cyrilzakka/clinical-trials huggingface dataset:
Health Coaching for Patients Waiting for Total Hip or Knee Replacements

This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
* have access to the internet and the ability to navigate web-based programs;
* able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
* able to comprehend the requirements and purpose of the study and give informed consent

Exclusion Criteria:

* other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
* neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
* systemic inflammatory disease (e.g. rheumatoid arthritis);
* previous total joint replacement surgery (hip or knee)
Medical and Physiological Benefits of Reduced Sitting

The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.


Eligibility Criteria:
Inclusion Criteria:

* Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
* Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
* BMI 25-40
* Blood pressure \< 160/100 mmHg
* Fasting plasma glucose \< 7.0 mmol/l
* Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009

Exclusion Criteria:

* History of a cardiac event
* Insulin or medically treated diabetes
* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
* Presence of ferromagnetic objects that would make MR imaging contraindicated
* Abundant use of alcohol
* Use of narcotics
* Smoking of tobacco or consuming snuff tobacco
* Diagnosed depressive or bipolar disorder
* Previous PET imaging or considerable exposure to radiation
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality.

The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up.

The participation will require:

1. Attend the 12 therapeutic exercise sessions
2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).

The items to be evaluated will be the following:

1. The Ronald Morris Disability Questionnaire (RMDQ)
2. Anxiety (State-Trait Anxiety Inventory (STAI))
3. Depression: Beck Depression Inventory (BDI)
4. Quality of Life: SF-12
5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)
6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)
7. Perform a pre blood test on interleukins IL-18 and IL-1β

This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights.

In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years old
* Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.

Exclusion Criteria:

* Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes).
* Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.
TSO for Plaque Psoriasis

This is a randomized, blinded, multicenter study to assess the safety and treatment effect of 12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 75 years old.
* Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
* Baseline moderate to severe psoriasis, defined as both of the following:

  1. Psoriasis covering a body surface area (BSA) ≥ 10%, and;
  2. PGA ≥ 3, and;
  3. PASI ≥ 12

Exclusion Criteria:

* Patients who are currently taking or have taken in the past 30 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, methotrexate, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system. Patients who are on inhaled or ophthalmic steroids are allowed.
* Patients who have demonstrated a primary lack of response to any one of the following biologic agents: etanercept, adalimumab, infliximab or ustekinumab. Patients who initially responded to one of these agents but subsequently lost response (secondary lack of response) are eligible for study entry; however, secondary lack of response to more than one of these agents will exclude the patient from study entry.
The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.

TSCI is an incurable condition with devastating consequences. The physical, psychosocial and financial implications in addition to a variable recovery and an uncertain prognosis have a profound impact on quality of life.The pathophysiology of TSCI is dual consisting of a primary injury and a secondary injury. The immediate trauma to the spinal cord and nerve roots causes the primary injury, while a prolonged cascade of events causes the secondary injury. The neuroinflammatory response is considered to be an important event. Current clinical measures to evaluate acute TSCI consist of clinical examination and routine imaging modalities. These measurements are inaccurate to assess injury severity, prognosis, and therapeutic efficacy, especially in the early acute phase. Biomarker measurement may provide a more accurate measure.

This study aim to assess the diagnostic and prognostic potential of biomarker measurement in acute TSCI, and to examine the neuroinflammatory response to acute TSCI. To achieve this, immune cells, cytokines, autoantibodies and structural proteins will be analysed in blood and cerebrospinal fluid by Flow Cytometry and assay techniques. These analyses will be correlated to clinical outcome assessed according to international standards.

Hopefully, this will contribute with new knowledge of the neuroinflammatory response and biomarkers in acute TSCI, and provide the needed knowledge for conducting futures trials in novel therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury (Bony level C1-L1)
* ISNCSCI score A-C upon inclusion.
* Age \>18-70 years.

Exclusion Criteria:

* Prior major spine surgery in the traumatised location.
* Major co-morbidities or co-injuries.
* Penetrating spinal cord injury.
* \>72 hours from injury to sample collection.
Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

The purpose of this study is to determine whether the contract-relax technique of proprioceptive neuromuscular facilitation, and the static stretching exercise are effective in reducing the frequency, intensity and duration of headache and in improving the perception of quality of life in women with migraine.

This is an randomized clinical trial, double blind, comparing two interventions in women with migraine, whose diagnosis was confirmed by a neurologist.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18and 40 years
* Clinical diagnosis of migraine
* Participants with at least one day with acute migraine per month, with attacks lasting 4-72 hours.

Exclusion Criteria:

* Obesity type I, II or III, according to the classification of Body Mass Index.
* Pregnancy, lactation or both.
* Presence of meningitis, demyelinating diseases, cerebral aneurysm, intracranial hypertension, myopathies, myelopathy, fibromyalgia, symptomatic neck disc herniation, rheumatoid arthritis and history of tumors in the brain or spine.
* Participants who performed other manual therapeutic interventions or other physical therapy modalities in the head or neck during the survey period.
* Participants who have daily prophylactic medication for migraine.
Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

The goal of this study is to conduct a prospective controlled trail of four currently approved Department of Defense (DOD) - formulary medications for use as medical expulsion therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic urolithiasis in there life. Several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal ureteral calculi. None of these studies have been widely publicized outside the specialty of urology. Recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. The investigators will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications.

Patients presenting to Naval Medical Center San Diego with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. Upon consent, patients will be randomly assigned to one of four outpatient treatment arms, randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg twice daily. The primary endpoint is stone expulsion rate and secondary endpoints are time to expulsion, need for additional intervention, degree of pain control, amount of narcotic use, and evaluation of study drug side effects. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Single ureteral stone \< 1 cm in greatest dimension

Exclusion Criteria:

* Age \< 18 years
* Active unstable angina
* History of or active postural hypotension (\>20 mmHg drop in orthostatic SBP)
* Allergy to alpha-blockers
* Acute or Chronic Renal Failure as demonstrated by a serum creatinine of \> 1.4 mg/dl
* Urinary tract infection
* Multiple ureteral stones
* Current uncontrolled diabetes
* Alpha-blocker therapy within 30 days for any reason
* Current pregnancy or lactation
* Patient desire for immediate stone removal
Fibular Fixation in Ankle Fractures:Plate Verses Nail.

The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation.

The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation. This objective will be accomplished using the Olerud-Molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. It is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (ADL) level. It does not involve physician-measured outcomes. The best possible score is a total of 100. Patients will be given a form to complete throughout follow-up and be utilized for data analysis. Functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.

Eligibility Criteria:
Inclusion Criteria:

* Distal fibula fracture
* Pilon fractures
* Open fractures
* Ipsilateral foot

Exclusion Criteria:

* Weber A distal fibula fractures
* Pathologic fractures
Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysed patients
* predialytic blood pressure greater or equal to 140/90 mmHg

Exclusion Criteria:

* history of heart failure
* history of ischemic heart disease
* severe aortic stenosis
* known allergy to aliskiren or amlodipine
* severe disorders of liver function
The Gentle Cardiac Rehabilitation Study

The purpose of this study is to develop a tai-chi based exercise program designed for patients who recently had a heart attack and do not wish, or are unable, to attend traditional cardiac rehabilitation.

We will estimate the feasibility, acceptability and safety of two different doses of the Tai Chi intervention (primary outcome). 60 patients (30 per dose arm) will be randomly assigned to a standard dose of Tai Chi (the dose used by our group in large studies of heart failure patients) or to a high dose matching the recommended frequency and duration of exercise classes in current CRs. Acceptability assessments will include surveys and focus groups to formally assess the impact of Tai Chi on facilitators and barriers to CRs in this population. We will also obtain estimates of effect sizes of each dose on accelerometry measured physical activity and on the proportion of patients achieving the current American Heart Association (AHA) recommendation for physical activity (secondary outcome). Additional outcomes will be cardiac fitness, quality of life, body weight, and sleep. In addition, we will gather exploratory information on possible mechanisms by which Tai Chi training may affect physical activity. We will collect information on possible mediators such as exercise self-efficacy, perceived social support, and depression. In addition, since Tai Chi training is associated with meditative practices aimed at increasing present-moment awareness, we will gather information on mindfulness levels. Measurements will be conducted at baseline, 3-, 6-, and 9 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and speak English
2. Age ≥21
3. Physically inactive
4. Ability to understand the study procedures and willingness to commit to the demands of the study protocol

Exclusion Criteria:

1. Inability or unwillingness to give informed consent
2. Planning to move out of the area within the study period
3. Unstable angina
4. Blood pressure \>200/110 or symptomatic orthostatic blood pressure decrease\>20 mmHg
5. Uncontrolled atrial or ventricular arrhythmias; 3rd degree Atrio-Ventricular block
6. Pericarditis or myocarditis
7. Recent embolism/thrombophlebitis
8. Abnormal stress test without study cardiologist's clearance
9. Medical conditions likely to limit lifespan
10. NYHA functional class IV
11. Signs of cognitive impairment (BOMC \>10)
12. Orthopedic problems prohibiting Tai Chi practice
13. Ongoing Tai Chi or other mind-body training
14. Current enrollment in a CR program
15. Severe depression (HADS scores\>14)
16. Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
Effect of Pilates Core Stabilization in Adjunct With Plyometric Shoulder Training on Low Back Pain in Fast Bowlers(RCT)

This RCT will seek to determine both the Pilates core stabilization and plyometric shoulder training on LBP in fast bowlers. The research problem will emphasize the absence of detailed rehabilitation protocols that address the upper and lower limb strength dysfunction, pain, quality of life, and biomechanics of fast bowlers. Prior literature has not examined the combined use of these two training interventions to address LBP, which affects the performance of fast bowlers. In this study, participants will be randomly assigned to two groups. Group A (experimental) will receive Pilates core stabilization and plyometric shoulder training, while Group B (control) will receive conventional physiotherapy for LBP. There will be two sessions per week for six weeks, and the intensity of the exercises will gradually increase to address athletes' strength, flexibility, and movement control.

Assessments will be conducted using multiple scales of upper limb strength for the Cricket Ball Throw Test, lower limb strength for the Vertical Jump Test, Quality of Life for the Oswestry Disability Index, biomechanics analysis to determine movement efficiency and Pain Intensity for Numeric Pain Rating Scale. This study will give information about the efficiency of adding core and shoulder training to managing LBP in fast bowlers, increasing their athletic performance and bringing helpful value to the sports and physiotherapy domain.

Eligibility Criteria:
Inclusion Criteria:

* Age between 17-25 years
* Male cricket players
* Playing cricket for more than 2 years
* Low back pain without radiation
* Chronic low back pain for more than 3 months
* Non-specific mechanical type without identifiable specific anatomical or neurophysiological causative factors and medically fit

Exclusion Criteria:

* Any pathological condition of the spine, hip, knee, and pelvis.
* Any history of musculoskeletal injury in the past 6 months.
* Any history of a neurological condition.
* Uncontrolled metabolic disorders such as Diabetes Mellitus
* Any surgical h/o shoulder or elbow in the past 6 months
A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population

This is a prospective, non-interventional, non comparative drug study. The efficacy of Quinapril in Asian population has been evaluated, but specifically in Indian patients the data is sparse. Data in a real world setting in a large population of Indian patients would shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian population.


Eligibility Criteria:
Inclusion Criteria:

* Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

* Patients having a Week 0 visit blood pressure reading of more than 180/110 mm of Hg will not be eligible to participate in the study.
* Women of child bearing age, not willing to use contraceptives, will not be eligible for the study
* Women using oral contraceptives will also not be included in the study
* Patients who have received any drug other than Acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial
* Patients having any complication at Week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study
* Patients having any contraindications as per the LPD of Acupil®
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ATTR-CM with either wild-type or variant TTR genotype
* End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening
* NT-proBNP \> 2000 pg/mL at Screening
* Treatment with a loop diuretic for at least 30 days prior to Screening
* History of heart failure NYHA Class II-IV at Screening
* Life expectancy of ≥ 6 months as per the Investigator's judgment
* Males and females of childbearing ability must use contraception

Exclusion Criteria:

* Known leptomeningeal amyloidosis
* Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
* Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
* Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
* LVEF \< 30% on echocardiography
* Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening
* Polyneuropathy with PND score IV
Pretreatment Group Consultation for Patients With Colorectal Cancer

An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer

The group consultation is planned to be on the Friday of the same week as the patient recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her colorectal surgeon. During the group consultation the steps necessary for the patient to take responsability for in connection with the operation. Ample time for questions, clarifications and discussions. Appropriate clinical trials are presented

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in the pretreatment group consultation

Exclusion Criteria:

* Not able to answer questionnaire