cyrilzakka/clinical-trials huggingface dataset:
Effects of Chair-Based Exercise Training on Exercise Capacity in Patients With Acute Exacerbation of COPD

Chronic obstructive pulmonary disease (COPD) is the leading cause of morbidity and mortality worldwide, a respiratory disease characterized by chronic airflow limitation that is not completely reversible.

Impaired pulmonary functions, decreased exercise capacity and quality of life and increased dyspnea perception is prevalent in patients with acute exacerbations of COPD.It was demonstrated exercise training has beneficial effects in patients with acute exacerbations of COPD.

The purpose of this study to evaluate the effects of chair-based exercise training on exercise capacity, respiratory functions, dyspnea, balance, depression anxiety and quality of life in COPD patients in acute exacerbation.

Acute exacerbations of COPD are generally defined as events in the natural course of the disease characterized by a change in the patient's initial dyspnea, cough or sputum beyond normal daily variations. The main consequences of COPD in acute exacerbation are increased mortality, deterioration in health-related quality of life, faster decline in lung function, marked reduction in physical activity and worsening of peripheral muscle weakness, which have a direct impact on patients' health. Although exacerbations are diagnosed based on respiratory symptoms, there is evidence that they have systemic consequences, including a detrimental effect on skeletal muscle function, exercise tolerance and quality of life.

Chair-based exercise training is defined as a structured and progressive exercise program applied by trainers that provides stability using a chair, which is a part of exercise training for the elderly. It is thought that it would be beneficial to study such an exercise program, since COPD patients in acute exacerbation have less mobilization during hospitalization.

In a limited number of studies, some inconsistencies were observed in the exercises of patients with acute exacerbation of COPD. Studies can therefore now focus on investigating comparisons between different intervention lengths, session durations and frequencies, and intensities of exercise training. For this reason, in our planned study, we will investigate the effects of chair-based exercise training in COPD patients in acute exacerbation. There is no study in the literature investigating the effects of chair-based exercise training in COPD patients in acute exacerbation. For this reason, our study will provide important information support to the literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were hospitalized due to acute exacerbation of COPD

Exclusion Criteria:

* Patients with orthopedic or neurological problems that may interfere with assessment and education,
* Uncooperative patients,
* Patients with advanced heart problems such as acute coronary syndrome, stable angina pectoris, severe arrhythmias (Atrial fibrillation etc.), decompensated heart failure.
Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants

The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.


Eligibility Criteria:
Inclusion criteria:

* Female
* Participants aged 18-70 years
* Participants with typical stable angina but without coronary obstruction (defined as coronary occlusion less than (\<) 50%) by invasive coronary angiography or coronary computed tomography angiography (CTA) in recent three months
* All other long acting cardiovascular disease medicines, including but not limited to aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins, ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before screening period
* For participants who met these four criteria above, MFR will be tested by stress PET. Participants whose MFR \<3.0 could be included in the study

Exclusion criteria:

* Severe or uncontrolled hypertension (resting Systolic blood pressure \[SBP\] \>=160 millimeter of mercury (mmHg), or resting Diastolic blood pressure \[DBP\] \>=100mmHg at screening period)
* Participants with shock (including cardiogenic shock), or hypovolemia
* Severe hypotension (resting SBP\<90mmHg，or resting DBP\<60mmHg)
* Significant valvular heart disease, congenital heart disease or cardiomyopathy
* Congestive heart failure(New York Heart Association \[NYHA\] III-IV), echocardiographic ejection fraction\<45%
* Acute pulmonary edema;
* Hepatic or renal dysfunction, defined as:

  * Serum Alanine Aminotransferase (ALT) \> triple of the normal value upper limit;
  * Serum Aspartate Aminotransferase (AST) \> triple of the normal value upper limit
  * Serum creatinine \> twice of the normal value upper limit
* Glaucoma
* Active peptic ulcer or active skin ulcer
* Taking glyburide, phosphodiesterase type 5 (PDE-5) inhibitor, soluble guanylate cyclase stimulator(s)
* Known to be hypersensitivity to nicorandil, nitrates, niacin, or any of the excipient
* With contraindication to complete stress PET test
* No legal ability and legal ability is limited
* Participants unlikely to cooperate in the study or with inability or unwillingness to give informed consent
* Child-bearing period women without effective contraceptive measures, pregnancy and lactation
* Participation in another clinical trial within the past 30 days
* Other significant disease that in the Investigator's opinion would exclude the participant from the trial
Research on Precision Pharmaceutical Care for Heart Transplant Recipients

Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients.

In recent years, model-guided precision medication has become synonymous with modern individualized drug therapy methods. Heart transplantation (HT) is the preferred treatment for patients with end-stage heart failure, as it not only improves the quality of life but also extends the patient's lifespan. However, the host's immune response to the allograft after transplantation has always been one of the main factors affecting the short-term and long-term survival rates after heart transplantation. Recipients need to take immunosuppressants for a long time to improve the long-term survival rate of the graft and the recipient. However, there is a significant individual difference in the clinical application of these drugs. Establishing a risk prediction assessment model for drug administration and an evaluation system for pharmacodynamics and adverse events is an urgent clinical issue to be resolved. For example, tacrolimus (TAC) is a macrolide calcineurin inhibitor with strong immunosuppressive properties. More than 93% of heart transplant recipients use TAC to prevent transplant rejection, which is the cornerstone of the triple immunosuppressive regimen. Studies have shown that acute rejection, infection, acute kidney injury, and other complications usually occur in the early stage after heart transplantation and are significantly related to TAC blood concentration levels. Therefore, accurately estimating the individualized dosage of immunosuppressants after transplantation and accurately predicting the risk of various adverse events such as rejection, infection, and acute kidney injury in heart transplant patients after taking immunosuppressants, constructing a precise pharmaceutical service system for heart transplant patients, can improve the safety and effectiveness of medication for heart transplant patients, and has important clinical value.

Eligibility Criteria:
Inclusion Criteria:

* Patients after heart transplantation

Exclusion Criteria:

* Graft failure or death after surgery
* Patients who have received two or more organ transplants
* Patients with incomplete clinical data
Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

Research question:

Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?

Primary objectives:

To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.

Benefits:

There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.

Risks/disadvantages:

The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.


Eligibility Criteria:
Inclusion Criteria:

* Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
* Age over 18 years of age
* Patient able to give informed consent

Exclusion Criteria:

* Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
* Patients under 18 years of age
* Patients unable to give informed consent
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

The purpose of the research is to perform a quality assurance evaluation using randomized prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.

The investigators goal is to show the use of prophylactic antibiotics in orbital blowout fractures does not significantly decrease the rate of orbital cellulitis and is thus not indicated.

Orbital fractures are a common occurrence in association with a wide variety of blunt trauma injuries to the face. One type of fracture is that involving the orbital floor, or an isolated blowout fracture. One common current practice is to use prophylactic antibiotics in these cases to prevent the theoretical occurrence of an orbital cellulitis originating from sinus flora, though there is no current standard of care regarding this practice. Many surgeons may elect to not use antibiotics for this very reason.

The use of prophylactic antibiotics in isolated blowout fractures where there is no occlusion of the ostium is not defined, and no prospective controlled study has been undertaken to suggest the most appropriate course of action to take. Our goal in this study is to determine a correct course of action for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Isolated orbital blow out fracture in patients between the ages 5 to 99 years old

Exclusion Criteria:

* Involvement of the orbital rim in the floor fracture requiring the use of antibiotics
* Involvement of the orbital rim in the floor fracture
* Radiographic evidence of occlusion of the maxillary sinus ostium
* Determined need for surgical intervention or prior use of synthetic implanted material in or around the involved maxillary sinus
* Any symptoms of sinonasal disease in the preceding 3 month for any reason
* Any use of oral or IV antibiotics in the preceding 3 month for any reason
* Documented allergy to penicillin or amoxicillin prohibiting its use
* Any currently immunosuppressed state, including actively treated autoimmune disease; use of steroids, immunomodulatory medication, or chemotherapy within the last year; diagnosis of active cancer within the last year
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.

The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.

The secondary objectives of this study are to:

* Describe the safety and reactogenicity of high-dose and standard-dose TIV.
* Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
* Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
* Written informed consent (and assent, if applicable) obtained.
* Participant has a diagnosis of cancer or HIV.
* If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks

Exclusion Criteria

* Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
* History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
* Not willing to agree to acceptable birth control for three months after study immunization
Effect of Deep Oscillation Treatment as a Method for Recovery in Soccer

The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated recovery within the first 48h after fatiguing training with positive effect on the maximum strength, rated perceived exertion, creatinkinase (CK) values and DOMS compared to no treatment after an .

Recovery time between in association football (soccer) often is not long enough to completely restore. Insufficient recovery can result in a reduced performance and suboptimal development in the training process and a higher risk for injuries. The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. Deep Oscillation is a unique method which is characterized by an alternating electrostatic which results in a deep resonance vibration of patients tissue.

Methods: In a randomized crossover study design including 10 soccer players of the 5th german devision the following parameters will be evaluated directly before and 48h after an fatiguing soccer specific exercise: Maximum isokinetic strength of the leg and hip extensors and flexors (Con-Trex® Leg Press, Physiomed, Germany), rating of perceived exertion (RPE) during isokinetic testing (Borg scale 6-20) and creatine kinase (CK) serum levels. Delayed Onset Muscle Soreness (DOMS; visual analogue scale 1-10) will be recorded 24 and 48h post-exercise. At random half of the group will perform a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. 4 weeks later in a cross-over design the same procedure will be conducted again.

Eligibility Criteria:
Inclusion Criteria:

* active soccer player in of the 5th devision

Exclusion Criteria:

* health problems
* medication with impact on the endpoints
Reducing Sedentary Time in Obese Adults (Study 2)

Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery patients and other obese individuals will be considered
* Body mass index \>= 25 kg/m2

Exclusion Criteria:

* Report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance
* Are currently involved in a physical activity intervention.
* Are unable to read or understand the study materials
* Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
* Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.
Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin

The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (\<350 pg/mL).


Eligibility Criteria:
Inclusion Criteria:

* Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL
* Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (\>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).
* General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula

Exclusion Criteria:

* Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;
* Daily use of neutralizing antacids (e.g. Maalox®)
* Inability to ingest oral medication
* Clinically significant laboratory value at screening
* Hypersensitivity or allergic reaction to vitamin B12
* Participation in a clinical research study involving a new chemical entity within 30 days of the first study dose
* Folate levels below the reference range provided by the clinical laboratory.
* Renal insufficiency
* Vitamin B6 deficiency
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 65 years and older
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Esophageal Fistula After Anterior Cervical Decompression and Fusion

This study aims to evaluate the incidence, risk factors, and preventive measures of esophageal fistula following anterior cervical decompression and fusion. By understanding the mechanisms and clinical manifestations of this complication, the study seeks to provide clinicians with better guidelines for treatment and improve postoperative outcomes for patients.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 and older. Diagnosed with a secondary esophageal fistula following anterior cervical decompression and fusion surgery.

Postoperative confirmation of the esophageal fistula via imaging studies or endoscopy.

Presence of clinical symptoms such as dysphagia, coughing, or signs of infection.

Patients or their legal representatives must provide informed consent.

Exclusion Criteria:

Preexisting esophageal diseases such as esophageal cancer, severe esophagitis, or congenital anomalies.

Other types of fistulas not related to the surgery. Severe comorbid conditions, including: Uncontrolled diabetes, severe cardiovascular diseases, immunosuppression, pregnant women.

Individuals unable or unwilling to comply with study protocols. Life expectancy of less than six months due to other underlying health conditions.
A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis

The fracture risk of diabetic patients proves to be higher than those without diabetesdue to thehyperglycemia, usage of diabetes drugs, the changes in insulin levels and excretion, and this risk begins as early as adolescence.Many factors may be related to bone metabolism in patients with diabetes, including demographic data (e.g. age, height, weight, gender), medical history (e.g. smoking, drinking, menopause) and examination (e.g. bone mineral density, blood routine), urine routine).However, most of existing methods are qualitative assessments and do not take the interactions of the physiological factors of humans into consideration. In addition, the fracture risk of diabetic patients with osteoporosis has not been further studied before. In order to investigate the effect of patients' physiological factors on fracture risk, in the paper, we used a hybrid model combining XGBoost with deep neural network to predict the fracture risk of diabetic patients with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients in Hospital's outpatient and inpatient His database between July 2012 and November 2022, diabetic patients were combined with osteoporosis.

Exclusion Criteria:

* Patients with fractures before diagnosis of diabetes; patients with fractures before diagnosis of osteoporosis; patients with hyroid disease and other diseases that seriously affect bone metabolism.