cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (\<100 mg/dL) and non-HDL-C (\<130 mg/dL).

The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female between the ages of 20-75 years.
2. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
3. Diagnosed with type 2 diabetes mellitus.
4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
6. All patients give written informed consent.

Exclusion Criteria:

1. A history of hypersensitivity to statins.
2. A history of rhabdomyolysis or hereditary muscle disorders.
3. Insulin-treated patients.
4. Patient with any conditions of acute or chronic pancreatitis.
5. Creatine kinase ≧3-fold upper limit of normal (ULN).
6. Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).
7. Overt proteinuria (repeat spot urine protein \>300mg/dl by dipstick method).
8. Patients are taking cyclosporine.
9. A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.
10. Patients with alcohol and drug abuse in past 3 years.
11. Serious or unstable medical or psychological conditions.
12. Hypothyroidism (TSH \> 5 μIU/mL).
13. In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.
Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder

The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women diagnosed with Genito-Pelvic Pain Penetration (GPPD) Disorder.

The main questions it aims to answer are:

Does a GMI programme reduce pain intensity levels in women diagnosed with GPPPD? Does a GMI programme have an effect on sexual function in women diagnosed with GPPPD?

Participants will undergo a GMI programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome

Graded Motor Imagery has been extensively used in several populations suffering pain-related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain

Women suffering from Genito-Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated.

The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity and improve sexual function in women diagnosed with Genito-Pelvic Pain Penetration Disorder.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with persistent pelvic pain
* Pain suffered for a period of a minimum of 3 months
* Adult (\>18 years) women

Exclusion Criteria:

* Medical condition that logically explains the presence of pain
* Pain suffered for a period of less than 3 months
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.

Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.

Eligibility Criteria:
Inclusion Criteria:

* Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
* 1 to 5 lesions
* Signed informed consent

Exclusion Criteria:

* Facial lesions
* Significant co-morbidity
* Pregnancy or breast-feeding at enrollment
* Previous treatment for leishmaniasis
Wellness Enhancing Physical Activity for Young Children

Wellness Enhancing Physical Activity for Young Children (WE PLAY) is a teacher training that is based online and was designed to support early childhood educators' efforts to promote physical activity (PA) through structured and unstructured active play with preschoolers. WE PLAY includes six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs that are designed to work synergistically. The purpose of this study was to examine the impact of WE PLAY on children's levels of moderate to vigorous physical activity (MVPA) during school hours. We hypothesized that children whose teachers received WE PLAY would have higher levels of MVPA during school hours at post-intervention relative to pre-intervention and relative to children whose teachers did not receive WE PLAY. A second purpose was to examine the impact of WE PLAY on teacher outcomes (i.e., knowledge, intentions, perceived behavior control, subjective norms, perceived power beliefs, normative beliefs, and moral norms). We hypothesized that teachers who participated in WE PLAY would demonstrate higher scores on each of these variables at post-intervention relative to pre-intervention and to teachers in the control group. A cluster randomized controlled trial was used in this study. Six Head Start preschools were pair matched and randomized to the intervention (WE PLAY) or control groups. Preschool children (N=57) and their teachers (N=25) participated. Child MVPA was measured using accelerometers for 5-day periods at pre- and post-intervention. Teacher variables were measured using online surveys.


Eligibility Criteria:
Inclusion Criteria:

* All teachers at the participating programs, and all children within the participating teachers' classrooms, were eligible to participate in this study.

Exclusion Criteria:

* There were no exclusion criteria based on gender, race/ethnicity, language spoken at home, socio-economic level, or any other demographic variable.
Assessment of Sleep Quality in Cannabinoid Therapy

The current study aims to assess the impact of starting cannabinoid therapy on sleep quality for individuals with sleep disturbance.

After the initial signing of the consent form, they will complete a battery of baseline questionnaires online on sleep, including the Sleep Regularity Questionnaire, Epworth Sleepiness Scale, Insomnia Severity Index, and the Depression, Anxiety, Stress Scale (DASS-21). That night, before beginning active treatment, participants will be monitored using Cerebra's Level 2 plus ECG system (the Prodigy).

After 6 weeks of active treatment, participants will again complete a night of Level 2 plus ECG recording using the Prodigy, evening, and morning questionnaires, and will repeat baseline sleep questionnaires.

Eligibility Criteria:
Inclusion Criteria

1. A Pittsburgh Sleep Quality Index score \>5
2. Between the ages of 40-65
3. No current recreational or medical cannabis use within 4 weeks of the study initiation OR positive urine drug screen (UDS) for Tetrahydrocannabinol
4. No use of anti-psychotics, tricyclic antidepressants, or prescription stimulants
5. No use of medications for promoting sleep (e.g., anti-histamines, benzodiazepines, melatonin).
6. Low risk of Obstructive Sleep Apnea (Low Risk on Berlin Questionnaire), or no presence of moderate or severe Obstructive Sleep Apnea on baseline polysomnography (AHI \<15).
7. Has been prescribed THC:CBD combination therapy
Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy

The primary aim of this prospective, randomized study is to evaluate the effect of erector spinae block (ESP) on quality of recovery with the QoR-40 questionnaire in patients undergoing elective laparoscopic cholecystectomy.

Laparoscopic cholecystectomy, one of the most common general surgical procedures, is the gold standard for the treatment of symptomatic gallbladder diseases. Although it is considered as minimally invasive surgery, pain in the early postoperative period is still meaningful. Proper pain control is essential for optimizing clinical outcomes and earlier ambulation after surgery. Traditional pain management with opioids provide good pain control, however, have undesirable side effects such as nausea, vomiting, and respiratory depression. Multimodal analgesia strategies with different classes of analgesics or local anesthetics may enhance pain relief and reduce side effects after surgery. The ESP a newer regional nerve blockade, has been used as part of a multimodal strategy to optimize postoperative pain control. The primary aim of this study is to evaluate the effect of ESP block on postoperative recovery quality in patients undergoing laparoscopic cholecystectomy with QoR-40 recovery questionnaire. Secondary aim is to assess the effect of ESP block on postoperative pain, nausea, and vomiting.

Study hypothesize is that patients who receive an ESP block in addition to the current standard of care, consisting of parenteral opioids and paracetamol, will have a clinically significant improvement in their QoR-40 at postoperative day 1 and lower pain levels, as measured by NRS in comparison to those patients who receive the current standard of care along.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status I-II
* Scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

* a history of allergy to local anesthetics
* known coagulation disorders
* infection near the puncture site
* Chronic opioid intake
* Patient with psychiatric disorders
* inability to communicate
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.


Eligibility Criteria:
Inclusion Criteria:

* A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Exclusion Criteria:

* A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
* A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) before local radiotherapy 8 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.


Eligibility Criteria:
Inclusion Criteria:

1. Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
2. Aged ≥18 years and \<80 years；
3. ECOG 0-1;
4. Live-GTV volume \> 700ml;
5. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
6. Estimated life expectancy should be more than 3 months;
7. Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months;
8. Child-Pugh Score A5,A6,B7;
9. Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal;
10. ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
11. Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
12. Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
13. Coagulation function: no bleeding tendency;
14. Informed and voluntarily participated in the study and signed informed consent.

Exclusion Criteria:

1. Currently in the process of other clinical trials within recently four weeks;
2. Previous abdominal radiotherapy and liver transplantation;
3. Patients with severe chronic diseases of heart, kidney, liver and other important organs;
4. Pregnant or lactating women;
5. Suspected or indeed drug abusers, drug abusers and alcoholics;
6. Allergic to lenvatinib or other treatments.
7. Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
Arterial Inflammation and E-Cigarettes

Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.

Qualified participants will undergo a singe PET/CT to detect arterial inflammation.

Eligibility Criteria:
Inclusion Criteria:

Healthy

* Nonsmokers OR
* Daily e-cigarette user OR
* Daily tobacco cigarette smoker

Exclusion Criteria:

* Cardiac disease
* Respiratory Disease
* Diabetes mellitus
Thoracic Fluid Content in Prediction of Failure of Weaning From Mechanical Ventilation

This study aims to test the accuracy of the total thoracic fluid content (TFC) measured by cardiometry can predict weaning failure. Area under receiver operating characteristic curve (AUROC) will be determined, sensitivity, specificity, and best cutoff value will be calculated for TFC in prediction of weaning failure.

Weaning from mechanical ventilation is a serious and challenging process in critical care practice. Weaning failure is associated with poor patient outcomes. Increased mortality in patients with failed weaning was due to development of complications related to re-intubation. Detection and correction of the cause of failed spontaneous breathing trial (SBT) helps the intensives to improve the outcome of the next trials.

Fluid overload and positive cumulative fluid balance is a risk factor of weaning failure in both cardiac and non-cardiac patients.

Many tools for prediction of lung congestion as a risk factor for weaning failure have been reported. The gold standard for detection of cardiac cause of weaning failure was pulmonary artery catheter. More simple tools had been investigated for detection of cardiac cause of weaning failure in patients with or without previous cardiac dysfunction such as extravascular lung water and B-natriuretic peptide (BNP) levels.

Although measurement of extravascular lung water is a reliable tool for prediction of cardiac cause of weaning failure, it has the disadvantage of the need of advanced monitor with invasive arterial line. Bioreactance is a new technology used for measurement of cardiac output and total thoracic fluid content (TFC). More recently, electrical velocimetry is a newer technology with good performance in cardiac output monitoring. The use of electrical velocimetry in measurement of TFC has the advantage of being non-invasive with no need for advanced skills. The aim of this work is to validate the use of TFC (measured by electrical velocimetry) in prediction of weaning outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) on pressure support ventilation.

Exclusion Criteria:

* Age \< 18 years old.
* Pregnant patients.
* Neuromuscular disease (stroke, myasthenia gravis and Guillain-Barrésyndrome).
* Tracheostomy.
Metabolic Derangements in Acute Heart Failure Syndrome

To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age \> 18 yrs) patients admitted to the Heart Failure Intensive Care Unit (H22) with Acute Heart Failure Syndrome (AHFS) requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy.

Exclusion Criteria:

* History of Congenital Heart Disease.
* Acute HF in the setting of acute myocardial infarction.
* Severe Anemia
* Patients listed for cardiac transplantation.
* Terminal Malignancy, AIDS or CNS disease.
* Concomitant sepsis, ARDS, trauma, aortic dissection, or pericardial tamponade
Application of Large Language Models in Emergency Neurology

Emergency neurology covers a wide range of conditions, often involving urgent situations such as acute cerebrovascular diseases, seizures, central nervous system infections, and consciousness disorders. However, due to the time constraints in emergency care and limited patient information collection, misdiagnosis and missed diagnoses are common issues. Large language models (LLMs) possess powerful natural language processing and knowledge reasoning capabilities, enabling them to directly handle and understand complex, unstructured medical data such as patient medical records, dialogue notes, and laboratory test results. LLMs show broad potential for application in complex medical scenarios. This study aims to evaluate the application value of LLMs in emergency neurology, specifically examining their diagnostic accuracy in emergency neurology conditions, analyzing the feasibility of treatment plans and further examination recommendations proposed by the model, and exploring their potential in improving diagnostic efficiency and aiding decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18-80 years, male or female.
* Patients seeking emergency neurology care.
* Patients who can provide complete medical records (including consultation recordings, physical examination, test results, etc.).
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Patients who directly enter the resuscitation process due to the severity of their condition(e.g., patients who are immediately placed in the ICU).
* Patients with unstable vital signs.
* Patients who are unable to communicate effectively (e.g., severe consciousness impairment or severe cognitive disorders).
* Patients who are currently participating in other clinical trials.
Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus

Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up.

The purpose of this research study is to understand the long-term effects of COVID-19 infection on individuals without any prior history of diabetes. This study will look at several measures of diabetes, such as glycemic control (blood glucose/sugar levels), function of beta cells (cells that make insulin to control sugar), insulin secretion and insulin sensitivity (fasting insulin levels).

The following participants will be enrolled: 1) have had COVID-19 infection and were hospitalized and recovered, or 2) have had mild COVID-19 infection and were seen at outpatient clinics or ER and were not required to be hospitalized, or 3) have not had COVID-19 infection but were seen in outpatient clinics or ER during the same time period.

The researchers hope to learn the long-term effects of COVID-19 infection in hospitalized patients. Specifically, they will be focusing on the subsequent development of diabetes and associated metabolic disturbances, such as impaired insulin secretion and insulin resistance. A relationship between COVID-19 and diabetes needs to be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass index (BMI) \< 40 kg/m2

Exclusion Criteria:

* History of diabetes prior to SARS-CoV-2 infection
* Took medications used to treat diabetes prior to SARS-CoV-2 infection
* History of myocardial infarction or stroke within 6 months
* History of major organ system disease prior to COVID-19 infection
Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients

RATIONALE: Understanding the emotional needs of spouses or others who are living with and caring for patients who have undergone stem cell transplantation may help improve the quality of life of both the caregivers and the patients.

PURPOSE: This clinical trial is studying the emotional needs of caregivers of patients who have undergone stem cell transplant.

OBJECTIVES:

* Assess expression of emotion, as a function of patient presence, among spousal or other cohabiting caregivers (CG) of post-hematopoietic stem cell transplantation patients.
* Assess desynchrony among subjective (self-report) and expressive indicators of emotion, as a function of patient presence, in these participants.
* Correlate CG dispositional inhibition and desynchrony with physical and marital satisfaction in these participants.

OUTLINE: Caregivers (CG) complete written questionnaires assessing demographics, positive and negative affect, dispositional inhibition, marital satisfaction, and physical health over 45 minutes to 1 hour on day 1. CG then engage in two oral emotional expression exercises (on the topic of caregiving and the transplant) over 2 hours on day 2. Patients are present for one oral emotional expression exercise.

Participants are followed at 2 weeks and 6 months.

PROJECTED ACCRUAL: A total of 60 patient/spouse couples will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* In a marriage OR long-term, committed, heterosexual or homosexual, cohabiting relationship in which one member is post-hematopoietic stem cell transplantation

  * Patients must meet the following criteria:

    * At least 1 year since prior first bone marrow, stem cell, or umbilical cord blood transplantation

      * Allogeneic or autologous
    * Diagnosis of malignancy, myelodysplasia, or non-malignancy
    * No indication of possible or confirmed relapse
  * Spouse/caregiver (CG) must meet the following criteria:

    * Serve as the primary CG to the patient
    * No prior or concurrent neurologic disorder

PATIENT CHARACTERISTICS:

Age

* 21 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No concurrent major psychiatric disorder
* English-speaking

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified