cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis

This study is a single-center, randomized, double-blind, placebo-controlled trial.

The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
2. 50-90 years old, regardless of gender.
3. Sequential Organ Failure Assessment (SOFA) score ≥ 2.
4. Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
5. Voluntary participation with signed informed consent.

Exclusion Criteria:

1. ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
2. Patients with allergies or allergic constitution to the investigational herbal medications.
3. Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight \> 150 kg), trauma, or surgical factors.
4. Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
5. History of gastrointestinal surgery.
6. Long-term use of corticosteroids or immunosuppressants.
7. Severe psychiatric disorders or inability to cooperate with trial protocols.
8. Participation in other clinical trials within 30 days.
9. Pregnant or lactating women.
10. Participated in other clinical studies in the past 3 months.
Glomerular Filtration Rate (GFR) Reporting on Nephrology Referral Patterns by Internists

The addition of an estimate value of glomerular filtration rate (GFR) per Modification of Diet in Renal Disease \[MDRD\] (LEVEY) equation is being included and reported on all routine chemistry panels in the experimental group. The control group is only having serum creatinine, the current standard of care, reported on routine chemistry panels.

All patients already referred to or being followed by nephrologists were excluded. Inclusion criteria were all patients in the Internal Medicine clinic at NMCSD who were sent to the lab to obtain routine chemistry panels for follow up by their primary care providers. The primary outcome is increased referral to nephrology in accordance with NKF K/DOQI guidelines if GFR values are reported on routine chemistry panels. Key secondary outcomes are Primary Care Provider knowledge of NKF K/DOQI guidelines, specifically when patients with chronic kidney disease need to be referred to a nephrologist for further evaluation.

Eligibility Criteria:
Inclusion Criteria:

* All patients in the Internal Medicine Clinic at Naval Medical Center, San Diego (NMCSD) who were sent to the lab to obtain follow up by their primary care providers.

Exclusion Criteria:

* All patients referred to or being followed by nephrologists.
Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.

Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.

The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.

The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiology) class I-IV
* age 81-75

Exclusion Criteria:

* ASA class V
* morbid obesity
* patient refusal
* patients with chronic pain or on pain medications
* allergy to LA
* patients receiving any additional regional techniques
* coagulopathy
* patients receiving systemic anticoagulation
* local infection
* procedures anticipated to last more than 5 hours.
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
* Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
* Major patient
* Patient having signed an informed consent

Exclusion Criteria:

* Minor patient
* Patient with cognitive impairment diagnosed by a physician
* Patient under tutorship or curatorship
* Patient deaf or hard of hearing
* Patient not fluent in the French language (at the decision of the investigator)
Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting

Close to one-third of Medicare decedents use the Medicare skilled nursing facility (SNF) benefit in the 6 months prior to death. SNF care often increases the risk for more aggressive, potentially burdensome treatments and unrecognized or undertreated symptoms. Palliative care is goal-directed, patient and family-centered care that focuses on a wide range of physical, psychosocial, and spiritual needs for persons with serious, life-limiting illnesses. Effective palliative care relieves suffering, enhances communication, and improves end-of-life care and decision making for seriously ill older adults. Despite its association with improved quality of care, higher satisfaction, and better symptom management at the end of life, palliative care is not widely available to Medicare patients in the Skilled Nursing Facility (SNF) setting. Palliative care consultation (PCC) is one approach that can potentially improve care for older adults with advanced illness in SNFs. This pilot study will test an evidence-based palliative care consult intervention for older adult SNF patients in nursing homes by comparing the patient/family caregiver reported quality of life in two participant groups: one receiving a PCC and the other receiving standard care.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a participating nursing home under the Medicare SNF benefit
* English speaking
* If non-verbal or unable to participate in a conversation, a legally authorized representative(LAR) or surrogate decision maker who can participate in the study
* A diagnosis of one or more advanced serious illness using established criteria
* One global indicator for a PCC at SNF admission (i.e., primary provider would not be surprised if patient died in 12 months; frequent hospital or SNF admissions; complex care requirements; decline in function; feeding intolerance; or unintended decline in weight)

Exclusion Criteria:

* Patients who have previously received or are referred for a SNF-based PCC by their primary care team
Tramadol to Reduce Opioid Withdrawal Symptoms

Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.

Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal symptoms may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a medication that is currently used to treat moderate to severe pain in individuals with cancer, joint pain, or pain resulting from surgery. Because of its pharmacological profile, tramadol may also be useful in treating opioid withdrawal. Further research is needed to confirm the benefits of tramadol for opioid addicts. The purpose of this study is to evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals.

This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be required to reside at the research clinic for the entire study. All participants will receive morphine maintenance treatment on a daily basis. Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms. Participants will complete performance tasks to measure psychomotor and cognitive functioning. Heart rate and blood pressure will be monitored throughout the experimental sessions. A specialized camera will also be used to assess pupillary response of the eyes. Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms. Following the end of the study, all participants will be offered outpatient drug abuse treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV diagnostic criteria for opioid dependence
* Is in good physical health
* Qualifies for treatment with opioid agonist therapy (e.g., methadone)
* If female, must have a negative pregnancy test prior to study entry

Exclusion Criteria:

* Evidence of significant medical illness (e.g., insulin dependent diabetes mellitus)
* Evidence of significant psychiatric illness (e.g., schizophrenia)
* Currently seeking treatment for substance abuse
* Pregnant or breastfeeding
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1

The goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations.

Pause and Play will take a prospective observational epidemiological approach before and after enactment of new regulations. 10 childcare centers licensed in East Baton Rouge Parish will be randomly selected and standardized behavioral observation scales will be used to objectively quantify the physical activity and screen-time environment of the centers and the children's behaviors both in and outside the center. These assessments will be collected twice during the 2-year grant period to capture potential changes after the policies are implemented.

Eligibility Criteria:
Inclusion Criteria:

* Licensed by DOE as a Class A or Class B childcare center
* Located in East Baton Rouge Parish
* Current childcare enrollment of at least 18 children between the ages of 3-4 years

Exclusion Criteria:

* Childcare center and/or childcare center director unwilling to participate
Results Of Usage Of Bridging Plate In Multi-fragmentary Distal Radius Fracture

using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal

The plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions.

One distal over 2end metacarpal and Other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative Assess the Functional Outcome Of the wrist joint after metal removal

Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature patients
2. presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
3. articular with or without metaphyseal comminution
4. Very distal fractures 5 )osteoporotic bone fractures

Exclusion Criteria:

1. Dorsal soft tissue defect or tendon injuries
2. Metacarpal fractures (esp 2end MC)
3. open grade 3 fractures
Whole Exome Sequencing in Bicuspid Aortic Valve Patients

Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies.

Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field.

The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.


Eligibility Criteria:
Inclusion Criteria:

* bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography
* With or without an aneurysm of the ascending thoracic aorta nonsyndromic

Exclusion Criteria:

* aortic syndromic pathology
* antecedent of acute articular rhumatism
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia

Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.

This is a Phase IV, randomized, multi-center, double-blind, parallel-group 12-week study of Cimzia with concomitant methotrexate (MTX) or other DMARD compared to MTX or other DMARD alone in patients with an inadequate secondary therapeutic response to a TNF-alpha inhibitor as defined above and active rheumatoid arthritis (RA) followed by a 12-week open-label phase with concomitant MTX or other DMARD and Cimzia.

Subjects must washout from the previous TNF inhibitor for at least 4 weeks prior to the baseline visit. Subjects unable to tolerate MTX must have been on a stable dose of another non-biologic DMARD for at least 3 months. Subjects' diagnosis of RA must be based on the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis.

Subjects will be screened for eligibility and, up to 28 days later, at the baseline visit, randomized to one of two treatment groups (2:1): Cimzia or placebo (in addition to concomitant MTX or other DMARD). All subjects will continue MTX/other DMARD at the same dose utilized prior to study entry.

After the Week 12 study visit, all subjects will have the opportunity to continue in the study on open-label Cimzia treatment (using an induction regimen for all subjects, regardless of their treatment in the blinded phase).

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of RA at least 6 months
* Have received treatment with a TNF-alpha inhibitor
* Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another non-biologic DMARD if Methotrexate intolerant \*Have at least 6 tender joint and 6 swollen joints\*
* Have an CRP greater than or equal to ULN
* Availability of a chest x-ray that shows no evidence of active TB or infection

Exclusion Criteria:

* Prior exposure to Cimzia
* Prior treatment with B-cell depleting therapy
* No significant response to previous TNF inhibitor
* Congestive heart failure
* Clinically abnormal laboratory tests
* History of cancer
* Active TB
Stiffness Measurement of Liver Tumors and Visceral Parenchyma

The investigators are measuring hepatocellular carcinoma(HCC)stiffness using Acoustic Radiation Force Impulse (ARFI) technique to enhance the diagnostic accuracy for HCC stratifications and treatment efficacy.

Regression modelings as well as validity testings including cut-off identification will be acquired by performing both qualitative and quantitative measurements of HCC using reference diagnostic modalities e.g. pathology grading, dynamic CT scanning, etc.

Eligibility Criteria:
Inclusion Criteria:

with HCC

Exclusion Criteria:

* subjects with liver cancer other than HCC
* subjects with treated HCC
* post major abdominal surgery
* contraindications to liver tumor biopsy
* contraindications to local percutaneous treatment of liver tumors
* ARFI measurement low quality
Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

Parkinson's disease (PD) is a chronic, degenerative disease described by motors and non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of tracheal aspiration largely responsible for increased morbidity and mortality in this population. Thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia, with consequent improvement of the prognosis of individuals with PD. Objective: To determine the impact of combined oral motor exercises and breathing exercises on swallowing disorders in individuals with PD. Method: Clinical trial, randomized and blinded for the examinator. For all subjects will be given the stage of PD and applied quality of life questionnaire. The swallowing complaints will be investigated through structured questionnaire and functional aspects of swallowing with videofluoroscopy. The Manovacuometry Spirometry will determine measures of respiratory function. The assessment of vocal and speech disorders will be done with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis of intelligibility. Three groups of intervention will be defined: one of them doing oral motor exercises for swallowing, one doing breathing exercises and another must do this two interventions combined. Effect of intervention will be assessed through measures of swallowing, breathing, voice and speech. The groups will be compared, according to the principle of "intention to treat" by appropriate statistical tests, according to the distribution of the dependent variables.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosed following UKPDS Criteria
* Complaints and symptoms of dysphagia
* Dopaminergic treatment

Exclusion Criteria:

* Cranial trauma
* Severe heart disease
* Others neurologic disease
* Psychiatric diseases
* Therapy for swallowing or breathing in the last 3 months
Born In Guangzhou Intervention Study

The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending prenatal care at Guangzhou Women and Children's Medical Center (GWCMC) \<20 weeks' gestation
* Pregnant women plan to deliver at GWCMC
* Pregnant women intend to reside in Guangzhou for at least 3 years

Exclusion Criteria:

* Multiple pregnancies
* Existing medical conditions (uncontrolled diabetes, hypertension or thyroid disease; other serious cardiovascular diseases, respiratory or systematic disorders)
* Use of drugs (aspirin, metformin, low molecular weight heparin)
* Women with reading and/or writing difficulties
* Women with serious mental disorders
* Women with eating disorders
Physiological and Appetitive Effects of CBD Supplementation

CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.


Eligibility Criteria:
Exclusion Criteria:

* No history of any substance abuse
* Have used tobacco regularly (\>2x in a week) within the past 6 months
* Are suffering from any condition that may affect study outcomes
* Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers)
* Have given a standard blood donation within 30 days of screening
* Are currently pregnant or lactating
* Are allergic/intolerant to any ingredients in food items we provide during the study (relevant allergens: oats, milk)

Inclusion Criteria:

* Males and females, aged 18-50, who do not meet the exclusion criteria