cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Physical Fitness After Stroke

This study aims to examine the evolution and determinants of physical fitness after stroke.

Stroke is a major cause of chronic severe disability. More than 50% of stroke survivors have residual motor and functional deficits which have an impact on their participation and quality of live (Patel et al, 2006). Limitations on daily functioning may lead to physical inactivity and a sedentary lifestyle. Sustained physical inactivity (deconditioning) induces a reduction in aerobic capacity, which may further increase the risk of cardiovascular diseases in these individuals above that associated with stroke itself. Therefore, improving aerobic capacity may be essential in prevention of secondary diseases due to lack of fitness in the stroke population. Previous studies have also indicated that a critical level of aerobic capacity must be met in order to function independently (Cress et al, 2003). Therefore, in addition to disease prevention, enhancing aerobic capacity in individuals with stroke may also have beneficial effects on promoting functional abilities and independent living. It is also known that a limitation in functional performance is mostly associated with a restriction in social activities (ICIDH-2-model). Clearly, stroke survivors can benefit from counseling on participation in physical activity and exercise training. A recent meta-analysis (Pang et al, 2006) showed that there is good evidence to support the use of aerobic exercise to improve aerobic capacity in individuals with stroke. However, before going on that road, one needs to know more about the level of physical activity and physical fitness in the stroke population.

Eligibility Criteria:
Inclusion Criteria:

1. first-ever stroke as defined by WHO
2. aged \< 75 years,
3. able to comprehend simple oral instructions.

Exclusion Criteria:

1. other neurological impairments with permanent damage
2. stroke-like symptoms due to subdural haematoma, tumour, encephalitis or trauma
3. pre-stroke Barthel Index \<50
4. unable to perform a maximal exercise test in accordance with absolute contra-indications for exercise testing (ACC/AHA)
5. no informed consent.
Medtronic Evolut™ EXPAND TAVR I Feasibility Study

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

Single-arm, descriptive, multi-center, international

All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Eligibility Criteria:
Key Inclusion Criteria:

* Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm\^2, or aortic valve area index ≤ 0.6 cm\^2/m\^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
* Subject denies symptoms attributable to aortic stenosis, including but not limited to:

  * Dyspnea on rest or exertion
  * Angina
  * Syncope in the absence of another identifiable cause
  * Fatigue
  * Left Ventricular Ejection Fraction (LVEF) \>50%

Key Exclusion Criteria:

* Age \<65 years
* Class I indication for cardiac surgery
* Bicuspid, unicuspid, or quadricuspid aortic valve
* In need of and suitable for coronary revascularization
Effects of Passive Blood-Flow-Restriction on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty

This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.

This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty Surgery.

Eligibility Criteria:
Inclusion Criteria:

* The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
* All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
* All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.

Exclusion Criteria:

* Acute or chronic infections of the extremities
* Open wounds on the lower extremity
* Pregnancy and breastfeeding
* Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team
Nebulized Colistin for Hospital-Acquired Pneumonia

Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age\>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion Criteria:

* pregnancy
* lactating woman
* colistin allergy
* severe renal impairment
* epilepsy
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis

The aim of this study is to examine the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis

The Effect of Mandala on Coping with Fatigue, Psychological Well-Being and Stress in Patients Treated with Hemodialysis

Eligibility Criteria:
Inclusion Criteria:

* be over 18
* Ability to communicate adequately
* Absence of psychiatric problems
* Volunteering to participate in the research
* Receiving hemodialysis treatment for at least 6 months

Exclusion Criteria:

* None
Comparison of The Success Rates of Four Different Pulpotomy Techniques

This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

Exclusion Criteria:

* The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.
Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults

The subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. The investigator's program will provide meals containing different proportionated protein.As this project is a double blind test, only the investigators will know which subject corresponding to specific group of diets.

Besides, the investigators use the valued-based healthcare standard set as well as the Center for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized controlled trial design to validate if increased protein density diet could improve the vitality and health of mid-aged and old adults .

With aging, functions of every organs become to decline. Muscle mass, is one of the decline. According to previous research, adults would lose 40% among from aged 20 to 70. If muscle mass decline combining with the decline of muscle strength is so called Sarcopenia.When muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.

Eligibility Criteria:
Inclusion Criteria:

* People who aged 40-75 years
* Patients with following characteristics:
* feeling loss in activity
* detecting decline in self's walking speed.
* feeling tired of doing everything.
* having fell in last year.
* People can accept undergoing MRI
* People willing to follow the program and cooperate with us for following tracking.
* People who are neither vegan nor vegetarian
* People agree and be able to sign the informed consent.

Exclusion Criteria:

* People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.
* People with any disease affecting their limbs, including:
* having fracture on limbs in the past 6 months
* having severe arthritis in the past 6 months
* any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
* People with intermittent limp caused by peripheral artery diseases
* People with weak control of mental disorder
* People with weak control of Cardiopulmonary disease
* People with weak control of Malignant tumor
* People with weak control of kidney diseases (eGFR \<60ml/min/1.73)
* People with Visual impairment and Hearing disorder which cannot help to complete the program.
* People who are unable to undertake MRI
* People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
* Any other condition that PI recognized as not suitable
MRI Guided Management of Occlusive Peripheral Arterial Disease

The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.

Patients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.

Patients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.

Please see attached study protocol.

Eligibility Criteria:
Inclusion Criteria:

A. General Inclusion Criteria:

i. All patients will be ≥ 40 years old with PAD (Rutherford Category 4, 5, 6)

B. Anatomic inclusion criteria:

i. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \> 50% stenosis by investigator visual estimate

Exclusion Criteria:

A. General Exclusion Criteria:

i. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications

B. Anatomic Exclusion Criteria:

ii. Aim 2 only - Chronic total occlusions
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Masseter prominence at the Day 1 visit
* BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/\[height (m)\]2
* A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods

Exclusion Criteria:

* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* An anticipated need for surgery or overnight hospitalization during the study
* An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
* Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
* Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1
* History of temporomandibular joint disorder (TMJD)
* Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy)
* Known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures
* History of alcohol or drug abuse within 12 months of Day 1
Safety Study of Chinese Herbal Therapy to Treat Asthma

The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.

Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.

We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in atopic patients with asthma and will lead to identifiable changes in serum immunologic markers.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination
* History of asthma documented by a physician
* Documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or RAST testing
* The subject agrees to participate in the study
* Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.

Exclusion Criteria:

* Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
* Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
* Abnormal hepatic function
* Abnormal bone marrow function
* Abnormal renal function
* Clinically significant abnormal electrocardiogram
* Current uncontrolled moderate to severe asthma with FEV1 \<80% predicted
* Participation in another experimental study within 30 days of this study
* History of alcohol or drug abuse (by self report)
* Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test to be considered for this study
* Current smokers
Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)

This is a single centre, open-label, feasibility randomised controlled trial. The study aims to assess the feasibility of conducting an RCT to compare the PneuX ETT with standard care in hospitalised patients requiring mechanical ventilation. The patient population for this study are those who are experiencing critical illness requiring intubation and ventilatory support. Patients will be randomised in equal proportions into one of 2 arms: to be intubated using a Venner PneuX Endotracheal Tube (ETT) or using the standard tube. For this feasibility study, a total of 50 patients will be randomised into two groups (25 in each). All patients will be recruited at a single site (University Hospital of Wales, part of Cardiff \& Vale UHB). The study will investigate several feasibility measures including recruitment, delivery of the intervention (including device-related adverse events), acceptability and adherence to the intervention and sampling, use of Peptest to measure microaspiration events, rate of pepsin positive samples, rate of tracheobronchial colonisation, volume of sub-glottic aspirate, rate of VAP, length of ICU and hospital stay, demonstrate the validity of study documentation and provide preliminary data for 50 patients. The data will inform the pilot and main phase of the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old (no upper age)
* Patient required endotracheal intubation
* Expect to remain intubated for 24 hours post randomisation

Exclusion Criteria:

* The person intubating the patient assesses that the patient has already aspirated.
* GCS 7 or less on presentation to hospital
* Patient is pregnant
* Patient has tracheostomy
* Patient has gastrectomy
* Patients who have been intubated prior to arrival at hospital
* Patients who are already endotracheally intubated and require a tube change.
CureDRPLA Global Patient Registry

The objective of the CureDRPLA Global Patient Registry is to establish a longitudinal database of patient-reported data on individuals affected with Dentatorubral-pallidoluysian atrophy (DRPLA) from anywhere in the world.

The CureDRPLA Global Patient Registry will address patient needs by:

* Expanding patient engagement by documenting quality of life outcomes.
* Providing anonymized data to the DRPLA research community on patient experience with the disease and priorities for treatment.
* Connecting DRPLA patients with opportunities to participate in clinical research.

The CureDRPLA Global Patient Registry aims to collect data from Dentatorubral-pallidoluysian atrophy (DRPLA) patients worldwide to identify a well-characterized cohort for participation in retrospective and prospective research. Participants will be required to read and sign an IRB-approved informed consent document prior to accessing questionnaires within the Registry. The Registry is solely for patients diagnosed with DRPLA.

After informed consent is given, and assent for those age 12 to the age of consent, participants will be asked to complete a series of questionnaires to include information on demographics, specifics of diagnosis, medical history, research, functional mobility, quality of life, and health economics. Participants will be asked to indicate if they are interested in being contacted by the Registry Coordinator for potential participation in future clinical trials and/or studies. Participants will have the option to withdraw from the Registry at any time, and upon withdrawal, they will no longer be contacted from the Registry for any reason. Data that they have entered will remain part of the Registry, but their identification will not be released for any reason. Active participants in the Registry will receive yearly email reminders to update their questionnaire data to reflect the current status of disease progression.

The Registry is available in English, French, Italian, Japanese, Korean, and Portuguese to encourage DRPLA patients worldwide to register. Participation is completed online, please visit our website for more information https://curedrpla.org/en/global-patient-registry/

The REDCap Cloud platform will serve as the Registry Data Coordinating Center and will manage data entered into a web based electronic data capture (EDC) system that is 21 CFR Part 11 validated, ISO 27001 certified, HIPPA, CDISC, and GDPR compliant.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of all ages with a self-reported diagnosis of DRPLA.
* Understand and sign the informed consent form (IFC). Participants who lack the capacity to consent (e.g. cognitively impaired individuals) will require consent from the legal authorized representative, and the assent of the subject will be obtained to the extent compatible with their capacity. Participants at age 12 to age of consent will require assent along with the consent of their parent or legal guardian.

Exclusion Criteria:

* Ataxia conditions other than DRPLA.
* Failure to sign the IFC (and assent form, as needed).
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be enrolled in this study.

Within 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans will be read by a single experienced radiologist who will identify regions of interest (ROI) with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of the prostate will instead be recorded.

One to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate biopsy will be performed. Immediately following completion of systematic TRUS biopsies, fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for Gleason score and percent cancer involvement.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* PSA of 2-10 ng/mL
* Clinical stage T1c-T2a on digital rectal exam
* Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care
* Willingness to sign informed consent and comply with all protocol requirements

Exclusion Criteria:

* History of prior prostate biopsy
* Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
* Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
* Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
* Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives