cyrilzakka/clinical-trials huggingface dataset:
Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients

The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

The study will last 15 days for each participant. The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients

This was a non-interventional retrospective cohort study of de novo heart failure with reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment on either sacubitril/valsartan or commencing or continuing angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blocker (ARB) therapy for HF in the United States (US) using the secondary source of data, Optum Electronic Health Records (EHR).


Eligibility Criteria:
Inclusion Criteria:

Sacubitril/valsartan cohort:

* Prescribed sacubitril/valsartan within the identification period.
* With at least one International Classification of Diseases, 9th Revision (ICD)-9 or 10th Revision (ICD-10) code for diagnosis of HF within 30 days prior to the index date (including index date), that had non-missing sex and year of birth data.
* Active in the database for 759 days prior to index.
* With left ventricular ejection fraction (LVEF) ≤ 40% known prior to index day (including index date).
* That were treated as part of the integrated delivery network (IDN).

ACEi/ARB cohort:

* Prescribed ACEi or ARB within the identification period.
* With at least one ICD-9 or ICD-10 code for diagnosis of HF within 30 days prior to the index date (including index date), that have non-missing sex and year of birth data.
* Active in the database for 759 days prior to index.
* With LVEF ≤ 40% known prior to index day (including index date).
* That were treated as part of the IDN.

Exclusion Criteria

Sacubitril/valsartan cohort:

* That were \< 18 years old at index date.
* That were prescribed sacubitril/valsartan within the baseline period or identification period (whichever was earlier) at any time prior to the index date (excluding).
* With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period, excluding the 30 days prior to index in which HF was initially identified (patient should have had no prior history of HF).
* That were prescribed ACEi/ARB \> 2 days before index date, and within 30 days after a HF diagnosis during the identification period (i.e. any patient included in the ACEi/ARB cohort with an earlier index date, regardless of whether LVEF was ≤ 40% or \> 40%)
* With LVEF ≤ 10% as the closest value to index date (including).

ACEi/ARB cohort:

* That were \< 18 years old at index date.
* That were prescribed sacubitril/valsartan within the baseline period or identification period (whichever was earlier) at any time prior to the index date, on the index date, or until ≤ 2 days after the index date.
* With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period, excluding the 30 days prior to index in which HF was initially identified (patient should have had no prior history of HF).
* With LVEF ≤ 10% as the closest value to index date (including).
The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.

This study investigates the immune response in the cancer population in Belgium being vaccinated with an approved vaccine types being authorized for use in Belgium. This question needs to be answered to make sure that this vulnerable population is properly protected against possible SARS-CoV-2 infection and that vaccine administration is safe.

Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19 and should be at high prioritisation for vaccination against SARS-CoV-2. The COVID-19 vaccine trials have not included cancer patients as such, the efficacy and duration of immunity in patients with cancer are still unknown. Keeping in mind that cancer patients are often immunocompromised, the immune response upon vaccination needs further investigation.

The REAL-V is a prospective, multicenter cohort study. The humoral immunity response based on anti-SARS-CoV-2 IgG antibodies upon COVID-19 vaccination will be investigated in blood samples taken 4 months, 6 months and 12 months after (first) vaccine administration. Potential factors that affect immunity, will be recorded, such as type and stage of cancer, anti-cancer treatment, concomitant medication,..To investigate the safety of different COVID-19 vaccines, incidence and severity of systemic adverse events will be reported using an App based system answering questionnaires about specific vaccine related complaints.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Oncological or hematological malignancy or history of it
* Life expectancy \> 3 months
* Ability to provide informed consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Immune deficiency not related to cancer or cancer treatment
* Allergy (multiple); to be determined by physician
Unlimited or Restricted Fluid Intake in Patients with Heart Failure

Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
* Physical, cognitive and linguistic ability to carry out all aspects of the study

Exclusion Criteria:

* Reversible cause of HF (thyroid disorders, severe anemia, etc.)
* Hyponatremia at baseline (sodium \<130 mmol/L)
* eGFR at baseline \<30mL/min/1.73m2
* Scheduled cardiac surgery, coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) within 3 months
* Myocardial infarction within 3 months
* Comorbidity for which fluid restriction or unlimited fluid intake is advised
* Life expectancy \<6 months
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects

The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
2. Patients with the following diseases of clinical significance, including but not limited to those with gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases.
3. nown allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.
4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any drugs that inhibit or induce liver metabolism within 28 days before the first dose, or use of any of the following drugs within 28 days before the first dose: monoamine oxidase inhibitors, opioids, serotonergic drugs, sympathetic nerves Drugs, breast cancer resistance protein substrates, dopaminergic antagonists, etc.
5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
6. Positive results from urine drug screen test.
7. History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study.
9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
10. Subjects who plan to receive or have had organ transplants.
11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
13. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Ancillary Study to Protocol 20060104

Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104

Exclusion Criteria:

* Meet exclusion criteria outlined in Amgen Protocol 20060104
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)

The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.

Time Perspective: Retrospective and Prospective

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.
Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma

The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or montelukast for at least 4 weeks.

This is a two-part study; each part of the study (Part 1 and Part 2) will be approximately 34 weeks in duration including a 4-week screening phase, a 24-week placebo-controlled treatment phase and a six-week follow-up phase. In Part 1, patients will be randomly assigned to receive placebo or JNJ-39758979 300 mg once daily through Week 24. In Part 2, patients will be randomly assigned to 1 of 4 treatment groups to receive treatment with placebo, 30 mg, 100 mg, or 300 mg of JNJ-39758979 once daily through Week 24. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of asthma will be performed both on a daily basis via electronic diary and at study visits.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of asthma for at least 6 months before screening. -Has been receiving inhaled corticosteroids (≤ 1000 µg fluticasone or its equivalent) alone or in conjunction with long-acting Beta 2-agonist (salmeterol, formoterol, etc.) and/or montelukast.
* Have an ACQ score ≥ 1.5 at screening. - Must be healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control.

Exclusion Criteria:

* Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit admission due to asthma. -Has a history of any other chronic respiratory condition including chronic obstructive pulmonary disease, bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea or pulmonary hypertension.-Has initiated or discontinued allergen immunotherapy within 12 weeks of screening. -Has smoked within 3 years of screening or has a history of smoking ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) or equivalent, or a positive urine cotinine test at Screening. -Has any known malignancy or has a history of malignancy with the exceptions of basal cell carcinoma or squamous cell carcinoma. -Has chronic or recurrent infectious disease, including, but not limited to: active tuberculosis.-Has a clinically significant, acute respiratory infection within 4 weeks of screening. -Has had a substance abuse (drug or alcohol) problem within the previous 3 years.
Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy

The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.

Bowel preparation quality for colonoscopy is influenced by several factors and preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process, it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a prospective randomized control study to evaluate the effectiveness of fixed PC interval for satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message service (SMS), which reported that it could increase patient's compliance in other practical era

Eligibility Criteria:
Inclusion Criteria:

* 18 and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)

Exclusion Criteria:

* unavailable mobile phone nor SMS
* age younger than 18 years
* pregnancy
* breastfeeding
* history of large-bowel resection
* renal failure (serum creatinine ≥ 3.0 mg/dL \[normal 0.8-1.4\])
* drug addiction or major psychiatric illness
* allergy to PEG
* refusal to participate in the study.
A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy

This prospective observational study is designed to assess the individualized baseline disease burden in pediatric participants aged 1 year to 16 years, with early-onset SCN2A-DEE by characterizing and quantifying changes in clinical features over a period of up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. The participant has a documented SCN2A variant through genetic testing obtained via a laboratory accredited per Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP) or equivalent.
2. The participant has onset of seizures prior to 1 month of age.
3. The participant has a phenotype consistent with a developmental and epileptic encephalopathy (DEE).
4. The participant has a minimum of 8 countable motor seizures (as defined in the note below) in the 4 weeks prior to Screening, as reported by the parent/guardian or in the opinion of the investigator, as documented within the medical notes. (Note: Motor seizures are defined as tonic, tonic-clonic, atonic/drop attacks, focal with secondary generalization, or focal with motor symptoms. Myoclonic seizures or absence seizures only will not be considered as motor seizures for this study.)

Exclusion Criteria:

1. The participant has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or drug abuse or dependence, environmental factor, or any ongoing or history of any psychiatric, medical, or surgical condition that in the judgment of the investigator in consultation with the medical monitor and/or sponsor's designee, might jeopardize the participant's safety, impact the scientific objectives of the clinical study, or interfere with participation in the clinical study.
2. The participant has a clinically significant genetic variant other than an SCN2A variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
3. The participant has any other or additional etiology for epilepsy and/or DEE (eg, cortical dysplasia, encephalomalacia, etc), in the opinion of the investigator.
4. The participant has received any experimental or investigational drug within 30 days or 5 half lives (whichever is longer) prior to Screening, including any prior use of gene therapy.
Osteolysis Development Around Uncemented Cups With or Without Screw Holes

In order to investigate the role of acetabular cup screw holes for the transport of osteolysis-inducing particles in a total hip arthroplasty articulation, the investigators compare the amount of bone loss around acetabular cups with and without holes. Bone loss is measured with computed tomography at 7 years and 15 - 18 years of follow-up.

Particles generated by wear and corrosion within an artificial hip articulation can cause biologically mediated bone loss in the surrounding pelvis. Particles can be found within immunologically active cells inside bone lesions. Holes intended for screw fixation in uncemented acetabular cups are believed to be a main route for these particles from the articulation into the pelvic bone. Using pressfit, screws are not always necessary for a successful fixation of an uncemented cup. The investigator's hypothesis is that a pressfit fixated cup without screw holes will display a decreased amount of periacetabular osteolysis compared to a cup with screw holes. Therefore, 95 hips (90 patients) were randomized to receive either pressfit cups without screw holes or the same type of cup with screw holes. The occurence and size of periacetabular osteolysis will be compared between the two groups. In addition, since the patients will have a computed tomography examination at 7 years and between 15 and 18 years the investigator will also analyze development of periacetabular osteolysis over time. The different cups were paired with three different types of femoral stems. Also, articulation wear and cup and stem fixation will be analyzed using radiostereometry.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary osteoarthritis

Exclusion Criteria:

* Inflammatory osteoarthritis, hip joint infection
Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration

This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC) implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via needle injection into the eye.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females between Age 50 and 90 years
* Patients with dry AMD
* Visual acuity in the study eye \<20200 (equal to or worse than 20/200)

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Inability to undergo syringe liposuction procedure or have any medical problems that contraindicate the procedure.
* Life expectancy \< 6 months due to concomitant illnesses.
* Vitrectomized eyes
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. . If patients have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis, an expert will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which might affect a patient's survival over the follow-up period
* Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Patients with severe coagulation disorders
* Systolic blood pressure (supine) ≤90 mmHg;
* Resting heart rate \> 100 bpm;
* Active clinical infection being treated by antibiotics within one week of enrollment.
* Cerebrovascular accident within 6 months prior to study entry
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Severe COPD or severe asthma that would contraindicate surgery
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
* Unwilling and/or not able to give written informed consent.