cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI

Patients undergoing Percutaneous Coronary Intervention (PCI) are exposed to the risk of suffering from a damage to the kidneys which goes under the name of Contrast-Associated Acute Kidney Injury (CA-AKI), which is more common if the subject has advanced heart or kidney disease. Up to 1 high risk patient in 3 can suffer from CA-AKI. Impella is a pump which sustain the heart in the course of PCI in high risk individuals. Incidentally, Impella was shown to also reduce the incidence of CA-AKI. The reason why Impella protects the kidneys is not currently known. The investigators aim at understanding it through measurements of kidney blood flow and metabolism.

Contrast-associated acute kidney injury (CA-AKI) is among the major determinants of morbidity after percutaneous coronary intervention (PCI). Patients undergoing complex, high-risk indicated procedures (CHIP) are exposed to an increased risk of CA-AKI. Recent observational data suggested that mechanical circulatory support (MCS) with Impella in the course of CHIP PCI, i.e. Impella-protected PCI, may abate the risk of CA-AKI. A direct effect of MCS in improving renal perfusion has been postulated, but mechanistic evidence on the pathophysiologic effects of Impella on kidney hemodynamics is lacking. The investigators hypothesize that such improved renal outcomes during Impella protected PCI are attributable to increased blood flow as well as increased oxygen delivery to the kidneys granted by MCS. The aim of the present study is to fully characterize the renal hemodynamics as well as renal oxygen delivery and consumption during Impella-protected PCI using state-of-the-art invasive measurements, and to correlate those with functional magnetic resonance imaging of the kidney.

Eligibility Criteria:
Inclusion Criteria:

Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program

* Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature
* LVEF ≤45% and estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2 and ≥1 complexity feature
* LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features

Complexity features

* Planned treatment of ≥2 vessels
* Left main PCI
* Bifurcation intervention with 2-stent strategy
* Planned use of atherectomy (rotational, orbital, laser)
* Chronic total occlusion PCI
* PCI on last remaining vessel
* LVEDP \>18 mmHg
* Cardiac index \<2.0 l/min/m2 or pulmonary artery O2 saturation \<55%

Exclusion Criteria:-

* Pregnancy or lactation
* Presence of non-MRI compatible implanted medical device
* Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis
* Chronic hemodialysis before the index procedure
* Status post-renal transplant
* Prisoners
Salivary C- Reactive Protein, Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis

To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis


Eligibility Criteria:
Inclusion Criteria:

* - Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following:
* (1) temperature instability (hypothermia, hyperthermia) .
* (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) .
* (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) .
* (4) neurologic alterations (hypotonia, lethargy, seizures)
* (5) gastrointestinal alterations (feeding intolerance, abdominal distension). CRP values \>10 mg/L were considered to be positive.

Exclusion Criteria:

* - Preterm neonates .
* Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study
Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery

Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients with motor deficits. As shown in previous reports brain stimulation can, in fact, interact with the intrinsic ability of the brain to "repair" damaged brain functions, increasing the involvement of compensatory functional networks and thus inducing neuroplasticity. If these low-cost, easy-to-use stimulation techniques prove to be useful in improving motor deficits with long-term effects, the current study would open up new and interesting avenues in the field of neurorehabilitation. Given the potential long-lasting effects of tDCS, there is currently a growing interest in the clinical sector with the aim to reduce motor deficits in patients with brain injury. The most widely used protocols in stroke patients include the application of either anodal on the hypsilesional hemisphere or cathodal tDCS on the unaffected hemisphere (contralateral), so as to increase and decrease the excitability of the motor cortex, respectively (Nitsche and Paulus, 2001).

The main objective of this study is to evaluate the effectiveness of transcranial direct current stimulation in enhancing the functional recovery of the upper limb of stroke patients after three weeks of neuromotor training and subsequent follow-up. The secondary objective is to evaluate the treatment effects on balance, gait, motor dexterity and disability, besides the functional recovery of the lower limb.


Eligibility Criteria:
Inclusion Criteria:

* First-ever ischemic stroke
* Red or white stroke
* Barthel Index \> 90 before lesion onset

Exclusion Criteria:

* Previous inborn neurological disease
* Previous acquired neurological disease
* Previous or current major psychiatric illness
* Epilepsy or anticonvulsant treatment
* Use of calcium channel blocker drugs
* Treatments with other technologies (robotics, FES, etc.)
* Neurolytic treatments with botulinum toxin
Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya

The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age
2. Have provided verbal and written informed consent
3. Willing to comply with all study related visits and procedures

Exclusion Criteria:

* None
Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weaknesss

Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.Thyroid disorders are also associated with neuromuscular abnormalities and may decrease the threshold for the development of any type of myopathy. However, no previous study investigated the direct relationship between thyroid dysfunction and ICUAW.This study aims at evaluation of the association between thyroid dysfunction and intensive care unit acquired weakness.

Intensive care unit acquired weakness refers to muscle weakness encountered in the intensive care unit as a consequence of critical illness. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.

There are three distinct entities for ICUAW that can only be differentiated by neurophysiological studies. These are critical illness myopathy (CIM), critical illness polyneuropathy (CIP) and critical illness neuromyopathy (CINM).

Identification of risk factors responsible for the development of ICUAW is the first step in the prevention and management of this disorder. Till time septic shock, hyperglycemia, high dose steroid therapy, prolonged mechanical ventilation and the use of neuromuscular blocking agents are the main accused.

Thyroid disorders are also associated with neuromuscular abnormalities. Unfortunately, the prevalence of thyroid dysfunction in the intensive care is high reaching 90%. Moreover, patients with severe critical illness, who are typically prone to the development of ICUAW, show changes in their thyroid biochemistry namely low T3 levels (with or without low T4 levels) in the presence of normal TSH levels. These changes are collectively known as Non-Thyroidal illness syndrome (previously low T3 syndrome and Euthyroid sick syndrome) which is the most common form of thyroid dysfunction in the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes admitted to the general ICU of Ain Shams University Hospitals with critical illness for more than 7 days \* Diagnosis of ICU acquired weakness will be made based on clinical criteria for ICUAW and confirmed by nerve conduction studies.

Exclusion Criteria:

* Patients with cerebrovascular accidents, neuromuscular disorders, spine abnormalities, spinal cord or head injuries, CNS tumors, secondary thyroid disorders and electrolyte disturbances were excluded from the study. Patients receiving thyroid replacement or anti-thyroid drugs for the treatment of any throid disorder will be also excluded from the study as these drugs may alter their thyroid biochemistry
Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test

Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical presentation of a patient in each visit is not representative of the current disease status. Dermatologists are trying to integrate an evaluation process of each treatment visit regarding both clinical condition and life quality concern. The Urticaria Control Test is the key for a better treatment outcome in a routine management. To translate this questionnaire into Thai is essential in our subject of interest for offering local patients a higher well-being standard. The Thai-version test will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

1. Independently adaption of the UCT questionnaire into Thai version by using forward-backward translation by two bilingual translators. The original German version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version UCT questionnaire for items comprehensibility and integrates the first consensus version which re-translated into German by German native speaker afterwards. The comparison between the backward German version UCT questionnaire and the original UCT is carried out to find out any misconception and mistranslation in the intermediary forward version of questionnaire. The second version will be tested on 15 chronic urticaria patients to detect any misunderstanding points. Finally, this Thai-version of UCT questionnaire will be used to investigate the validity, reliability, interpretability and minimal clinical important difference.
2. To investigate the validity, reliability and interpretability of Thai-version of Urticaria Control Test, the severity of urticaria symptoms will be assessed by investigators and patients using UAS28, Patient's global assessment of disease severity (PatGA-LS), Physician's global assessment of disease control (PhyGA-LS), the UCT and DLQI questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or above
* Diagnosed as chronic urticaria based on "The EAACI/GA(2) LEN/EDF/WAO Guideline: the 2013 revision and update" by dermatologists
* Literate in Thai language and can complete the questionnaire by themselves.

Exclusion Criteria:

* Have other active skin diseases
* Have a psychiatric problem
* Cannot understand the questionnaire by themselves.
Pain Control for Anterior Cruciate Ligament Reconstruction Patients With Adductor Canal or Femoral Perineural Infusions

Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. Recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("Adductor Canal" and "Femoral"). However, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. The investigators plan to study this by randomizing patients presenting for ACL reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and CPM compliance.

covery score, opioid use, and CPM compliance.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years
* ASA physical status I, II, or III
* Scheduled for ACL reconstruction surgery with patellar autograft

Exclusion Criteria:

* Pregnancy
* Incarceration
* Age \<18
* BMI \>35
* Pre-operative opioid use \>15 mg morphine equivalents per day
* Inability to communicate with investigators by telephone
* Pre-existing neuropathy of the operative extremity
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting \> 3 months or ≥ 2 flares within the previous 12 months.
* Screening and baseline IGA-CHE 3 or 4.
* Baseline CHE-related Itch NRS ≥ 4.
* Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
* Willingness to avoid pregnancy or fathering children based on the criteria below.

Exclusion Criteria:

* Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
* Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
* Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Laboratory values outside of the protocol-defined criteria.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
* Further exclusion criteria apply.
Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects with ARDS: a Prospective Physiological Study

The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways，and analyzed the correlation of the optimal PEEP in these different ways.


Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanical ventilated patients in ICU within 48 hours
* Be over 18 years old
* With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)

Exclusion Criteria:

* Severe chronic obstructive pulmonary diseases
* Pulmonary bulla(\>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
* Pregnancy
* BMI≥35kg/m2
* Suspected pulmonary vascular hemorrhage
* Disturbance of consciousness or intracranial hypertension
* Severe cardiac dysfunction (New York Heart Association Class III or IV, acute -Coronary syndrome or persistent ventricular tachyarrhythmia), cardiogenic shock or after major cardiac surgery
* Hemodynamic instability (i.e., mean arterial pressure \[MAP\]\<60 mm Hg despite vasopressor use
* The medical team considering short periods of high pressure to be unsafe
* Contraindications for placement of esophageal pressure catheters (e.g., esophageal varix or fracture of skull base)
* Contraindications for EIT monitoring (including pacemaker, or cutaneous diseases which limiting electrode placement)
* Agonal stage or end-stages of diseases
Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort

The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for outpatients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.

All major community and academic clinics treating HIV-infected persons in the District of Columbia (DC) will initially be included in the development of a city-wide "DC Cohort" of HIV-infected persons in care, with consideration to be given subsequently to the inclusion of large private physician practices. Socio-demographics, risk factors, treatments, diagnoses, labs and procedures documented in outpatient medical record systems will be included in the DC Cohort database. Routine reports will be generated every six months for sites comparing their participants' socio-demographics, clinical status, treatments, and outcomes to all other data in the DC Cohort database, and other comparisons specifically requested by sites. All sites will be provided analytic support in research areas of interest.

Eligibility Criteria:
Inclusion Criteria:

* Patient is receiving care for HIV at one or more of the twelve participating clinics in the DC Cohort.
* Patient is either age 18 years or older, or seeks HIV care independently and is able to understand and sign informed consent.
* Patient is a minor who is consented by a parent or legal guardian.

Exclusion Criteria:

* Patient is unable or refuses to provide informed consent.
* Minor children ages 12 through 17 who are unaware of their HIV status
Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome (CVS)

The primary aim of this study is to characterize the quality of life of youth with Cyclic Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at risk youth. The impact of CVS on the child's parent and family will also be assessed.

A second aim is to evaluate the associations among coping strategies, personal strengths and vulnerabilities and the frequency and intensity of CVS attacks to determine if particular coping styles and personal characteristics are associated illness severity, psychiatric co-morbidity and quality of life


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CVS

Exclusion Criteria:

* Children and parents who are not English speaking
* Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.
Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease

The aim was to investigate whether endoscopic balloon dilatation combined with PRP injection can help prevent or prolong restenosis in patients with Crohn's disease with colonic stenosis, and to explore the concentration of PRP. The study was a single-center, randomized, non-controlled study. Experimental group of patients underwent endoscopic balloon dilation and submucosal injection of PRP (PRP prepared by the blood transfusion department of our hospital) at the wound edge, historical control was used, and the patients included in the study were randomly divided into high concentration group and low concentration group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as CD;

  * Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation \>3cm;

    * Narrow length \<5cm; ⑤ The patients agreed to undergo endoscopic balloon dilatation and voluntarily signed the informed consent to participate in this study, and were capable of complying with the agreement.

Exclusion Criteria:

* The patient has contraindications for endoscopic therapy, such as coagulation disorder, severe cardiopulmonary dysfunction, active bleeding, and inability to cooperate.

  * Deep and large active ulcer was found in the stenosis;

    * \< 18 years old;

      ④ Foreign patients;

      ⑤ Patients with a history of malignant tumors, including melanoma (except local skin cancer);

      ⑥ Pregnant or nursing patients;

      ⑦ Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk;

      ⑧ Other diseases that researchers believe could put patients at risk.