cyrilzakka/clinical-trials huggingface dataset:
Effects of Isolated LBBB on Maximal Functional Capacity

Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized.

The study's main objective is to evaluate the effect of LBBB on maximum functional capacity.

Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized.

The main objective of the study is to evaluate the effect of LBBB on maximum functional capacity (objectively evaluated by the maximum oxygen consumption -VO2max- at peak exercise in a cardiopulmonary stress test -CPET-) in subjects with LBBB without known cardiovascular disease and compare these data with controls without LBBB.

This is a prospective study that will be carried out in a single centre. All patients with a diagnosis of LBBB and without evidence of structural heart disease in imaging tests will be enrolled. For each candidate with LBBB, one control without LBBB and matched for age, sex, body surface area, and daily physical activity will be selected. All included subjects will undergo a CPET and echocardiography. A sample size estimation \[alpha: 0.05, power: 80%, and a clinically significant VO2max difference between groups of at least 10%\] of 148 subjects (74 subjects with LBBB + 74 controls) would be necessary to test our hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years old
* ECG criteria of left bundle branch block (for controls without left bundle branch block )
* Provide informed consent

Exclusion Criteria:

* Inability to perform a maximal baseline exercise test;
* Structural heart disease, valve heart disease or diastolic dysfunction estimated by two-dimensional echocardiography;
* Previous ischemic heart disease, heart failure, myocardiopathy or myocarditis
* Effort angina during cardiopulmonary exercise testing (CPET);
* Any moderate pulmonary disease;
* Anaemia
* Left ventricular ejection fraction \< 55%.
Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate

to determine the comparison of nasal masks and nasal prongs on the pain response of neonate

To see the comparison of nasal masks and nasal prongs on the pain response of neonates, by measuring salivary cortisol levels before and after the intervention

Eligibility Criteria:
Inclusion Criteria:

* Newborn with espiratory distress and need noninvasive respiratory support

Exclusion Criteria:

* Syok, multiple congenital anomaly
Safe Mothers, Safe Children Initiative

The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. The study intervention is adapted from Skills Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal and child well-being by reducing the effects of maternal PTSD and depression on parenting.

The investigators plan to recruit mothers with high levels of trauma-related symptoms from preventive service agencies, and invite them to participate in the study. This study is a single group design, and data will be collected pre-treatment, post-treatment, and 12-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who are receiving preventive services at the time of study enrollment and have histories of trauma, have symptoms of PTSD, without a history of psychotic disorder, or current domestic violence or substance abuse
* Have a child within the 2-9 age range, and are the child's primary caretaker
* Can communicate in English and/or Spanish

Exclusion Criteria:

* Women who have a history of psychotic disorder and/or who meet current DSM-IV criteria for abuse of drug or alcohol
* Women who are experiencing domestic violence at the time of the assessment
* Pregnant women are excluded from this pilot study because they are a potentially particularly vulnerable population. However, women who become pregnant while participating in the study will not be excluded
* Women who report suicidal ideation in the past two weeks on the SCID, or have a history of a suicide attempt during the last year as reported during the SCID interview
* Children who meet diagnostic criteria for developmental disorders (e.g., autism and mental retardation), and/or have a history of childhood psychosis
Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly mistreatment) victims, to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. PROTECT is built on a model which postulates that chronic stress promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability to flexibly respond to the environment and limits their reward activities. PROTECT therapists work with victims to develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has been designed in an iterative process with community EM providers of the New York City (NYC) Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and referral for service. In the current study, the investigators will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). The investigators intend to enroll 50 subjects that will participate in the study for approximately 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* Capacity to consent (per Elder Mistreatment staff)
* Significant depression (per Elder Mistreatment staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in Elder Mistreatment (EM) agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression)
* Need for EM services

Exclusion Criteria:

* Active suicidal ideation (Montgomery Asberg Depression Rating Scale item 10\>4)
* Inability to speak English or Spanish
* Axis 1 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses other than unipolar depression or generalized anxiety disorder (by Structured Clinical Interview for DSM-5)
* Severe or life-threatening medical illness
* EM emergency and or referral out of EM agency (per EM staff)
The Effects of Technological Oral Health Management

The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is:

•Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective.

Participants will:

* Experimental group: oral mastication training and texture and diet education.
* Control group: only texture and diet education.
* Cases were tracked in month 1 and will be tracked again in month 6.

Expected Results：

1. To establish an oral mastication training and texture and diet education program for the elderly who have poor chewing and eating ability after dentures are installed.
2. Provide teaching programs tailored to the evidence-based and individualized needs of the elderly.
3. Through the implementation of evidence-based oral mastication training and a texture and diet education program, the experimental group and the control group are expected to show variations in oral health, eating ability, nutrition, and physical function over time.

Eligibility Criteria:
Inclusion Criteria:

1. residing in Chiayi County who are 65 years of age or older
2. capable of self-care, conscious
3. able to communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. non-residents of Chiayi County
2. unable to take care of themselves or are unconscious
3. demented or mentally challenged and are unable to cooperate
Spinal Epidural Lipomatosis: a Case Report and Review of the Literature

Introduction Lumbar spinal epidural lipomatosis (SEL) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. The objective of this case report is to document a clinical case of SEL presenting within a multidisciplinary spine clinic and to compare our clinical findings and management with the current literature.

Case presentation A 51-year-old female presented at a spine clinic with low back pain, bilateral leg pain and difficulty walking. MR imaging of the lumbar spine showed L4-L5 and L5-S1 degenerative disk disease with evidence of severe central canal stenosis due to extensive epidural lipomatosis. The patient was initially advised to lose weight, undergo a course of physiotherapy, and consult with the pain clinic. Because of lack of improvement, the patient was scheduled for L4-S1 posterior spinal decompression and L4-L5 posterior spinal instrumented fusion.

Discussion The discussion will include the diagnosis of SEL, imaging appearance, its risk factors, etiology and management.

Conclusion This case report describes a case of lumbar spinal stenosis due to SEL with neurological symptoms. Some risk factors have also been identified in the literature. MRI is considered as the reference standard for its diagnosis. The therapeutic approach of patients with SEL is not standardized. Thus, reporting and investigating the diagnostic process and treatment of this patient will positively contribute to better management for other future patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults patient with a clinical diagnosis of Spinal Epidural Lipomatosis (MRI and clinical diagnosis)

Exclusion Criteria:

* Absence of clinical diagnosis of Spinal Epidural Lipomatosis
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT

Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-40 kg/m2
* ASA 1-3
* undergoing total hip arthroplasty
* no controindications to subaracnhoid block
* able to understand and sign a written informed consensus
* METs \> o = 4

Exclusion Criteria:

* baseline SBP \< 100 mmHg
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19.

Study Aim: To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Study Hypothesis: Among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at Day 15.

.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Currently hospitalized or in an emergency department with anticipated hospitalization.
3. Symptoms of acute respiratory infection, defined as one or more of the following:

   1. cough
   2. fever (\> 37.5° C / 99.5° F)
   3. shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 \<92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
   4. sore throat
4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.

Exclusion Criteria:

1. Prisoner
2. Pregnancy
3. Breast feeding
4. Symptoms of acute respiratory infection for \>10 days before randomization
5. \>48 hours between meeting inclusion criteria and randomization
6. Seizure disorder
7. Porphyria cutanea tarda
8. Diagnosis of Long QT syndrome
9. QTc \>500 ms on electrocardiogram within 72 hours prior to enrollment
10. Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
11. Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
12. Receipt of \>1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
13. Inability to receive enteral medications
14. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
15. Previous enrollment in this trial
16. The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient
Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation

Statement of the problem:

• Does the thoracic block technique has effect on atelectasis in Children on Mechanical Ventilation?

Null hypothesis:

• there is effect of thoracic block technique on atelectasis in children on Mechanical ventilation.

Subjects:

The study targets the children from both sexes. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital intensive care units ,Cairo to participate in the study

Study design:

Randomized controlled clinical trial.

A. Inclusion criteria:

1. age range from 6 months to 4 years .
2. diagnosed with pneumonia, receiving Mechanical ventilation.
3. start from second day of admission to intensive care unit.
4. have unilateral mild to moderate atelectasis according to medical referral .
5. should be vitally stable during the session.

B. Exclusion criteria:

The children will be excluded from the study if they had one of the following:

1. medically unstable ( examples: tachycardia and tachypnea).
2. uncontrolled convulsion.
3. irritable or moderate to sever pain
4. rib fracture
5. pneumothorax

Children will be assessed by measuring heart rate, respiratory rate, chest x-ray, arterial blood gases,dynamic compliance, oxygen saturation index before and after ten days of receiving intervention

Eligibility Criteria:
Inclusion Criteria:

1. age range from 6 months to 4 years .
2. diagnosed with pneumonia, receiving Mechanical ventilation.
3. start from second day of admission to intensive care unit.
4. have unilateral mild to moderate atelectasis according to medical referral.
5. should be vitally stable during the session.

B. Exclusion criteria:

The children were excluded from the study if they had one of the following:

Exclusion Criteria:

The children were excluded from the study if they had one of the following:

1. medically unstable ( examples: tachycardia and tachypnea).
2. uncontrolled convulsion.
3. irritable or moderate to sever pain
4. rib fracture
5. pneumothorax
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.

This is a Phase 1 open label, one-sequence, crossover study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects. The safety and tolerability of MEDI0382 in combination with warfarin and esmolol will also be evaluated. Following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.

Eligibility Criteria:
Inclusion Criteria:.

* Healthy volunteers aged ≥ 18 to 45 years
* BMI between 18 -30 kg/m2
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
* Concurrent participation in another study of any kind
* Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
* History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Impaired renal function is defined as estimated glomerular filtration rate (eGFR) \< 60 mL/minute/1.73 m2 at screening.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.
* History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
Laser Efficiency on Metabolic Parameters

Non-invasive laser therapy is laser blood irradiation improves many metabolic parameters. So, this study aims to assess the impact of Non-invasive laser therapy on lipid metabolism and renal out comes

The metabolic syndrome is a constellation of interrelated metabolic risk factors especially central obesity, dyslipidemia, hyperglycemia, which all affect worse their kidney function, and all of this causing mortality. This time line requires a quick procedure that will enable us to implement safe and non-invasive therapeutic instruments adjacent therapy for metabolic syndrome cases.

Eligibility Criteria:
Inclusion Criteria:

* The patients have Metabolic syndrome, started more than one year ago.
* BMI ranged 30- 35Kg/m2.
* They are on medical therapy for more than one year.
* Clinically stable.

Exclusion Criteria:

* taking specific drugs uncontrolled diseases
* cardiovascular instability
* sever e autonomic neuropathy
* infection wound,
* burn, allergy or another external injury
* hypothyroidism
* hemorrhagic disorders
* history of cancer
* pregnant women,
* mental illness as schizophrenia or dementia.
Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers

This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers. Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.

SECONDARY OBJECTIVES:

I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.

OUTLINE:

Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.

After completion of study, participants are followed up at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
* ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
* ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
* ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
* ELIGIBLE PATIENTS: Be able to speak and read English
* ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
* ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
* ELIGIBLE PATIENTS: Be able to provide informed consent
* ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
* ELIGIBLE CAREGIVERS: Be able to speak and read English
* ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
* ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
* ELIGIBLE CAREGIVERS: Be able to provide informed consent

Exclusion Criteria:

* Have a current meditation practice (\> 2 episodes or \> 1 hour total, weekly)
* Be currently enrolled in a stress reduction program
* Have extensive hearing loss such that ability to participate in the study would be impaired
* Have participated in the original Being Present pilot study (BP1)
* Be caregivers of patients who decline Being Present 2.0 (BP2) study participation