cyrilzakka/clinical-trials huggingface dataset:
Maverick Total Disc Replacement in a 'Real World' Patient Population

The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.


Eligibility Criteria:
Inclusion criteria:

* Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
* Foraminal stenosis due to loss of disc height
* Back pain and/or leg pain.

Exclusion criteria:

* Spondylolisthesis at the affected or adjacent level
* Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy
* Obesity
* Osteoporosis
* Metallic allergy to cobalt-chromium-molybdenum alloys
* Psychosis
* Infection
* Spinal canal stenosis
* Overlying thoracolumbar kyphosis
* Systemic infection or infection at the site of surgery
* Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Diseases of bone metabolism
* Pregnancy
* Signs of local inflammation
* Fever or Leukocytosis
* Grossly distorted anatomy caused by congenital abnormalities
* Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level)
* Any case where the implants or components selected would be too large or too small to achieve a successful result
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Any patient unwilling to follow postoperative instructions.
Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
* Consenting to participate
* Not meeting exclusion criteria will be included in the study population.

Exclusion Criteria:

* Patients not candidates for PRK will be excluded from the study.
* Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.
* Additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications.
* Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.
* Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.
* Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.
Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection


Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years of healthy volunteers

Exclusion Criteria:

* Subject who had been treated with Etanercept before
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
* aged from 18 to 75 years
* without conflict to the written, informed consent signed prior to the enrollment
* no severe hepatic or renal disorders
* no known carotid artery stenosis
* no coagulation disorders
* no hypertension

Exclusion Criteria:

* being in pregnancy, lactation period or under a pregnancy plan
* being allergic to the test drug
* not compatible for the trial medication
* without full legal capacity
Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea

The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.

Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Women with a complaint of primary dysmenorrhea,
* Volunteer women who have a regular menstrual cycle (28 ± 7 days)
* Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months

Exclusion Criteria:

* Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
* Those who have given birth,
* Those who have a pregnancy status,
* Those who use intrauterine devices,
* Those who have had pelvic surgery,
* Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
* Those with a pathological history and radiological findings showing secondary dysmenorrhea
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2

To determine the effects of different intensities of Continuous Aerobic Exercises on Fatigue levels, Mental Well- Being \& Mindfulness in Cardiac Rehab Phase 2.

Physical activity has a strong association with health outcomes as it enhances physical and mental function by maximising cardio respiratory fitness and reduces the risk of multiple chronic diseases.

Aerobic exercise is the type of physical activity that accelerates and maintain fitness, well being and quality of life of human being. Aerobic means in presence of oxygen and is based on the power generating process by the utilization of oxygen as a major fuel to cope up the energy demands during sustained physical activity. During Aerobic exercise lungs get more efficient by enhancing their breathing capacity which leads to the removal of carbon dioxide and maximal utilization of oxygen and improvement of its transport to lungs and muscles by circulating blood. Aerobic is the form of exercise which helps in oxygen transportation and absorption while enhancing the efficiency of cardiovascular system. Long term aerobic exercises significantly affect the structure of heart and improve stroke volume of heart.

Fatigue is a feeling of tiredness and leads towards the inability of muscles to perform physically. It is mostly complained during cardiovascular disease and affects the functioning and quality of life in cardiac patients.

Mental well-being is an important constituent of health. Good mental health proves to be beneficial for patients' recovery and independency in activities of daily living. Chronic diseases have a very strong association with mental disorder.

Mindfulness is the ability to be fully alert and mental presence in the moment. Physical training boosts the mindfulness by enhancing the functioning of anterior cingulate cortex that has been linked to the improvement of self-regulation and attention. Aerobic exercises can improve the mood mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) (class 1, class II)
* Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
* Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
* Post Coronary artery bypass grafting (CABG)
* Patients diagnosed with mild to moderate depression on basis of Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Recurrent myocardial ischemia or Infarction (MI)
* Unstable angina
* Any diagnosed psychological disease
* Patients with impaired cognition function
* Patients with severe life-limiting illness such as cancer, and renal failure.
* Congestive Heart failure
Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain

This study aims to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks.

This will be a pilot randomized controlled and experimental study. There will be two groups, one group will receive an intervention strategy based in basic postural re-education exercises (Pilates) and self-management strategies, and the other group will perform a program based in pain neuroscience education and gradual exposure to exercise. Both interventions will be delivered in the physiotherapy office of a paper industry. Participants will be randomly allocated according to the work team they belong, to an intervention arm.

The inclusion criteria to participate in the study are: to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour and not receiving treatment for low back pain. Participants will be excluded if during the physical examination they show altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids; presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.

Once inclusion criteria have been ascertained, participants will be assessed for sociodemographic and anthropometric data, pain, disability, knowledge of pain neurophysiology, pain catastrophizing, fear of movement, presence of a neuropathic component, workstation evaluation and global impression of change related to intervention.

The intervention will last for 8 weeks, during which participants will have 1 face-to-face session per week with a duration of approximately 60 minutes each. One group (Pilates group) will receive an intervention based on Pilates' and and postural education. The other group will have theoretical sessions of PNE and gradual exposure to exercise (PNE plus graded exposure group).

Eligibility Criteria:
Inclusion Criteria:

* to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour;
* not receiving treatment for low back pain.

Exclusion Criteria:

* altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids;
* presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.
A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males

A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.


Eligibility Criteria:
Inclusion criteria:

1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
3. Written informed consent
4. Given full explanation of this study and is willing to and able to comply with the protocol requirements

Exclusion criteria:

1. Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
2. Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality
3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I
6. Had nutritional supplements, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage) which may affect drug metabolizing enzymes and transporters, within 1 weeks before Period I
7. Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1
8. Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis
9. Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
10. Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms
Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients

It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 25 to 60 years old
* Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
* Fasting blood glucose is above 11.0mmol/L.
* Half of the patients with BMI below 24 and the other half with BMI above 24.

Exclusion Criteria:

* type 1 diabetes mellitus
* type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
* Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.
Babesia Testing in Blood Donors

Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.

Two laboratory methodologies will be utilized:

1. - PCR, to look for the presence of B.microti in whole blood
2. - IFA, to look for significant titers of B.microti antibody

Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.

Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation

Eligibility Criteria:
Inclusion Criteria:

* same as for donating blood

Exclusion Criteria:

* donor refusual to sign informed consent for this investigational babesia testing
Patient-Centered Care for the Older Adult With Hematologic Malignancy

This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.

Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
* Assessed to be pre-frail or frail on formal baseline geriatric assessment.

Exclusion Criteria:

* Not willing to participate
Treatment Engagement With Technology-assisted Treatment

This research is being done to study whether using an Internet-based program, called the Therapeutic Education System (TES), would be helpful for the treatment of substance use and other psychiatric problems.

TES has been shown to be helpful as substance abuse treatment in certain groups of people, mainly in the outpatient setting by using interactive modules for education. This study will expose some participants to this program while participants are hospitalized on an inpatient unit, and give the participants access to it after participants are discharged from the hospital. Those participants will still receive treatment as usual, as will the control group.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of drug or alcohol problem, plus another psychiatric problem, such as depression or anxiety
* drug or alcohol use in the last 30 days
* proficiency in English
* able to consent to study
* willing to engage in outpatient treatment
* willing to allow study team to contact outpatient providers

Exclusion Criteria:

* psychotic symptoms, such as hearing voices
* involuntary admission
A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)

The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
* Has a body mass index (BMI)≥18 and ≤32 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer
Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

The investigators will conduct acupuncture for participants with chronic fatigue syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the fatigue, reducing accompanying symptoms and for improving the life quality of CFS.

This trial is a randomized, placebo controlled clinical trial. 72 participants with CFS are randomly allocated to two different groups. Treatment group is acupuncture, while the control group is sham acupuncture. The ratio of treatment group and control group is 2:1. Both acupuncture and sham acupuncture group will receive 12 sessions of verum/sham acupuncture in 4 weeks.

The result of this trial (available in 2011) will supply evidence on the efficacy of acupuncture for sleep disorder of CFS.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who meet the diagnosis criteria of CFS;
2. Clinically evaluated, exclude any disease that can explain the chronic fatigue;
3. The onset age of CFS is between 18 and 50 years old;
4. Have not taken any hypnotic, melatonin, or antidepressants within 45 days;
5. Willing to finish the whole observation period;
6. With written consent form signed by themselves.

Exclusion Criteria:

1. Chronic fatigue caused by diseases such as internal diseases(for example, pulmonary emphysema, rheumatoid arthritis, etc.), mental illness(for example, any type of dementia paranoids, depression, etc.), some diseases that just onset or evaluated (for example, sleep deprivation, untreated diabetes, etc.), some diseases that need recovery gradually(for example, restless legs syndrome, lactation, etc.), morbid obesity;
2. Participants in other clinical research;
3. Pregnant women, lactating women.