cyrilzakka/clinical-trials huggingface dataset:
Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery

Heart disease is the leading cause of death globally, accounting for 16% of the world's total deaths. The number of cases is expected to increase as our population ages. Heart disease also results in large economic burden. It costs the United States about $219 billion per year. Some patients have symptoms that aren't helped by drugs or other medical treatments. These patients will need a surgery that is called cardiac artery bypass graft (CABG) surgery. CABG helps to improve chest pain which is one of the most common complaints of heart disease, and has life-prolonging potential. A limitation of CABG is that it results in increased inflammation. These patients also report high levels of anxiety and depression. Depression and anxiety in the several days surrounding surgery are related to several important things. These include worse health outcomes, worse quality of life, increased risk of death, and increased health care cost. Acceptance and Commitment Therapy (ACT) is a kind of therapy. ACT is adaptable, easy to access, and effective in brief formats. ACT has been gaining evidence for its use in many patient samples. Few studies have used ACT with heart disease patients. No known studies currently exist that have used ACT within the few days surrounding CABG surgery. To address this need, the investigators will conduct a two-arm feasibility randomized control trial (RCT). Patients will be randomized to one of two groups. The first group will complete a brief, 2-session telehealth ACT intervention. The second group will be a control group. The control will consist of treatment as usual. The investigators will evaluate the feasibility of this brief ACT intervention delivered in the peri-operative period. The investigators will also examine preliminary efficacy of the ACT intervention. The investigators will examine anxiety, depression, psychological inflexibility, well-being, and cardiovascular health-related quality of life. The investigators will also examine the intervention's impact on inflammation by measuring two inflammatory markers. The results from this study will also lay the groundwork for larger or multiple site RCT studies.


Eligibility Criteria:
Inclusion Criteria:

* admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG
* access to a personal phone or device with video or audio capabilities
* ability to provide informed consent
* English fluency.

Exclusion Criteria:

* life-threatening comorbid (noncardiac) medical condition(s)
* active suicidal ideation or intent
* psychotropic medication use lasting less than four weeks
* inability to provide informed consent and comply with study procedures
* those undergoing repeat revascularization
Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-12 years old
* ASA I-II level
* Sign an informed consent form

Exclusion Criteria:

* Developmental delay or neurological and psychiatric disorders
* Severe malnutrition or severe obesity
* High risk of stomach fullness and reflux aspiration
* Allergic to benzodiazepines and opioids
* Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
* Severe sleep apnea
* Abnormal liver and kidney function
* Recently participated in other clinical studies
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death.

Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy.

A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.


Eligibility Criteria:
Inclusion Criteria:

* histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction
* referred to first line chemotherapy.

Exclusion Criteria:

* Age \< 18
* Living outside the greater Copenhagen area
* Any other malignancy requiring active treatment
* Not eligible for chemotherapy
* Performance status \> 2
* Not able to swallow liquids
* Parenteral nutrition or enteral nutrition via feeding tube
* Physical or mental disabilities that prohibit execution of test or training procedures
* Pregnancy
* Inability to understand the Danish language
TVMR With the Innovalve System Trial - Pilot in Georgia

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%
Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.

The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.

This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged 20-60 years old
* body mass index is greater than or equal to 24 kg/m2, or body fat more than 30%

Exclusion Criteria:

* Subjects diagnosed with cancer and on curative care.
* Subjects diagnosed with heart disease and on curative care.
* Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
* Subjects with systemic infection requiring antibiotics.
Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. A detailed knowledge of symptoms and early diagnose of delirium increase the chances of early therapy. To what extent the occurrence of postoperative delirium influences hospital therapy in the Cardiac Surgical Postoperative ICU in University Clinical Centre in Gdańsk is unknown so far.

Study type: prospective, observational cohort study. Facility: tertiary, university hospital Methods: Patients will undergo routine, continuous observation for symptoms of delirium by a trained nursing staff. Occurrence of delirium, Delirium Observation Screening Scale (DOSS) grading, and therapy will by annotated on case record forms (CRFs) every 12 hours. Additionally, collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, body mass index (BMI), angiotensin converting enzyme (ACE) inhibitors / angiotensin receptor blockers (ARBs) therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, corona virus disease 2019 (COVID19) infection and/or vaccination; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, hours on mechanical ventilation (HOV), number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation (CPR), renal replacement therapy (RRT), mechanical circulatory support (MCS), duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.

Statistical methods: Delirium morbidity and risk will be calculated from two-by-two table. Associations between delirium and secondary outcome measures will be evaluated by simple and logistic regression with use of ANOVA test for continuous variables with homogeneous distribution, or Kruskal-Wallis test for continuous variables with non-homogeneous distribution, or categorical variables. Significant will be considered results with p\<0.05.

A period of one year was assumed sufficient to draw conclusions on the primary endpoints of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.

Exclusion Criteria:

* Deny to sign or absence of an informed consent.
Comparative Pharmacokinetics of YH14659

The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
* Healthy male volunteers of aged between 20 years to 55 years
* Have standard weight of ≤ ±20% based on Broca index\* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
* Have no history of neither congenital nor chronic disease
* Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
* Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period

Exclusion Criteria:

* Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
* Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
* Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
* Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
* Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
* Have the following abnormal findings on diagnosis;

  * have AST or ALT \> 1.25 times of normal upper limit
  * have total bilirubin \> 1.5 times of normal upper limit
  * have higher PT, aPPT, BT than normal range
  * have PLT below 150,000 or above 350,000
* Have been drug abuse, excessive caffeine (\> 5 cups/day), heavy smoking (\>10 cigarettes/day), continuous alcohol intake (\> 30g/day) or have drunk within the last 7 days prior to the first administration
* Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
* Donated blood within 60 days prior to the first administration
* Participated in any other clinical trials within 60 days prior to the first administration
* Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
* Subject who is judged to be ineligible by principal investigator or sub-investigator
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]

The purpose of this study is to evaluate the safety and effectiveness of creatine treatment in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS but the cause of the cell death is unknown. It has been shown that there is overactive nerve activity due to increased levels of a chemical called glutamate and that there is abnormal cellular metabolism along with increased production of substance called "free radicals." Improving cellular metabolism and readjusting the activity of glutamate in the brain may be beneficial to ALS patients.

Creatine is a naturally occurring compound, which improves energy metabolism in cells. Creatine has been given to patients with energy metabolism defects in their muscles, and to athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS have received creatine for up to six months without any side effects. Overall, creatine has been well tolerated and safe.

Half of the subjects in this study will be selected by chance to receive creatine treatment for 6 months and the other half to receive placebo. Neither the subject nor the investigator will know which drug the subject is receiving, although this information will be available in case of emergency. It is anticipated that all subjects will have the choice to receive creatine after the 6 months study in an open-label study for an additional 12 months. A total of 114 patients will participate at 15 centers. Approximately 8 subjects will be enrolled at the Washington University.

The effectiveness of creatine will be determined first by assessing any changes in strength in the arms and second by changes in grip strength, functional activities, electromyography changes or changes of the level of SOH 2'dG in the urine.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of definite, probably or laboratory supported probably ALS, either sporadic or familial ALS according to a modified El Escorial criteria
* Willing and able to give informed consent
* FVC greater than or equal to 50% predicted
* Evidence of abnormality in upper and/or lower extremity motor function (clinical evidence of muscle atrophy and weakness in an upper and/or lower extremity). The patient should have at least 4 or 8 testable upper extremity muscle groups.
* Subjects may take riluzole. Riluzole must have been at stable doses for at least thirty days prior to baseline visit.
* If woman of childbearing age, must be non-lactating and surgically sterile or using an effective method of birth control (double barrier or oral contraceptive) and have a negative pregnancy test
* Disease duration less than five years
Cognitive Neurology Unit Clinical Registry

A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

Alzheimer's disease (AD) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. It causes progressive cognitive impairment, especially memory, and is invariably fatal. Currently, there is no effective treatment for AD. A new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mAbs) to reduce amyloid accumulation in brain. There are currently two anti-amyloid mABs, aducanumab and lecanemab, approved by the FDA under FDA's "accelerated approval" pathway. However, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mAB therapy1. This study is designed to help determine the therapeutic benefit of anti-amyloid mABs therapy by treating AD patients in our clinic with anti-amyloid mABs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. This study has 4 specific aims.

SPECIFIC AIM 1: TO CREATE A CNU ANTI-AMYLOID MONOCLONAL ANTIBODY REGISTRY

SPECIFIC AIM 2: TO DETERMINE WHETHER ANTI-AMYLOID MABs SLOW COGNITIVE AND FUNCTIONAL DECLINE

SPECIFIC AIM 3: TO IDENTIFY ANY ASSOCIATIONS BETWEEN SIDES EFFECTS AND PATIENT CHARACTERISTICS

SPECIFIC AIM 4: TO ESTABLISH THE TIME COURSE OF CLINICAL BENEFITS

Eligibility Criteria:
Inclusion Criteria:

* o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease

  * Patient has evidence of cognitive impairment on neuropsychological testing
  * Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement
  * Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease
  * Amyloid PET imaging positive
  * CSF p-Tau/Abeta42 ration \>0.023 and ABeta42 \< 1027\*\*
  * 3T MRI in past 6 months
  * Patient has a care partner
  * Patient under the care of an appropriate BI-Lahey amyloid clinic
  * Patient is on a stable medication regimen

Exclusion Criteria:

* o Recent stroke or suspected TIA in the past year

  * Pregnancy
  * Active autoimmune or immunological disease
  * Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives
  * Bleeding disorder with Plts \< 50,000 or INR \> 1.5
  * On warfarin, heparin, or DOAC
  * On dual antiplatelet therapy
  * Non Alzheimer disease cause of dementia/MCI
  * ApoE e4 homozygote
Access to Care and Adherence Tuberculosis (TB) Survey

Prompt access to care and treatment adherence are the hearth of tuberculosis control.

This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 yrs of age
* recent new TB diagnosis
* Tuberculosis treatment prescribed
* Ability to sign the informed consent
ICP Versus Intracranial Compliance Guided Management in SAH

The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.

In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage, acute
* Intracerebral pressure monitoring device inserted

Exclusion criteria:

* No intracranial pressure monitoring
* Age \< 18 years
Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* predicted time of mechanical ventilation more than 48 hours

Exclusion Criteria:

* no enteral nutrition pathway
* refuse to informal consent
* surgeon refuse the protocol
* palliative care
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.

Primary Objectives:

* To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
* To describe the post-dose 3 pertussis antibody responses.

Secondary Objectives:

* To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
* To describe the safety after each vaccination following co-administration with Prevenar®.


Eligibility Criteria:
Inclusion Criteria:

* Infants 55 to 75 days old, inclusive on the day of first vaccination
* Born at full term of pregnancy (\> 37 weeks)
* Informed consent form signed by the parent(s) or the legal guardian
* Parents or the legal guardian able to read and write in the local language
* Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.

Exclusion Criteria:

* Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
* Moderate or severe acute illness with or without fever
* Participation in another clinical trial in the 30 days preceding first study vaccination
* Planned participation in another clinical trial during the present study period
* Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination
* Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations
* Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days
* Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
* History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
* Blood or blood-derived products (immunoglobulins) received since birth
* Known Human immunodeficiency virus (HIV) seropositivity
* Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination
* History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
* Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.