cyrilzakka/clinical-trials huggingface dataset:
Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke

The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke

Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after stroke. The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation (VNS) paired with rehabilitative training enhances recovery of function in models of stroke and is currently under investigation for use in chronic stroke patients. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Sub-Acute stroke (3 months to 6 months)
* Between grade 0 and grade 2 on modified Ashworth scale.
* Patients who will be able to walk without assisted devices and can stand for 2 minutes.
* Either type Ischemic or Hemorrhagic
* Age bracket 40-60 Years

Exclusion Criteria:

* Previous surgical intervention on vagus nerve
* Severe pain in upper extremity
* MoCA score of less than 10
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
* Patients must have moderate to severe erosive esophagitis

Exclusion Criteria:

* Significant gastrointestinal bleeding
* Severe heart, lung, liver or kidney disease
* Esophagitis not related to acid reflux
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily

1. In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release

1. Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
2. Cross over study design:

   * Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
   * Group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months
3. Dose adjustment may be done in the first 4 weeks.
4. Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-80
2. Parkinson disease
3. On dopamine agonists (Ropinirole IR or Pramipexole IR) and are considering to change into Ropinirole PR
4. On stable antiparkinsonian medication for at least 4 weeks
5. Who signed consent to the study

Exclusion Criteria:

1. Who are on less than 2 mg of Ropinirole IR or 0.375 mg of Pramipexole IR
2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
3. Who are allergic to the similar medications
4. Who has history of heavy metal poisoning
5. Who were on othe clinical trials of other medications within the last 4 weeks
6. Whoa re pregnant or lactating
7. Who are considered not eligible by the investigator
To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients

To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin
* Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal

Exclusion Criteria:

* Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
* Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.
Colchicine Use for Primary Prevention of Coronary Artery Disease

Colchicine has been widely used as an anti-gout medicine in the past decades. Some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. However, the effect on primary prevention has not been observed sufficiently. The objective of this study is to determine whether colchicine reduces the incidence of CAD in patients and its safety for long-term use.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females who have at least 3 risk factors for CAD. 2. GFR\>90mmol/L. 3 People are within 40-70 years old.4. Patients are not pre-diagnosed with CAD, which is defined by negative results of CT coronary angiography.

Exclusion Criteria:

1. Patients with any pre-existing diagnosis of coronary artery disease.2.Other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.Cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.Currently on treatment with colchicine.5.Patients who are known to be allergic to colchicine.6 Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before recruitment.7.Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.8.Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Lateral wall bladder tumour
* ASA I-II patients

Exclusion Criteria:

* Contraindications for spinal anesthesia,
* Tumors that disrupt the integrity of the bladder,
* Coagulation disorders,
* Uncooperative patients,
* Allergy to local anesthetics.
PREMOD2 With Near Infrared Spectroscopy Sub-study

Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns \<32 weeks, but did not show any differences in cerebral oxygenation.

This substudy will include 400 infants \<28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* 23 weeks 0 days to 27 weeks 6 days.
* Enrolled in PREMOD2 trial.

Exclusion Criteria:

* NIRS Device not available
* Research Personnel not available
Comparative Evaluation of Pectoral Nerve Block Type II Versus Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Mastectomy for Postoperative Analgesia: a Randomized, Controlled Trial

This study aimed to investigate the analgesic effects of Pectoral Nerve Block Type II and Rhomboid Intercostal and Subserratus Plane Block after radical mastectomy for breast cancer.This prospective, double-blind, randomized controlled trial recruited 67 female patients with complete follow-up records who underwent unilateral modified radical mastectomy (MRM) at Inner Mongolia Baotou Steel Hospital from December 1, 2023 to December 1, 2024. Subjects were assigned to the observation group and the control group at a 1:1 ratio using a random number table. Among them, 30 patients who received pectoral nerve block (PECS II) for analgesia were included in the observation group, and 30 patients who received Rhomboid Intercostal and Subserratus (RISS) block for analgesia were included in the control group. The primary outcomes included the 40-item Quality of Recovery (QoR-40) scores at 6 hours and 24 hours after surgery, and the Visual Analogue Scale (VAS) pain scores in the Post-Anesthesia Care Unit (PACU), as well as at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.T he secondary outcomes included the consumption of sufentanil in patient-controlled intravenous analgesia (PCIA) after surgery, the number of effective compressions, the use of remifentanil during the operation, the number of additional analgesic administrations, the sleep quality on the first day after surgery, and the incidences of block-related complications and postoperative adverse events.


Eligibility Criteria:
Inclusion Criteria:

* patients met the diagnostic criteria of breast cancer;
* tolerance to surgery and anesthesia

Exclusion Criteria:

* Patients with severe systemic diseases or anesthesia problems: Such patients were excluded to ensure safety and avoid the occurrence of irrelevant complications;
* Those with coagulation disorders;
* Patients with puncture contraindications or infections;
* Those allergic to local anesthetics;
* Those who refused to sign the informed consent form;
* Patients with cognitive or communication problems
Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.

PRIMARY OBJECTIVE:

I. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response.

SECONDARY OBJECTIVE:

I. To determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers.

EXPLORATORY OBJECTIVES:

I. Interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts).

II. Identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response.

OUTLINE:

Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. MD Anderson employees and student employees with existing MRN
2. Must be able to donate blood
3. Participants must be age 18 or older
4. Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health
5. Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws

Exclusion Criteria:

1. Participants with a contraindication to the recommended annual influenza vaccine

Pregnant women may be included in this study.
Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth

This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.


Eligibility Criteria:
Inclusion Criteria:

* Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
* American Society of Anesthesiologists class 1 patients aged 5-9 years
* Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
* Patients having teeth with two-thirds of each root remaining
* Absence of periapical lesions and interradicular radiolucency
* Moderate to very severe (2-4) five-face scale pain scores in the 24-hour period before the procedure.

Exclusion Criteria:

* Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
* Teeth with pathologic root resorption
* Teeth with excessive mobility.
Drug-Drug Interaction Study in Healthy Adult Volunteers

The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of K 877 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
A Population-based Study of Celiac Disease in South Europe in Children Between 1 to 5 Years of Age

Celiac disease (CD) was diagnosed for years almost exclusively in children. This is due to the fact that in adulthood it manifests in a much more attenuated form, while the classic form with severe diarrhea, malnutrition and dehydration is observed almost exclusively in children. Classic studies, carried out prior to the widespread use of serology as a CD diagnostic tool, already showed that there is variability in gluten sensitivity and that in a non-negligible proportion of cases (10%) gluten sensitivity appears to be transient. Subsequent studies, including patients diagnosed by serology or population screening studies, suggest that progression to gluten latency or tolerance may occur in a higher proportion of patients, ranging from 20 to 50% depending on the geographical region.

In the first decade of the 2000s, the researchers group performed a prevalence observational cross-sectional study survey in Catalonia (autonomous region in the northeast of Spain) that accurately reflected the distribution of the reference Catalan population in terms of sex and age. The results showed a drastic and significant drop in the prevalence of CD disease in relation to age, with the prevalence of CD in children being 5 times higher than adults (1:71 vs. 1:357). Strikingly, the reduction in prevalence was especially notable in the first 4 years of life.

Two possibilities were proposed to explain this unexpected finding in a disease that is lifelong: 1) The existence of an environmental effect (cohort effect) acting as a disease trigger in early childhood during the study period (e.g., bacterial or viral infections, vaccines, food policies related to gluten introduction, use of antibiotics, etc.). 2) The appearance of age-related tolerance to gluten in a proportion of cases. Interestingly, it has been suggested that immunological tolerance might be more frequent in children diagnosed with CD before the age of two.

The aims of the present epidemiological study are: 1) to determine the prevalence of CD in Catalonia in children under 5 years of age and compare it with the results obtained in the previous 2004-2007 study; 2) to investigate the potential effect of environmental factors on disease prevalence; and 3) to evaluate longitudinally the appearance of tolerance to gluten in the CD cases detected. Therefore, this study has been designed using exactly the same CD screening methodology and reproducing the reference population in the same geographical area as the previous 2004-2007 study.


Eligibility Criteria:
Exclusion Criteria:

* Heart failure or unstable cardiopathy
* COPD or respiratory insufficiency
* Coagulopathy
* Hepatic cirrhosis
* Kidney failure
* Active neoplasm
* Gluten-free diet without CD diagnosis
Macrophage Infiltration in Human Adipose Tissue

Quantification of macrophage infiltration and characterization of macrophage phenotype in adipose tissue of 60 obese subjects and 20 non obese subjects

Obesity results from a disequilibrium in energy balance and an inability to adapt to lifestyles which encourage increased energy intake and sedentariness. These last years, numerous studies contributed to show that obesity is the pathology of an organ, the white adipose tissue (AT), characterized by a low grade inflammation when it is enlarged. The fact that adipocytes secrete a number of inflammatory factors or "adipokines" has forced several groups to reassess the involvement of the AT in wide range of physiological and pathophysiological processes. Adipose tissue probably contributes to the links between obesity, inflammation and insulin-resistance. Our previous results based on transcriptomics studies, showed that genes encoding inflammatory molecules are mobilized in adipose tissue of obese subjects and that caloric restriction improves greatly inflammatory profile. Our preliminary studies on the morphology of adipose tissue lead us to observe a major infiltration of macrophages in morbidly obese subjects. This project is based on a clinical protocol performed in massively obese subjects (BMI\>40 kg/m²), where drastic weight loss is achieved by gastric bypass. This project has several objectives. It will allow us to characterize the infiltration of macrophages in the subcutaneous adipose tissue of 60 obese subjects compared with 20 normal-weight subjects, to study the evolution during surgically-induced weight loss and to compare the infiltration observed in adipose tissue to that of other tissues (visceral adipose tissue, muscle, liver, bowel and stomach). This study will be not only quantitative (number of macrophages) but also qualitative by characterizing the phenotype of macrophages with transcriptomics and immunohistochemical approaches. We will analyze the relationships between morphological characteristics of adipose tissue and clinical and biochemical parameters related to insulin sensitivity. More generally, this project might lead us to go thoroughly into the knowledge of the link between obesity and associated comorbidities, particularly metabolic complications, and to consider novels therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* Obese subjects group :

  * Obesity with BMI\> 40 kg/m² or obesity with BMI between 35 and 40 kg/M² with comorbidities (OAS, diabetes, hypertension etc...)
  * Age: 18-60
* Non obese subjects group

  * Abdominal surgery planned
  * Age: 18-60

Exclusion Criteria:

* Inflammatory disease
* cancer
* stroke
* Drugs (AINS)
Effect of Capecitabine on the Pharmacokinetics of BMS-247550 and BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the body.


Eligibility Criteria:
Inclusion Criteria:

* Recovery from surgery or radiation therapy
* Measurable or non-measurable disease
* Available for follow-up

Exclusion Criteria:

* Neuropathy
* Uncontrolled pulmonary or cardiovascular disease
* Known history of HIV infection
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis

Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive treatment option to manage bladder storage symptoms, however, the potential efficacy of TTNS among people with multiple sclerosis is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. The feasibility and acceptability of TTNS to manage storage bladder symptoms using Transcutaneous Electrical Nerve Stimulation (TENS) needs to be established before proceeding with a definitive randomised trial. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS

The investigators will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in multiple sclerosis. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland's communication channels; 2) Recruitment from a convenience sample of people with MS who have previously participated in a qualitative study. The investigators will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life using International classification of incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events and acceptability of using TTNS.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported diagnosis of any type of Multiple Sclerosis
* Male or female
* Aged ≥18 years old
* Ambulatory
* At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence).

Exclusion Criteria:

* People with an indwelling urethral catheter or indwelling suprapubic catheter
* Urologic disease including bladder malignancy
* Diabetic mellitus
* Pregnant women or planning to be pregnant during the study time
* Recent pelvic related surgery \<1 year
* Pacemaker or other metallic internal devices
* Urinary tract infections (UTIs) during recruitment phase.