cyrilzakka/clinical-trials huggingface dataset:
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals. Risk of falls is multi-factorial and impaired balance has been shown to contribute.

The investigators aimed to demonstrate that, IMT performed during a PRP may improve Postural control in COPD patients.

Chronic obstructive pulmonary disease COPD is a preventable and treatable disease. According to the WHO, COPD would be the third leading cause of death by 2030. This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall.

Individuals with COPD, especially those with inspiratory muscle weakness, increased their reliance on ankle muscle proprioceptive signals and decreased their reliance on back muscle proprioceptive signals during balance control, resulting in a decreased postural stability compared to healthy controls. These proprioceptive changes may be due to an impaired postural contribution of the inspiratory muscles to trunk stability.

Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life. However, the effect of inspiratory muscle training on postural control is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on posture in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Were COPD diagnosed by pulmonary function testing
* Clinically stable
* Abscence of other obstructive diseases
* Signed written consert

Exclusion Criteria:

* Were previous pneumonectomy or lobectomy in the past 6 months
* Spontaneous risk of pneumothorax or rib fracture
* Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
* Lower limb injury
* Neurological injury or disease
* The absence of written informed consent
Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation

The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.

When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.

Eligibility Criteria:
Inclusion Criteria:

* living donor kidney transplantation recipients
* patients who were performed kidney biopsies because of laboratory and clinically suspected rejection
* Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative
* Single luminex panel reactive antibody (PRA) I \& II mean fluorescent intensity (MFI) \< 3000

Exclusion Criteria:

* patients who received other major organ transplantation
* combined with urinary tract infection or obstruction
* combined with acute antibody mediated rejection
* poor compliance
Evaluation of the Erector Spinae Muscle in Different Position and the Change After Receiving Myofascial Release.

The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.

In clinical practice, manual muscle testing (MMT) and Modified Ashworth scale (MAS) grading systems are often used to assess muscle tension and tension. Although these methods are considered feasible, because these methods are mainly classified based on the subjective perception of the evaluator, the reliability and accuracy of the evaluation results are often questioned. Therefore, we should seek a way to objectively evaluate muscle tension with biomechanical properties and quantitative data to solve these deviations. MyotonPRO (Myoton AS, Tallinn, Estonia) is a tester that uses biomechanical principles to collect muscle tension status. This handheld muscle tension tester uses mechanical pressure and reaction force feedback to calculate through biomechanical conversion. The tone, stiffness and elasticity of the muscle are expressed as quantitative data. There have been many use reports showing that the muscle tone meter has the feasibility of quantifying muscle tone.

The erector spinae is one of the most important back muscles of the human body. After contraction, the entire spine can be erected, allowing the upper body to stand upright. When the posture changes, such as: sitting posture, hunchback, bending over, erector spinae will be stretched or continuously contracted due to different postures, resulting in changes in muscle characteristics. Therefore, if the erector spinae is used improperly for long-term poor posture, the erector spinae is easily damaged due to heavy burden, which can easily cause back pain. Myofascial release (myofascial release) is a soft tissue massage method that loosens the fascia with hands. By changing the mechanical properties of the muscles, it can loosen over-tension or tense muscles. It is the most commonly used by physical therapists to loosen muscles. One of the operation techniques. However, there is no literature to quantify the effect of myofascial mobilization. The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.

Eligibility Criteria:
Inclusion Criteria:

age 20-65 healthy adult

Exclusion Criteria:

1. Radicular neurological signs
2. spinal deformity e.g.scoliosis, spondylolisthesis
3. infection or tumor
4. Rheumatologic conditions
5. Previous spinal surgery
6. History of hip or pelvic disorder that required treatment
7. male BMI\> 27 and female BMI\> 26
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health

The aim of the study is to determine the effect of resistance training (RT) combined with time-restricted eating (TRE) or normal diet (ND) on muscle mass, and strength. Additionally, the study will compare between TRE and ND and its effects on cardiometabolic health, mitochondria function and body composition among people with metabolic syndrome.

In this randomized controlled trial, 50 males with metabolic syndrome (elevated waist circumference, blood pressure, triglycerides, fasting glucose and low high-density lipoprotein cholesterol) between the age of 40-60y and with BMI between 25-33 kg/m2 will be randomized to either TRE+RT (n=25) or ND+RT (n=25). All participants will perform supervised and monitored RT three time per week for the 10 weeks of intervention Study measurements; Changes in body composition, muscle mass and adipose tissue distribution will be measured by 3-Tesla magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DXA), air displacement plethysmography (BODPOD) and Bioelectrical Impedance analysis (BIA). Muscular Strength will be assessed. Blood samples, including lipid and glycemic profile. muscle biopsy taken from the vastus lateralis muscle.

Primary aim. Determine the effect of TRE or ND, combined with RT training, on muscle mass and strength as adaptive response to 10 weeks of intervention among people with metabolic syndrome.

Secondary aims. Determine the effect of TRE combined with RT on cardiometabolic health lipid profile and HbA1C (C), Mitochondria function and oxygen consumption (D) and Body composition assessment (E).

Eligibility Criteria:
Inclusion Criteria:

* Subject with metabolic syndrome
* BMI between 25-33 kg/m²
* Age 40-60
* Without cardiac and pulmonary disease
* Did not engage exercise training in the last year.
* Willing and able to read, understand and sign an informed consent

Exclusion Criteria:

* Participants that have cardiopulmonary disease
* Inability to attend scheduled clinic visits and/or comply with the study protocol
* Active smokers
* Previous regular exercise training in the previous yea
* Major orthopedic injury at the past 3 months
* Inability to perform an MRI (due to claustrophobia, or metal in their body)
* Subjects that uses drugs that affect muscle metabolism
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests)
* 18 to 55 years of age
* BMI within 18.5 to 30 kg/m2
* Non-smoker
* Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, and heart rate between 60-100 bpm, inclusive.
* Female subjects of childbearing potential should be either sexually inactive (abstinent) or be using one of acceptable methods of birth control for 15 days prior to the first dose of the study, throughout the study and for at least 30 days after the last aprepitant dose.
* Able to swallow whole aprepitant capsules
* Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer.

Exclusion Criteria:

* Clinically significant illness or surgery within 8 weeks prior to dosing.
* Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.
* History of allergic reactions to the study drug and/or its excipients.
* Subjects concurrently treated with drugs that are metabolized through CYP3A4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc.
* History of drug or alcohol abuse within the last 6 months.
* Severe mental disorders.
* Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
* Pregnant or breastfeeding.
* Use of recreational drugs, prescription medications (other than hormonal contraceptive agents),non-prescription medications (over-the-counter) or natural health products within 7 days or 5 half-lives (whichever is longer) prior to the administration of the first dose of study medication.
* Consumed grapefruit or grapefruit products within 7 days of each study period
* Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study

The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.

Adolescents and young adults (AYA) living with HIV show lower ART adherence, higher loss to follow-up and higher AIDS-related mortality than other age groups. Innovative approaches are needed that address AYA's unique needs and improve their adherence and retention in HIV care. There is evidence that peer support and mobile messaging with healthcare workers (HCW) are two strategies that may be effective in this group, but their evaluation has been limited and no interventions have combined them. Since 2014, youth-run virtual support groups have spontaneously started at HIV clinics, using the mobile social media application WhatsApp. These groups present valuable case studies from which the proposed project will develop a structured social media intervention that combines peer and HCW support to improve ART adherence and retention, guided by the preferences of AYA. The SPECIFIC AIMS are to (1) Characterize the existing WhatsApp groups through in-depth interviews with members and detailed content analysis of the group's communications during a 6-week observation period. This will define the elements and features desired by AYA in a social media intervention. (2) Guided by findings from Aim 1, behavioral theory, and the study team's ongoing research on mobile messaging to improve ART adherence, to develop and refine structured content for a reproducible WhatsApp intervention that incorporates peer and HCW interaction. (3) Pilot the structured intervention for 6 months in another clinic and evaluate its impact on intermediate outcomes ART knowledge, depression and stigma.

Eligibility Criteria:
Inclusion Criteria:

* Living with HIV
* On ART
* Aware of HIV status
* Has access to WhatsApp
* Literate
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from clinically significant illness or disease.
* Male and female subjects of non-childbearing potential aged 18 to 55 years.
* Normal or non-clinically significant 12-lead ECG.
* Holter recording with no clinically significant abnormalities.
* Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg

Exclusion Criteria:

* A History of severe adverse reaction or allergy to any medical product.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder.
* A history of tuberculosis.
* Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.
* Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators.
* Clinical relevant abnormal medical history, or physical findings or laboratory values.
* Clinically significant 12-lead ECG abnormalities.
* Clinical relevant abnormal findings in echocardiograph.
Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)

In 2010 there was published new European recommendations for assessment of adult and elderly men and women, who want to start with physical activity and/or participate in endurance contests. In this study we want to test if a group of people with positive score on a self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have more undetected heart diseases than a control group with no reported or detected risk factors.

Forty senior athletes between 35 to approximately 80 yrs old with a positive score will be included in one group, and another forty seniors without positive score in a control group. Each of them will be tested with an cardiorespiratory exercise test (CPET) with ECG and examined with echocardiography together with an usual medical examination and blood tests (cholesterol and HbA1c-glucose). Some with symptoms of arrhythmias will be examined by 24-hours Holter-monitoring.

The main purpose of the study is to assess if men and women with a positive score on the questionnaire og NORRISK-screening (risk calculator for coronary heart disease) have more detectable heart diseases than the control group.

Eligibility Criteria:
Inclusion Criteria:

\> 35 yrs old Master athletes Positive score on symptom based questionnaire or high risk score No known heart disease Participated in long-term endurance competitions

Exclusion Criteria:

\< 35 yrs old Known heart disease
Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder

Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.

In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Panic disorder with or without agoraphobia due to DSM-IV
* Written informed consent
* Score of 17 or more on the P\&A scale
* Score on the CGI of 4 or more (markedly ill)

Exclusion Criteria:

* Pregnancy, lactating or insufficient contraception (pearl index \>1)
* Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc.
* Clinically relevant abnormalities in physical examination or laboratory results
* Prior major depression or bipolar disorder
* Suicidality
* psychotropic medication other than promethazine
* current psychological treatment
* unable to perform regular aerobic exercise
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients

The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.

Eligibility Criteria:
Inclusion Criteria

Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:

* Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
* Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician
* Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
* Patients of 18 years of age or older, and are being treated by the adult AML service.
* Able to speak and read English.
* Willing and able to provide informed consent.

Exclusion Criteria

* Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.
* Patients older than 80 years
* Patients with \<6 months projected survival due to active second malignancy or other medical problem.
Taurine Supplementation on Cognitive Function in Patients With Diabetes

Diabetes has become important risk factors for threatening human life and health. Studies have shown that chronic hyperglycemia lead to microvascular brain injury. The more common types of dementia are Alzheimer's disease (AD). Cognitive dysfunction is a precursor to Alzheimer's disease. Mild cognitive impairment (MCI) is a cognitive impairment between normal aging and dementia, mainly manifested as memory impairment, especially episode memory defects, but also named obstacles, but the overall cognitive function is normal, daily life ability is normal. Studies have shown that middle-aged diabetic patients' cognitive ability will decline by about 19% in 20 years compared to people without diabetes.

Sulfur amino acid is the indispensable amino acid in mammals, and its metabolites include Taurine, Hydrogen sulfide (H2S) and sulfur dioxide (SO2). Taurine was first isolated more than 150 years ago from ox (Taurus) bile. Although the taurine can be synthesized in vivo by cysteine in the presence of cysteine dioxygenase, it is mainly acquired from dietary sources, such as eggs, meat, and seafood. H2S is a biologically relevant mediator and plays potential roles in several physiological processes and disease states in the body. H2S is synthesized from 2 sulfur-containing amino acids, l-cysteine andl-methionine, by the 3 enzymes,cystathionine-γ-lyase (CSE), cystathionine-β-synthetase(CBS), and3-mercaptopyruvate sulfurtransferase (3-MST). Previous studies have demonstrated that Taurine and H2S may play important roles in the development of themicroangiopathy and lower extremity arterial occlusive.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Type2 diabetes with acute diabetic complications.
* Type1 diabetes.
* History of depression, schizophrenia or dementia.
* History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
* History of parkinson's diseases, head injury,toxic encephacopathy,epilepsy.
* Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
* Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
* Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
* Fertile woman without contraceptives.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
* Allergic to or have contraindication to the intervention drugs.