cyrilzakka/clinical-trials huggingface dataset:
Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy

One of the most significant goals of hepatic encephalopathy (HE) treatment is to reduce ammonia levels by lowering its synthesis and enhancing its detoxification which can be achieved by using non-absorbable disaccharides, antibiotics, branched-chain amino acids (BCAA), L-ornithine L-aspartate (LOLA), and probiotics.

LOLA decreases ammonia, therefore, it is presumed to decrease agitated delirium in HE patients and thus decrease their need for other sedatives. On the other hand, BCAA improve mental function in HE patients by increasing the detoxification of ammonia in muscles.

The most often utilized criteria for grading HE are the West Haven criteria (WHC). This grading distinguishes four levels of clinically evident hepatic encephalopathy.

West Haven criteria (WHC): \[R\]

Stage Consciousness

0. Normal

1. Mild lack of awareness
2. Lethargic
3. Somnolent but arousable
4. Coma

REFERENCES:

Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy-definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congress of Gastroenterology, Vienna, 1998. Hepatology 2002; 35: 716-21.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiological and/or histopathology.
* Patients having overt HE, West Haven criteria (WHC) grade III-IV.

Exclusion Criteria:

* Age \< 21 years.
* Inability to obtain an informed consent from the first degree relative and/or legally authorized representative.
* Advanced cardiac or pulmonary disease.
* Presence of underlying chronic renal failure (serum creatinine \> 3 mg/dL).
* Neurodegenerative disease (including head injury and drug intoxication).
* Major psychiatric illness.
* Use of sedatives or antidepressants.
* Pregnancy or breast-feeding .
* Hepatocellular carcinoma.
* Acute on top of chronic liver failure.
Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.

Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.

Eligibility Criteria:
Inclusion Criteria:

Patient who will undergo unilateral ureteral stent fixation:

1. To relieve upper urinary tract obstruction caused by ureteric calculi
2. After ureteroscopic lithotripsy for ureteral calculi.

Exclusion Criteria:

1. Patients who had LUTS before stent fixation.
2. Ureteral stent fixation after open or laparoscopic surgery.
3. Bilateral ureteral stents.
4. Patients who developed complications related to the primary endoscopic procedure
5. Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement
Lymphedema Prevention in Breast Cancer

OBJECTIVE: To find out the effectiveness of early application of physical therapy in the prevention of lymphedema after breast surgery and lymphadenectomy.

DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration. Patients will be randomly assigned to one of these groups: Experimental group: Early physical therapy + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th and 6th after 3, 6, 12 and 24 months.

SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in Principe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form.

SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of 60%.

DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive women diagnosed with breast cancer and undergoing unilateral surgery with axillary lymph-node dissection at the Príncipe de Asturias Hospital in Alcalá de Henares, Madrid (Spain) are candidates for inclusion in the study.

Exclusion Criteria:

* Patients without axillary lymph-node dissection or with bilateral BC, systemic disease, locoregional recurrence, or any contraindication to physical therapy are excluded from the study.
Safety of an Early Discharge Protocol After Sleeve Gastrectomy

Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.

This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for Sleeve gastrectomy
* BMI 35 to 50
* ASA I to III
* Conventional address close to our Hospital
* Laparoscopic surgery
* Accompanying person after discharge
* Availability for a smart phone

Exclusion Criteria:

* ASA IV
* Revisional Surgery
* Conversion to laparotomy
* ICU Admission after surgery
* Insulin dependent Diabetes Mellitus
* Surgery finishing after 3 pm
Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.

PRIMARY OBJECTIVES:

I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE).

SECONDARY OBJECTIVES:

I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up.

OUTLINE:

Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for 90Y radioembolization for HCC as part of their standard of care

Exclusion Criteria:

* Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency \[RF\] ablation or transarterial chemoembolization \[TACE\])
* Pregnant or nursing
* Known cardiac shunt
* Known pulmonary hypertension
* History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason
* History of hypersensitivity to iodinated contrast agent
* Cannot consent for himself or herself
Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term

Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. The etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. The vast majority of syncope management costs are related to hospitalizations. Hospitalization in the immediate aftermath of emergency care is justified by a short-term prognosis. The current relevance of hospitalizations and the prognostic assessment of syncope is questioned.

The improvement of cardiac troponin assay techniques has increased its sensitivity to detect myocardial ischemic conditions, even at the expense of a loss of specificity. Myocardial infarction type 2 is due to an imbalance between needs and oxygen supply to cardiomyocytes at the time of an increase of the first and / or a decrease of the second and is favored by an underlying cardiovascular field fragile. Syncope, because of the low flow that they imply, can be the cause of a type II myocardial infarction on fragile cardiovascular ground.

The study is prospectively conducted in all patients admitted for syncope to assess the actual diagnostic performance of hypersensitive troponin in the syncope risk stratification. The primary benefit is to identify patients at risk of serious cardiac events in the short term. The secondary benefits expected from the study are a decrease in unjustified hospitalizations of patients admitted to the emergency for syncope and thus a decrease in the cost of care.

The validation of the indication of the troponin assay in the stratification of the risk after a syncope passes by its prospective evaluation in a prognostic study.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.

Exclusion Criteria:

* Patient under guardianship or safeguard of justice
* Refusal to participate
* Inability to contact the patient again at M1, M3, M6
* Malaise without loss of consciousness (lipothymia)
* Loss of post-traumatic knowledge (after head trauma)
* Loss of consciousness of toxic origin
* Loss of consciousness of confirmed epileptic origin (known epileptic or strongly evocative history with post-critical state)
* Diagnosis performed during the initial emergency assessment of a major adverse cardiovascular event.
Abdominal Electromyographic Control in Vojta Therapy

A randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old.
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Vaccinated in the 10 days prior to the intervention
* Fever
Observational Study on a Chinese Population

An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Han population, living in Shenzhen City for \> 2 y, not in pregnancy, without hepatic diseases and renal diseases

Exclusion Criteria:

* caught by organic diseases
Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score

Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.

Exclusion Criteria:

* syndromic clubfoot
To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.

Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients

All patients satisfying the inclusion criteria, written informed consent will be taken and patients are randomized into intervention group ( Portocaval Shunt Group) and Non intervention group ( No Shunt Group).Patients from both the groups will be assessed for Hemodynamic parameters, Urine Output, Blood loss, blood products requirement , Duration of surgery during the procedure. They will be assessed for renal function, presence of sepsis, Morbidity, early graft dysfunction, ICU stay and total hospital stay in the post operative period.All patients will be followed up till discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

1) All Adult LDLT Recipients at ILBS, New Delhi

Exclusion Criteria:

1. Acute Liver Failure as an indication for transplant
2. Pediatric transplants
3. Presence of Yerdel grade III and grade IV Portal vein thrombosis
4. Presence of significant portosystemic shunting (greater than 10mm) in pre operative period.
5. Patients who have undergone TIPS procedure.
6. Hypercoagulable states like Budd-Chiari syndrome
7. Refusal to participate in the study
Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

The most common type of stroke is ischemic (lack of blood flow to the brain due to a clot blocking a blood vessel). Time is brain and an average of 1.9 million brain nerve cells per minute are destroyed in patients experiencing a typical LVO. The main goal of treatment is to help restore blood flow as quickly as possible and prevent brain tissue and cell death. Acute treatments like clot-busting medication or clot removal by wire are standard of care but are available in comprehensive stroke centers in a few urban centers. Often, patients need to be transferred to these centers via ground or air ambulance, sometimes over hours, and no active treatment can be provided during these transfers.

Enhancing or increasing blood flow to the brain is associated with good outcomes in stroke. This study involves an innovative approach combining two treatment interventions - Remote ischemic conditioning (arms) and Air compression therapy (legs, applied simultaneously to all four limbs, that may help improve blood flow to the brain. Remote Ischemic Conditioning is a type of treatment delivered with the help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles, much akin to blood pressure measurement, but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Air Compression is delivered by a commercially available device (Normatech Elite). They are inflatable sleeves resembling puffy thigh-high boots that deliver compressive pulses stimulating blood flow in the legs, in a graded manner from the ankles to the thighs. We believe this air compression device may help improve and divert blood flow to stroke-affected areas in the brain.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Both male and female participants will be included
3. History of Stroke Symptoms
4. Baseline modified Rankin scale score \< 2
5. Participant or substitute decision-maker able to provide informed consent.

Exclusion Criteria:

1. Injury to the upper arms, lower limbs (from ankles to thighs), or any other musculoskeletal disability/pain that precludes tolerating RIC and/or Pneumatic compression therapy.
2. History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.
3. History of peripheral arterial disease
4. Treatment of ongoing malignancy with expected survival \< 6 months
5. Presence of hypertensive urgency and emergency
6. Presence of hemodynamic instability and ongoing pulmonary edema
7. Presence of clinical or imaging signs of raised intracranial, intrathoracic, and /or intra-abdominal pressure.
8. Presence of ongoing systemic infection with antibiotic therapy
9. Pregnant and lactating women
10. Participant not part of other clinical intervention trial
A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong

In this retrospective study, we aim to investigate the demographic and clinical features of patients with nontuberculous mycobacteria (NTM) lung disease in our hospital and the trends and diversity of NTM species isolated in the period of 2009-2018.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* patients with one or more respiratory isolates (namely, sputum, tracheal aspirates, bronchial washing, bronchial aspirates, bronchial trap and bronchoalveolar lavage) of mycobacteria collected in the Prince of Wales Hospital in the period of 2009-2018.

Exclusion Criteria:

* none
Muscle Fatigue and Carbonic Anhydrase Inhibitors

The objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years.
* Regularly physically active
* Male

Exclusion Criteria:

* current or ex-smokers
* pulmonary function \<80% of predicted
* esophageal tumour or ulcer
* have had recent (\<6 months) musculoskeletal injury or any surgery to the lower leg
* have contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
* are obese (BMI \>30 Kg/m2)
* taking diuretics, blood thinners, or anti-platelet drugs.
Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study

The aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of Quetiapine XR in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.

Description of the use of Quetiapine Extended Release (XR) in real-life practice in France

Eligibility Criteria:
Inclusion Criteria:

* New patients treated with Xeroquel XR
* Patients aged 18 years and over
* Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria

Exclusion Criteria:

* Patient included in a therapeutic trial (Huriet-Serusclat Act)
* Patient refusing to participate in the study
* Pregnant women
NMES in Critically Ill Patients

Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.


Eligibility Criteria:
Inclusion Criteria:

* All adult ICU patients with a predicted prolonged ICU stay

Exclusion Criteria:

* Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, ...)
* Receiving neuromuscular blocking agents
* Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease )
* Focal neurological conditions of the pelvis and/or lower limb
* Skin disease (e.g. burns)
* Presence of a pace-maker or defibrillator
* Hemodynamic or Respiratory Instability, active cardiac ischemia
* High fever (\>39°)
* Pregnancy
* Brain death
* Intracranial pressure \>20 mmHg
* An anticipated fatal outcome
* Psychiatric disorders or severe agitation
* Re-admission to the ICU
Neuromuscular Training in Female Youth Soccer

The goal of this clinical trial is to analyze the effectiveness of an NMT-based, injury prevention training program ('FIFA 11+ for Kids') in pre-adolescent (Ages 8 to 11) elite female soccer players by measuring neuromuscular control and motor coordination through pre-intervention and post-intervention testing. As well as monitoring the incidence of injury throughout a soccer season.

This study will recruit females aged between 8-11 from several teams within a large, competitive elite soccer club. Whole teams will be assigned to either the intervention group or an age-matched control group. Participants will be informed which group they will be placed in prior to participation in the research study. As directed by their respective coaches, the intervention group will receive neuromuscular training (NMT) through an already established, validated protocol (FIFA 11+ Kids); whilst the control group will perform their standard warm-up during soccer practice sessions. The program will last for the duration of the spring soccer season (January - May 2023; 5 months). All study participants will be required to attend two evaluation sessions (pre-intervention and post-intervention) in order to measure performance in speed, agility, hop testing, dynamic balance and strength.

Eligibility Criteria:
Inclusion Criteria:

* Elite female soccer players aged 8-11.
* Member of an elite youth soccer club.

Exclusion Criteria:

* Female not aged 8-11 years old.
* Not a member of a youth soccer club.
* Unable to attend the pre-intervention or post-intervention evaluation, for reasons other than injury.
* Unable to attend 80% or more of scheduled training sessions.
* If a participant discontinues playing soccer they will be excluded.
* Declines to participate in study.