cyrilzakka/clinical-trials huggingface dataset:
Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention

Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.

Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University;
* people aged over 18;
* patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more.

Exclusion Criteria:

* severe comorbidity history;
* coronary stenosis less than 70%;
* severe cardiac dysfunction;
* central nervous system disease;
* troponin I levels have rised before entering the hospital;
* pregnant woman；
* history of mental disorders;
* alcoholic and long-term use of sedatives and opioids history;
* drug allergy history.
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations

PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

* Extensive carious lesions indicated for indirect restorations
* Lower first molars
* Age of patients range is 18 -50 years
* Patients have not received antibiotic therapy for 1 month before sampling
* Males or Females (Both genders)
* Patients with Good oral hygiene
* Co-operative patients approving the trial

Exclusion Criteria:

* Pregnancy
* Systemic disease or severe medical
* Patients having complications as:

Periodontal problems Mobile teeth, arrest caries and non-vital teeth

* Heavy smoking patients
* Xerostomia
* Lack of compliance
Protocol Biopsies in High-risk Renal Transplant Recipients

The present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.

This will be a prospective study undertaken at the Renal Transplant Unit of Hospital of Clinics of Porto Alegre. In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. The presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.One hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. The hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. Therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.

Eligibility Criteria:
Inclusion Criteria:

Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:

* Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
* Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
* Calculated panel reactivity greater than 50% in class I and / or class II;
* Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
* Occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy.

Exclusion Criteria:

* Patients with contraindication to renal graft biopsy;
* Patients whose biopsy fragments are not representative;
* Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.
Effects of HFMH-EMS on Ocular Artery Circulation

Investigated the effects of high-frequency multi-band harmonic electromagnetic stimulation on ophthalmic and central retinal artery circulation.

This study investigated the effects of prolonged smartphone usage for over 90 minutes on ophthalmic and central retinal artery circulation before and after smartphone use and compared the effects with versus without intervention by high-frequency multi-band harmonic electromagnetic stimulation.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 65 years old

Exclusion Criteria:

* hypertension
* diabetes
* heart disease
* eye-related diseases
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients

A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.


Eligibility Criteria:
Inclusion Criteria

* Male or Female aged 18-75 years.
* Primary anterior cervical discectomy fusion (ACDF) and required two level spinal fusion or were active smokers and required either single or two level spinal fusion.
* Pain VAS score \>5 and/or extreme weakness at target operative level(s).
* At least one post operative clinical outcome assessment (VAS pain/ NDI/OC score) at each follow up interval.
* Completed 6 month follow up visit or time to fusion assessment, whichever is sooner.

Exclusion Criteria

* Treated with a bone growth stimulator device other than the SpinalogicTM CMF device.
* Previous cervical vertebrae fusion surgery at any level (posterior or anterior approach)
* Systemic administration of any type of corticosteroid, antineoplastic, immune- stimulating or immunosuppressive agents within 30 days of primary ACDF surgery and/or within 12 weeks post-operatively.
* Active history of systemic malignancy at pre-operative assessment or during 12- month follow up period.
* Untreated malignant neoplasm(s) or underwent radiotherapy or chemotherapy at pre- operative assessment or during 12-month follow up period.
* Implanted with cardiac pacemaker or implantable cardioverter defibrillator at pre- operative assessment or during 12-month follow up period.
* Pregnant at pre-operative assessment or during 12-month follow up period.
* Mental or physical condition that would interfere with post-treatment assessments and/or care (e.g., neuromuscular disease, psychiatric disease,
* Paraplegia, quadriplegia, etc.) at pre-operative assessment or during 12-month follow up period.
* Prescribed non-steroidal anti-inflammatory, calcium channel blockers and/or diphosphonate therapy within 12-weeks of surgery period.
* Prescribed bone morphogenic protein (BMP) during 12-month follow up period.
* Implanted with a Titanium cage during the primary ACDF that precludes an outcome determination via plain radiographs.
* Osseous or ligamentous spinal trauma at pre-operative assessment or during 12- month follow up period.
* Paget's disease at pre-operative assessment or during 12-month follow up period.
* Absence of X-ray fusion assessment documentation at 6 months follow-up visit.
Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults

This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.

There are no studies investigating Cannabidiol (CBD) in an acute pain model in human beings. This is however of great clinical value because:

1. Patients are often treated insufficiently with the commonly used analgesics in acute pain therapy or the available selection of analgesics is limited by their contraindications and side-effects.
2. CBD could be an option to optimize pain therapy if the pain relief is not satisfactory.
3. CBD in contrast to ∆9-tetrahydrocannabinol (THC) has only few side effects and due to a possible dose reduction of other analgesics patients might benefit from a better side-effect profile.

This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* BMI between 18.5 until 25 kg/m2
* Able to understand the study and the NRS scale
* Able to give informed consent

Exclusion Criteria:

* Regular consumption of cannabinoids or other drugs / substances
* Regular intake of medications potentially interfering with pain sensation (analgesics, antihistamines, calcium and potassium channel blockers, serotonin / noradrenaline reuptake inhibitors, corticosteroids)
* Neuropathy
* Chronic pain
* Neuromuscular disease
* Psychiatric disease
* Known or suspected kidney or liver disease
* Pregnancy/ Lactation
* Allergy / hypersensitivity to cannabidiol
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

The purpose of this study is to:

1. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is 10 to 18 years of age
2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
3. The subject is scheduled for elective posterior spinal fusion and instrumentation.
4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
2. The subject is pregnant or nursing.
3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine
5. The subject is an ASA classification of 4 or greater (See Appendix I)
6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
8. The subject had a recent opioid exposure (within 1 month of surgery)
9. The subject is obese (body mass index \>30kg/m2)
10. The subject is planned for elective postoperative ventilation
11. The subject has a known ocular disease not permitting pupillometric examination
12. The subject has used any investigation products in the past 30 days
Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study

This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

In the past, osteoporosis is usually viewed as a woman disease. However, men and women are shown to lose their bone mass at the same rate by more than 65 of age, and osteoporosis in men causes higher mortality in men than those in women. Thus, osteoporosis in men has recently aroused public attention. Androgen deficiency was the main cause leading to osteoporosis. Bone structure is maintained by a dynamic balance of osteoblast-mediated bone formation and osteoclast-mediated bone resorption. Androgens and androgen receptor (AR) play critical roles in regulation of bone formation and resorption. MicroRNAs (miRNAs) are non-coding small RNAs and participate in regulating activities of osteoblasts and osteoclasts by postranslationally targeting certain gene expressions. miR-133 and -135 can target BMP-2, Runx2, and Smad5 and then regulate osteoblast differentiation. Likewise, miR-141 and -200a negatively regulated osteoblast differentiation. Nevertheless, the functional roles of miRNAs in osteoporosis in men are still unknown. In addition, miRNA are stable and can be detected in the blood as novel biomarkers for certain diseases. A recent study analyzed the levels of miRNAs in circulating monocytes of 10 high and 10 low bone mineral density postmenopausal Caucasian women and found miR-133a is a potential biomarker for postmenopausal osteoporosis. In comparison, the roles of blood miRNAs in osteoporosis in men have not been evaluated. Therefore, this study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Eligibility Criteria:
Inclusion Criteria:

1. Twenty oriental men (mean age, 80 years; age range, 70-90 years).
2. Candidates have no clinical evidence or history of focal lesions of the femur; previous hip surgery or irradiation; hip trauma; spinal trauma.
3. Participants who have thoroughly understood and signed the consent form.
4. Ten normal adult male (age range, 20-40 years).

Exclusion Criteria:

1. Participants with secondary causes of osteoporosis, such as thyroid, parathyroid disease, osteogenesis imperfect and osteomalacia.
2. Participants with Paget's disease, serious liver disease, serious renal disease (indicated by a serum creatinine concentration of more than 1.6mg/dL).
3. Participants who currently or have history of using steroids or hormone replacement therapy.
4. Participants who fail to sign to the consent form.
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
* Life expectancy ≥ 3 months.
* Patients previously diagnosed with multiple myeloma
* Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.
* Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
* Women must have a negative serum pregnancy test
* Voluntarily signed and dated written informed consent

Exclusion Criteria:

* Concomitant diseases/conditions
* Women who are pregnant or breast feeding.
* Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
* Known hypersensitivity to any involved study drug or any of its formulation components
Assessment of Ovarian Reserve in Women With Rheumatologic Diseases

Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (AMH).


Eligibility Criteria:
Inclusion Criteria:

* Rheumatologic disease

Exclusion Criteria:

* none
Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up

the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic female patient with 6.5\<H1AC\<7.2.
* Monotherapy with Metformin.
* 18-45 years of age.
* Body mass index (BMI) between 27-35 kg/ m².
* Consume DBs regularly during their habitual diet.
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Unwilling to change intake of beverages during the study period.
Home-based Resistance Training to Patients With Type 2 Diabetes

The purpose of this study is to compare motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise (elastic band to non-elastic band) to improve physical activity, muscle strength, body composition, and self-efficacy of exercise in type 2 diabetic patients. The effectiveness of performance and exercise compliance.

This study adopts an experimental research design. A total of 90 cases of type 2 diabetes who are not exercising regularly are recruited from the outpatient clinic of the Metabolism Department of a medical center in the north to participate in the study. Blocks 6, and 12 (Block) are randomly assigned. The research subjects were assigned to the behavior change and resistance exercise group, and home-based resistance exercise( with elastic band), and the control group. The behavior changes and resistance exercise group received motivational interviews and self-efficacy theory-based exercise behavior changes and resistance exercise guidance intervention, home resistance exercise. the group received home elastic band resistance exercise training, and the control group received regular exercise guidance. The three groups received data collection of physical activity, muscle strength, body composition, physical activity function, and exercise self-efficacy in the pre-test, the sixth week, and the twelfth week. During the study period, the exercise log was used to collect the mediating variable about exercise compliance (Time × frequency) data collection. This study compares the effectiveness of motivational interviews and self-efficacy theory-based exercise behavior intervention and home resistance exercise training programs. The result will show an empirical evidence for type 2 diabetic patients to increase physical activity and muscle strength in the future, and will also apply to training of muscle strengthening in diabetes and other chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* diabetes type 2
* age \>50 years old
* sedentary lifestyle (PASE questionnaire leisure time physical activities score female \<30 points, male \<40 points)

Exclusion Criteria:

* severe congestive heart failure (New York Heart Association Functional Class III and IV)
* severe renal failure (estimated Glomerular Filtration Rate \< 15 mL/min/1.73m2)
* stroke ((The National Institutes of Health Stroke Scale \> 15)
* Peripheral Arterial Occlusive Disease
* Foot ulcer over 6 month
* Severe muscle diseases and rheumatoid arthritis
* Cognitive or mental disorders who cannot understand and cooperate with the exercise plan
* those who are accessed by the doctor to be avoided for exercise