cyrilzakka/clinical-trials huggingface dataset:
Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)

Key Points:

1. Objective:

   o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries.
2. Methodology:

   * A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.
   * Respiratory and hemodynamic parameters were measured at various time points.
3. Results:

   * No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.
   * Both anesthesia techniques maintained stable intraoperative conditions.
4. Clinical Implications:

   * Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.
   * TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.
5. Future Research:

   * Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.
   * Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.

This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.

Eligibility Criteria:
Inclusion Criteria:

* The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.

Exclusion Criteria:

* Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)
* Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%
* Atrioventricular blocks of second and third degrees
* Allergies to any drugs
* Severe neurological disorders
* History of sedative or opioid use
Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder that causes an inversion of the normal luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio. Females with PCOS also experience chronic inflammation. This hormonal imbalance and persistent inflammation can reduce muscle strength and mass. Consequently, this may affect the lumbopelvic muscles, potentially leading to postural abnormalities and spinopelvic misalignment.

1.1. Study design This was an observational case-control study. Participants This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches.

Exclusion Criteria:

* were excluded from this study if they were obese with BMI \> 30 Kg/m2 (obesity induces an increase in anterior pelvic tilt and increased sacral inclination) (15), suffered from musculoskeletal deformities, previous gynecological and spinal surgeries, spinal deformities, leg length discrepancy, orthopedic and neurological disorders, receive hormone replacement therapy (affect functional biomechanical properties by increasing tensile stiffness in the uterosacral ligament and decreasing it in the round ligament)
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes

The intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.

Intracavernous transplantation of stem cells has been shown to improve erectile function in some preclinical studies. However, inadequate cell homing to damaged sites limited its functions. The investigators explore the effect of HUCMSC on improving erectile function of diabetic men, and whether collagen scaffolds contribute to long-term cell retention in the corpus cavernous and improves erectile function of diabetic men.

Eligibility Criteria:
Inclusion Criteria:

1. type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i;
2. have a consistent partner who is willing to engage in sexual activity more than twice per month during the study;
3. males age 20-65 years;
4. IIEF-5 score is under 16;
5. penile arterial insufficiency or venous leakage (doppler): PSV \<25 cm/sec, or PSV \>25 cm/sec, EDV\>5cm/sec, RI\<0, 75;
6. HbA1c is between 6.5% 10%;
7. physical examination with no abnormalities;
8. who is willing to consent to participate in the study follow-up;
9. willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.

Exclusion Criteria:

1. severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy;
2. positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test;
3. Testosterone level is less than 200ng/dl;
4. serum AST/ALT \>3\*upper limit of normal or creatinine \>1.5\*upper limit of normal;
5. HbA1c exhibit greater than 10%;
6. in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery;
7. patients partner is trying to conceive during the trial period;
8. exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study;
9. unwilling and/or not able to give written informed consent.
Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section

Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged.

In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.

A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with American Society of Anesthesiologist (ASA) 2-3
* scheduled for elective cesarean section.

Exclusion Criteria:

* refuse to participate in the study,
* requiring emergency obstetric care,
* ASA IV or V,
* having systemic diseases,
* a known fetal anomaly,
* placenta previa,
* abruption placenta
* with a history of hypersensitivity or allergy to any of the study drugs,
* operation time longer than 1.5 hour,
* blood loss more than 1500 millilitres,
* those with any contraindication to the technique proposed,
Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy

The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.

* The European Society for Clinical Nutrition and Metabolism has pointed out that under-nutrition can led to change in body composition (e.g. depletion of body fat mass) and diminished function and outcome.
* The prevalence of under-nutrition in children with CP varies from 3.9 per cent to 71 percent mainly depending on the method of assessment, the severity of motor involvement and feeding problems.
* Studies indicate that children and adults with both mild and severe forms of CP have postural impairments. Dysfunctional posture control interferes with the activities of daily life .
* Children with CP may have impaired muscle tone and abnormal postural control, both of which affect functional balance capacity.
* There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.

There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.

Knowledge of anthropometric measurements and whether they affect balance in children with CP will help clinicians to develop treatment programs which in turn will improve the overall balance and functional abilities of children with CP.

* Childeren age will be ranged from 8-12 years and on level Ⅰ and Ⅱ on Growth Motor Function Classification System
* Weight would be obtained on a digital scale (UNISCALE )
* Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece.
* CDC 2000 charts will be used to measure BMI
* The Biodex balance system will be used for the assessment of static and dynamic balance of all children

Eligibility Criteria:
Inclusion Criteria:

1. Their age will be ranged from 8 to 12 years.
2. The degree of their spasticity will be ranged from 1 to 2 according to Modified Ashworth' Scale.
3. They will be on level Ⅰ and Ⅱ on Growth Motor Function Classification System (GMFCS).
4. They will be able to stand without the use of an assistive device
5. Children can follow instructions and understand given orders.

Exclusion Criteria:

1. Severe visual or hearing impairment.
2. Fixed deformities or surgical interventions in the lower extremities.
3. Botulinum toxin injections in the last 6 months.
Cardiac Rehabilitation Needs Among Individuals with Atrial Fibrillation

The goal of this survey- and registry-based study is to learn about the cardiac rehabilitation needs of individuals with atrial fibrillation (AF). The main objectives of the study is to:

1. Investigate cardiac rehabilitation needs among eligible individuals with AF in a large AF population
2. Estimate how many needs referral to primary care programs, according to a needs assessment model.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults globally. It poses significant public health challenges and is associated with substantial morbidity and mortality. AF affects quality of life with an enlarged symptom burden. To improve life expectancy and quality of life, medical treatment along with risk factor management and cardiac rehabilitation is needed. In many countries, referral to cardiac rehabilitation remains low. Furthermore, no guidelines or evidence provides details on whom should be referred. Thus, we do not know how many individuals with AF presents with cardiac rehabilitation needs.

This study is a survey and registry-based study. Danish health registries are used to draw a population of individuals with incident AF in 2023-2024. Following the exclusion criteria, these will receive a survey covering the described outcomes which are used to investigate needs of rehabilitation. A statistical predicitive analysis will be performed to estimate how many needs referral to cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with recidence in Denmark, 18 years of age or above, with a CPR number (personal identification number) registered with a diagnosis of incident AF in 2022 or 2023 (ICD-10: DI480\*).

Exclusion Criteria:

* Death.
* Name- and address protection.
* Exemtion from using digital post.
* Living in a nursing home.
* A diagnosis of dementia.
* Hospital admission or ambulant contacts due to mental illness within one year before diagnosis (except depression or anxiety).
* Individuals receiving palliative care or treatment.
Obstructive Apnea in Patients Submitted to Partial Laryngectomy

The investigators intend to study the prevalence of obstructive apnea in patients submitted to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy. We will try to correlate the residual glotic area with the number of apneas per hour.

We are trying to avaliate the residual glotic area using spirometry e laryngoscopy

Eligibility Criteria:
Inclusion Criteria:

* PARTIAL LARINGECTOMY, OVER 18 YEARS,

Exclusion Criteria:

* TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE
Taiwan Registry for Leadless Pacemaker

Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.

Eligibility Criteria:
Inclusion Criteria:

1. The patients who had successfully received leadless pacemaker implantation
2. The patients who attempt to receive leadless pacemaker implantation

Exclusion Criteria:

N/A
HHV8 and Solid Organ Transplantation

Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation.

In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.

Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8.

As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed.

AFTER SOLID ORGAN TRANSPLANTATION

* Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant.
* In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation).
* With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).

Eligibility Criteria:
SOT DONORS:

Inclusion Criteria:

* all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation

Exclusion Criteria:

* None

SOT CANDIDATES RECIPIENTS:

Inclusion Criteria:

* All patients listed for solid organ transplantation (lung, liver and kidney)

Exclusion Criteria:

* None
Perillyl Alcohol in Treating Patients With Refractory Cancer

Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per day in patients with refractory malignancies.

II. Describe the toxic effects and pharmacokinetics associated with this regimen.

III. Evaluate any antitumor activity of perillyl alcohol in these patients. IV. Assess the ability of perillyl alcohol to induce tumor differentiation and reduce telomerase activity in patients from whom serial biopsies can be obtained.

OUTLINE: This is a dose escalation study to determine the maximum tolerated dose of perillyl alcohol.

Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day until the maximum tolerated dose or recommended phase II dose is determined. Treatment at the assigned dose continues until disease progression or unacceptable toxicity intervenes. Patients with stable disease after 8 weeks of treatment are removed from study.

Patients are followed for duration of response and survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed solid malignancy or lymphoma for which no effective therapy exists
* Measurable or evaluable disease
* No CNS metastasis unless stable for at least 4 weeks following surgery and/or radiotherapy and no requirement for anticonvulsants

PATIENT CHARACTERISTICS:

* Age: Over 18
* Performance status: ECOG 0-2
* Life expectancy: At least 3 months
* ANC at least 1,500
* Platelets at least 100,000
* Bilirubin no greater than 2.0 mg/dL
* AST less than 2.5 times normal
* Creatinine clearance at least 50 mL/min
* No concurrent cholesterol-lowering agents
* No active infection (including HIV)
* No concomitant medical condition that precludes study compliance
* No pregnant or nursing women
* Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin)
* At least 4 weeks since wide-field radiotherapy
* Fully recovered from prior surgery
Time Limited Eating in Type 1 Diabetes

This study is a randomized-control pilot study that aims to evaluate Time Limited Eating (TLE) in the pediatric T1D population, implemented within the first six months after diagnosis. This period is characterized by residual β-cell function, during which TLE may have the ability to preserve and improve β-cell activity, indicated by increased C-peptide production. The investigators aim to assess the feasibility, acceptability, and safety of TLE in the pediatric T1D population, as well as to investigate the impact of TLE on β-cell function, insulin sensitivity, and glycemic control.

This will be a two-armed study with an intervention and control group. Feasibility and acceptability will be assessed by using questionnaires. Safety will be indicated by hypoglycemia occurrence. β-cell function and insulin sensitivity will be evaluated using mixed meal tolerance test with C-peptide and glucose levels. Glycemic control will be indicated by continuous glucose monitor (CGM). Block randomization will be utilized to ensure the groups are balanced in terms of BMI. The study period will be 9 weeks in duration, including a week-long run-in period and an 8-week intervention period. There will be two in-person study visits at week 0 and week 9. Anthropometrics including weight, height, and pubertal status will be evaluated at these times.

Group 1- Standard Care (control)

* includes a minimum 12-hour feeding window for 7 days per week
* no caloric restriction will be used
* will wear a continuous glucose monitor

Group 2 - TLE (intervention)

* includes an 8-hour feed/16-hour fast for 7 days per week
* will be instructed to consume all of their calories in the afternoon/evening period
* can consume non-caloric beverages (water, tea, coffee) during the fasting period
* will wear a continuous glucose monitor
* no caloric restriction will be used

Eligibility Criteria:
Inclusion Criteria:

* includes age of 12-25 years
* T1D diagnosed within 6 months
* at least one positive pancreatic antibody including glutamic acid decarboxylase (GAD) antibody, islet tyrosine phosphatase 2 (IA2) antibody, or insulin antibody
* can be on either insulin injections or insulin pump
* can be of any BMI status
* can speak any language

Exclusion Criteria:

* negative pancreatic antibodies
* unwillingness to wear a CGM
Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families

It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families.

It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families. This will be a pilot RCT using a two-group pre- and post-test within-subject design. The investigators plan to recruit 40 children in the Kwai Tsing District to participate in this study via the Asbury Methodist Social Service. Participants in the intervention group will be invited to join the mountain craft training programme. The research team will work with Mountain \& Stream (https://www.mtandstream.com/) to offer a tailor-made hiking training programme for Form 1 students. Participants will be invited to join a control intervention that mimics the time and attention received by participants in the intervention group but will be designed to have no specific effect on the outcome variables. The investigators hypothesise that participants who receive mountain craft training (six sessions) over 3 months will report significant improvements in: (i) resilience, (ii) self-esteem; (iii) depressive symptoms, and (iv) physical well-being compared with those in the placebo control group at the 6-month follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Form 1 students
* able to speak Cantonese and read Chinese, and
* from low-income families (with a half-median monthly household income or the recipients of Comprehensive Social Security Assistance)

Exclusion Criteria:

* Children with identified cognitive or learning problems, chronic illness, or physical disabilities