with Bispectral index values 40-50, is achieved (T2: sedation steady state); immediately after placement of endotracheal tube (T3: intubation); five minute after tracheal intubation (T4: post-intubation). Secondary end-points of the study include the incidence of apnoea during induction process, diagnosed as absence of carbon dioxide trace for more than 10 seconds, the incidence of induction complications, defined as presence of laryngospasm, coughing and patient movement, and intubation conditions, defined as cord opening.

Discussion: We present the development phase of this anaesthesiological trial. A total of 40 patients have been enrolled from April 2009.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing cervical spine surgery;
* Male or female;
* Aged 18-75 years.

Exclusion Criteria:

* Severe cardiovascular pathology;
* Liver disease;
* Renal disease;
* BMI \>35;
* Allergies to any anaesthetic drugs.
Operative Management of Scapular Fractures

Assessment of functional outcome of operative management of scapular fractures through Arabic version DASH score

Scapular fractures are rare, accounting less than1% all fractures. 3-5%all fractures of shoulder girdle, however very serious because 80-90% due to high energy trauma such as Motor car accidents or Fall from height. It can be associated with life-threatening injuries such as thoraco-scapular dissociation and vascular injury as subclavian and axillary vessels and brachial plexus injuries.So morbidity and mortality reports are relatively high.It can be diagnosed by X ray and computed tomography scan (CT scan) that play important role to discover scapular fractures and associated injuries ,and to guide clinical decision such as approaches and other surgical interventions.Most of scapular fractures are managed conservatively by Immbolization in sling .literature stated that conservative management of scapular body fractures and scapular neck fractures displaced less than 10 mm have satisfactory outcome and operative management suitable for displaced glenoid fossa fractures and scapular neck fractures more than 10 mm and associated with better functional outcome.Others stated that conservative management with highly displaced scapular body and neck fractures are associated with satisfactory long -term functional outcome with minor loss of motion and strength.

So standard treatment of scapular fracture is still controversial and there is no clear guidelines about management of scapular fractures.

In Investigators hypothesis, Operative management of scapular fractures is better choice due to better functional outcome, early rehabilitation ,high union rate and less complications. Investigators will try to answer this question ''What is the effect of operative management of scapular fractures on functional outcome?''

Eligibility Criteria:
Inclusion Criteria:

* 1.All patient presented with scapular fractures more than 18 years old involving body, neck and glenoid 2.Intraarticular glenoid fractures with step-off \>4 mm 3.\>20% of the joint is involved and Fragment large enough to be hold by lag screw.

Exclusion Criteria:

1- Low demanded patients:Age \>65 yrs . 2.Scapular fractures of acromion and coracoid process and Osteoporotic fractures .

3.Scapular fractures associated with brain injuries cervical spine injuries and brachial plexus injuries.
Comparison Of Direct Myofascial Release And Bowen's Technique For Non-Specific Neck Pain

Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day. Non-specific neck pain is the common cause of neck symptoms that is mainly due to mechanical causes, postural problem, depression, anxiety or occupational activities. Poor posture causes abnormal muscle loading and muscle injury

Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day.Poor posture causes abnormal muscle loading and muscle injury.It becomes a constant source of neck pain and instability. It reduces range of motion and weakens the shoulder and neck muscles. According to a population based survey the prevalence of lifetime neck pain ranges from 67% to 87%.

Trigger points cause myofascial pain syndrome which is among the leading cause of non-specific neck pain. Myofascial release technique (MRT) is often used to treat non-specific neck pain.Another therapy that focuses on myofascial work is Bowen therapy that follows a dynamic approach to release fascia and muscles. The technique involves very gentle cross fiber movements that are applied on fascia, muscles, tendons and viscera to induce the effect. The technique is applied at specific body regions following specific sequences with regular rest intervals that cause fascial stretching. The technique consists of slightly picking up muscles and then rolling the muscles to direct them toward a specific region of body. The rest periods help the body to integrate and absorb the effects of therapy. The sensory impulses caused by the Bowen therapy interact with nervous system and realign and correct the disturbed mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific neck pain ≥ 3 months without symptoms radiating to the upper limbs
* Presence of a maximum of 1-2 active Myofascial Trigger Points
* Pain of more than 3 on a NPRS
* For the diagnosis of a Trigger Point, compliance with the following criteria:

  * (1) A hypersensitive spot in a palpable taut band,
  * (2) Palpable or visible local twitch on pincer palpation
  * (3) Reproduction of referred pain elicited by palpation of the sensitive spot.

Exclusion Criteria:

* Diagnosed with cervical radiculopathy or myelopathy
* Neck Pain due to trauma, fractures, or whiplash; neoplasia, severe osteoporosis, infectious, or inflammatory processes;
* Patients with pacemakers, congenital anomalies, previous neck surgery
* Patients diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3 patients per site. It is anticipated that half the patients will be receiving GnRH analog treatment and the other half will be treatment naïve. All patients will undergo selective PK sampling post-implantation to assess histrelin profile. At 12 months, provided that the patient continues to meet the safety and efficacy parameters, the original implant will be removed and the patient can receive a new implant. At 13 months, patients who receive new implants will be evaluated at the study site and administratively transferred to the initial extension study. At Month 24), the implants inserted at Month 12 will be removed. At this time, patients who have completed the initial extension study and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and to enter an additional 12-month extended access phase at the discretion of the investigator. At Month 36, the implants inserted at Month 24 for the Extended Access Phase will be removed. At this time, patients who have completed the Extended Access Phase and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and to enter the Long Term Extended Access Phase (referred to as the Implant Treatment Phase) at the discretion of the investigator. The purpose of this phase is to provide patients with the opportunity to continue to receive a new implant at the end of each 12-month period until the patient no longer requires hormone suppression. Once implant therapy is discontinued, all patients are eligible to enter the Long Term Follow Up Phase (Post Implant Phase) of the study.

Eligibility Criteria:
Inclusion Criteria:

* Pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty
* Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before initiation of treatment

Exclusion Criteria:

* Children who are less than 2 years of age at enrollment
* Children whose chronological age is greater than 8 years (naive) and 10 years (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the onset of the study
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to test the hypothesis that radiotherapy of head and neck carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a hypoxic radiosensitizer in association with accelerated fractionation, in an unselected patient population in a global environment.

Squamous cell carcinoma in the head \& neck region (HNSCC) accounts for approximately 7% of all cancers worldwide \& around 75% of all HNSCC cases are seen in the less developed countries.

Significant improvement in loco-regional control \& disease specific survival by radiation therapy could be achieved by reducing the overall treatment time by "Accelerated Fractionation" schedule.

Modification of hypoxia by Nimorazole demonstrated significant improved local effect of radiation with neither serious nor lasting side effects. So, it is expected that the optimal treatment option is reducing the overall treatment time with concomitant use of Nimorazole. Such treatment principle is optimal for testing in developing countries.

The aim of the study:

* To determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity, and
* To determine whether the addition of Nimorazole to primary curative radiotherapy is feasible and tolerable on a worldwide scale.
* To evaluate the tolerance, compliance and toxicity of using nimorazole.

Eligibility Criteria:
Inclusion Criteria:

* Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification.
* Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor.
* Informed consent according to the Helsinki declaration and local regula-tions.
* The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
* Performance status 0-2 according to WHO criteria.
* The patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
* Normal function of liver and kidney by routine laboratory examinations. The patient must not be pregnant

Exclusion Criteria:

* Distant metastases.
* The patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
* Surgical excision (except biopsy), prior or planned (including elective neck dissection).
* The existence of synchronous multiple malignancies (not leukoplakia).
Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data

The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. The aim of this approach is to cause electrical isolation of the pulmonary veins. The purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. Patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. The time taken to achieve pulmonary vein isolation is the primary end-point of the study.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion)

Exclusion Criteria:

Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for atrial fibrillation Unwillingness or inability to complete the required follow up arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or severe structural cardiac abnormality Known severe left ventricular systolic function (ejection fraction \<35%) Known hypertrophic or infiltrative cardiomyopathy