cyrilzakka/clinical-trials huggingface dataset:
3-Dimensional Accelerometer Sub-Study

This is a prospective, unblinded sub-study to the E-30 to gather physiological data.

This sub-study to the E-30 is designed to collect vital signs, accelerometer and ECG data on subjects, and will consist of two phases. Phase 1 is designed to collect data in an Epilepsy Monitoring Unit (EMU) and Phase 2 is designed to collect data in an everyday (ambulatory) setting.

Eligibility Criteria:
Inclusion Criteria:

(Phase 1)

* Subject be scheduled to participated in the E-30 parent study for a minimum of 48 hours
* Subject has a clinical diagnosis of epilepsy based on a prior EMU visit

(Phase 1\&2)

* Subject is currently enrolled or previously participated in the E-30 study
* Subject must be 6 years of age or older

(Sleep State: Optional)

* Subject must be 12 years of age
* Subject is currently enrolled in the E-30S sub-study and is willing to stay in a light controlled environment in the EMU for up to 120 hours

Exclusion Criteria:

(Phase 1\&2)

* Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the sub-study.
* Subject who has implanted defibrillator, pacemaker or Vagus Nerve Stimulation Therapy® (VNS) System
* Subjects who are pregnant or lactating
* Subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the sub-study.
* Subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm.
* Subjects prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
* Subjects with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to activity, stress, or seizure. This would include but not be limited to chronic atrial fibrillation or chronotropic incompetence.
* Subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.

(Sleep State: Optional)

* Subjects with a history if gastrointestinal disease (GI)or GI surgery
* Subjects with a history of difficulty swallowing
* Subjects with diabetes mellitus
* Subjects with uncontrolled hypertension
* Subjects with planned MRI during EMU stay
The Impact of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients

This study evaluated the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep, and quality of life in pediatric oncology patients.

Sleep disturbances and fatigue were common issues among pediatric oncology patients, significantly impacting their overall quality of life. This study aimed to evaluate the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep patterns, and quality of life in this patient population. The research was structured as a parallel-group, randomized controlled trial. Pediatric oncology patients, aged 8-18 years, were recruited for participation.

The study intervention group used the Ocean Wave and LED Starry Sky Projector each night for one month, along with receiving the standard care typically provided in the oncology unit. The projector created a soothing visual and auditory environment designed to help induce relaxation, potentially improving sleep and reducing fatigue. Meanwhile, the control group received only the standard care offered to pediatric oncology patients, without the addition of the projector intervention. This study offered valuable insights into the use of non-pharmacological interventions for improving sleep quality and reducing fatigue among pediatric oncology patients.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric oncology patients aged 8-18 years.
* Recently diagnosed (\&amp;lt; 1 month).
* Active receiving chemotherapy treatment
* Able to read and write in Turkish.
* Willing to participate voluntarily.

Exclusion Criteria:

* Being at the end of life
* Diagnosed with mental problems.
* Haemoglobin levels below 7 mg/dL).
* Having visual or hearing impairments.
* Unable to understand or communicate in Turkish.
Study of Having a Female Friend as Labor Support

The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous (never given birth before)
* Singleton pregnancy
* Vertex presentation
* Low risk pregnancy
* Has a female friend willing to be a doula

Exclusion Criteria:

* Placenta previa
* Abruptio placenta
* Multiple pregnancy
* Breech presentation
* Planned operative delivery
Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.

This is a multicentre, prospective, study of EGFR mutation status in advanced NSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months. The study will enroll patients with histologically confirmed, systemic treatment naïve adenocarcinoma metastatic cancer (stage IV). This will be a single visit study. No study medication will be prescribed or administered as a part of study procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who provide written informed consent
2. Patients aged 18 years and older
3. Newly diagnosed patients with Metastatic (stage IV) NSCLC.
4. Histologically confirmed Adenocarcinoma NSCLC patient as per tissue biopsy and Tissue sample sent for EGFR mutation analysis OR result for EGFR mutation test is available from last 28 days from the date of enrolment.
5. Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)

Exclusion Criteria:

1. Patient with any medical condition that, in the opinion of the investigator, would interfere with outcome of the study
2. Patient participating in any other interventional clinical study/trial.
Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older

Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode.

We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of life.

Many patients who are 80 years of age and older, develop AF or CHF. Physiologic pacing has been shown to prevent AF compared to ventricular pacing. Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown.

The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities.

Patients recruited to the study will be randomized to either DDDR or VVIR pacing, and followed in the clinic every 6 months for the 3 years of the study.

Eligibility Criteria:
Inclusion Criteria:

* 80 years of age and older
* Symptomatic bradycardia

Exclusion Criteria:

* Permanent atrial fibrillation
* Previous pacemaker implant
* Life expectancy less than 1 year
* Geographic isolation
* Unable to give informed consent
Treatment in Occupational Therapy With Significant Activities to Improve Quality of Life

We followed a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia.

Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups (experimental group (60 each) and control group (60 each) the first one followed up by private centres in Spain endowed with Occupational Therapy and the second by public centres in the region of Modena.

The course of dementia goes through different stages and during the moderate and advanced stages cognitive decline and functional deterioration are frequently accompanied by the so-called behavioural and psychological symptoms of dementia (BPSD), that put severe stress on the persons with dementia (PwD), on their families and on the health system. Worldwide consensus guidelines recommend non-pharmacological approaches to be first line.

The occupational therapist studies human activity as a therapeutic resource to prevent and treat physical and/or psychosocial difficulties, in order to improve the person's quality of life.

Subjects were not randomly assigned to different treatment groups (control group and experimental group); instead, consecutive sampling was chosen by assigning subjects based on an odd-and-even-numbered technique (odd subjects were assigned to the control group and even subjects to the experimental group). Both groups presented the same pathological, cultural, and sexual characteristics, and belonged to the same age group.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of primary dementia (DSM V)
* a MMSE score ≤ 24
* a NPI global score ≥ 32/144
* a treatment with significance activities in Occupational Therapy
* live in a nursing home

Exclusion Criteria:

* presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD

  * concomitant psychiatric disorders or chronic alcoholism
  * concomitant diseases severe enough to reduce life expectancy \< 6 months
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.

This is a randomized (study drug assigned by chance), 2-arm, double-blind study to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) versus placebo in combination with the standard of care (SoC) therapy (peginterferon alfa-2a \[pegIFN alfa-2a\] and ribavirin) in adult treatment-naïve patients (who never received treatment for HCV) with chronic genotype 1 HCV infection in Japan. The study objective is to evaluate and compare the efficacy of TMC435 vs placebo by the proportion of the patients with undetectable HCV ribonucleic acid (RNA). In the TMC435 treatment group, patients will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus SoC followed by an additional 12 or 36 weeks of treatment with SoC. In the placebo treatment group, patients will receive 12 weeks of treatment with placebo once daily plus SoC followed by an additional 36 weeks of treatment with SoC. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment will be given for 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 mcg pegIFN alpha-2a and administered subcutaneously (injected by a syringe under the skin) once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg based on body weight), and taken orally by mouth two times a day after meals.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have chronic genotype 1 HCV infection with HCV RNA level \>= 5.0 log10 IU/mL
* Patient has never received treatment for HCV
* Patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication

Exclusion Criteria:

* Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
* Diagnosed with hepatic cirrhosis or hepatic failure
* A medical condition which is a contraindication to pegIFN or ribavirin therapy
* History of, or any current medical condition which could impact the safety of the patient in the study
Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 induced adult ARDS patients admitted to the medical ICU
* PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on HFNC treatment

Exclusion Criteria:

1. If the patients have a consistent SpO2\<80% when on evaluation with a FiO2 of 0.6, or signs of respiratory fatigue (RR \> 40/min, PaCO2\> 50mmHg / pH\<7.30, and obvious accessory respiratory muscle use);
2. Immediate need for intubation (PaO2/FiO2\< 50mmHg or SpO2/FiO2 \<90, unable to protect airway or mental status change);
3. unstable hemodynamic status(SBP\<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
4. unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
5. chest trauma or any contraindication for PP
6. pneumothorax
7. age \< 18 years
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone


Eligibility Criteria:
Inclusion Criteria:

* Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
* Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

Exclusion Criteria:

* Patients with secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Active Surveillance of Papillary Thyroid Microcarcinoma

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise.

The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States.

Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation.
* 2.0 cm or smaller nodules by ultrasonographic criteria
* Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form
* Must be able to read and write English fluently to participate in the questionnaire portion of the study

Exclusion Criteria:

* High-grade or poorly differentiated PTC variants
* Central or lateral neck lymphadenopathy suspicious for PTC
* Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)
* History of radiation to neck
Imaging Biomarkers of the Effects of a Mixed Exercise Program

The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (Intervention Group, n=30; Control Group, n=30) will participate in the study. Intervention Group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. Data will be take trough 2 measurements that will be take place at baseline and post-intervention. Criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. Moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders,
* aged 70 years old or more,
* with habitual residence in Valencia,
* with independent wandering (they can have technical aids, but not from someone else)
* that meets Fried's pre-frailty or frailty criteria
* EGWSOP's sarcopenia criteria
* who has agreed to participate in the study and signed the informed consent

Exclusion Criteria:

* Patients with life expectancy less than six months
* Institutionalized patients
* Patients with severe visual or auditory deficits
* Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)
* Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.
* Patients with severe psychiatric illness or moderate or severe cognitive impairment.
* Patients who refuse to sign the informed consent.
A Pilot Study of the Learn, Connect, and Quit Mobile Application

This research study aims to develop and test the effectiveness of a mobile application for patients who smoke to use while waiting in the clinic exam room to see their provider. The application will present patients with a variety of videos designed to increase their engagement in evidence-based smoking cessation treatment and offer them action steps to engage in smoking-related treatment or discussions with their provider.

The overarching goal of this study is to develop a novel, effective mobile application for patients to use while waiting in the clinic exam room to see their provider and to access on-line after their visit. The Learn, Connect, and Quit (LCQ) application will present patients with a variety of videos designed to increase their understanding of, and engagement in, evidence-based smoking cessation treatment (e.g., videos that address barriers to cessation and explain treatment options). The LCQ app will also be coordinated within the clinical care system to allow patients to self-refer for smoking treatment and will serve as a prompt to begin a conversation with the provider thereby connecting smokers to evidence-based treatment with minimal staff burden, thus, increasing the feasibility and sustainability of this intervention. This research will pursue the following specific aims:

Specific Aim 1: Develop the Learn, Connect, and Quit mobile application to: 1) present educational and motivational content in an easily accessible manner (i.e., via videos); and 2) provide avenues for smokers to connect to evidence-based treatment (e.g., request a referral to the Wisconsin Tobacco Quitline via the app, initiate a discussion with their provider).

Specific Aim 2: Identify optimal implementation procedures and clinical workflows to facilitate the use of the LCQ app within the clinical setting.

Specific Aim 3: Establish the feasibility, acceptability, and preliminary effects of the Learn, Connect, and Quit app among smokers in a primary care clinic to support an NIH R01 application.

This research will create an innovative, patient-driven intervention that can be integrated into healthcare systems and leverage the patient wait times in traditional clinical settings to provide motivational content and treatment information to increase: motivation, smoking treatment engagement, and connections with evidence-based treatment resources. This innovative product will then be tested in larger implementation trials with external funding.

Eligibility Criteria:
Inclusion Criteria for Smoker Participant Group:

* participant be age 18 or older, speak and understand English, smoke cigarettes, and complete the referral form agreeing to be contacted for an assessment

Exclusion Criteria:

* none

Inclusion Criteria for Clinic Staff Group:

* must be either rooming staff or clinical provider (e.g., physician, nurse practitioner, etc.)

Exclusion Criteria:

* none