cyrilzakka/clinical-trials huggingface dataset:
Effect of Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery

This study investigates whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section, and explores its possible mechanisms of action through an exploratory study.

Post-cesarean section pain, if improperly managed, may affect the prognosis of the mother and the health of the infant. There is an urgent need to explore safer, more effective, and more direct non-pharmacological, non-invasive adjunctive interventions to alleviate the pain associated with cesarean section. Non-invasive transcutaneous auricular vagus nerve stimulation is a green neuromodulatory measure that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. This study aims to investigate whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section and to explore the possible mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.
2. Scheduled for elective cesarean delivery under spinal anesthesia.
3. Patients are aged between 19 to 45 years old.
4. Patients have provided written informed consent.

Exclusion Criteria:

1. Local skin infection occurs in the auricular area during transcutaneous auricular vagus nerve stimulation.
2. Cases where spinal anesthesia fails and general anesthesia is required.
3. Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.
4. Patients who have used opioid medications at least 6 months prior to surgery.
5. Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.
6. Patients with a history of psychiatric illness.
Propofol Versus Sevoflurane on Acute Postoperative Pain

This study was performed to compare the acute postoperative pain intensity and opioid consumption after total shoulder arthroplasty between propofol-remifentanil and sevoflurane-remifentanil anesthesia.

After approval of the Institutional Review Board and written informed consent, 48 patients, aged 18-65 years for shoulder arthroplasty were enrolled in this prospective, randomized, double-blinded study.

Patients were assigned to one of two groups : group PR, the propofol-remifentanil group; and group SR, the sevoflurane-remifentanil group.

In the group PR, anesthetic induction was achieved with an initial target concentration of propofol 4 ㎍/mL and remifentanil 3-4 ng/mL using target controlled infusion (TCI) devices and rocuronium 0.8 mg/kg. After intubation, anesthesia was maintained with fixed target concentration of propofol 2-4 ㎍/mL and remifentanil 2-3 ng/mL to keep acceptable hemodynamic response and bispectral index (BIS) values 40-60.

In the group SR, anesthetic induction was achieved with thiopental 5 mg/kg and initial target concentration of remifentanil 3-4 ng/mL using TCI and rocuronium 0.8 mg/kg. Anesthesia was maintained with 1.5-2.5% end-tidal concentration sevoflurane in 50% oxygen with air and remifentanil 2-3 ng/mL was continuously infused adjusting to maintain an acceptable hemodynamics and BIS values 40-60.

The administration of propofol or sevoflurane with remifentanil was stopped at the surgery ended.

Postoperative pain intensity was assessed using a numerical rating scale (NRS: 0; no pain, 10; worst pain) at the 30 min, 2, 6, 12, 24 h. Also, the patient-controlled analgesia (PCA) was infused immediately after post anesthetic care unit arrival. The PCA device was set to deliver 0.38 ㎍/kg/h of fentanyl as a basal infusion rate and 20 ㎍ on demand with a 15 min lockout time. The total PCA volume, number of patients to need rescue analgesics was recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I or II and aged 18-65 years for total shoulder arthroplasty

Exclusion Criteria:

* Use of routinely using analgesics, history of neurologic or psychologic disease, body mass index more than 35 kg/m2, and intake of any sedatives or analgesics within 24 h before surgery
Β-Thalassemia Treatment with KL003 Cell Injection

This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major.

This is a single-arm, multi-site, single-dose, Phase 1/2 study to assess KL003 Cell Injection in up to 41 participants with transfusion-dependent β-thalassemia (TDT) who are ≥3 and ≤35 years of age. KL003 Cell Injection is autologous CD34+ stem cells transduced Ex Vivo with a lentiviral Vector encoding βA-T87Q-Globin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age between 3-35 years;
* Diagnosis of transfusion-dependent β-thalassemia and a history of at least 100 mL/kg/year of pRBCs or ≥8 transfusions of pRBCs per year for the prior 2 years;
* Karnofsky performance status ≥70 for participants≥16 years of age; Lansky performance status of ≥70 for participants\<16 years of age;
* Eligible to undergo auto-HSCT;
* Willing and able to follow the research procedures and conditions, with good compliance;
* Willing to receive at least the 2 years follow-up;
* Participant and/or legal guardians voluntarily participated in this clinical trial and signed the informed consent form.

Exclusion Criteria:

* Diagnosis of composite α thalassemia;
* Prior receipt of gene therapy or allo-HSCT;
* Meet the criteria for allo-HSCT and with an identified willing donor with full HLA match;
* Participants with severe iron overload at the time of screening;
* Presence of unusual antibody of red blood cell antigens or tested positive for platelet antibody;
* Known allergy to clinical trial drug (plerixafor or G-CSF or busulfan) or ingredient(DMSO etc.);
* Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the clinical investigator;
* Subjects positive with the following etiological tests: human immunodeficiency virus(HIV-1-2),human cytomegalovirus (HCMV-DNA),EB virus（EBV-DNA）,HBV (HBsAg/HBV-DNA positive),HCV antibody (HCV-Ab), Human T-lymphotropic virus antibody (HTLV-Ab), Treponema pallidum antibody (TP-Ab);
* Uncorrectable coagulation dysfunction or history of severe bleeding disorder;
* History of major organ damage including:

  1. Liver function test suggest AST or ALT levels \>3× upper limit of normal（ULN）;
  2. Total serum bilirubin value\>2.5×ULN;if combined with Gilbert syndrome, total bilirubin\>3×ULN and direct bilirubin value\>2.5×ULN;
  3. Left ventricular ejection fraction \<45%;
  4. Baseline calculated eGFR\<60mL/min/1.73m2;
  5. Pulmonary function:FEV1/FVC\<60% and/or diffusion capacity of carbon monoxide (DLco) \<60% of prediction;
Pre-Clinical White Matter Changes and Associated Connectivity Effects in Fabry Disease

The purpose of this research project is:

* to use an advanced quantitative MRI technique (FBFI) to detect and quantify brain lesion in patients with FD
* to use fMRI to identify altered brain function
* to use FBFI and fMRI together to map altered connectivity in response to brain lesions

Fabry disease (FD) is a lysosomal storage disease caused by a deficiency in an enzyme that degrades components of the outer cell wall. A deficiency of this enzyme in humans has been associated with stroke. In males with FD, 6.9% have a stroke by 39 years of age. In females with FD, 4.3% have a stroke by 46 years of age.

Magnetic resonance imaging (MRI) is the main tool for studying stroke in FD. Importantly, MRI has identified other types of lesions in the brain beyond that caused by stroke. These additional lesions may herald stroke or be a different manifestation of FD in the brain. These lesions are seen in \>50% of men and women with FD.

Diffusion-based imaging MRI has been the leading approach for studying these lesions in FD. However, these lesions that appear to be specific to FD are difficult to quantify, analyze, and interpret using this and other current MRI methods. The Investigators would like to use a form of MRI called fast bound-pool fraction imaging (FBFI), which is a technique better suited to capture and quantify these lesions, to study these lesions in patients with FD. In parallel, the investigators would like to use functional MRI (fMRI) to study how these lesions alter brain function and connectivity in FD. The combination of these techniques (FBFI + fMRI) will also provide us the opportunity to study brain plasticity in response to injury as Fabry disease is slowly progressive over decades allowing the brain to remodel connections to maintain function.

Eligibility Criteria:
Fabry Cohort

Inclusion Criteria:

* Have Fabry Disease
* Must be 18yrs or older

Exclusion Criteria:

* Subjects who are claustrophobic
* have metal implants
* Cannot pass the MRI safety screening questionnaire.

Unaffected Controls

Inclusion Criteria:

* Must be 18yrs or older
* unaffected with Fabry Disease
* considered healthy with no previous history of stroke, multiple sclerosis, diabetes mellitus, or other neurologic disease.

Exclusion Criteria:

* Subjects who are claustrophobic
* have metal implants
* Cannot pass the MRI safety screening questionnaire.
Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction

The instigators hypothesize that IVIG, given in the acute phase following MI in patients at risk for developing HF, will improve cardiac performance, and by attenuating cardiac remodeling in this phase, such therapy will prevent the development of chronic HF resulting in long term beneficial effect also after the therapy has been stopped.

This double-blind placebo-controlled study represents a new approach to cardiovascular disease. The project deals with unresolved issues in the intersection between cardiology, immunology and molecular biology.

IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline, and 6 and 12 months with MRI and echocardiography.

The objectives are:

1. The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI) which offers an unsurpassed precision in the measurements of heart volumes and function. End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall motion score index (WMSI), and LV-ejection fraction (LV-EF).
2. The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20.
3. The tertiary objective of this study is to evaluate the effect on IVIG on:

   a. Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c. Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6, IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv. Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors (i.e., TIMPs) and procollagen III N-terminal.

   d. Effect on neurohormones. e. Withdrawals. f. Side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-80 years
* Have a recent MI (\<5days)
* Have ASAT \>100 U/L or CKMB \> 50 U/L.
* Have LVEF \<40%.
* Are on optimal medical treatment and considered unsuitable for surgical intervention.

Exclusion Criteria:

* Evidence of unstable disease, concomitant ischemia or unstable angina during the hospitalization.
* Significant concomitant disease such as infections, pulmonary disease or connective tissue disease.
* Participating in other studies.
* Inability to participate.
* Diseases that require surgery.
* Planned revascularisation.
* Known hypersensitivity to IVIG.
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Prior PC diagnosis
* No evidence of Prostate Cancer
* Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month

Exclusion Criteria:

* \<1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT)
* Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea
* Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome)
* Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia)
* Initiation of new medications for urinary symptoms in the past 4 weeks
* Altered dosing of medications for urinary symptoms in the past 4 weeks
* Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study
* Implanted electronically charged medical device
* Unable to provide consent for himself
* Unwilling to adhere to all study-related procedures
Caffeine Reduction and Overactive Bladder Symptoms

A. Statement of Objective: To conduct a randomized trial to evaluate the impact of caffeine restriction on Overactive Bladder(OAB) symptoms including urinary frequency, nocturia, incontinence episodes, symptom severity and bother and quality of life.

B. Specific Aims/Hypothesis:

1. To determine if reduction in caffeine intake decreases urinary frequency, nocturia and incontinence episodes as measured on a 3-day voiding diary in women with Overactive Bladder (OAB).

   We hypothesize that women with overactive bladder will report less frequent urination and decreased nocturia and incontinence episodes with caffeine reduction.
2. To determine whether caffeine reduction results in decreased symptom severity and bother and improved quality of life scores as measured by the Questionnaire for Incontinence Severity Index (ISI), Questionnaire for Urinary Incontinence Diagnosis (QUID), Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7).

We hypothesize that women with OAB who reduce their intake of caffeine will report decreased symptom bother and improved quality of life as measured by the ISI, UDI-6 and the IIQ-

Objective: To evaluate the impact of caffeine reduction education on urinary frequency.

Methods: Women with overactive bladder (OAB) symptoms who scored a 6 on the Questionnaire for Urinary Incontinence Diagnosis and who consumed at least 200 mg of caffeine daily were recruited. After completing baseline 3-day bladder diaries including amount and type of caffeine consumption, as well as validated urinary symptom severity, bother and quality of life questionnaires, women were randomized to receive caffeine reduction education vs. a control group who reviewed their voiding diary with no counseling to reduce caffeine; both groups were asked to maintain total fluid intake. Participants repeated the 3-day bladder diary and validated questionnaires following randomization. A total of 80 women were required to achieve 80% power with an alpha error of 0.05 to detect a difference of 1.3 in mean number of daily voids averaged over a 3-day voiding diary.

Eligibility Criteria:
Inclusion Criteria:

* only women 18 years and older with Overactive Bladder syndrome and who report that they consume an average of two cups of caffeinated beverages (approximately 200mg caffeine) daily will be included.

Exclusion Criteria:

* Women presenting with stress predominate bladder symptoms as evaluated by the QUID, urinary tract infection or hematuria as evaluated on urine dip analysis, currently pregnant or pregnant within the past six months or history of radiation to the pelvic floor will be excluded from participation
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 2 Diabetes Mellitus

Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2 diabetes mellitus.

The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™ insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin.


Eligibility Criteria:
Inclusion Criteria:

1. Completed the VIAject™-08J protocol
2. Informed consent must be obtained in writing for all subjects.

Exclusion Criteria:

1. History of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator
2. History of known hypersensitivity to any of the components in the study medication
3. Progressive disease likely to prove fatal
4. Known significant hepatic disease or serum AST or ALT values \> 3 times the upper limit of normal or bilirubin levels \> 1.5 times the upper limit of normal
5. Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy (see Appendix B), proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse.
6. History of moderate to severe ketoacidosis within the 3 months preceding screening for the study
7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
8. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
9. A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study
10. Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
11. A history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients

This study is a substudy of the MAN2 -study (Mycophenol mofetil in Antiretroviral Naïve patients 2, see elsewhere in the ClinicalTrials.gov database). In the MAN2 study, HIV-1 infected patients who are not treated with antiretroviral treatment will be randomized to treatment with Mycophenol mofetil (MMF)500 mg BID or a control group without treatment (open label). Both patients randomized to treatment with MMF and patients randomized to the control group will be asked to participate also in this substudy.

In this substudy we want to show whether monotherapy with Mycophenol mofetil (MMF) in patients infected with HIV-1 can reduce acceleration of atherogenesis by attenuating various inflammatory pathways normally involved in progression of atherosclerosis.

* background Immune activation plays an important role in atherogenesis. In HIV-1 infection, the immune system is chronically hyperactivated. There also seems to be an increased incidence of cardiovascular disease in untreated HIV-1 infection. Mycophenol mofetil (MMF) will be used to treat this immune activation in untreated HIV-1 infected patients in the MAN2-study (see elsewhere in this ClinicalTrials.gov database).
* Hypothesis T-cell inhibition with MMF attenuates T-cell number, T-cell activation and T-cell - monocyte interaction, thereby minimizing the T-cell-driven inflammatory amplification loop.

In addition, MMF reduces expression of adhesion molecules on endothelial cells and leucocytes, thereby attenuating recruitment of circulating leucocytes to the atherosclerotic plaque. Combining these effects MMF treatment will improve anti-atherogenic defence mechanisms, such as improvement of endothelial function and attenuation of the pro-inflammatory state.

\*design This will be a substudy of of the multi-center, double-blind, randomized, trial "Mycophenol mofetil in Antiretroviral Naïve patients 2 (MAN2 study)" (called the main study hereafter). The aim of the substudy is to evaluate the effects of mycophenolate mofetil on ´surrogate markers´ for atherosclerosis in a group of HIV-1 infected patients. All 90 patients to be included in the main study will be asked to participate in this substudy. A separate informed consent is needed.

Patients participating in this substudy will undergo study procedures for the substudy only on day 0 and week 48 of the main study (i.e. before the first dose of MMF and after 48 weeks of MMF treatment for the patients randomized to MMF treatment). Extra blood will be drawn to measure several biochemical markers associated with atherosclerosis and will be measured. Furthermore measurements of the condition of the blood vessels will be performed (using ultrasound, amongst others).

Eligibility Criteria:
Inclusion Criteria:

* Any patient included in the MAN2-study van enter this substudy (see protocol MAN2 study)

Exclusion Criteria:

* Any condition, illness or use of medication which according to the investigator is not compatible with the conduct of the substudy or which could interfere with the evaluations required by the study.