cyrilzakka/clinical-trials huggingface dataset:
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery

There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.

Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.

As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial neuromuscular blockade is usually maintained during general anesthesia for MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.

Eligibility Criteria:
Inclusion Criteria:

* Those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution

Exclusion Criteria:

* Patients were excluded from the study if they had any of following: severe cardiopulmonary disorder with hemodynamic unstability (pulmonary hypertension, cardiomyopathy, mechanical ventilation, American Society of Anesthesiologists physical status III or more), severe hepatic or renal disease.
* Those who can not undergo MEP monitoring due to central or peripheral neuromuscular disease, e.g. cerebral palsy, myasthenia gravis, acute spinal injury, neurologic shock
Theracal Pulpotomy in Primary Molars

Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* healthy, cooperative children
* mandibular primary molars with vital pulp exposures

Exclusion Criteria:

* clinical or radiographic evidence of irreversible pulpitis
* physiological root resorption
SeRenade Parent-Child Music Class Program

This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.

This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on families of children with and without autism spectrum disorders (ASD). This study examines the impact of this program on social development in children with ASD, parental stress and efficacy, and parent-child relationships. A primary goal of this study is to examine multiple levels of analysis including families' experience within and outside of the music class program.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with ASD or children without ASD

Exclusion Criteria:

* currently enrolled in music therapy or parent-child music classes (for children with ASD); significant behavior problems (e.g., aggression toward other children); significant hearing or visual impairments
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)

In this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 3parts(Part1-3). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.

To evaluate safety and efficacy of CBA-1205 in the following three parts in a stepwise manner:

* In Part 1, safety and tolerability in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.
* In Part 2, safety and tolerability in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.
* In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.
* PK analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients who provide voluntary written informed consent to participate in the study
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment:

Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.

* Patients having solid tumors with no standard therapy available or refractory or intolerable to standard therapy
* Patients with unresectable advanced/recurrent hepatocellular carcinoma refractory or intolerable to standard therapy (Part2, 3: HCC)
* Patients with Child-Pugh A or B (Part2, 3; HCC)

Exclusion criteria:

* Patients who have undergone major surgery within 28 days before enrollment
* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
* Patients who have received any other investigational product within 28 days before enrollment
* Patients with current or previous inadequately controlled or clinically significant cardiac disease
* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate
Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

The current study will compare the effectiveness as well as the safety of Itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal 5.

Exclusion Criteria:

* Patients who met the following criteria were excluded:

  * Age less than 18 years or more than 60 years.
  * Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
  * Clinically significant hepatic dysfunction. (\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
  * Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
  * Patients with arrhythmia or atrioventricular blocks.
  * Any condition or comorbid disease that might interfere with gastric emptying such as diabetes.
  * Patients with head injuries.
Qualitative Descriptive Study of the Meaning of the Ward Round

1. A qualitative descriptive design.
2. A phenomenologic approach to investigate the meaning of the ward round.
3. Interviews of patients, nurses and physicians.
4. A Master thesis.


Eligibility Criteria:
Inclusion Criteria:

* Grown-ups, normal cognitive function, speaks norwegian.

Exclusion Criteria:

* Children, vulnerable patientgroups, students.
Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.

To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.

A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 weeks or more.
* Preeclampsia/eclampsia

Exclusion Criteria:

* Epilepsy or seizures previous to pregnancy.
* Renal disease
* Heart disease
* Liver disease
Constructing a Model of Pupillary Parameters in Predicting Delirium Among Critically Ill Patients in the Intensive Unit

Delirium is commonly observed in critically ill patients in intensive care units (ICUs), imposing significant burdens on both patients and the healthcare system. Existing assessment tools have certain limitations. Studies have indicated a correlation between pupil parameters and neurological disorders including delirium. Automated Infrared Pupillometry, widely used in neurological disorders, is employed in this study to assess its accuracy and predictive power in evaluating delirium among critically ill patients. The aim is to investigate the accuracy and predictive capability of these parameters in assessing delirium, while identifying the optimal cut-off points. The research findings will contribute to enhancing early detection and prevention of delirium in ICU settings.

Delirium is an acute impairment of attention and cognitive function commonly observed in critically ill patients in intensive care units (ICUs). It leads to long-term cognitive impairment and increased risk of mortality for patients, while also causing distress for healthcare providers and family members, imposing substantial burdens on patients, families, and healthcare systems. Although there are assessment tools and predictive models available for detecting delirium, they have certain limitations.

Recent studies have indicated an association between delirium and the neurotransmitter acetylcholine (ACh). Acetylcholine not only regulates consciousness and cognitive wakefulness but also modulates pupil constriction and light reflex. In clinical practice, the Automated Infrared Pupillometry (AIP) has emerged as a robust tool for assessing acetylcholine, aiding in early delirium detection. However, more research is needed to clearly establish their relationship. This study aims to investigate the accuracy and predictive power of Automated Infrared Pupillometry in assessing delirium among critically ill patients. It involves collecting pupil parameters from critically ill patients and examining the correlation between delirium and pupil parameters using the Intensive Care Delirium Screening Checklist (ICDSC). The goal is to explore the accuracy and predictive capability of these parameters in evaluating delirium, identifying optimal cut-off points. The findings will contribute to enhancing early detection and prevention of delirium in intensive care settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit from internal and surgical departments.
* Ages 18 and above.

Exclusion Criteria:

* Acute brain injury (hemorrhagic, ischemic stroke).
* Other brain-related diseases (brain tumor, brain infection, oculomotor nerve paralysis, etc.).
* Ophthalmic diseases that prevent monitoring of pupil measurements.
* Patients with pre-hospital cardiac arrest or in-hospital cardiac arrest.
* Estimated stay in the intensive care unit not exceeding 72 hours.
* Refusal to participate in this study.
Bedtime Stories: A Sleep Health Education Program for Healthcare Providers

This is a pilot intervention of the Bedtime Stories Sleep Health Education Program for healthcare providers serving school aged children and their caregivers. The intervention uses a pre-post design across participants.

To date, there are no established sleep health education programs for healthcare providers. To address this gap, the investigators previously conducted semi-structured interviews with community-based healthcare providers to improve our knowledge and understanding of healthcare providers' attitudes and beliefs about sleep health, factors that may contribute to poor sleep health, and identify potential sleep health promotion strategies for low income, racial and ethnic minority children and their families. Data from those sessions helped to inform and refine content to develop a sleep health education program for community healthcare providers. The purpose of this protocol it assess the effectiveness of the Bedtime Stories Sleep Health Education Program in Community Healthcare Providers (BTS-HP).

Healthcare providers from participating community healthcare centers will be invited to participate. Once a healthcare provider expresses interest in participating, they will receive a REDCap link to provide their informed consent. The provider will then complete a short demographic questionnaire via REDCap. Once the healthcare provider consents and completes the short questionnaire, they will receive a secure link to the Bedtime Stories Sleep Health Education Program for Healthcare Providers (BTS-HP). The BTS-HP is an online sleep health education program supported by the Boston Children's Hospital Department of Education (CE Courses - BCH Education (childrenshospital.org). The provider will also receive access to an educational webinar on Melatonin. The provider can participate all modules and the webinar in one sitting or overtime. Once the provider completes the online modules, they will immediately receive an email with a REDCap link to complete their post-participation questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over
* Community Healthcare Provider (physicians, residents, registered nurses, nurse practitioners) at participating community healthcare centers in the Boston area
* Serve families with school-aged (4-10 years of age) children
* English fluency

Exclusion Criteria:

* Community healthcare providers that do not see school-aged children (4-10 years of age)
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 25-30 kg/m2

Exclusion Criteria:

* type 2 diabetes,
* treatment with antibiotics within the past 3 months
* history of gastrointestinal diseases (Inflammatory bowel disease, Crohn's disease, malabsorption etc )
* cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study
* thyroid disorders not controlled by drug therapy,
* kidney (creatinine \>1.7 mg/dl or proteinuria) and liver diseases (ALT/AST \>twice the upper limits)
* anaemia (Hb \<12 g /dl)
* pregnancy or breastfeeding,
* celiac disease, cancer or any other chronic disease
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
* Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
* Screening HbA1c ≤8.5%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
* Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45 kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol
A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients

The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load (level of HIV in the blood) and raising the level of CD4 cells (cells of the body that help fight infection).

Patients are randomized to receive one of three doses of 1592U89. During this randomized dosing phase, if a patient meets one of the following criteria, he/she is offered open-label 1592U89 (300 mg) plus zidovudine (ZDV) plus lamivudine (3TC) (or other licensed antiretrovirals according to standard practice). Criteria are based on falling CD4 counts (return to baseline on two occasions at least 1 month apart), disease progression (defined as occurrence of a new AIDS-defining event according to CDC classification excluding CD4 counts less than 200 cells/mm3), or lack of virus suppression (defined as less than 0.7log10 reduction in viral load at Week 4 with a repeat value 1 week later, more than 5000 copies/ml HIV RNA at Weeks 12, 16, 20, or 24, or 5000 copies/ml or more anytime after Week 24).

Eligibility Criteria:
Dental Support Device During Breastfeeding as a Mean for Pain Control

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Dental support device is effective in increasing isometric force in different muscle contraction \[1-7\]. In 2009 an avant-garde study \[8\] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age 18-45 years.
2. Normal vital signs.

Exclusion Criteria:

1. Contraindications for breastfeeding.
2. Significant systemic disease that cause pain or require chronic pain relief.
Epidural Sonoanatomy Between Parturient and Non-Pregnant

The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. This may result in multiple trying attempts at needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of this study was to explore the difference of epidural space between parturient and non-pregnant women by assessing ultrasound image.

We will enroll 30 non-pregnant female volunteers and 30 parturients(ASA I-III) underwent epidural blocks. A low frequency ultrasound (2-5 MHz) with a curved array transducer is used to obtain spinal sonography for each subject. The paramedian axis was used to obtain optimal ultrasound image for spinal sonography. Outcome was evaluated by the diameter and depth of epidural space at three lumbar interspaces. Paired T-test was carried out to evaluate the statistical significance of epidual diameter and depth.

Eligibility Criteria:
Inclusion Criteria:

* parturients scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia

Exclusion Criteria:

* Pregancy induced hypertension gestational Diabetes patients who refuse
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.

The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
2. TR grade ≥3+ (5 grade classification)
3. Patient is eligible to receive the PASCAL device per the current approved indications for use

Exclusion Criteria:

1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
4. Any patient considered to be part of a vulnerable population