cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal

Postoperative pain after gall bladder removal can be significant, mobility limiting and extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following gall bladder removal.

Postoperative pain after open cholecystectomy can be significant and mobility limiting, causing increased risk of deep venous thrombosis, pulmonary complications, and extended hospital stay. With increasing emphasis on early postoperative mobilization, adequate postoperative pain control is essential. Acute postoperative pain is currently managed largely with opioids and co-administration of nonsteroidal anti-inflammatory drugs (NSAIDS). Opioids are highly effective in managing acute postoperative pain, however dosing is often limited by side effects such as respiratory depression, nausea and vomiting, and sedation. NSAIDS are administered to reduce opioid use, but may also have limiting side effects, such as gastrointestinal toxicity and platelet dysfunction. New strategies to manage acute postoperative pain would provide clinical benefit. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following open cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis
* American Society of Anesthesiologists (ASA) Class I or II

Exclusion Criteria:

* Active pancreatitis, any obstruction of the biliary tree, or hyperbilirubinemia (total bilirubin \> 2.5 mg/dL)
* Previous abdominal surgical procedure with the exception of inguinal hernia repair or appendectomy by the lateral approach or cesarean section or hysterectomy if the surgery was performed more than 1 year prior to study participation and the subject experienced no postoperative complications
* Diabetes mellitus with HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes mellitus
* Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg
A Tele-detection and Referral Pathways Model for Early Childhood Caries Control

The aim of the study is to assess the effectiveness of ECC tele-detection methods combined with referral pathways, with and without user fee removal, in controlling ECC.


Eligibility Criteria:
Inclusion Criteria:

* Age \<6 years old with primary dentition only.
* Written consent from the legal guardian

Exclusion Criteria:

* Children above 6 years old.
* Children with mixed or permanent dentitions.
* Children with physical disabilities or psychiatric disorders.
* Children with intellectual disabilities.
* Children indicated for dental treatment under general anesthesia
Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During the COVID-19 Pandemic

This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE.

PRIMARY OBJECTIVE:

I. To determine whether patients perceive their healthcare practitioner as more empathetic during an in-person interaction with the practitioner wearing personal protective equipment (PPE), or during a video interaction without the need for PPE.

SECONDARY OBJECTIVES:

I. To assess whether certain physicians perform better with video whereas others perform better in person.

II. To characterize generational differences in patient perception of healthcare practitioner empathy during an in person interaction with the practitioner wearing PPE, or during a video interaction without the need for PPE.

OUTLINE: After initial visit, patients are randomized to 1 of 2 groups.

GROUP A (NO PPE): Patients receive standard of care via video call with treating physician.

GROUP B (WEARING PPE): Patients receive standard of care in-person physician visits.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* Able to speak and write in English
* Able to understand and willing to sign a written informed consent document
* Willing and able to complete the study assessment(s)

Exclusion Criteria:

* Refuses to participate
* Too ill to participate, in the estimation of the patient's physician
Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

In a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoporosis patients

Exclusion Criteria:

* Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.
The ICALIC Accuracy Validation in Geneva Study

This study aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center.

The measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition analysis.

Indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (VO2) and CO2 production (VCO2). Energy expenditure is calculated by the Weir's equation using the measured VO2 and VCO2 values.

The new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. It also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled O2 and CO2 compositions. The new dynamic micro-mixing chamber technique is used to meaure VO2 and VCO2 to derive the energy expenditure.

The mass spectrometer measures the inhaled and exhaled gas compositions. The mass spectrometer samples inhaled gas from the mechanical ventilator circuit. A mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. The collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. The volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. The measurements will be used to calculate the VO2 and VCO2 to derive the energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

• Mechanically ventilated adult ICU patients

Exclusion Criteria:

* Fraction of inhaled oxygen (FIO2) \> 70%
* Positive end expiratory pressure (PEEP) \>10cmH2O
* Peak ventilatory pressure \> 30cmH2O
* Presence of air leaks from thoracic drain tube
* Changes in vasoactive agent dose (\>20%, \<1 hr before and/or during IC)
* Agitation or change in sedative dose (\>20%, \<1 hr before and/or during IC)
* Change in body temperature (\>0.5°C, \<1 hr before and/or during IC)
* Expected duration of ICU stay \< 24 hours
* Expected survival of the patient \< 24 hours
Pain Related Variables

Chronic neck pain is a common problem among the general population. Patients with chronic neck pain used health care services twice as much as the population on average, mainly due to intense pain intensity. It is well-known that pain intensity depends on the association of pain processing in several levels of central pain processing.

Identifying the association between conditioned pain modulation, temporal summation, and somatosensory representation, all represent separate central pain processing, will provide an opportunity to develop treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* pain in the back of the neck region
* pain longer than 3 months
* pain intensity at least 3 based on the visual analog scale

Exclusion Criteria:

* vertebra fracture
* fibromyalgia
* chronic fatigue syndrome
* surgery to the neck or shoulder
* radicular pain
* neurologic deficit due to disk hernia
* spinal stenosis
Text Message Appointment Reminders

This project proposes administer and evaluate via a randomized controlled trail a text message-based appointment reminder system to promote attendance at clinic appointments after ED discharge.

Failure to attend scheduled clinic appointments causes inefficiency within the healthcare system, and frequently results in ED visits for non-emergent conditions such as medication refills, ambulatory care sensitive conditions which are potentially preventable with appropriate outpatient management (e.g. foot infections). Many patients seen in the ED report they were unaware of past or future outpatient appointments for which they had been scheduled. These patients are clearly in need of primary care, yet fail to attend 30% of all scheduled outpatient appointments. Patients most often report that they failed to attend scheduled appointments as a result of forgetfulness or confusion regarding dates, times, or locations. National data confirmed by our previous work in the LAC+USC ED demonstrates that \> 80% of this population reports using a text-capable mobile device. The investigators believe a system of text message appointment reminders has tremendous potential to facilitate clinic attendance among these patients in desperate need of primary care.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Able to provide consent and read in English or Spanish
* Have a text message capable mobile phone
* Know how to receive text messages
* Have upcoming scheduled clinic appointments

Exclusion Criteria:

* Unable to provide written informed consent
* Incarcerated
* Critically ill
* Altered Mental Status
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Post-stroke Cognitive Impairment

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of post-stroke cognitive impairment patients' cognitive function by altering the cortical excitability.

Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in post-stroke cognitive impairment patients.


Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Who can perform the 2-back verbal and non-verbal working memory task

Exclusion Criteria:

* K-MMSE score under 9
* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain
Cervical Motor Control in Long-term Breast Cancer Survivors

The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.

Background: Breast cancer is becoming a common disease; however survival rates have improved throughout the last years. As a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. It is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor.

Aim: To determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life.

Methods: Fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). The experimental group will receive a nine-week tailored exercise training focused on cervical motor control.

Discussion: There is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. Therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.

Eligibility Criteria:
Inclusion Criteria:

* To be over 18 years old
* Have passed a period equal o more 5 years since breast cancer diagnosis
* Have diagnosis of stage I, II or IIIA breast cancer
* Have signed informed consent
* Have medical clearance for participation
* Inability to get level 2 in the craniocervical flexion test

Exclusion Criteria:

* Have diagnosis of arthritis or fibromyalgia
* Have cancer recurrence
* Have been operated through previous surgery of cervical column
* To be taking any treatment for pain or altered motor control during last 12 months
Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes

For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes.

For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.

* Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries.
* Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs.
* Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed.
* for OFD group; following debridement and saline irrigation, wound closure proceeds.
* for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure.
* for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure.
* from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus
* At 6 months postoperative: the same baseline clinical measurements are obtained.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
* 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth

Exclusion Criteria:

* Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
* Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
* Vulnerable groups
* Interdental craters and 1 wall osseous defects
* Active periapical pathosis
Nasal Bridge Pressure Injury Prevention

The primary goal of this study is to explore whether applying the Mepilex foam on the nasal bridge directly between the skin and the N95 mask will prevent nasal bridge pressure injury among nursing staff, secondary to long-term ( \>8+ hours) wear time. The secondary goal is to evaluate if using the Mepilex maintains the seal of the mask.

Nurses use the N95 Mask as part of the personal protective equipment (PPE) when caring for patients with COVID-19. The N95 mask covers their nose and mouth with a tight seal. Nurses wear the mask for more than 8 hours per day, as a result they are at increased risk for skin injury on the nasal bridge. Mepliex is foam dressing which has been used to prevent pressure injuries to the skin. This study will evaluate if using Mepilex or band-aid on the nasal bridge of the nurses who wear the N95 for more than 8 hours decreases the potential for skin injury. In addition, the investigators will test if the Mepilex or band-aid also maintains the seal of the mask. Maintaining the seal is important to ensure that the nurse is not exposed to the virus. The investigators will be working with nurses who do not directly take care of COVID-19 patients to ensure the safety of all participants.

Eligibility Criteria:
Inclusion Criteria:

* The sample will consist of nursing staff working on non-COVID units, including: Medical Surgical Units, Operating Rooms or Ambulatory Care- Labor and Delivery Unit, Maternity Unit and Medical Oncology Unit, at NewYork-Presbyterian (NYP) Lawrence Hospital.

Exclusion Criteria:

* Exclusion Criteria: A score on \> 5 the COVID Anxiety Scale. The scale has 4 questions with 5 possible options (rated 1 - 5), to evaluate the effect of COVID19 on the individual. The lowest possible score is 0, the highest possible score is 20. A score of 5 states that the individual experiences COVID19 related anxiety for 'Rarely' or 'Not at All". Excluding participants with a score of \> 5 will prevent unnecessary harm to study participants or exacerbate symptoms of anxiety.
* Nurses working in the Emergency Department, Intensive Care Unit or a unit with a focus on the exposed COVID-19 population
* Non-clinical nurses, volunteer or agency registered nurses
* Known history of skin breakdown or damage to the nasal bridge
* History of skin-related conditions including (acne vulgaris, Psoriasis, Herpetic lesions to mouth, nasal areas)
* History of surgery to nasal bridge
* Pregnant nurses in their third trimester
* History of respiratory extended respirator use in addition to the hours collected in this study.
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between

1. Six and twelve weeks of antibiotic therapy if there is an implant left in place
2. Three and six weeks of antibiotic therapy if there is no implant left


Eligibility Criteria:
Inclusion Criteria:

* Spine surgery and intraoperative debridement with any technique
* At least 12 months of scheduled follow-up from hospitalization
* Bacterial spine infection of any nature, independently of implants or co-morbidities

Exclusion Criteria:

* Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine
* Non-resected cancer in the infection site
* Bone marrow or recent solid organ transplant patient (Recent: \<5 years)
* Any other infection in the patient requiring more than 6 weeks of antibiotic therapy
* More than three intraoperative debridements performed for spine infection
* Absence of at least one surgical intraoperative debridement of infection
Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases

Initially investigators will find LncRNA which to be able to affect Notch2 signaling pathway; then confirm the relationship between Notch2 and LncRNA, and analysis the regulation mode of LncRNA to Notch2 signaling pathway, and to observe the correlation between LncRNA and thymoma complicated with autoimmune diseases.

1. This study plans to research the correlation between Bregs and thymoma complicated with autoimmune diseases and the regulation the severity of the disease.
2. Clarify different expression levels of Notch2 signaling pathway in thymoma complicated with autoimmune diseases, and the effect on Regulatory B Cells(Bregs).
3. Find the effective regulation mode of Notch2 signaling pathway and the regulation of Bregs cell development and function in LncRNA.

Eligibility Criteria:
Inclusion Criteria:

* (1) The patients with the diagnosis of mediastinal tumors (thymoma, thymic hyperplasia);

  (2) The patients with the diagnosis of autoimmune diseases;

  (3) Age of 18 years or older which expected to stay in ICU for≥5 days.

  (4) APACHE II score \> 15;

  (5) The patients or authorized clients agree to participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* (1) the patients with circulatory, respiratory failure and major organ dysfunction after being endangered and transferred to ICU;

  (2) patients with severe liver and renal dysfunction;

  (3) pregnant or lactating women;

  (4) patients who have not signed the informed consent;

  (5) any factors that may be expected to increase the risk of patients or other factors that may interfere with the outcome of clinical trials.
Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury

Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.

The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).

In this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4

Exclusion Criteria:

Inability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days