cyrilzakka/clinical-trials huggingface dataset:
Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome

PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with severe acute respiratory distress syndrome (ARDS) supported with veno-venous extracorporeal membrane oxygenation (VV-ECMO).

Controlling respiratory effort in patients with ARDS can be challenging, as they often exhibit a very high respiratory drive despite receiving high doses of sedatives. Consequently, these patients usually receive full neuromuscular blockade, with the goal to avoid such injurious respiratory efforts. Unfortunately, full neuromuscular blockade is not without complications. To address this issue, the use of partial neuromuscular blockade has been proposed as a strategy to maintain respiratory muscle activity while providing lung protective ventilation.

The objective of this study is to demonstrate the safety and feasibility of safe spontaneous breathing using partial NMB in severe ARDS patients supported on VV-ECMO.

An esophageal balloon and a catheter will be placed. Once adequate sedation has been ensured, small boluses of cisatracurium will be administered. Then, an infusion of cisatracurium will be started to maintain spontaneous breathing at esophageal pressure swings (Pes) of 3-10 cm H2O or selected diaphragm electrical activity (Edi) targets. After establishing a sedation and NMB dosing regimen at which safe spontaneous breathing is achieved, we will document whether these targets can be maintained over a 24-hour period.

Eligibility Criteria:
Inclusion Criteria:

1. Potentially injurious respiratory efforts as defined by esophageal pressure swings or occlusion pressure swing AND Riker Sedation-Agitation Scale (SAS) ≤2 (if the clinical team has elected to sedate to that depth).
2. The medical team has undertaken a trial of discontinuing neuromuscular blockade and determined that the patient requires reinstitution of neuromuscular blockade to ensure toleration of ECMO and they are willing for the patient undergo a trial of partial neuromuscular blockade
3. The patient is receiving neuromuscular blockade with no plan to discontinue neuromuscular blockade until the next day and the medical team is willing for the patient to undergo a trial of partial neuromuscular blockade

Exclusion Criteria:

1. Decannulation from VV-ECMO is anticipated within 24 hours
2. Contraindication to esophageal catheterization
3. Contraindication to neuromuscular blockade (allergy, history of malignant hyperthermia)
4. Patient has a condition deemed by the medical team to require complete NMB
Hemodynamic Responses During Induction: Comparison of Marsh and Schnider Pharmacokinetic Models

To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with much more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean arterial pressure, systemic vascular resistance , central venous return or stroke volume would be observed.

Current systems of propofol TCI are pre-programmed with the Marsh and Schnider pharmacokinetic models. Rate constants of Marsh are fixed, whereas compartment volumes and clearances are weight proportional. Schnider model has fixed values for VC, V3, k13, and k31, adjusts V2, k12, and k21 for age, and adjusts k10 according to total weight, lean body mass (LBM), and height. One major beneﬁt of the Schnider model is that it adjusts doses and infusion rates according to patient age. This provides a strong argument for using the Schnider model in the elderly and unwell patients which may improve hemodynamic stability and safety.

However for the vast majority of young and middle age patients, whether Marsh or Schnider would be a better choice for hemodynamic stability remains unknown.

With marsh model, as VC is scaled to body weight, the amount of drug delivered is dependent of body weight. In the Schnider model, as VC at 4.27L is independent of body weight, VC in terms of ml/kg decreases as body weight increases. This and the influence of height and weight on clearance results in heavier patients receiving less propofol on a mg/kg basis whereas those with a lower lean body mass will initially receive about 30% less than delivered by Marsh, but after 30 min, the Schnider model delivers about 15% more. Besides, when Schnider model is used in the morbidly obese, the LBM equation can generate paradoxical values resulting in excessive increases in maintenance infusion rates. Nevertheless, the purpose of this study was to investigate the vast majority of Asian patients whose body weight were in normal range. Only patients with BMI between 18 and 29 were included to minimize the influential factor of body weight in TCI system.

To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with much more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean arterial pressure, systemic vascular resistance , central venous return or stroke volume would be observed.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 years and 70 years
* ASA physical status I and II
* surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring.

Exclusion Criteria:

* Patients younger than 16 y or older than 65 y
* Body Mass Index (BMI) \<18 or \>30
* emergency surgery
* allergy to any of the drugs used
* inability to communicate effectively
* severe cardiovascular dysfunction
* patient refusal and patients on long-term opioids or sedative medication.
Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA

The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.

The main question\[s\] it aims to answer are:

* Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
* Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-80 years
* Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
* ASA classification I-II

Exclusion Criteria:

* Valgus deformity
* BMI \> 40kg/m2
* History of previous knee surgery
* Active infection of the knee joint
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity

The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Caucasian patients aged ≥18 and ≤70 years
* Voluntarily signed informed consent
* Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
* Reflex volume of ≤250 mL
* Intact reflex arcs in the area of segments S2-S4

Exclusion Criteria:

* Patients suffering from multiple sclerosis under unstable conditions
* Augmented reflex bladder
* Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
* Acute urinary tract infection
* Electrostimulation therapy (within 4 weeks propir to Visit 1)
* Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
* Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
* Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
* Pre-existing medical contraindications for anticholinergics
* Cardiac insufficiency (NYHA stage III/ IV)
* Therapy with botulinum toxin within the last 12 months
* Evidence of severe renal, hepatic or metabolic disorders
* History of drug or alcohol abuse
* Concomitant medication known to have a potential to interfere with the trial medication
* Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
* Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
* Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
Depth of Anesthesia on Implicit Memory

Purpose of this study is to see if different levels of anesthesia have an effect on hearing spoken words without awareness of having heard them or anxiety after surgery.

Amnesia (lack of recall) is one of the most important goals of general anesthesia. Inadvertent free recall during a major surgical procedure is not only inhumane, but also predisposes the patient to morbidity such as post-traumatic stress disorder. Therefore, it is standard practice among anesthesiologists to inquire about free (explicit) recall during a post-anesthetic visit.

Free recall requires a functional long term memory. Historically, lack of free recall during general anesthesia has been regarded as complete absence of long term memory activity. However, recent evidence suggests that the relationship between general anesthesia and memory is more complex than previously thought.

Objectives of the proposed are twofold: (1) to test the presence of implicit memory under two different planes of surgical general anesthesia in elderly males (55-90 years old) during a uniform surgical procedure (urologic procedures via transurethral approach) (2) to compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.

The study is divided into three phases: pre-operative, operative, and post-operative.

Pre-operative phase will consist of a cognitive function test (mini-mental state exam). This will be administered at the urology or pre-operative anesthesia clinic visit, after obtaining the informed consent of the patient.

Operative phase will start with a baseline anxiety test (Spielberger state-trait anxiety test) just before being taken to the operating room. This will be followed by playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.

Post-operative phase will have of a spoken word-stem completion test (just before discharge from the hospital) and a repeat of the anxiety test mentioned above (2 to 3 weeks post-operatively).

Eligibility Criteria:
Inclusion Criteria:

* Persons signing informed consent
* Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
* Literate
* Native English speaking

Exclusion Criteria:

* Hearing impaired
* History of cognitive dysfunction
* Subjects requiring post-operative sedation for any indication
Retrospective Study in a NSCLC M+ p

This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.

At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
* Confirmed EGFR mutation by a validated test
* Availability of medical record

Exclusion Criteria:

* Participating on a blinded randomized clinical trial at any time during the study period
* Pregnant women (due to they do not reflect daily clinical practice)
Resorbable Magnesium Scaffolds Registry

The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).


Eligibility Criteria:
Inclusion Criteria:

* According to the IFU

Exclusion Criteria:

* According to the IFU
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 \[Day 1\], Visit 2 \[Day 1-13 telephonic\], Visit 3 \[Day 14\], Visit 4 \[Day 15 to Day 21 telephonic\], Visit 5 \[Day 22\], Visit 6 \[Day 23 to 27 telephonic\] and Visit 7 \[Day 28\]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.

Eligibility Criteria:
Inclusion Criteria:

* Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder
* Participants with pain scores greater than and equal to 4 on the average in the last 24 hours
* Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain
* Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
* Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial

Exclusion Criteria:

* Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified)
* Participants with acute pain or who have pain on movement
* Participants who have received a fentanyl patch within the last 5 days
* Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response)
* Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse
The Effect of Aerobic Exercise in Patients With Lacunar Stroke

In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.

Little is known about effect of exercise for patients with lacunar stroke, no studies have investigated the feasibility or effect of aerobic exercise in this subgroup of stroke. The patients have few and temporary symptoms and are therefore early discharged from the hospital. After an cerebral infarct the patients have increased risk of recurrent stroke and they are at risk of developing cognitive deficits or vascular dementia over time. Researchers want to investigate if high-intensity training at home in the acute phase has an effect on aerobic fitness, endothelial response and health profile in this potential fragile group of patients. We hope to increase the patients´ physical and mental function, and thereby prevent a recurrent stroke and slow the progression of vascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* lacunar stroke verified by clinical examination and CT- or MRI-scans
* able to speak and read Danish

Exclusion Criteria:

* previous large artery stroke,
* symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling,
* dyspnoea caused by heart or pulmonary disease,
* aphasia or dementia which hinder completion of the Talk Test.

Amendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days).

Also, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI.

Amendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.

There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes.

This study is designed to record EEG during birth transition through the first 10 minutes of life.

Eligibility Criteria:
Inclusion Criteria: Term infants

* Signed Informed consent

Exclusion Criteria:

* Known congenital anomalies
A Study of Invasive Hemodynamic for MACHD Registry

This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.


Eligibility Criteria:
Inclusion Criteria:

* Capacity to Consent
* BMI \</= 30
* Systolic BP \</= 140mmHg
* Diastolic BP \</= 90
* eGFR \> 30 (within prior 3 months) to confirm kidney function
* Able to undergo an MRI

Exclusion Criteria:

* History of Cardiovascular disease that may affect the results of the testing performed.
* Any Current orthopedic limitations
* Currently taking any cardiac medication
* Pregnancy
CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects

This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
* Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries

Exclusion Criteria:

* History of relevant drug and/or food allergies.
* Using tobacco products
* Positive drug and alcohol screen
Self-management of Low Molecular Weight Heparin Therapy

There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment.

Hypothesis:

Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients.

Data collection:

* telephone interviews with structured questionnaires at the beginning and at the end of the therapy
* monitored self-injection in the study center or at patient's home (direct observation technique \[DOT\])
* compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes
* recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder and Hand" questionnaire (DASH questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment.
* self-application of the LMWH
* german / english speaking

  -\> clinical setting:
* Dalteparin

  -\> daily life setting:
* all LMWH (ready-to-use syringes)
* control group: self-application or application by another person (family member, medical person, etc.)

Exclusion Criteria:

- patient's home far away from study center