cyrilzakka/clinical-trials huggingface dataset:
Long-term Prednisone Use for End-stage Heart Failure

Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year mortality. Currently, there was no evidence-based therapy such as mechanically assisted circulatory support available in China. The investigators found glucocorticoid treatment such as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or beta blocker titration. With its help, most of the patients with stage D heart failure could be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization. However, the efficacy of long-term, low-dose of prednisone use in such patients with limited life expectancy remain unclear. Therefore, the investigators designed this study to observe whether putting low-dose of prednisone on the patients with stage D heart failure for long term could further improve their survival. All patients will receive prednisone treatment during hospitalization and receive maximum tolerated guideline-directed medical therapy (GDMT). After discharge from hospital, the patients will be randomized to receive long-term, low-dose prednisone treatment or standard GDMT.


Eligibility Criteria:
Inclusion Criteria:

* Repeated (\>2) hospitalizations or ED visits for HF in the past year
* Inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
* Left ventricular ejection fraction ≤35%
* Serum uric acid level ≥500μmol/L
* Received prednisone treatment during hospitalization period and And more 5 of the followings

  1. Progressive deterioration in renal function (e.g., rise in BUN and creatinine)
  2. Weight loss without other cause (e.g., cardiac cachexia)
  3. Intolerance to ACE inhibitors due to hypotension and/or worsening renal function
  4. Intolerance to beta blockers due to worsening HF or hypotension
  5. Frequent systolic blood pressure \<90 mm Hg
  6. Recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose \>160 mg/d and/or use of supplemental thizide therapy
  7. Progressive decline in serum sodium, usually to \<133 mEq/L
  8. Gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites, or severe lower-extremity edema

Exclusion Criteria:

* Any condition (other than heart failure) that could limit the use of prednisone
* Any concurrent disease that likely limits life expectancy;
* Active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
* Myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
* Indication for hemodialysis
* Uncontrolled systolic blood pressure \> 160 mmHg
* Complex congenital heart disease
* Poorly controlled diabetes
Bike Skills Training for Children With Cerebral Palsy

An assessor blinded multi-centre randomized controlled trial will be conducted in which 60 participants will be randomized to either a novel task-specific approach to training bike skills or a parent-led home program comparison group. Baseline assessment will take place within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The primary outcome is attainment of individualised two-wheel bike specific goals at T1. All statistical analysis will be conducted on an intention-to-treat basis. Logistic regression will be used to assess the effect of providing the novel intervention compared to the parent-led home program on bike-specific goal attainment.


Eligibility Criteria:
Inclusion Criteria:

* Live in Victoria, Australia
* Diagnosis of cerebral palsy
* Aged 6 - 15 years
* Independently ambulant without mobility aids
* Have goals specific to two-wheel bike skills
* Have medical clearance to participate
* Have access to an appropriate bike and helmet
* Have a primary care giver who understands written and spoken English available to participate for each participant.

Exclusion Criteria:

* Has a moderate to severe intellectual impairment
* Has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. This includes; Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician
* Had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
* Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.

The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.

Eligibility Criteria:
Inclusion Criteria:

* seen in the Grady Liver Clinic during the study time period
* have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)

Exclusion Criteria:

* no chronic hepatitis C infection
* co-infection with HIV or hepatitis B
* non-English speaking
* unable to consent to participate
* already started HCV therapy
Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock

Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.

Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.

Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.

Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.

This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the ICU with a diagnosis of SIRS, sepsis or septic shock,
* aged ≥ 18 years,
* body mass index (BMI) ≤ 35 kg / m2,
* without diabetic polyneuropathy,
* without cardiac pacemaker,
* without diagnosis of neuromuscular diseases,
* absence of skin lesions.

Exclusion Criteria:

* heart attack,
* death.
Study of Erenumab (AMG 334) in Women With Hot Flashes

The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.

This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with hot flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

Eligibility Criteria:
Inclusion Criteria:

* female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

* History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants

The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.

This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.

Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.

Eligibility Criteria:
Inclusion Criteria:

* The participant has completed the preceding study.
* The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.

Exclusion Criteria:

* The participant has undergone blood collection of \>= 400 mL within 90 days prior to the start of treatment in this study.
* The participant is required to take any of the excluded medications or treatments.
* The participant is required surgery or hospitalization for surgery during the study period.
Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Primary open-angle glaucoma in one eye
* Visual acuity 20/80 or better
* Intraocular pressure in the study eye ≤ 24 mm Hg
* Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

* Known allergy to brimonidine tartrate
* Uncontrolled systemic disease or infection of the eye
* Recent eye surgery or injections in the eye
* Female patients who are pregnant, nursing or planning a pregnancy
Validation And Turkish Cross-Cultural Adaptation of Stroke Knowledge Test

Cerebrovascular diseases are the leading cause of disability, work loss, and quality of life reduction, the third leading cause of death globally, and significantly impact hospital admissions and expenses. This prevalence rises with an aging population and comorbidities. Recognizing stroke symptoms quickly is crucial for timely treatment. Miscommunication or misunderstanding among hypertensive patients, who are at the highest risk for stroke, increases stroke risk and complications. Educating the public about stroke symptoms and responses is essential for prevention. Therefore, a valid and reliable tool to assess hypertensive patients' stroke knowledge is important for improving long-term outcomes. This research aims to adapt the Stroke Knowledge Test into Turkish and evaluate its validity and reliability in hypertensive patients.

Cerebrovascular diseases are the group of diseases that cause the most disability and loss of work, affect the quality of life the most and are the third leading cause of death in the world, and also have a significant place in hospital admissions and expenses. This rate increases with the aging population and comorbidities. The recognition of stroke symptoms by the society is the most important factor in patients reaching treatment opportunities without wasting time.

It is known that failure to provide accurate information to hypertensive patients, who are the highest risk group for stroke, or the patient's failure to understand stroke is associated with a higher risk of stroke and complications. These findings indicate that it is important to provide information to the public about how they behave when they encounter symptoms related to stroke and related conditions. Measuring stroke knowledge and risk factors in hypertensive and potential stroke patients can serve as a healthcare provider who informs the society to adopt stroke prevention behaviors.

Therefore, a valid and reliable assessment tool is of great importance in determining whether hypertensive patients have sufficient knowledge about stroke and improving the long-term clinical outcomes of stroke.

This research aims to perform the cross-cultural adaptation of the Stroke Knowledge Test into Turkish and to examine the validity and reliability of the assessment tool in hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Native Turkish and literate
* Diagnosed with hypertension / history of ischemic or hemorrhagic stroke and
* Patients who signed the voluntary consent form will be included.

Exclusion Criteria:

* Participants who are illiterate and
* Participants who have mental problems that may prevent them from answering the test will not be included in the study.
The Clinical Application of Horticulture Therapy in Psychiatric Rehabilitation

Horticultural Therapy (HT) uses plants, gardening, and the close relationship between well-beings and plants. It integrates effort, hope, expectation, harvest and the enjoyment of whole process to help people with disabilities. During the process, patient can learn more about themselves and experience the nature.

It can be traced to 1798, Dr. B. Rush found farm work helped people with mental illness. Today, horticulture therapy is well applied in disabilities, elderly and children. It needs detailed evaluation for the condition of illness to achieve optimal efficacy. It contains two parts- to sense and to operate! Patients can relax themselves and learn to work with others, realize the responsibility of caring another life, understand their relationship with environment. Patient can tolerate frustration better via acceptance the withered plants. In cultivation, it trains patient the occupational technique ( to operate instrument), communication, social skill, independence, stable mood.

Based on studies, 0ne third patients with mental illness stabilized after treatment. However, aggressive rehabilitation is necessary to maintain their function. In our study, it plans to incorporate horticulture therapy into psychiatric clinical practice in our hospital. We plan to recruit horticulture therapist, visiting staffs, residents, occupational therapists and nurses to participate the design and operation in class.

This program will recruit patients with schizophrenia, bipolar disorder, organic brain syndrome and other mental illness in our daycare. We will help patients with personal treatment record. We will use case study to report some typical cases. All the cases will be investigated qualitatively with intensive interview to explore the subjective experience on this therapy. We will also use simple questionnaire to found quantitative study in the further.

To sum up, this program helps the connection for horticulture therapy and psychiatric rehabilitation. It promotes " patient-centered" support and offers physical, mental , social, spiritual services. It not only produces academic performance but fulfills the ideal of holistic health care!


Eligibility Criteria:
Inclusion Criteria:

* 18\~65 both sexes
* Adequate daily function for horticultural activities
* Day care patients or referred from OPD
* Willing to accept and cooperate with H/T

Exclusion Criteria:

* Substance abuser or PD
* Severe suicide or harmful behaviors
* Severe physical problem impeding horticultural activities
* Lack of motivation for H/T
Validation of RDQ Questionnaire

The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will be compared with other established approaches to the diagnosis of gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
* The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
* The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1

Exclusion Criteria:

* Upper GI endoscopy performed within a year prior to Visit 1
* Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
* Contra-indication to the Bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure)
GXR RM China BE Study (Darmstadt - Jiangsu)

The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator.
* Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square).
* Participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
* Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
* Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
* Participation in a clinical study within 90 days prior to first drug administration.
* Non-acceptance of study high-fat breakfast.
* Other protocol defined exclusion criteria could apply .
Unilateral Wrist Extension Training After Stroke

Following stroke, muscle weakness and impaired motor function are expressed in both the more (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance training is well recognized, training the MA limb directly may be initially difficult due to muscular weakness. "Cross-education" is training one side of the body increases strength in the untrained and opposite side. This concept can be applied in strength training when training the more affected sides cannot be initiated. Recently, our lab found six weeks of dorsiflexion resistance training in the LA leg improved the strength of both trained and untrained legs of chronic stroke participants.

The current project explored if cross-education exists in the upper limb in chronic stroke participants and if there are related changes in cortical and spinal cord plasticity. We hypothesized that unilateral strength in the less affected arm could enhance wrist extension strength bilaterally with related neural adoption and improved clinical function.

Stroke produces muscle weakness seen on both more (paretic, MA) and less affected (non-paretic, LA) sides. "Cross-education" is training one side of the body increases strength or motor skill in the same muscles on the untrained side. This can be applied to enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance training with the LA leg improved strength bilaterally in chronic stroke. To explore if cross-education occurs also in the upper limb after stroke, participants will complete a 5-week unilateral wrist extension training.

Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia. Before and after training, maximal voluntary contraction wrist extension force was measured with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and partial Wolf Motor Function Test were performed by the same physical therapist at each location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal inhibition from transcranial magnetic stimulation were measured in participants at UBC.

Eligibility Criteria:
Inclusion Criteria:

* Over 6 months post-stroke;
* One side of arm shows muscle weakness
* Pass the screening test of Physical Activity Readiness Questionnaire
* Pass the screening test for dementia
* Free from dementia (score \< 24 on the Montreal Cognitive Assessment) and any other contradiction for TMS test

Exclusion Criteria:

* Had medication affecting muscle tone within the past 3 months
* Wear a pacemaker