cyrilzakka/clinical-trials huggingface dataset:
Remifentanil and Fentanyl in Dental Surgery (REFEDS)

This study was a prospective comparative study. The purpose of this study was to investigate the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary aims were to investigate comparatively their effect on patients intraoperative hemodynamic response and postoperative analgesia.

The study included 46 adult patients with cognitive impairment who underwent day-case dental surgery under general anesthesia with propofol aiming to keep a BIS-values range between 40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if needed.

Patients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R, n=23). Randomization was performed using using a computer-generated randomization schedule.

Intraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone 125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was administered to to reverse neuromuscular blockade. Intraoperative monitoring included non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry, capnography and Bispectral Sedation Index (BIS®).

Postoperatively, patients remained under surveillance in the post-anesthesia care unit \[PACU\] for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min time-intervals for the first 3 hours, and every 3 hours thereafter by an independent observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.

Inflammation markers and stress hormones \[cortisol, Tumor necrosis factor (TNF-a), substance-P, melatonin and β-endorphin\] were measured in each patient before induction of anesthesia, after tracheal intubation and at the end of operation.

Statistical Analysis was performed using Kolmogorov-Smirnov test, Student's unpaired t-test or Repeated Measures ANOVA with Holm's post-hoc analysis appropriately. A p value less than 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cognitive impairment
* of category II according to the American Society of Anesthesiology (ASA) classification
* scheduled for elective dental surgery with short duration

Exclusion Criteria:

* Patients of more than category II of American Society of Anesthesiology (ASA) classification
* Prolonged duration of surgery (\>1 hour)
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury

The study will investigate whether the impact of PEMF and RF therapies is safe and efficacious for the treatment of pain associated with soft tissue injuries as compared to treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.

This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF) and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment of pain associated with soft tissue injuries, and to show the comparative effects on blood flow (BF) and range of motion (ROM). Total expected duration of the clinical study is approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks) while individual participation will take three weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand and provide written informed consent to receive treatment.
2. Healthy, adult male or female, 18 - 75 years of age.
3. Sustained recent (within 30 days), painful unilateral mild to moderate soft tissue injury.
4. Seeking treatment for pain associated with mild to moderate soft tissue injury.
5. BMI score is greater than 18.5 and less than 29.9.
6. Able and willing to comply with the treatment and follow-up schedule and requirements.

Exclusion Criteria:

1. Pregnant, planning to become pregnant or nursing during the ocurse of the study.
2. Open wound or infection at site of soft tissue injury.
3. Evidence of severe injury, including fracture or nerve injury.
4. History of musculoskeletal disorders, including arthritis, tendonitis, bursitis, ankylosing spondylitis.
5. Moderate to severe ligament tear.
6. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of anticoagulant use as per the subject's physician discretion is permitted).
7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
8. Having an anesthetic or corticosteroid injection within 4 weeks of study enrollment.
9. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
10. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
11. History of any form of cancer or pre-malignancy in the treatment area.
12. Severe concurrent conditions, such as cardiac disorders, uncontrolled hypertension, etc.
13. Patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area.
14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
15. Poorly controlled endocrine disorders, such as diabetes.
16. Skin piercings in the treatment area.
17. Having a history of anxiety-depression syndromes.
18. Any condition which in the opinion of the investigator may jeopardize the patient's safe participation.
Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).

Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.


Eligibility Criteria:
Main inclusion Criteria:

1. Male subjects considered healthy and aged between 18 and 40 years
2. Subject with a body mass index (BMI) between 18 and 30 kg/m2
Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases

Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with symptoms evocative of CNS involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available

Exclusion Criteria:

* Infectious CNS disease
* Tumor CNS disease
* Active CNS bleeding
* Monoclonal gammapathy
* Severe chronic renal failure (glomerular filtration rate \<30 ml/mn)
NAC Effect on Hox Genes Expressions in RIF

Comparison of the group treated with NAC-supplementation and placebo- administered groups showed elevations in HOXA cluster genes (all members) expression level in endometrium of women with RIF.

Despite significant developments in assistant reproductive technology (ART) that have overcome many underlying causes of infertility, pregnancy success rates remain relatively low, mainly due to implantation failure. Embryo quality and endometrial receptivity are two significant factors that believed to be the key points in implantation. Since recent studies that showed high expression of some HOXA genes affects on successful implantation rate, thus we examined the expression of HOXA genes in NAC supplementation during window of implantation (WOI) in women with (RIF). Also the effect of NAC on the improvement of implantation in RIF patients was investigated. Forty unfertile women with a diagnosis of RIF, referred to Royan Institute were included in the study. The study was of the type a single center, double blinded, placebo controlled, randomized trial. Expression of HOXA genes were assessed on the day of WOI (using Real Time PCR) biopsies from endometrium. Subjects randomly assigned to receive either NAC (A) or placebo (B) with both effervescent tablets having similar color, size and appearance. The patients were randomly categorized in two groups (A/B) to receive NAC 1200 mg/day or placebo, for at-least 6 weeks before starting ovarian stimulation. Pipelled-based biopsy from endometrium was done on specific day (19-21) of their cycle. Then patients were undergone ovarian stimulation (using NAC) ended to IVF treatment. RNA extraction and cDNA synthesis were performed from endometrium samples and then we evaluated expressions levels by Real-time PCR. Then we analyzed our data by independent Sample T-test and Mann-whitney U Test.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 40 years old
2. At least two IVF failure
3. BMI in the normal range

Exclusion Criteria:

1. Irregular menstrual cycle
2. Taking hormonal drugs except thyroid medication
3. Abnormal karyotype or chromosomal disorders
4. Coagulation problems.
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)

This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.

The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.

Eligibility Criteria:
Inclusion Criteria:

* Presence of severe traumatic injury requiring emergent surgery
* Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL)
* Acidosis was treated with either THAM or "usual care" (defined as crystalloid either or without sodium bicarbonate)

Exclusion Criteria:

* None
β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan and regular combined exercise on muscle strength, muscle mass, muscle function, and biomarkers in adults with relative sarcopenia for 12 weeks.

A previous human study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength in the elderly. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function, expanding the target population to adults aged 50 and older with relative sarcopenia, the safety of the compound are also evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline and 12 weeks of intervention. Eighty adults were administered either 1,000 mg of Aureobasidium pullulans produced β-glucan or a placebo each day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer
* Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2
* Grip strength of the frequently used hand is based on the following age-specific standards: Men in their 50s (less than 42 kg, women: less than 25.1 kg), Men in their 60s (less than 38.5 kg, women: less than 24.1 kg), Men 70 and older (less than 33.2 kg, women: less than 20.9 kg)
* Individuals with a Short Physical Performance Battery score of 9 or higher.

Exclusion Criteria:

* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* History of fracture during the previous year
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
* History of any central bone fracture within 1 year
* History of medication for psychiatric diseases such as severe depression, schizophrenia, and drug intoxication.
* Alcohol abuser
* Allergic reaction to Aureobasidium pullulans produced β-glucan
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons
The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy

The objective of the present study is to determine if spinal manipulations with a constant rate of force application but with different peak force and time to peak force lead to similar responses in healthy adults.

Although there are indirect evidences that the rate of force application modulates neuromuscular responses to spinal manipulation therapy (SMT) through peak force or thrust duration modulations, such an assumption remains to be confirmed. Therefore, the objective of the present study was to determine if different SMT force-time profiles where a constant rate of force application would be maintained (through the modulation of the peak force and the time to peak force) lead to similar neuromechanical responses. Based on the available data relative to the effect of SMT biomechanical parameters modulation, it was hypothesized that neuromuscular responses would be similar across SMT force-time profiles, while vertebral displacements would increase as SMT peak force increases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult

Exclusion Criteria:

* Thoracic or lumbar pain
* History of back trauma or surgery
* Severe osteoarthritis
* Inflammatory arthritis
* Vascular conditions
* Contraindication to the use of SMT
ADMSCs for the Treatment of Systemic Sclerosis

Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective.

Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.

There are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally.

Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.

In this study, the investigators will inject autologous Stromal vascular fraction.

1) Acquiring autologous stromal vascular fraction by plastic surgeon

1. Liposuction
2. Extraction and purifying SVF using Smart-X system (15-20 min)
3. Making syringe filled with autologous SVF

2) SVF injection

Inject SVF subcutaneously with 25G needle in finger

Eligibility Criteria:
Inclusion Criteria:

1. Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.
2. The skin lesion was not improved after 6 months treatment with conventional therapy.

Exclusion Criteria:

1. Pregnancy
2. Start new medications within 3 months prior to enrollment
3. Previous sympathectomy or amputation
4. Current systemic infection
5. AIDS, Syphilis, hepatitis B\&C
6. BMI \<17kg/m2
7. Cognitive dysfunction and other psychologic problems
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment

Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.

In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.


Eligibility Criteria:
Inclusion Criteria

* Females aged 18 to 45 years
* Subjects presenting with Heavy Menstrual Bleeding (HMB)
* Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more
* Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial

Exclusion Criteria

* Subjects with structural or organic pathology as an underlying cause of HMB.
* Subjects with hypersensitivity to dydrogesterone
* Known or suspected progestogen dependent neoplasms
* Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause
* Subjects with acute or chronic liver disease
* Patients with depressive illness
* Subjects who are known to have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Nursing mothers
* Use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc)
* Use of Non-Steroidal Anti inflammatory Drugs (NSAIDs)
HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.

Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥70 years living in a nursing home
* Be able to follow an active physical rehabilitation program
* Be able to read and wright
* Voluntary participation
* Capable and willing to provide an informed consent

Exclusion Criteria:

* Acute heart attack (recent 3-6 months) or unstable angina
* Uncontrolled atrial or ventricular arrhythmias
* Aortic dissecting aneurysm
* Severe aortic stenosis
* Acute endocarditis / pericarditis
* Uncontrolled high blood pressure (\>180/100 mmHg)
* Acute thromboembolism
* Acute or severe heart failure
* Acute or severe respiratory failure
* Uncontrolled postural hypotension
* Uncontrolled acute decompensated diabetes mellitus or low blood sugar
* A recent fracture in the last month.
* Coincident participation in any intervention trial
* HMB contraindication, intolerance, or allergy
* Community-dwelling people
* Have regularly performed exercise (\>20 minutes \>3 days/week) in the last 3 months
* Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix)
* Revascularization within 1 year
* Severe loss of vision, hearing, or communicative ability
* Conditions preventing cooperation
Study of Different Exercise Doses Through Videogames in Older Adults

The objective of this clinical trial is to assess the feasibility of applying different gamified exercises doses in older adults. It will also learn from possible adverse effects of the intervention.

The main questions this clinical trial aims to answer are:

* Are there any differences between heart rate, perceived exertion and enjoyment between groups?
* Are there any adverse effects? What is the magnitude of these adverse effects?
* Are there any correlations between gamification time and the occurrence of adverse effects?

A randomised clinical trial will be conducted in which the use of exercise doses between 10 and 30 will be tested. Participants will be recruited from Nueva Esperanza nursing home, Fuensalida, Toledo. The study will be conducted according to the CONSORT statement for clinical, crossover and parallel trials.

The study will have a total of two experimental groups, with different intervention times, between 10 and 30 minutes, respectively, using a mobile application. The intervention will consist of performing exercise in pairs in a single bout during the mentioned times.

Eligibility Criteria:
Inclusion Criteria:

* subjects over 60 years of age
* score equal to or greater than 20 on the Mini Mental cognitive test
* Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.

Exclusion Criteria:

* severe visual impairment
* medical contraindication for physical activity
* pathology or problem that could prevent the test from being carried out.
Breathe-Easy: Hayfever Care for Patients With Seasonal Allergic Rhinitis

This waitlist-controlled trial aims to evaluate the therapeutic effectiveness of Hayfever Care by assessing disease-specific symptoms over a 4-week period. Additionally, the study examines the tolerability and safety of the solution.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate symptoms during the hayfever season
* Generally healthy individuals without chronic illnesses
* Willingness to comply with study requirements, including completing symptom diaries.

Exclusion Criteria:

* History of anaphylaxis or severe hayfever symptoms requiring emergency treatment.
* Pregnant or breastfeeding
* History of substance abuse or excessive alcohol consumption.
* Use of systemic corticosteroids, immunotherapy