cyrilzakka/clinical-trials huggingface dataset:
The Association Between Visual Echocardiographic Scoring System and Clinical Outcomes in Patient With Acute Decompensated Heart Failure

This study aims to evaluate the association between visual echocardiographic scoring system (visual mitral and tricuspid = VMT score) with clinical outcome among patients with acute decompensated heart failure. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute decompensated heart failure. The data consist of demographic data, clinical presentation, laboratory, and echocardiographic result were collected from hospital registry by reviewing medical record and echocardiographic machine database. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility Criteria:
Inclusion Criteria:

* Patient with history of heart failure with reduced ejection fraction (LVEF \<40%)
* Age between 18 - 70 years old

Exclusion Criteria:

* Patient with pulmonary hypertension
* Patient with acute de novo heart failure (e.g. due to acute coronary syndrome)
* Significant valvular heart disease (more than moderate regurgitation or more than mild stenosis)
* Prior valve replacement/repair
* Patient with congenital heart disease
* Patient with pericardial disease
* Patient with poor echocardiographic images
Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC

The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Tumor marker (aFP, PIVKA) elevation
* Nodular lesion on USG
* Received RFA for HCC

Exclusion Criteria:

* hypersensitivity at iodine
* GFR under 30
* BMI over 30
* Nursing or pregnant women
* enrolled the other study
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain

The central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and Veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.


Eligibility Criteria:
Inclusion Criteria:

* men/women ≥18 years of age
* ability to understand and speak the English language
* current chronic pain diagnosis (including but not limited to ICD-9 diagnoses 338.0, 338.2xx, 338.
* current use of prescription opioids for \>3 consecutive months.

Exclusion Criteria:

* Mindfulness training experience (participation in MBSR/MBRP)
* opioid withdrawal evidenced by score ≥13 on the Clinical Opiate Withdrawal Scale
* current cancer diagnosis
* having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication
Staff Nurse Perceptions of MBT Skills Training for Working With BPD in AMH

Despite expert opinion unconvinced of any value for hospitalization in caring for people with borderline personality disorder (BPD), this patient group still accounts for a significant proportion of adult acute mental health (AMH) admissions. Staff nurses generally voice negative perceptions of BPD, a view which is linked to an uncertainty of how to approach these patients, and difficulties leading to personal distress and burnout. Mentalization-based treatment (MBT) is an evidence based approach, focusing on the mental states of both self and others, developed specifically to treat BPD and facilitated successfully in specialised settings. MBT Skills training is a compact and cost effective two day workshop which equips generalist mental health nurses with a skillset enabling them to work effectively with BPD. MBT Skills training was first offered to staff nurses in Royal Cornhill Hospital, Aberdeen in 2013. This study aims to assess staff perceptions on the value of MBT skills training, evaluating how it impacts on clinical practice when working with BPD in AMH.

Methodology: Using two focus groups with a neutral facilitator, a purposive sample of nine staff nurses took part in a semi-structured exploration of BPD in AMH. Participants discussed challenges with patients and the impact of MBT skills training and Clinical Supervision (CS). The focus groups were audio recorded and transcribed verbatim. Data was examined using a thematic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Staff nurses aged between 18 and 65, who had completed the 2 day Mentalization Based Treatment (MBT) skills training and were still working in acute mental health.

Exclusion Criteria:

* Staff nurses under 18 or over 65, who had not completed the 2 day Mentalization Based Treatment (MBT) skills training and were not working in acute mental health.
Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures

A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Having a BMI of at least 20 kg/m2
* Scheduled to undergo elective gynecological procedure
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* Individuals with BMI higher than 60 kg/m2.
* Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
* Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.
Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication

The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated. The study will assess the safety, tolerability, and ease of use of the EyeControl device, and examine its potential monitoring capabilities.

Critically ill patients, who are mechanically ventilated, suffer not only from their acute, potentially devastating illness, but also from the lack of ability to communicate in an effective manner. This is the direct result of the orotracheal tube or tracheostomy required for the mechanical ventilation, which does not allow speech to be produced. On top of the mechanical change in air flow, communication challenges result from sedation, neurological injuries (primary brain injury or secondary encephalopathy), and delirium.

Lack of communication can lead to increased frustration, anxiety, and overall psychological stress and could continue to the development of post-traumatic stress disorder (PTSD). On top of the subjective discomfort, the inability to communicate in an effective manner may impair medical care-for example, by failure to assess symptoms such as pain or breathing discomfort by behavioral cues only.

Currently, the solutions for communication deficits in mechanically ventilated patients are mainly using yes/no communication, attempting to write, and communication boards that allow people to point at defined pictures or letters. Recently, technological advancements led to incorporation of more sophisticated communication devices, proving the feasibility of an eye-tracking approach, for example.

The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. This approach eliminates the need for calibration, as most eye-tracking devices that use a screen require, and is relatively easy to operate.

This study will assess the safety, tolerability, and ease of use of the EyeControl device.

Eligibility Criteria:
Inclusion Criteria:

* Intensive Care Unit (ICU) Admission
* Mechanically ventilated for at least 24 hours
* Richmond Agitation Sedation Score (RASS) between -1 to 1 at the time of screening
* Ability to follow simple commands

Exclusion Criteria:

* Inability to follow commands during screening (at a minimum: open and close eyes, move eyes to one side or the other)
* Known cerebral injury (acute or chronic) in the dominant hemisphere concerning for aphasia on clinical assessment
* Significant pre-existing neurologic (i.e., dementia and/or cognitive deficiencies), psychiatric, or baseline communication challenges that would confound outcomes assessments
* Inability to blink or move eyes for any reason
* Prisoner or incarceration
* Inability or unwillingness to provide informed consent
* Unwillingness to be contacted for follow-up
Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip

The aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).


Eligibility Criteria:
Inclusion Criteria:

* Term infants
* Infants between 1 and 2 months of age at inclusion
* Clinically stable hip
* Pathological ultrasonography : pubo-femoral distance \>6mm and bony rim percentage \<50%
* Non objection of the family

Exclusion Criteria:

* Clinically unstable hip
* Normal ultrasonography
* Neuro-orthopedic disease
* Postural deformity of the pelvis
* Participation refusal
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years
* Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC)

Exclusion Criteria:

* Contraindications to MabThera/Rituxan therapy according to the approved SPC
Design of a Non-invasive Multi-modal Neonatal Monitoring System

This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.

300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.

The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.

The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.

To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.

Eligibility Criteria:
Inclusion Criteria:

* newborns less than 6 weeks old in corrected terms;
* newborns in one of the following situations:

  * persistent discomfort (apneas);
  * infection or suspicion of infection;
  * premature with uncomplicated evolution;
  * Premature brain lesion acquired in perinatal;
  * newborn having been exposed to premature rupture of the membranes.

Exclusion Criteria:

* Congenital malformation;
* Metabolic disease.
A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of carcinoma of the prostate without small cell features
* Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
* Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
* Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)

Exclusion Criteria:

* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
* Untreated central nervous system (CNS) metastases
* Leptomeningeal metastases
* Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Antibiotic Stewardship in Small Hospitals

Core elements of effective antibiotic stewardship programs (ASPs) have been identified and evidence-based guidelines have been developed for implementation. The majority of the evidence used for these guidelines are from published studies on the effectiveness of ASPs in large academic or large community hospitals. A significant portion of healthcare in the United States, however, takes place in small hospitals. In 2015, 73% of US hospitals had \< 200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days. Limited studies on the effectiveness of antibiotic stewardship implementation have been performed in hospitals with \< 200 beds. Antibiotic use rates and selection patterns in these small hospitals are similar to that of large hospitals and the majority of small hospitals lack formal ASP that meet the CDC's core elements. The objective of this real-world implementation study was to assess the effectiveness of three ASP strategies of escalating intensity designed specifically for small hospitals within a vertically integrated healthcare delivery system.

The investigators designed a clustered randomized controlled intervention to evaluate 3 antibiotic stewardship strategies designed for small hospitals. Each hospital was randomized to one of three ASP interventions with increasing levels of intensity and intervention (Programs 1, 2, 3). The investigators felt that clinical equipoise about the effect of ASPs did not exist and randomizing to a no-intervention group was unacceptable. Antibiotic use was compared within each group before and after the intervention. In keeping with other real-world implementation studies, secondary analyses were planned to include an interrupted time series design to evaluate the impact of each strategy. Randomization of hospitals was stratified based on patient volume. Hospital administration and clinical leadership were not blinded to which ASP program they were randomly assigned to, but there were no public announcements. The intervention started March 2014 and ended June 2015.

Eligibility Criteria:
Inclusion Criteria:

* Intermountain Healthcare acute care hospital with \< 200 licensed beds
* No formal antibiotic stewardship program in place

Exclusion Criteria:

-All Intermountain Healthcare specialty hospitals, regardless of bed size
Examination of Manual Skills in Individuals With and Without Chronic Neck Pain

This study will determine whether manual dexterity is affected in individuals with neck pain compared to individuals without neck pain. It is thought that determining the changes in dexterity in individuals with neck pain compared to healthy individuals will shed light on future more detailed studies on the current subject.


Eligibility Criteria:
Inclusion Criteria:

- Experiencing neck pain for at least 3 months

Exclusion Criteria:

- Having another medical condition that may affect dexterity
A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Participants of childbearing potential

Other protocol defined Inclusion/Exclusion criteria may apply.
Acupuncture and Skin Temperature Behavior

Objective: Evaluating the behavior of skin temperature through infrared thermography after application of acupuncture and electroacupuncture in Weizhong (B40) and Kunlun (B60) acupunctures points. Methods: A single-blind randomized clinical trial was performed with 54 participants of both sexes, mean of 21.88±2.53 years, randomized into three groups (n=18): electroacupuncture (EAG), acupuncture (AG) and control (CG). The application was bilateral in the acupoints (B60 and B40), for 20 minutes. The skin temperature of the lower limbs was measured at the following times: before application, 10 minutes of application, 20 minutes of application and 10 minutes after needle removal.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes;
* Aged between 18-30 years;
* Good general health;

Exclusion Criteria:

* Pregnant women;
* Hemophiliacs;
* Smokers;
* Patients with severe cardiovascular diseases.
Intervention for Anxiety After Falls

The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.

Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.

After an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).

Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* age \> or = 65 years
* English-speaking
* injured due to fall
* hospitalized
* returned home \< or = 3 months
* ambulatory
* full or subsyndromal PTSD or Fear of Falling
* residing in one of the five boroughs of New York City

Exclusion Criteria:

* Inability to understand assessment questions
* Marked cognitive impairment
* Dementia
* Schizophrenia
* Bipolar Disorder
* Depression with psychotic features
* Delusional Disorder
* Substance Use Disorder or Dependence
* Active suicidal ideation, intent, or plan
* Active homicidal ideation, intent or plan
* Aphasia
* Acute or severe medical illness or life expectancy \< 6 months
* Initiated psychotropic medications \< 6 weeks prior
* Initiated mental health treatment \< 6 weeks prior
* Psychosocial factors that would compromise study participation (such as not having a telephone)
HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\> 80 gm)

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH with failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 80 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP