cyrilzakka/clinical-trials huggingface dataset:
Bioinformation Therapy for Liver Cancer

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.

By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU

There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit (ICU) patients. The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies (2 recruitment and 2 retention) will be tested. Investigators will integrate the strategies into three existing studies that involve family members of ICU patients. Participants will be randomized using a 2x2 factorial design. The co-primary outcomes are recruitment percentage (participants enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).

Family engagement in the ICU is recommended by critical care professional societies, but insufficient evidence of its benefits for patients and family members has hindered clinical uptake. Thus, high-quality evidence is needed to promote and support family engagement practices. A specific unmet need is to identify strategies to improve the recruitment and retention of families in clinical trials in the ICU setting. The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting.

Methodological Approach: Investigators will use a Study Within a Trial (SWAT) design to embed a factorial randomized trial of 160 participants enrolled across investigator group's three ongoing studies involving family members of ICU patients: FAME, VR-Family, and NGAGE. Investigators expect 160 participants to be enrolled over a 6-month period. Participants will be randomized by 2x2 factorial design to selected recruitment and/or retention strategies. The co-primary outcomes will be (1) recruitment rate and (2) retention rate.

Eligibility Criteria:
Inclusion Criteria:

* Has family member admitted to an intensive care unit.
* Expected hospital stay \> 48 hours
* Able to participate in English or French

Exclusion Criteria:

* Has another family member participating in the trial
* Repeat admissions within the study period
Pediatric Post-Approval Registry

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.

This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.

Study data will be collected at the following timepoints:

Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant

1, 2, 3, 4, 5 years post-implant

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18 and 21 years of age;
2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
8. Subject is willing and able to provide informed consent.

Exclusion Criteria:

1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
5. Subject is pregnant or plans to become pregnant;
6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
7. Subject has a terminal illness with life expectancy \< 12 months;
8. Any other reason the investigator deems the subject is unfit for participation in the registry.
Radiation Oncology Patient Medical Physics Intervention Study

This investigation is designed to be a two-arm, non-randomized prospective phase 2 study evaluating the impact of medical physicist patient intervention on the anxiety level and patient satisfaction of patients undergoing a course of radiation therapy. The goal is to demonstrate that these interventions will have a significantly positive impact on the overall well-being of the oncology patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Patients receiving treatment in the outpatient setting.
* Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.

Exclusion Criteria:

* Patients receiving a single fraction of treatment.
* History of Prior Radiation.
Study of Neurophysiological Correlates of the Link Between Perception and Action

The main goal of this study is to better understand the link between motor system (action) and perception in variable sensorial forms by examining the time course and the dynamic of electroencephalography (EEG) activations. To do so, differents sensimotor study protocols in linguistics and in the fiels of emotional and spatial perception will be realised in order to study prcisely differents links parception-action.


Eligibility Criteria:
Inclusion Criteria:

* Signed free consent
* Medical exam done before participation to the study
* Age between 18 and 65 years
* Baccalaureate as minimum degree level

Exclusion Criteria:

* Subject already taking part in an other clinical and/or therapeutic trial still in progress
* Important audition or visual disorder
* Language disorders (aphasia, dysphasia, dysarthria, stammer, etc)
* Any counter-argument to MRI
* Pregnant, parturient or brest feeding women. A pregnancy test (urinary) will be offered to female participants during the inclusion medical interview. In the event of a refusal the woman will have to sign a discharge attesting that she doesn't take any risk of getting pregnant and to volunteer to participate to the trial without having recourse to the offered prgnancy test.
* Patient derpived of liberty by a judicial or administrative decision
* Patient under 18 years under a legal protection or unable to express their consent
* Alcohol ingested
Correlates of GERD Symptom Severity

This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. We will measure heart rate variability and galvanic skin response in patients during the visits and video record the visits. Subjects will complete a daily GERD symptom diary for 2 weeks and then return to the study center to complete additional questionnaires and an exit interview.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 21-70 years old
* Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
* English language proficiency
* Willingness to be videotaped and connected to physiologic monitoring devices during the visit

Exclusion Criteria:

* Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
* Heavy alcohol use (\> 6 drinks/week for women and \> 13 drinks/week for men)
* Pregnant women.
* Dementia or significant memory difficulties
* Severe, unstable psychiatric disease
* Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
* Failure to complete the baseline symptom diary for at least 6 of 7 days
* Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
* Allergy to adhesives
* Inability to provide informed consent
Paracetamol Metabolism in Post Operative Conditions

Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)

D-15 to D0: selection

* patient information and non-opposition obtained
* inclusion and non inclusion criteria check
* clinical exam

D-1 to D0 : 24 hours diuresis

D0 : operation day

Before anesthesia :

* urine collection (paracetamol metabolites dosage)
* blood sampling (glutathion and liver function test)

Surgery:

* 1st paracetamol intake before closing
* Then administration every 6 hours

D1 to D4 :

* 24 hours urine collection (metabolites dosage)
* blood sampling et D1 and D4(glutathion and liver function test)

D5 : final clinical exam

Eligibility Criteria:
Inclusion Criteria:

* aortic surgery
* treatment with intraveinous paracetamol (4 grammes daily during 4 days)
* patient agrees to participate

Exclusion Criteria:

* - patient disagrees
* paracetamol contra-indication
* paracetamol intake 5 days before surgery
Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction

Aims:

* evaluate the hydric status through bioimpedance spectroscopy in consecutive acute myocardial infarction patients referred for primary PCI;
* assessment of renal artery stenosis incidence through renal angiography in consecutive STEMI patients;
* fully characterize the complex hydration, metabolic and endothelial profile of these patients in the attempt to define the role played by dehydration in the complex dynamics of acute myocardial infarction.

Gathered data:

* descriptive general demographic data;
* previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);
* cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
* routine biological data;
* metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
* information regarding primary PCI (less than 12 hours of ischemic symptoms);
* coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
* echocardiography at admission (LVEF);
* renal arteries angiographic details performed in the same time with PCI (two independent operators evaluate stenosis based on a predefined scale);
* renal diameters;
* measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
* in-hospital and one month follow-up MACE.

Eligibility Criteria:
Inclusion Criteria:

* adults with ST elevation Myocardial Infarction (\<12h) diagnostic confirmed;
* included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

Exclusion Criteria:

* patients who do not sign informed consent for primary PCI
Cardiovascular and Neurovascular Regulation in GWI

Brain blood flow regulation and autonomic dysfunction will be measured in Veterans with and without Gulf War Illness who served in the Gulf War between 1990 and 1992.

Gulf War Illness (GWI) is a multi-symptom illness with unknown etiology. GWI is a leading cause of disability in Gulf War Veterans. Cognitive complaints are a common symptom of GWI, which suggests the brain is involved in the development of this condition. As Veterans age, these cognitive complaints may worsen and be compounded by the aging process. GWI may be a condition of "accelerated" brain aging. Therefore, there may be long-term consequences of GWI, and the presence of GWI may increase a person's risk for developing Alzheimer's Disease (AD) or other dementias. In comparison to other brain-related diseases such as stroke, relatively little is known about GWI and how this condition impacts the normal age-related changes in the brain.

The research aims are:

1. To determine if Veterans with Gulf War Illness demonstrate abnormal brain blood flow regulation and autonomic dysfunction when compared with Veterans without Gulf War Illness.
2. To determine if brain blood flow and autonomic nervous system variables in Veterans are associated with other markers of brain aging that are relevant to cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* Deployed to the Persian Gulf between 1990-1992
* Body mass \<300 lbs
* Diagnosis of Gulf War Illness based on CMI/CDC and Kansas definitions or No diagnosis of Gulf War Illness

Exclusion Criteria:

* Current or lifetime evidence of: Type II diabetes, neurological disease, cancer treatment, rheumatoid arthritis, lupus, bipolar disorder, psychotic disorders, or mood disorders with psychotic features
* Current illicit substance use or partial remission for less than 1 year
* Taking multiple sedatives or anticonvulsant medications
* Currently pregnant
* Absolute contraindications to exercise testing
* Contraindications to MRI
* Other significant medical conditions at investigator's discretion
A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease. Currently, whether these results translate favorably in humans is unknown. This is a pilot trial of testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one continuous caloric restriction (CR) diet where a small number of calories will be restricted every day or another intermittent CR diet where a caloric intake will be restricted more severely 2 days per week. Participants are randomized to one of the diets, and for the first 8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the conclusion of the controlled feeding study, all participants will transition to an unblinded phase for an additional 40 weeks where they are provided with instructions to follow an intermittent CR diet.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-50
* Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
* Meets 2010 criteria for McDonald MS;
* Relapse or new lesion in previous 2 years
* Expanded disability status score (EDSS) \< 6
* Disease duration ≤15 years
* Untreated or on stable on first-line MS therapy \[injectable\] for at least 6 months, with no anticipated changes in the next 10 weeks
* Unchanged vitamin D dose or thyroid replacement dose (for those on it) with no anticipated changes or in supplement use for the next 10 weeks.
* Non-regular smoker (average no more than 1 cigarette/day) for at least 2 months
* Stable weight, by self report, for past 3 months (± 8 lbs)
* Body mass index (BMI) \> 23 kg/m2

Exclusion Criteria:

* Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)

  * History of gastrointestinal disease causing malabsorption
  * History of diabetes requiring medication
  * History of stage IV/V chronic kidney disease or vascular disease
  * History of major surgery in past 3 months
  * Current use of warfarin
  * History of eating disorder
  * Currently on a special diet for MS/other diet (provided diet will be pork free)
  * Chemotherapy within the past year
Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria

Placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. When the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. Inpatient follow-up of this patients has negative effects like hospital infections in terms of the patient, workload in terms of health personnel and financial losses in terms of the country's economy. Placenta previa cases are complicated patients in which generalizations cannot be easily performed and they should be monitored at third level hospitals. In addition, care should be personalized considering the many reasons. In this study, placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery. Thus, in this study, it was aimed to determine the parameters that would allow systematic personalization of health service in this particular patient group by making risk assessment of placenta previa cases.


Eligibility Criteria:
Inclusion Criteria:

* Monitoring of placenta previa
* To apply before the 28th week
* To have a low-risk second trimester screening test
* No malformation detected in the anomaly screening

Exclusion Criteria:

* Multiple pregnancies
* Pregnancy complicated with preeclampsia
* Pregnancy complicated by gestational hypertension
* Pregnancy complicated by gestational diabetes mellitus
The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia

To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.

Dementia, regardless of its cause, has been recognized to be one of the most important and common problems among the elderly worldwide. The prevalence of dementia has been increasing gradually throughout the world. It is associated with medical and psychological consequences, especially in the advanced stage of the condition. Medications for dementia, specifically, acetylcholine esterase inhibitors, have proven efficacy but variable individual response. They are very expensive and stress families and insurance payers. Dementia and its neuropsychiatric co-morbidities effects not only individual patients, but also family members and care givers as it stresses interpersonal relationships, increases the need for personal care, nursing home placement, and the use of neuropsychiatric medications. Any new approach to improve cognitive function, behavior, mood and sleep quality among demented individuals therefore could have far reaching benefits for patients, care givers, financially responsive parties, and the country as a whole.

There are several studies focusing on the non-pharmacologic approaches to care of the demented. The objectives were to reduce reliance on prescribed medications with these adjunctive therapies. One of the interesting non-drug trials was about music therapy. It was found that music could improve behavioral and social functions among individual demented patients. However, the methodology of each music study varied considerably. To our knowledge, there has been no music study in dementia performed in Thailand using our unique Thai traditional music. We therefore aim to study this non-pharmacologic approach in Thai demented individuals using Thai traditional music. We hypothesized that regular listening to Thai traditional music will improve cognitive function, activities of daily living, mood, behavior and sleep quality in Thai demented patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10
* No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study
* CD player available at home
* Patient and care giver consent to study

Exclusion Criteria:

* Severe depression requiring aggressive treatment or hospitalization
* Dementia with Lewy body, multisystem atrophy
* Treatable dementia
* Active medical problems
* Profound hearing loss
Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with epilepsy
* Aged 12-65
* Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes
* Fluent in English
* Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)

Exclusion Criteria:

* Intellectual disability impairing ability to perform task
* Motor problems that preclude finger tapping task
* Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest