cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites

The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as:

Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
* Refractory ascites defined as one of the following:

  1. Ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day).
  2. Recurrence can't be prevented by medical therapy, Re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization.

Exclusion Criteria:

* Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
* History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
* History of hypersensitivity to SGLT2 inhibitors.
* History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
* Pregnant or lactating women.
* History of recurrent episodes of hypoglycemia defined as plasma glucose concentration \<70mg/dL.
* Severe renal dysfunction defined as, eGFR \<20 ml/min/1.73m2.
Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation

The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo surgery
* English speaking
* Ability and willingness to complete questionnaires and assessments
* Scheduled for total hip, knee, or shoulder replacement
* Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation.
* Not under the care of a current pain management provider

Exclusion Criteria:

* Any conditions causing inability to complete assessments
* Known pregnancy
* Elevated suicidality
* Enrollment in conflicting perioperative trial
Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy.

METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
* Scheduled for elective laparoscopic total hysterectomy

Exclusion Criteria:

* History of allergy to local anesthetics
* BMI\>30
* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative opioids medication and psychiatric
* preoperative bradycardia
* preoperative atrioventricular block
Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

By enrolling patients with Lung Neoplasms accompanied by Respiratory Function Insufficiency adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Lung Neoplasms Accompanied by Respiratory Function Insufficiency diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
A Prospective Longitudinal Breast Cancer Study

The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.

The study objectives are described below:

1. Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age≥ 18 years
* Histologic/pathologic confirmation of breast cancer
* Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
* Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
* Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
* Able to understand and willing to provide informed consent

Exclusion Criteria:

* Males and females, age \<18 years
* No histologic/pathologic confirmation of breast cancer
* Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
* Treatment plan with fewer than three visits expected in 3 years' time
* Unable to provide informed consent
Reducing Social Avoidance Among Adolescents With Special Educational Needs

The goal of this clinical trial is to examine the effectiveness of a Virtual Reality (VR) social avoidance intervention in reducing social avoidance symptoms among adolescents with special educational needs. Participants will complete tasks in the VR scenario with increasing difficulty and learn that they can cope in situations that they previously avoid. We hypothesize that, comparing with usual care (i.e. waitlist control), the intervention group will experience a significant reduction on social avoidance symptoms after treatment and this benefit will persist till 1-month follow-up.

Over the past 25 years, VR has been used to complement therapist-delivered psychological interventions, primarily exposure therapy for anxiety related disorders. VR renders real-world social interactions simulation, which allows users to experience an anxiety provoking situation with a greater sense of control. In Hong Kong, with the lack of mental health professionals being a perennial problem, VR-based interventions offer the potential to substantially reduce the treatment time and cost, as well as to increase access to evidence-based psychological interventions.

The Virtual Reality (VR) social avoidance intervention used in the current study is designed based on cognitive-behavioral approach with a virtual coach acting as the therapist. It is designed in tandem with input from Hong Kong users to ensure the scenario can resonate with them.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-19
* Can read traditional Chinese and understand Cantonese
* Self-report on experiencing social avoidance symptoms

Exclusion Criteria:

* History of photosensitive epilepsy
* Impairment of stereoscopic vision
* Balance problems
The Effect of Cold Application to the Sacral Area on Labor Comfort:

Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort.

Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks),
* having a single fetus, having a cephalic presentation,
* fetal weight of 2,5- 4 kg,
* pregnant women's having normal body mass index and receiving no antenatal trainings,
* having an 8 cm cervical dilation.

Exclusion Criteria:

* The women who had any kind of pregnancy complications (placenta previa, preeclampsia,
* premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder,
* intrauterine growth retardation, intrauterine dead fetus,
* macrosomia babies, fetal distress, etc.),
* who had any systemic or neurologic diseases
* contraction anomalies (hypotonic or hypertonic contractions),
* who had induced labor,
* who received narcotic analgesics,
* who had occiput posterior,
* who were in the latent and active phases of labor,
* who had irregular contractions were excluded from the study
A Study of MUSE Device for Midlife Women

The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption


Eligibility Criteria:
Inclusion Criteria:

* Women in the menopause transition or in menopause, based on clinical assessment
* PSQI score \> 5, with overall sleep quality rating of "fairly bad" or "very bad".
* Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.
* Access to an iPad, iPhone, or android device.
* Have ability to provide informed consent.

Exclusion Criteria:

* Suspected or confirmed obstructive sleep apnea.
* Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity).
* Use of hormone therapy or hypnotic agents.
* Use of supplements known to affect sleep.
* A known, active, untreated clinically significant psychiatric condition.
* Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
Preventing Knee Injuries in Adolescent Female Football Players

Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.

The investigators' hypotheses are:

1. a preventive training program reduces the incidence of ACL injury, and
2. a high match frequency and match play at senior level increase the risk of ACL injury.


Eligibility Criteria:
Inclusion Criteria:

* Teams with female football players aged 13-17 years

Exclusion Criteria:

* Teams that did not reply to the invitation or declined participation
* Teams having less than two scheduled training sessions per week
* Teams already using the preventive program
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention

The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or parental stress. The intervention "Mindful with your Baby" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the "Mindful with your Baby" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (18+y).
* First antenatal visit \< 12 weeks.
* Score above cut off on the Edinburgh Postnatal Depression Scale (EPDS), the anxiety subscale of the Symptom Checklist (SCL-90) and/or the Parental Stress Questionnaire (PSQ) at 8-10 weeks postpartum.
* Dutch-speaking or understanding Dutch.

Exclusion Criteria:

* Gemelli pregnancy (or higher order pregnancy).
* Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis).
* Severe psychiatric disease (schizophrenia, borderline or bipolar disorder).
* HIV.
* Drug or alcohol addiction problems.
* Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy.
* No access to the internet.
Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing

using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.

Zinc supplementation decrease plasma levels of oxidative stress markers, inflammatory cytokines and IL6. Low Serum zinc level was believed to influence the survival of laryngeal cancer patients and hence,using zinc supplementation would improve survival.Zinc help in increasing wound healing as involve in membrane repair, decreasing oxidative stress , coagulation , suppressing inflammation and modulating .Probiotics stimulates epithelial cells to release interleukin 6 (IL-6) and stimulates dendritic cells and macrophages that help in releasing TNF-α and IFN-γ , development IgA B lymphocytes that cause increase production of IgM, IgG and IgE antibodies.using probiotics preoperative or post-operative offer good chance for decreasing morbidity , infection rates , abuse of antibiotics and complications. zinc and probiotic suppose to provide better wound healing low incidence of infections and fistula after total and partial laryngectomy

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to ENT department will be subjected eligible Adults patients newly diagnosed at outpatient clinic with laryngeal cancer at any stage and will undergo total/partial laryngectomy surgery.

Patients with Level of hemoglobin \&gt;9 mg/dl and serum albumin 3g/dl According to (Crosetti et al. 2021).

Staging of laryngeal cancer according to the American Joint Committee on Cancer (AJCC) 8th edition by TNM system.

Exclusion Criteria:

- 1. Impaired renal function sr.cr≤2.5 (zinc clearance). 2.Previous history of cancer diseases in other sites( previous chemotherapy or radiation).

3.Hypersensitivity to probiotics and zinc.
Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease

It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for CAD. In recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from CAD, but the condition remains a major public health challenge worldwide. Looking into the other potential risk factors (OSA) for CAD, it may help to develop additional preventative strategies and further reduce the incidence and mortality of CAD.

Before initiating the study, all potential subjects were invited to attend an educational program that explained the purpose and methodology of this study. After getting informed consent from patients, demographic data including age, sex, medical history (including comorbidities and risk factors), current medicine, lifestyle habits, height (cm), and weight (kg) were recorded, and body mass index (BMI) was calculated as weight divided by height squared (kilograms per square meter, kg/m2). The included subjects need to perform transthoracic echocardiography or provide an echocardiographic examination within one month. CAD diagnosis was determined based on the results of the coronary angiography, using stenosis 50% cutoffs considered have coronary diseases or not.

Consecutive patients of both sexes with coronary angiography from outpatient or inpatient departments of Fuwai Hospital were recruited into the study. The inclusion criteria were Chinese, aged 35 to 75 years with CAD verified by coronary angiography, and able to give informed written consent. The subjects were excluded if they had New York Heart Association Class III-IV degree with ejection fraction \< 45%, severe pulmonary disease, significant psychiatric disease, or history of pharyngeal surgery for OSA or current use of CPAP treatment for OSA. They were also excluded if they declined to participate or were unable to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* aged 35 to 75 years with CAD
* CAD was verified by coronary angiography

Exclusion Criteria:

* Patients had New York Heart Association Class III-IV degree with ejection fraction \< 45%
* Severe pulmonary disease
* Significant psychiatric disease
* History of pharyngeal surgery for OSA or current use of CPAP treatment for OSA
* Subjects declined to participate or were unable to provide informed consent.
Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan

Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can be performed non-invasively, quickly and effectively. The investigators aim to study the use of Sudoscan in rare disease condition associated with small fiber polyneuropathy.

Small fiber polyneuropathy (SFPN) is diagnosed through a combination of symptoms, signs and confirmatory diagnostic testing. Nerve conduction studies are not sensitive enough in most of the cases leaving the ankle skin biopsy with measurement of intraepidermal nerve fiber density (IENFD) as the main diagnostic tool. Despite its utility and reproducibility, skin biopsy is invasive, expensive and requires a central laboratory for processing and interpretation. Quantitative sudomotor axon reflex testing (QSART) is also routinely used for evaluation of small fiber neuropathy as sudomotor axons can also be involved. This test however remains technically challenging and requires testing conditions in specialized labs that are not always suitable for all patients' population. By comparing findings on skin biopsy and/or QSRT, accepted gold standard for diagnosing SFPN, the investigators seek to find faster, less-invasive ways to diagnose and monitor small-fiber polyneuropathy in rare diseases using Sudoscan measurement.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with confirmed disease: Fabry (by GLA enzymes and/or DNA testing) naïve and on ERT, Mitochondrial diseases (electron transport chain and/or DNA testing) or connective tissue diseases (clinical criteria and/or DNA testing when available)
* Consenting adults (18 years and older) who agrees and consents to skin biopsy and QSART procedure

Exclusion Criteria:

* Subjects with cognitive, psychiatric, or other problems that preclude informed consent.
* Patients with history of glucose intolerance or diabetes.
* Patient on chemotherapy
* People with any open or bleeding wounds at any sensor plate contact surface location
* People with any type of implantable device
* People with missing hand(s) and/or leg(s)
* Pregnant women or women who are uncertain about a possible pregnancy
* Patients sensitive to chemicals used to induce sweating
* Patients with heat intolerance
* Patients with bleeding disorders
* Patients on current anticoagulant therapy
* Patients with keloids on the intended biopsy site
* People with hypersensitivity to local amide-type anesthetics