cyrilzakka/clinical-trials huggingface dataset:
The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain

Objectives:

To investigate the efficacy of omega-3 polyunsaturated fatty acids (PUFA) on patients with chronic nonspecific low back pain (NLBP).

Methods and Materials:

Twenty-nine patients with chronic NLBP were randomly divided into experimental and control groups. For 8 weeks, participants in the experimental group received omega-3 PUFA at 3000 mg/day plus physical therapy, while those in the control group received placebo plus physical therapy. The visual analog pain scale, pressure algometer, Biering-Sorenson test, Roland-Morris Low Back Pain and Disability Questionnaire (RMQ), and occupational burnout inventory (OBI) were used in assessments at baseline (T0) and after 4 (T1) and 8 weeks (T2). Serum erythrocyte sedimentation rate (ESR) and hypersensitive C-reactive protein (hs-CRP) were checked at baseline and T2.

Low back pain is a common symptom in modern society. However, nearly 85% of those who seek medical care for low back pain have no specific history and no specific finding in image study, and therefore do not receive a specific diagnosis. This type of low back pain is termed "nonspecific low back pain." Fish oil contains omega-3 polyunsaturated fatty acid, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA can reduce the synthesis of prostaglandin E2. They are also the precursors of the E-resolvin and D-resolvin that suppress inflammatory cytokine production and act to resolve inflammation. Several previous studies showed that fish oil has the effect of anti-inflammation and pain reduction without side effect that affecting stomach and renal function. Therefore, fish oil is considered a new type of NSAID, and many studies are investigating its effect of anti-inflammation and pain reduction on different diseases. The purpose of this study is to investigate the effects of fish oil on patients with chronic nonspecific low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 20-50
* Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS

Exclusion Criteria:

* History of major trauma or surgery at back
* Obvious spinal pathology on plain film (e.g. scoliosis, spondylosis, spondylolisthesis)
* Not suitable for taking fish oil or receiving physical modality treatment
* Having other inflammatory disease (e.g. rheumatic arthritis, endometriosis, ankylosing spondylitis, infection)
* Pregnancy
* Regularly taking fish oil or fatty fish more than 2 times per week
* Having coagulopathy or currently taking anti-coagulation agent
* Receiving oral or topical NSAID in the past one week
* Taking oral corticosteroid in the past 6 weeks
* Receiving local injection of corticosteroid or prolotherapy in the past 3 months
Drainage Amount for Removal of Thoracostomy Tube

The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.

Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.

Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.

Eligibility Criteria:
Inclusion Criteria:

* Thoracostomy tube in place for \<72 hours
* Age at least 14 years
* Hospitalized for traumatic injury or elective operation

Exclusion Criteria:

* Thoracostomy tube already removed from the pleural cavity of interest
* Mediastinal tubes
* Death expected within 48 hours
* Prisoner status
* Severe congestive heart failure
* End-stage liver disease
* End-stage renal disease
* History of or suspected empyema involving the pleural cavity of interest
* History of or anticipated need for pleurodesis of the pleural cavity of interest
* Malignant pleural effusion
* Pregnancy
* Previous participation in this study
* Thoracostomy tube drainage already \<2 mL/kg
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.


Eligibility Criteria:
Inclusion Criteria:

* Onset of development of secondary sex characteristics before 8 and 9 years in girls and boys, respectively breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II
* Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥5 IU/L)
* Difference between bone age (BA) (according to Greulich and Pyle method) and chronological age (CA) \>1 year
* Girls with Tanner staging ≥2 for breast development and enlarged uterine length and several follicles with diameter \>4 mm in the ovary at Screening visit; boys who have testicular volume ≥4 mL at Screening visit
* Age \< 9 years old for girls and \< 10 years old for boys at initiation of triptorelin treatment
* Weight at least 20 kg
* Subjects will qualify for the extension phase if they sign the corresponding specific consent form, are still benefiting from treatment at the end the primary study and have not experienced any unacceptable safety issues.

Exclusion Criteria:

* Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
* Non-progressing isolated premature thelarche
* Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible
* Evidence of renal (creatinine \>1.5 x upper limit of normal (ULN)) or hepatic impairment (bilirubin \>1.5 x ULN or alanine aminotransferase (ALT)/aspartate transaminase (AST) \>3 x ULN)
* Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use except topical steroids, renal failure, diabetes, moderate to severe scoliosis)
* Prior or current therapy with a GnRH agonist (GnRHa), medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
* Diagnosis of short stature, i.e. \>2.25 standard deviation (SD) below the mean height for age
* Major medical or psychiatric illness that could interfere with study visits
* Known hypersensitivity to any of the test materials or related compounds
* Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.
Comparing the "snifﬁng Position" , "Simple Head Extension" and "Neutral Position"

The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has conﬁrmed its superiority over "snifﬁng position" . In a prospective, randomized study, the authors compared the snifﬁng position , simple head extension and "Neutral Position" in awake orotracheal Intubation.

The study included seventy-five patients with anticipated difficult airways. The snifﬁng position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.

The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.

Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30 kg/m2
* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria:

* Exclusion criteria included age younger than 18 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.

1. Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.
2. Baseline evaluation: evaluate baseline situation of enrolled candidates.
3. Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.
4. Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.
5. Data analysis: analyze the results.

Eligibility Criteria:
Inclusion Criteria:

1. Age 30-90, no gender restrictions.
2. Onset of disease ≤7 days.
3. Meet either of the following two conditions:

   ① Transient ischemic attack (TIA)

   ② Ischemia stroke (IS) Note: Acute IS diagnosis criteria: sudden and persistent focal or widespread neurological dysfunction, excluding other non-vascular causes of brain dysfunction (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases), confirmed by image as new IS. TIA diagnosis criteria: sudden and reversible focal neurological or retinal ischemic deficit caused by a reversible ischemia, usually lasting less than 24 hours, with no evidence of new IS on imaging, and excluding other non-ischemic causes (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases).
4. Signed informed consent

Exclusion Criteria:

1. Clear cause of ischemic stroke other than atrial fibrillation.
2. Other ischemic strokes with a clear cause.
3. Presence of non-vascular intracranial disease.
4. Presence of severe systemic diseases.
5. Pregnancy or lactation.
6. Unable to tolerate or cooperate with MRI examination.
7. Unable to comply with follow-up due to geographical or other reasons.
Morbimortality in Major Urgent General Surgery in the Geriatric Patient.

Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.

Our principal goals are:

1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
2. To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies

Exclusion Criteria:

* Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors.

Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.

Eligibility Criteria:
Inclusion Criteria:

* Operation time should be equal or greater than 2h,
* Patients older than 65 years old,
* ASA Ⅱ or Ⅲ.

Exclusion Criteria:

* Clear arrhythmia,
* Need to apply PEEP,
* Peripheral vascular disease and arterial catheter contraindications.
Pathophysiology of Chronic Wounds

This study will compare blood from healthy volunteers and with wound fluid and tissue samples from patients with acute and chronic wounds enrolled in other NIH studies. Chronic wounds, such as venous leg ulcers, pressure sores, ischemic ulcers and diabetic foot ulcers, affect more than 4 million Americans each year and cost about $9 billion to treat. The nature of these wounds is not well understood and treatments are not always successful, for unknown reasons. Blood collected from healthy volunteers will be used to prepare a model for studying various processes involved in wound healing.

Normal healthy volunteers 21 years of age and older who do not smoke and have no medical problems of the heart, bones, muscles, stomach, lungs, blood, or nervous system, do not have problems going to the bathroom, and have no infections may be eligible for this study.

Participants will be interviewed briefly for information on their date of birth, gender, ethnic identity and medical history and will have a brief physical examination, including a check of height and weight, vital signs and heart and lung sounds. About 14 milliliters (2 tablespoons) of blood will be drawn from the arm.

Chronic wounds are "any interruption on the continuity of the body's tissue that requires a prolonged time to heal, does not heal, or recurs" (Wysocki, 1996). Venous leg ulcers, pressure sores, ischemic ulcers, and diabetic foot ulcers are examples of chronic wounds. These kinds of wounds affect over 4 million Americans each year and cost over $9 billion to treat. The pathophysiology of these wounds is not well understood and therapies directed at healing these wounds are not always successful for unknown reasons. To better understand the pathophysiology of these wounds we propose to collect blood by venipuncture from healthy volunteers. Blood will be used to prepare blood and plasma derived serum for use in an in vitro wound healing model and Boyden chamber assays to study cell migration, adhesion, genetic expression, expression of cell surface receptors, and protein expression to construct a profile of various healing processes. This baseline data will be used for studying the effect of acute and chronic wound fluids on cell migration, adhesion, genetic expression, expression of cell surface receptor and protein expression in an in vitro wound model (protocols to be submitted for each patient population).

Eligibility Criteria:
INCLUSION CRITERIA

Healthy volunteers, 21 years of age and older.

Male or female.

EXCLUSION CRITERIA

Volunteers with known neurological, cardiac, endocrine, skeletal, gastrointestinal, immunological, neoplastic, pulmonary, urologic, hematologic, or infectious disease.

Volunteers taking medications to treat a known diagnosed illness.

Smoker.

Children will not be used because chronic wounds are rarely seen in this population.
Healing Hearts of Hospitalized Patients

The study aims to investigate therapeutic virtual reality (VR) facilitation with adult inpatients using VR as an analgesic and anxiolytic during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience therapeutic VR with and without a trained facilitator as a form of escapism.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and above
* Able to provide informed consent
* Able to follow commands
* Adequate motor skills for upper extremities to operate VR equipment
* Clinically stable
* Experiencing anxiety related to their medical condition as evidenced by a VAS-A score \>4 at time of enrollment.
* English speaking
* Willing to engage in Therapeutic VR

Exclusion Criteria:

* Severe cognitive impairment
* Facial trauma prohibiting headset use
* Physical limitations in facial, neck, upper extremities that hinder use of VR equipment
* Aggression or violence
* Harm to self or others
* Isolation room
* History of seizures or other neurological conditions
* Severe motion sickness
* Active nausea
* Severe visual impairment
* Severe cognitive impairment
Vestibular Physical Therapy for People With Alzheimer Disease

The purpose of this study is to assess the tolerability and preliminary efficacy of an 8-week home-based vestibular physical therapy program in people with cognitive impairment.

This project uses a novel non-pharmacological treatment to improve balance and reduce falls in patients with Alzheimer Disease (AD) using a conceptual framework that combines current vestibular physical therapy (VPT) practice guidelines with the latest motor learning theories for cognitively-impaired patients. The modified VPT protocol for AD patients was developed by experts in VPT and motor learning in AD and will be tested. This pilot study will provide much-needed data about whether VPT can be adapted for patients with AD, and whether VPT shows promise in improving or stabilizing balance, spatial cognition, and gait function in patients with AD.

Eligibility Criteria:
Inclusion Criteria:

* mild-AD diagnosis
* complaints or observation of gat disturbance

Exclusion Criteria:

* inability to stand for 3 minutes without rest
* recent lower extremity fractures/severe sprains (within last six months)
* incapacitating back or lower extremity pain
* confounding neurologic or neuromuscular disorders
* presence of benign paroxysmal positional vertigo
* pain elicited during cervical range of motion or limited cervical range of motion
PICU-related Sleep and Circadian Dysregulation Pilot Study

A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.

Several of the identified sleep disruptors in a pediatric intensive care environment may not be modifiable, including restricting feeding to daytime hours and providing normal daytime light exposure. This study aims to measure the feasibility of measuring sleep and circadian patterns in a PICU during routine care and during 2 focused sleep promotion interventions: timed daytime light exposure (DLE) and daytime feeding restriction (DFR). The overall objective of this study is to test the hypothesis that, with multi-disciplinary efforts, providing chronotherapeutic care will be feasible and that reliably measuring sleep patterns and the CR of critically ill children with timed salivary melatonin assays and actigraphy is possible.

Eligibility Criteria:
Inclusion Criteria:

1. Child age 3 to 6 years old on the day of PICU admission
2. English-speaking parent at the bedside
3. Child expected to remain in the PICU over 24 to 48 hours

Exclusion Criteria:

1. Child is in end-of-life care
2. The child is receiving neuromuscular blockade for any reason
3. Caregiver or parent not at the bedside
Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study

The overall goal of this study is to examine if acupuncture intervention can reduce the post-concussion symptom (PCS), and affective and cognitive complaints among mild traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham acupuncture and waiting list control groups, patients in the real acupuncture group will have fewer symptoms of depression, sleep problems and post-concussion symptoms.

Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI that are reported to be precursors of post-concussion symptom, including affective (depression, anxiety) and somatic (headache, sleep difficulties) complaints. Evidence suggests that the increased intensity of these symptoms, particularly greater affective distress and injury-associated pain, increases vulnerability to neurodegenerative disease and PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will improve, and, as a result, the incidence of PCS in this patient population will be reduced.

Research plan: The overarching focus of this study is the use of acupuncture treatment, targeted to symptoms of mild TBI. The investigators propose a randomized, sham procedure and usual care-controlled clinical trial of acupuncture beginning at acute phase following mild traumatic brain injury (TBI). Participants meeting eligibility requirements will be randomized to 1 of 3 groups: verum acupuncture, sham acupuncture or waiting-list control. Acupuncture treatments will continue for one month, at which point all participants will be assessed for presence of mild TBI symptoms. Participants will be evaluated again after one-month acupuncture treatment and follow-up post-hospital discharge. The investigators hypothesize that true acupuncture will be more effective than sham acupuncture in reducing these outcomes at after treatment and follow-up stage. Patients were also scanned by 3T MRI scanner at baseline, one-month (after acupuncture treatment).

Eligibility Criteria:
Inclusion Criteria:

* subjects presenting to the study hospital emergency department (ED) after sustaining a acute head injury will be eligible if they:
* are aged 18-75 years;
* have a mild TBI, defined by the World Health Organization's Collaborating Centre for Neurotrauma Task Force (2005)
* no contraindications to MR
* injury within 7 days

Exclusion Criteria:

* experience with acupuncture treatment
* history of neurological disease, long-standing psychiatric condition, spinal cord injury, head injury, or a history of substance or alcohol abuse
* intubation and/or presence of a skull fracture
* administration of sedatives on arrival in the emergency department,
* the manifestation of mild traumatic brain injury (TBI) due to medications by other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury