cyrilzakka/clinical-trials huggingface dataset:
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department

Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.

Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting.

Promethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED.

Eligibility Criteria:
Inclusion Criteria:

1. An indication for opioid analgesia based in the ED (i.e. severe pain \> 70mm on a 100mm VAS)
2. Age between 18-65 years
3. American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease
4. Systolic blood pressure higher than 90 mmHg on admission
5. Willingness and ability to provide an informed consent
6. No known hypersensitivity to the medication used.

Exclusion Criteria:

1. Pregnant women
2. Patients who can not be under adult supervision following discharge from the emergency department.
Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

Multicenter Italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with CNS who performed severe CNA identified through asystolic pauses identification by implantable loop recorder. The study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the Italian Multidisciplinary Group for the Study of Syncope (GIMSI).

The so called "Cardioneuroablation (CNA)" focused on the endocardial ablation of atrial ganglionated plexi has proven to be efficacy in patients affected by neuro-mediated cardioinhibitory syncope (NCS). No center currently has sufficient case series to establish long-term efficacy and safety results, for which a multicenter interventional study is therefore needed.

The aim of the study will be to evaluate the efficacy and safety of CNA focused in NCS patients. The ablation procedure, consists of radiofrequency delivering at right atrial anatomic sites where the underlying presence of GP clusters is regarded as highly probable: 1) the inferior-posterior area (first ablation site): inferior right GP placed between inferior vena cava, coronary sinus ostium and near the atrio-ventricular groove, 2) the superior-posterior area (second ablation site): superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Patients with a clinical diagnosis of neuromediated syncope according to class I criteria of the ESC guidelines, Table 1
* Clinical history of recurrent syncope (≥2 in the last year or ≥3 in the last 2 years), severe, not tolerated by the patient
* Documentation of ≥2 asystolic pauses \>3 sec daytime on ECG monitoring by implantable loop recorder (ILR), with or without syncope
* Refusal by patient to perform pacemaker implantation

Tilt test is recommended but not mandatory. Patients with negative tilt test are also enrollable. It can be either positive or negative.

Exclusion Criteria:

* Absence of sinus dysfunction and atrioventricular node disease.
* Absence of structural heart disease
* Possible alternative diagnoses of syncope
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.

This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.

MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in 100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment. All patients will be followed up for 12 months post-treatment for safety.

Eligibility Criteria:
Inclusion Criteria:

* Women, age between 18 and 55 years
* Weight \< 140 kg
* Pre- or peri-menopausal
* Uterine size \< 24 weeks
* Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
* Fibroids selected for treatment meeting the following criteria:

  1. Total planned ablation volume of all fibroids should not exceed 250 ml, and
  2. No more than 5 fibroids should be planned for ablation, and
  3. Dominant fibroid (diameter) is greater than or equal to 3 cm, and
  4. Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
  5. Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated
* MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated
* Willing and able to attend all study visits

Exclusion Criteria:

* Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
* Desire for future pregnancy
* Significant systemic disease, even if controlled
* Positive pregnancy test
* Hematocrit \< 25%
* Extensive scarring along anterior lower abdominal wall (\> 50% of area)
* Surgical clips in the direct path of the HIFU beam
* MRI contraindicated
* MRI contrast agent contraindicated
* Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
* Calcifications around or throughout uterine tissues
* Communication barrier
* Suspected malignancy
Stem Cell Educator Therapy in Type 1 Diabetes

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association 2010. Other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells.

Exclusion Criteria:

* Exclusion criteria were any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
Interval Training and Parkinson's Disease

This research is designed to compare the impact of high-intensity interval training and high-velocity circuit resistance training on heart rate variability, gait, and functional performance in patients with Parkinsons disease.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of Parkinson's disease
2. Between the ages of 30-90 years of age;
3. Movement Disorder Society-Unified Parkinson's Disease Rating Scale ≤2, which will be provided by the participant's medical provider and be evaluated within 1 year of the study's inception.

Exclusion Criteria:

1. Uncontrolled cardiovascular disease that prevents participation in a training program
2. Documented HIV infection or another immunodeficiency syndrome
3. Other neuromuscular diseases besides Parkinson's disease
4. Current musculoskeletal injury that prevents exercise.
5. Having a pacemaker or other internal medical devices
Recovery Improved in Covert Stroke With Exercise

Silent ischemic, also known as "covert stroke vascular disease" (CSVD), contributes to neurological deficits that are caused by damage to small blood vessels in the brain. CSVD occurs six to ten times more often that an acute stroke. It is misleading to think, however, that CSVD is an inevitable part of "getting old" because people with CSVD are at high risk of developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more likely to develop day to day problems in planning, decision-making and speed of thinking. Unfortunately, there are no proven therapies designed to address CSVD. We propose to test whether aerobic exercise is an intervention that can combat CSVD because the disease is fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to study the brain in terms of structure, perfusion and function. Participants will be randomly assigned to either our established aerobic exercise program or a control stretching program. Both groups will take part in lab exercise sessions, which are designed to monitor progress and assess adherence to the program. The duration and intensity of their exercise will increase as participants progress. We will use activity log books, phone calls and extra "booster" exercise sessions, as needed, to maximize retention and adherence. We aim to show that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter, supports regional tissue growth, and improves cognitive function in CSVD adults with substantial risk of acute stroke and dementia. A positive outcome of this research will provide strong support for additional clinical trials aimed at sustaining cognition and maintaining independent living.


Eligibility Criteria:
Inclusion Criteria:

* Covert stroke: white matter hyperintensities of presumed vascular origin
* Ability to walk for 10 minutes without assistance from another person
* Fluent in English
* Ability to consent

Exclusion Criteria:

* Highly fit individuals exercising ≥ 150 minutes per week
* Dementia
* Multiple Sclerosis
* Disabling stroke (ischemic or hemorrhagic)
* Major concurrent illness (e.g. chronic obstructive lung disorder, current or metastatic cancer, chronic kidney disease)
* Major psychiatric illness (e.g. bipolar, schizophrenia, major depression)
* Contraindications to MRI scanning (e.g. claustrophobia, implants, prostheses, metallic fragments)
* Contraindications to exercise (participants must have medical clearance to exercise from their attending physician)
* Recent change in health status (e.g. hospitalization within past month)
Sleep Disturbance in Pregnant Women in Upper Egypt

Pregnant women are associated with hormonal, anatomic and mechanical changes that Change sleep patterns and quality of sleep. Several Investigators have reported Associations between sleep disturbances and hypertension, Coronary artery disease, Diabetes, and depression. Most of these associations have been established in the association with sleep disturbances


Eligibility Criteria:
Inclusion Criteria:

* All viable third trimester pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* Any History of neurological, mental disorder.
* Any previous diagnosed sleep disturbances breathing disorder before pregnancy.
* Any patient with respiratory infection in the pregnancy.
Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

Millions of Americans suffer from high blood pressure, diabetes, strokes and motor vehicle accidents due to ineffective treatment of obstructive sleep apnea (OSA). Our preliminary data suggest that physiological causes of OSA such as easy arousability (low arousal threshold) or unstable breathing control (high loop gain) may influence effectiveness of OSA's most common treatment, continuous positive airway pressure (CPAP). The NICE-PAP study will examine how the physiologic traits that cause OSA in each individual impact CPAP effectiveness and can lead to personalized OSA treatments that improve patient lives.

Most patients with OSA who are prescribed the gold-standard therapy, CPAP, are ineffectively treated. This is due to 1) poor CPAP adherence, 2) high residual apnea in 20% of users (low efficacy) and 3) inconsistent symptom improvement. To improve CPAP effectiveness, we propose to address novel physiologic targets that cause OSA in each individual: arousability (arousal threshold), ventilatory control sensitivity (loop gain) and pharyngeal muscle compensation.

Our overall objective is to determine the contribution of these traits to CPAP effectiveness independently of established biological, psychological and social predictors. This study leverages state-of-the art sleep study analysis tools and validated measures of the determinants of CPAP effectiveness to create a pragmatic, prospective cohort (n=267) of OSA patients. This unique dataset will help determine whether physiologic causes of OSA influence CPAP adherence, efficacy, sleep quality, symptoms, function and quality of life. The results will inform design and conduct of a randomized clinical trial designed to modify physiologic traits such as easy arousability to improve CPAP effectiveness and other patient-centered outcomes in OSA patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age of \>18 years
2. Newly diagnosed OSA naïve to CPAP
3. Apnea hypopnea index (AHI) ≥5/hr on in-laboratory polysomnography or home sleep test acquired and scored using standard criteria(59)
4. Referred for CPAP adherence management at Yale New Haven Hospital Sleep Center

Exclusion Criteria:

1. Need for supplemental oxygen
2. Central apnea index comprising \>50% of the AHI
3. Treatment recommendation with another modality (e.g., Bilevel PAP, Adaptive Servo-Ventilation, Automatic Volume Pressure Assured Pressure Support)
4. A referral for a sleep disorder other than OSA (i.e., narcolepsy, sleep related movement disorder, circadian rhythm sleep-wake disorder)
5. Prior CPAP or Auto-CPAP use over the past 3 years
6. Unstable medical or mental health condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end stage renal disease, psychosis)
7. Inability to participate in the informed consent process (e.g., cognitive impairment)
8. Pregnancy
9. Non-English language use as only means of communication (because the research budget does not provide adequate resources to ensure that the needs of non-English speaking patients can be adequately addressed)
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes.

The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Ages 18-40 years
* BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
* Medically cleared for participation in the study

Exclusion Criteria:

* Contraindication to MRI
* Consume \>10 alcoholic drinks/week
* History of chronic smoking or have quit less than 10 years ago
* History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
* Average screening blood pressure \>140/90 mmHg
* History of cardiovascular disease
* Pregnant, planning to become pregnant, or breastfeeding
* Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
* Use of beta-adrenergic antagonists.
* Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Vitamin D in Ectopic Pregnancies

According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including preeclampsia, gestational diabetes, low birth weight, preterm delivery, and cesarean section rates. The aim of the present study was to evaluate the vitamin D levels in ectopic pregnancies, which may have clinical importance in the etiology of this disorder.


Eligibility Criteria:
Inclusion Criteria:

* ectopic pregnancies and
* women with normal 1st trimester pregnancies

Exclusion Criteria:

* Patients without any known operations or
* disease history
Body Weight Growth After Birth and Bronchopulmonary Dysplasia

Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.

Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.

The aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.

Eligibility Criteria:
Inclusion Criteria:

* equal to or less than 32 weeks' gestational age

Exclusion Criteria:

* main congenital malformation
* parents' refusal
Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).


Eligibility Criteria:
Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt
2. Age ≥ 2 years old
3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

Exclusion criteria

1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
2. Presence of more than one distal shunt catheter in the study device measurement region
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of adverse skin reactions to silicone adhesives
5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
6. Subject not available for seven-day follow-up
Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms

Lower urinary tract symptoms is quite frequent in men and women. To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). In this study we aim to validate the LURN-29 score to Turkish language


Eligibility Criteria:
Inclusion Criteria:

* Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read

Exclusion Criteria:

* Patients above 18 years old