cyrilzakka/clinical-trials huggingface dataset:
Point of Care Ultrasound in Obstetric Triage

The research will find out if using portable ultrasound devices by nurses can make it quicker to get babies from 24 to 32 weeks on the doppler monitor.

In an acute obstetric unit such as labor and delivery triage, rapid determination of fetal status is crucial for optimal fetal outcomes. In most units, nursing staff holds the initial role of patient care for both mother and fetus. The expeditious and efficient application of external fetal monitoring (cEFM) acts as the cornerstone of fetal assessment in triage; however, factors such as early gestational age or maternal habitus may make an assessment with doppler alone challenging. The limited availability of physicians to assess with large, mobile bedside ultrasound units in these cases results in delays in care and decreases efficiency on the unit. Advanced ultrasound technology allows for the ready availability of point-of-care ultrasound devices using probes that connect to portable electronics through applications. Studies performed in low-resource and remote areas have demonstrated the utility of training nursing staff to perform point-of-care ultrasound (PoCUS); however, the literature needs to include studies performed at major academic centers. The study aims are to determine if the utilization of handheld PUM by nursing staff, as an ancillary tool to assist with applying cEFM in early preterm pregnancies, leads to decreased delays in the successful application of cEFM. The Butterfly Portable Ultrasound Device will be used for this study, which is a PUM that is lightweight, ultraportable and generates quality images equal to or better than the current larger SonoSite devices available. Secondary outcomes will examine the need for physician exams with bedside portable SonoSite ultrasound to apply cEFM as well as time to bedside once a physician is called for evaluation with bedside SonoSite.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

* Women maternal age 18 to age 50
* Gestational age between 24 weeks 0 days and 32 weeks 0 days
* Singleton pregnancy.

Exclusion Criteria:

Patients will be excluded if:

* They are incarcerated
* Outside the gestational window for inclusion
* Are below the age of 18
* If the fetus has a known lethal anomaly and a decision has been made by the patient to decline fetal monitoring.
LIFT: Telemedicine Breastfeeding Support

The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation


Eligibility Criteria:
Inclusion Criteria:

* maternal age 18-49 years
* late preterm delivery (34-37 6/7 weeks)
* enrollment up to 1 week postpartum
* breastfeeding initiated
* access to a smartphone, tablet, or laptop computer in their home

Exclusion Criteria:

* incarceration
* inability to communicate in English
* infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).
24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia

The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (\>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy.

Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase

Exclusion Criteria:

* Significant and/or unstable systemic illnesses
* Allergy or hypersensitivity to risperidone or paliperidone
* Significant risk of suicidal or violent behavior
* Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant
Comparison of Two Types of Face Mask Ventilation in Obese Patients

Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.

The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.

The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.

Eligibility Criteria:
Inclusion Criteria:

* obesity
* scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* predicted difficult intubation
* predicted difficult face-mask ventilation
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C ≥ 70 mg/dL
* High cardiovascular risk (diagnosis of HeFH or ASCVD)
* Be on maximally tolerated lipid-modifying therapy

Exclusion Criteria:

* Total fasting triglyceride ≥500 mg/dL
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50kg/m2
* Significant cardiovascular disease or cardiovascular event in the past 3 months
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial

The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children with Crohn disease.

Skeletal growth is characterized by increases in the size of the hard outer layer of bone (cortical bone), and the density of the inner layer of bone (trabecular or "spongy" bone). Children with Crohn disease (CD) have numerous risk factors for impaired bone accumulation, including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and inflammation. We reported that children with CD had significant deficits in trabecular bone mineral density (BMD), cortical dimensions, and muscle mass; bone deficits were strongly associated with muscle deficits. No trials of therapies that build bone or prevent bone breakdown have been conducted in chronic pediatric inflammatory diseases. The capacity to increase bone mass and dimensions in response to mechanical loading is greatest during growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical stimuli (LMMS) enhances bone mass and quality. This 12-month double blind, placebo controlled randomized trial will evaluate daily 10-minute treatments with LMMS in 160 children with CD. Trabecular BMD, cortical dimensions, and muscle area will be measured by quantitative computed tomography (QCT). The LMMS device monitors adherence; these data will be transmitted by modem to the psychologist who will work closely with subjects to optimize adherence. All subjects will be provided with calcium and vitamin D supplements. The primary aims are to determine if treatment with LMMS results in increased trabecular BMD in the lower leg and spine and increased cortical dimensions in the lower leg in children with CD, compared with placebo controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-21 years
* Diagnosis of Crohn disease \> 6 months
* Tibia vBMD z-score \< 25th%tile for age and sex

Exclusion Criteria:

* Pregnancy
* Weight \> 250 lb
* Medical illness (unrelated to Crohn)
* Cognitive/developmental disorder
* Do not speak English
* \> 1 primary residence
* Unwilling to commit to 2 year study
* Sibling or cousin enrolled in trial
NOninVasive Intracranial PrEssure from Transcranial DoppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients

This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length.

Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support:

Development and validation of noninvasive intracranial pressure (nICP) algorithms.

Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients

Development and validation of noninvasive approaches of detecting elevated ICP state.

Development and validation of approaches to determine most likely causes of ICP elevation.

Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years of age and older
2. Subjects who have an ICP Monitoring device

Exclusion Criteria:

1. Unstable medical illness such as recordings might interfere with medical care.
2. Subjects that don't have a viable temporal window to insonate the MCA.
3. Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.
Transverse vs Longitudinal Incision in Myomectomy

The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
2. Single myoma.
3. Women with BMI between 18.5-29.9 kg/m2.

Exclusion Criteria:

1. Pregnancy.
2. Patients with bleeding tendency
3. Previous laparotomies.
4. Patients with concomitant pelvic pathologies, such as ovarian cysts.
Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy

Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP

Hemiparetic CP affects one side of the body, typically with marked involvement of the upper extremity, and is associated with reduced selective motor control and limited forearm supination . Hemiparetic child has a significant reduction of the effective use of the arm and hand in ADL (e.g. drinking, eating, accomplishing self-care, combing hair or dressing), and their participation at home, school, and later vocational roles .

Finding a therapeutic modality to improve ROM of forearm supination is an issue of concern in this study as a child uses varying degrees of supination throughout the day to complete simple activities. Some tasks only involve a person to use half of their supination ROM (e.g: clapping hands together) while other activities require a person to supinate through their full ROM (e.g: carrying a lunch tray). Hemiparetic child has limited supination movement, therefore this study will be conducted to investigate and compare between the therapeutic outcomes of kinesiotaping and wrist wheel on ROM of forearm supination which is important for upper extremity functions of the children with HCP.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from six to eight years.
* Diagnosed as HCP.
* Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale.
* Children had impaired hand functions level II and III according to Manual Ability Classification System.
* They had the ability to follow simple verbal commands regarding assessment and treatment

Exclusion Criteria:

* Sever visual or auditory problems
* Children with severe sensory at the affected upper limb.
* Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb)
* Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.


Eligibility Criteria:
Inclusion Criteria

* Participants must have relapsed or refractory multiple myeloma (RRMM).
* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).
* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
* Participants must have measurable disease during screening.
* Participants must have adequate organ function.
* Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.

Exclusion Criteria

* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
* Participants must not need urgent treatment due to rapidly progressing MM.
* Other protocol-defined Inclusion/Exclusion criteria apply.
The Effectiveness of Augmented Reality Facilitated Education in Promoting Care Management of Malignant Fungating Wounds Among Oncology Nurses

Malignant fungating wounds (MFWs) affect 5-14% of patients with advanced cancer, making them a common complication in this population. Characterized by symptoms such as foul odor, heavy exudate, bleeding, moderate to severe pain, and infection, MFWs cause significant physical discomfort and pose life-threatening risks while also leading to profound psychosocial issues, including shame and social isolation. These factors severely impact patients' quality of life, with half of those diagnosed surviving only six months on average.

However, clinical nursing staff often lack adequate knowledge and skills in managing MFWs, with an average accuracy rate of just 56.5%. Notable deficiencies exist in areas such as wound disinfection, odor control, and wound assessment, directly affecting the quality of patient care and highlighting an urgent need for specialized MFW training. Traditional MFW education often lacks real-life clinical scenarios and hands-on practice, resulting in a gap between learning and application and leaving learners ill-prepared for the complexities of clinical settings.

In contrast, augmented reality (AR) technology presents new possibilities for nursing education. AR can create highly simulated clinical environments where learners can safely practice complex clinical skills, enhancing clinical decision-making abilities. The implementation of AR-based training programs provides nursing staff with a more realistic and effective learning experience, allowing them to better address the challenges posed by MFWs and ultimately contributing to improvements in patient care and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Full-time nursing staff working in oncology wards at a teaching hospital in northern Taiwan
* Individuals willing to participate in the study and who have signed the informed consent form

Exclusion Criteria:

* Nursing staff not assigned to oncology-related wards
* Individuals expected to be unable to complete full participation in the study
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* dignosed gastric adenocarcinoma
* tumor: size 4cm or smaller
* depth of invasion: mucosa, submucosa, proper muscle
* candidates of laparoscopic radical gastrectomy
* informed consent

Exclusion Criteria:

* metachronous malignancy
* number of tumors: 2 or more
* remnant gastric cancer
* indication for endoscopic resection
* history of chemotherapy or radiation therapy
* pregnancy
* allergy to ICG
* metastatic gastric cancer
Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies.

Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Demographics, splenic damage grade, approach (open or laparoscopic), surgery duration, intra-operative blood loss, transfusions, hospital stay, complications, and death were variables.

The spleen might be injured in left lower chest or upper abdomen trauma. Rib cage, diaphragm, pancreas, and bowel injuries may occur with splenic injuries. Hemodynamic instability, a rising heart rate, and low blood pressure are symptoms of damage, however the mechanism of injury requires a high index of suspicion.

Eligibility Criteria:
Inclusion Criteria:

* • At least 15 years old.

  * Male and female (not pregnant) patients; • Sonar and CT scans before surgery showed single splenic damage;

Exclusion Criteria:

* • Other damage to the abdomen, thorax, or nerves were found before surgery.

  * good use of non-surgical treatment or embolization
  * Woman who is pregnant.
  * Splenic cuts that go deep.
  * Previous surgery in the upper abdomen using a laparoscopic method. • Other injuries to the abdomen found during surgery, such as liver, intestine, or bladder injuries.
Brief Psychological Intervention for Suicidal Patients with Borderline Personality Disorder in the Emergency Department

When in crisis, people with borderline personality disorder (BPD) frequently seek care in emergency departments (EDs) often presenting with suicide and self-harm behaviour. There is no established evidence-based brief treatment for patients with BPD in ED settings, however a 4-session treatment for people with personality disorders in ED settings was tested in Australia and showed promising results in reducing health care use and improving symptoms. A recent pilot feasibility randomized controlled trial (RCT) comparing this 4-session treatment to treatment as usual was conducted at the Centre for Addiction and Mental Health and preliminary findings have shown that the treatment is feasible to deliver and acceptable to both patients and clinicians. The proposed fully powered RCT will build on this pilot data to assess the efficacy of delivering this 4-session intervention in the ED for people with BPD who present with suicidal ideation or self-harm with the aim of reducing emergency health care use and improving BPD symptoms, functioning and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Must be deemed to have capacity to provide informed consent;
2. Must sign and date the informed consent form;
3. Stated willingness to comply with all study procedures;
4. Aged 16 or older;
5. Presenting to ED with self-harm and/or suicidal ideation;
6. Meeting criteria for BPD on the International Personality Disorders Examination (IPDE).
7. Endorsing a score of 1 or greater on the Suicide Ideation Attributes Scale (SIDAS).

Exclusion Criteria:

1. Meeting DSM-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (SCID-5);
2. IQ \< 70 based on the Test of Premorbid Functioning (TOPF).