cyrilzakka/clinical-trials huggingface dataset:
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities.

If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.


Eligibility Criteria:
Inclusion Criteria:

* Infants ≥ 35 weeks post-menstrual age,
* Clinically stable, without significant respiratory support,
* Deemed safe to breastfeed by OT/SLP/lactation,
* Maternal interest in breastfeeding,
* Are not breastfeeding well despite the assistance of a lactation consultant.

Exclusion Criteria:

* Cardiomyopathy,
* Unstable bradycardia,
* Significant respiratory support,
* Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia,
* Maternal HIV without adequate viral suppression,
* Maternal illicit drug use.
Investigation of Laterality and Sensory Acuity Abilities of Frozen Shoulder Patients

The brain contains the body representation necessary for normal functioning, including goal-directed movements and behaviors. Body representation involves integrated sensory input and ideas about one's body. Both executed and imagined movements depend on the representation of the body in the cortical area. Laterilization is one of the motor imagery methods that requires activation of proprioceptive, somatosensory and premotor regions and enables the determination of pain-induced cortical changes. Another method to determine pain-related somatosensory changes is the two-point discrimination test.

It is suggested that laterization and sensory acuity responses may change due to long-term pain and stiffness experienced in people with frozen shoulders. Therefore, the aim of this study is to investigate the laterization and sensory acuity abilities of patients with frozen shoulder.


Eligibility Criteria:
Frozen Shoulder Group:

Inclusion Criteria:

Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear; Patients with ability to follow simple orders; iii) Patients with ability to sign to provide informed consent

Exclusion Criteria:

Normal passive ROM External ROM \< 30 To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint Pain \< 3 according to the numbered pain assessment scale

Healthy group :

Inclusion criteria:

No actual shoulder pain or previous history of shoulder complaints including Frozen Shoulder.
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance

There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance.

The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).

This study consists of two visits, from three to fifteen days apart. Patients with different levels of insulin resistance will be enrolled in this study.

The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp that will be performed at the second visit.

The first visit :

* Subjects will be on an empty stomach
* A blood test including HbA1C, C-Peptid, lipid profile, creatinine,urea, hepatic workup
* An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken two time (T-15', T0) 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes (T15', T30', T 45', T60', T75', T90', T105', T120' and 180') to measure insulinemia, blood sugar, and IRAP concentration.

The second visit includes a 3-hours hyperinsulinemic euglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* Patient without known diabetes
* Abdominal perimeter greater than 80 cm for women and greater than 94 cm for men
* Patient affiliated to social security insurance or beneficiary of social security insurance.
* Signed consent

Exclusion Criteria:

* Consumption of narcotic
* Medication that may interfere with glucose metabolism
* History of bariatric surgery
* Known acute or chronic renal insufficiency
* Hyperinsulinemic euglycemic clamp contraindication
* Contraindications with insulin, G20 glucose and Di-potassium phosphate
* Histories of coronary pathology
* History of heart rhythm disorders requiring chronic treatment
* Period of fast
* Pregnant women
Reference Diameter and Characteristics of Distal Radial Artery by Ultrasonographic Assessement in Korean Patients

Radial access is recommended as the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI) based on the evidence in which RA reduced mortality and bleeding events compared with femoral access. Recently, the use of distal radial artery (DRA) is rapidly increasing in accordance with the publication of several studies that have shown easy hemostasis, reduced bleeding complications and low arterial occlusion rate via distal radial approach. However, the diameter of DRA is relatively smaller than radial artery (RA) which can limit the widespread use of this access route. Regarding the size discrepancy, there is a lack of evidence to guide which patients are acceptable or not for CAG and PCI. Therefore, the main purpose of this study was to provide the reference diameter of DRA using ultrasonography in Korean patients. The clinical predictors for small DRA also were evaluated.

Radial access is recommended as the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI) based on the evidence in which RA reduced mortality and bleeding events compared with femoral access. Recently, the use of distal radial artery (DRA) is rapidly increasing in accordance with the publication of several studies that have shown easy hemostasis, reduced bleeding complications and low arterial occlusion rate via distal radial approach. However, the diameter of DRA is relatively smaller than radial artery (RA) which can limit the widespread use of this access route. Regarding the size discrepancy, there is a lack of evidence to guide which patients are acceptable or not for CAG and PCI. Therefore, the main purpose of this study was to provide the reference diameter of DRA using ultrasonography in Korean patients. The clinical predictors for small DRA also were evaluated.

Assessment of arterial diameter by ultasonography Patients were lying on the bed with relaxation in an quiet room. The outer diameters of both DRA and RA were assessed by a perpendicular angle using a linear ultrasound probe (3-4-10.8 MHz) and the average values were recorded. The diameter of RA was measured from 2-3 cm above wrist crease. Anatomical landmark for the measurement of DRA was the bony surface area just distal space from extensor pollicis longus tendon in which the DRA was best palpable then runs down between the first metacarpal and second metacarpal bone (just out of anatomical snuffbox area)

Eligibility Criteria:
Inclusion Criteria:

* Patients planned to perform transthoracic echocardiography with arterial ultrasonography

Exclusion Criteria:

* Age under 20-year
* Poor image quality
* repeated measurement
APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.

Previous studies on synthetic mesh repair on perineum are almost lacking.

The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.

30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.

Eligibility Criteria:
Inclusion Criteria:

* Abdominoperineal resection and permanent colostoma

Exclusion Criteria:

* Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
* Potentially curable resection not possible
* Patient undergoing emergency procedure
* Metastatic disease
* Pregnant or suspected pregnancy
Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty (TKA) in Central Sensitization Patients

Postoperative wound complications such as wound dehiscence, skin necrosis, persistent wound drainage, delayed healing, and superficial skin infection could have devastating consequences, leading to arthroplasty failure and patient morbidity requiring additional operations and prolonging hospitalization with substantial burden in cost of care. Recently, interest and research on central sensitization (CS) have been increasing. CS is closely correlated with excessive pain. It has two main characteristics: allodynia and hyperalgesia. CS is an abnormal and intense enhancement of pain mechanism by the central nervous system. One of the mechanisms by which this excessive pain occurs in CS is reduced activation of descending inhibitory pathway associated with deficiency in pathways primarily in response to serotonin and norepinephrine. Serotonin plays an important role in normal wound healing by affecting the formation of neovascularization, inflammatory reactions, fibroblasts and tissue proliferation essential for wound healing. Norepinephrine is also closely related to wound healing by controlling chemotaxis of macrophage essential for normal wound healing. CS is a risk factor for the development of postoperative wound complication after primary Total Knee Arthroplasty (TKA). Preclinical models of central sensitization suggest that duloxetine is effective in the treatment. Investigators will compare the wound complication following TKA of central sensitization patients in duloxetine group (n=40) with those in non-duloxetine group (n=40). Investigators will classify the central sensitization patients by central sensitization inventory and divide the central sensitization patients in to 2 groups (duloxetine and non-duloxetine group) randomly. Investigators checks the wound complication after primary TKA and visual assessment scale at preoperative, postoperative 2 days and 1, 2,6,12 weeks. All participants will receive postoperative pain control after TKA using the same pain control regimen and wound dressing regimen except duloxetine.


Eligibility Criteria:
Inclusion Criteria:

* Patients for total knee arthroplasty
* having medicare insurance
* Central sensitization inventory (CSI)\> 40 (Central sensitization patient )

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Allergy or intolerance to study medications
* Patients with an American society of anesthesiologist (ASA) classification of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
* Chronic gabapentin or pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Alcohol, drug abuser
* Narcotics addiction
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain

A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. However, no manual therapy procedures were incorporated into the physical therapy treatment program despite recent evidence suggesting that thrust and non-thrust manual therapy techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the purpose of this study is to compare the effectiveness of a physical therapy management approach consisting of manual therapy and exercise to a home program of exercise only. The investigators hypothesize that the group receiving manual therapy and exercise will have better outcomes.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.
* The following inclusion criteria will be used to determine eligibility for this study:

  * Primary complaint of ankle pain, status post inversion ankle sprain.
  * The investigators decided to include patients with both acute and chronic ankle sprains since our previous work has shown that patients from both stage have exhibited positive benefits with manual therapy.66
  * Age between 16-60 years old
  * NPRS score \> 3 points (average score) over past 24 hrs.
  * Does not meet criteria for needing radiographs per the Ottawa Ankle Rules
* The following exclusion criteria will be used to determine ineligibility for this study:

  * Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, RA, osteoporosis, prolonged history of steroid use, severe vascular disease, etc.)
  * Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals).
  * Grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System and/or tenderness along the anterior medial malleolus as described by,51 fracture, or other absolute contraindications to manual therapy.
  * Insufficient English language skills to complete all questionnaires
  * Inability to comply with treatment and follow-up schedule
Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients

This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases.

Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.

Eligibility Criteria:
Key Inclusion Criteria:

1. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol

Key Exclusion Criteria:

1. Patients who have EGFR, ALK or ROS1 variants
2. Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date
3. Patients actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
An Online Study of the Reliability of the Brain Performance Test (BPT)

The purpose of this study is to evaluate test-retest reliability of each subtest (correlation coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).

This is an open-label, randomized online study in which participants will be invited to take versions of the Brain Performance Test (BPT) on two consecutive days.

In parallel, all current Lumosity subscribers are invited to take the BPT at the beginning of their premium Lumosity experience and again every 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Electronically signed informed consent
* English-speaker
* Current Lumosity free user (test-retest portion) OR current Lumosity subscriber (longitudinal portion)

Exclusion Criteria:

* Visual or physical impairment that impedes computer use or completion
* Under 18 years of age
Utilization Patterns of Pulmicort in Real Life Practice

The purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion
* Patients previously treated with Pulmicort CFC who have changed their treatment to Pulmicort HFA

Exclusion Criteria:

* Disability that, from investigator point of view, prevent from complying the follow up schedule
* To have participated in any clinical study in the past 6 months
Correlates of Protection for Cholera

Background: Vibrio cholerae causes millions of cholera cases and thousands of deaths annually. Vaccines are in short supply. There is no agreement on how to introduce new vaccines or evaluate their effectiveness, and the lack of 'correlates of protection' (CoPs) against cholera is a major obstacle to vaccine development. CoPs are markers of effective immune response to vaccination. While other infectious diseases have well established CoPs, none are widely accepted for cholera.

Relevance: Lack of accepted CoPs impedes development of cholera vaccines, limiting progress toward improved vaccines, slowing the licensure of new vaccines, and contributing to the current vaccine shortage; an immediate obstacle to achieving reductions in cholera-related illness and deaths. The identification of new CoPs will speed the development of improved cholera vaccines and provide a pathway to their licensure and use.

Hypothesis: The investigators hypothesize that some individuals who receive inactivated oral cholera vaccine (OCV) will develop antibody responses which predict protection against V. cholerae infection and that specific immune responses distinguish individuals who are protected against cholera by prior natural infection from those who are protected from OCVs.

Objectives: The investigators will administer an OCV or typhoid vaccine (TCV) control and monitor antibody responses to identify better CoPs for cholera following both vaccination and natural infection.

Methods: The investigators will randomize 1219 participants; 554 participants will receive an inactivated bivalent OCV, 665 participants will receive a TCV control. The investigators will collect 12 blood samples over two-years following vaccination to measure antibodies against V. cholerae and to monitor for re-infection.

Outcome measures/variables: The endpoint of interest is V. cholerae infection after vaccination. The investigators define infection as positive culture or PCR for V. cholerae or seroconversion events observed over the 2-year follow up period.


Eligibility Criteria:
Inclusion criteria

1. Ages 2 - 80 years.
2. Informed consent from study participants and guardian in case of children (2-17 years) and assent from children aged 11-17 years.
3. Intention to participate in the study for a 2-year period.
4. No major co-morbid conditions, per the supervising clinician investigator, including underlying immunodeficiency, diabetes, liver diseases, renal disease, cardiac disease, and/or active malignancy.

Exclusion criteria

1. Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months.
2. History of taking another oral cholera vaccine.
3. History of taking any other live or killed enteric vaccine in the last 8 weeks.
Loxapine and Weaning From Ventilator

Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.

Mechanical ventilation is a life-saving procedure in critically ill patients. This procedure is however not devoid of risks and every effort should be made to shorten its duration. This is best accomplished by the implementation of weaning protocols. Sedation (by opiates and benzodiazepines) is often required in such patients for their comfort and adaptation to the respirator. Withdrawal of sedation in order to allow patients to resume spontaneous breathing may be associated with agitation and confusion that may hinder weaning. In such cases, reinstitution of heavy sedation will prolong ventilator-dependency. It may therefore be interesting to administer a neuroleptic (loxapine) with good anxiolytic properties but that does not notably interfere with spontaneous breathing ability.

Patients will be included when they fail a spontaneous ventilation trial (see inclusion criteria) because of marked agitation. Usual simple clinical (respiratory frequency, P01 measured on the respirator, arterial pressure, cardiac rate) and biological criteria (arterial blood gas determination) and a measurement of sedation/agitation with validated scales (Richmond agitation sedation scale, Ramsay score) will be gathered when a patient is deemed ready for a trial of spontaneous ventilation for weaning. In cases of marked agitation according to validated scales, patients will be given a conventional dose (150 mg) of loxapine by the nasogastric tube and the efficacy of this treatment will be evaluated on the same parameters as above. Demonstration of the facilitation of weaning by this simple strategy would be useful in order to reduce risks associated with mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for weaning from the respirator (FIO2 less than 50%; positive end expiratory pressure \[PEEP\] level less than 6 cmH2O)
* Patients whose agitation (according to accepted scores) during a weaning trial precludes extubation

Exclusion Criteria:

* History of convulsions or epilepsy