cyrilzakka/clinical-trials huggingface dataset:
Minimum Effective Dose (MED) & Epidural Bupivacaine

Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose, accidental injection in a blood vessel or slow absorption from the area of injection. The risk of toxicity when performing regional anaesthesia can be reduced significantly by injecting the optimal dose of local anaesthetic at the correct site.

To date most of the local anaesthetic dose finding studies for epidural labour analgesia has focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic for epidural analgesia in labour.

The dose determined from this research trial will guide the anaesthetists to the optimal starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to decreased chances of toxicity and will improve patient safety.

We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5 cm) requesting epidural analgesia to answer the research question based on the continual reassessment method. Patients will be recruited according to well-defined criteria. They will be fully informed about the study and have the choice of not participating or opting out at any time during the study. It is not going to affect the kind of treatment they receive. The experts in the field with full safety precautions will perform this study at St James' Hospitals, Leeds.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) 1-3 patients
* Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.

Exclusion Criteria:

* Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (\> 5 cm cervical dilatation)
* Multigravida patients ( ≥ 2nd pregnancy)
* ASA \> 3
* Allergy to Bupivacaine
* Unable to give written informed consent
* BMI \>35
* Abnormal blood coagulation profile
* Patients taking any medication that are indicated in the Summary of Product Characteristics (SPC) as not recommended
Biological Mesh Repair of Complex Hernias in High Risk Patients

Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.

Obervational study

Primare outcome: Surgical site occurence

Secondary outcome: Hernia recurrence

Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.

Eligibility Criteria:
Inclusion Criteria: Abdominal wall reconstruction with biological mesh -

Exclusion Criteria: Pregancy,

-
Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal

In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction.

It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male ≥ 18 years old
2. With an indwelling urinary catheter placed after any of the following procedures:

   A uro-endoscopic surgery from the list below:
   * Endoscopic prostate resection (or transurethral prostate resection).
   * Laser prostate enucleation
   * Prostate thermotherapy by radiofrequency
   * A high-intensity focused ultrasound treatment for prostate cancer
   * Cervico-prostatic incision or internal urethrotomy
   * Endoscopic/Transurethral Resection of Bladder Tumor (TURBT)
   * Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation)
3. Patient who has given written consent to participate

Exclusion Criteria:

1. Patient who is unable to perform intimate hygiene alone in a standing position
2. Patient with a painful genital lesion
3. Patient with an extended pelvic pathology
4. Need to remove the indwelling urinary catheter at the patient's home instead of hospital
5. Patient under guardianship or curator
6. Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial

This phase I/II trial examines if buffered lidocaine reduces the pain that patients may experience during prostate biopsy. Prostate biopsies are typically performed awake, in the office, with only local anesthetic. As a result, many patients note considerable pain during these procedures. Local anesthetics such as lidocaine are typically acidic, which is thought to cause pain and burning during infiltration (injection). As a result, buffered local anesthetic has become the standard of care (SOC) in multiple specialties using awake local anesthetic. However, it has not been explored during prostate biopsies. Adminstering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.

ARM B: Patients receive buffered lidocaine via injection during SOC prostate biopsy on study.

After completion of study intervention, patients are followed up 1-2 days post-biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* 18 years old or older
* Patients with prostates
* Those with and without a prior diagnosis of prostate cancer
* Recommended to undergo a prostate biopsy in the urology clinic. Only patients that have been scheduled for a biopsy (for clinical purposes) will be enrolled. May include all of the following types of prostate biopsies:

  * Transperineal or transrectal
  * Systematic or targeted/fusion biopsy
  * 12 core biopsy or \> 12cores
  * Biopsy naïve or prior biopsy

Exclusion Criteria:

* Anorectal pathology precluding placement of a transrectal ultrasound
* Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
* Concomitant chronic pain condition
* Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
* Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
* Prostate biopsy completed in the operating room
* Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
* Patients taking anxiolytics in the 6-hours prior to the biopsy
* Those with a known hypersensitivity, allergic reaction, or contraindication to using sodium bicarbonate. This includes patients who are receiving diuretics known to produce a hypochloremic alkalosis
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.

This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with an ICD9 code indicative of chronic pain.
* Participants must be starting a new regimen of topical therapy with multiple compounded agents.
* Participants must be expecting to receive therapy for at least 12 weeks.
* Participants must be between 18 and 65 years of age.
* Participants must be able to provide sound written and verbal informed consent.

Exclusion Criteria:

* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
* Participants must not be pregnant or breastfeeding women.
* Participants must not have a diagnosis of cancer within the past 5 years.
Project ACTIVE a Clinical Intervention

This is a clinical Randomized Controlled Trial where the study personnel will run a personalized prevention clinic with patients in attempts to improve their preventive health outcomes and compare their health outcomes with a matched control sample of patients who do not receive the clinical intervention.

The Project ACTIVE intervention was constructed around the following framework, and then adapted to suit workflow demands of a busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model that was published in Annals of Internal Medicine to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each USPSTF preventive care guideline, with estimates personalized based on that patient's risk factors and medical history, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals patient aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals. The program supplements rather than substitutes for normally scheduled primary care visits, and is coordinated with these visits whenever possible.

Eligibility Criteria:
Inclusion Criteria:

* Non-elderly non-pregnant adults already in care at Bellevue Ambulatory adult care clinic
* Subjects with at least one of twelve unfulfilled clinical management goals from USPSTF Grade A and B recommendations
* English or Spanish speaking
* Capable of understanding informed consent.

Exclusion Criteria:

* Age \>65
* Pregnant
* Dominant comorbidity (one that disproportionately impacts care plans and/or life expectancy).
Fructose-induced Intestinal de Novo Lipogenesis

8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two sub-studies Sub-study 1) after ingestion of two or three different of the following test-meals: A)cream and whey protein B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein, fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood Sub-study 2) after ingestion of two or three different of the following test-meals: A)cream labelled with 13C6 palmitic acid and whey protein B))cream labelled with 13C6 palmitic acid, whey protein, fructose and glucose

Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood in sub-study 1

Their exogenous lipid absorption kinetics will be assessed by measuring 13C palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in sub-study 2


Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years
* sex male or female
* less than 2 kg body weight change over the past 3 months subjects

Exclusion Criteria:

* antidiabetic and hypolipemic drugs
* alcohol consumption \>20g/day
* severe eating disorders
* severe psychological problems
* vegetarian diet or other specific diet
* consumption of illicit substances
* pregnancy
* weight gain or weight loss \> 1 kg in the last 3 months
EXerCise wEight Loss

The overall aim of this study is to investigate the effects of home-based resistance exercise programme on changes in body composition and strength during weight loss, in people living with obesity or overweight.


Eligibility Criteria:
Inclusion Criteria:

* Obesity or overweight (BMI ≥ 25kg/m2).
* Passing the Physical Activity Readiness Questionnaire (PAR-q+)

Exclusion Criteria:

* Currently take part in more than 1.5 hours of structured exercise per week.
* Having recently (\<6 months) taken part in any resistance exercise training, taking any medications known to affect weight loss.
* Actively engaged in a weight loss programme, having lost more than 2kg weight in the last 6 months.
* Any other reason which would limit ability to perform the exercises and outcome measurements safely.
Impact of TAVI on Cognition, Mood and Health-related Quality of Life

In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.

The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.

In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
* Women and men between the ages of 19 and 90
* Clinical indication for TAVI intervention
* No previous psychiatric illness before TAVI
* No other serious disease affecting the immune system

Exclusion Criteria:

* Non-compliance with the inclusion criteria
* Persons unable to give consent (e.g. dementia, delirium etc.)
* Magnetic resonance imaging (MR) contraindications
* ophthalmological inability to read
Evaluation of the Ulthera® System for Treatment of the Face and Neck

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
* Mild to moderate rhytids in the periorbital or perioral region.
* Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
* Mild to moderate vertical perioral lines
* Mild to moderate marionette lines.
* Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat on the cheek.
* Excessive skin laxity on the lower face and neck.
* Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
* Excessive hooding with or without redundant skin in the areas to be treated.
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented obstructive sleep apnea
* with untreated mild systemic hypertension

Exclusion Criteria:

* pregnancy or lactation
* daytime alveolar hypoventilation
* severe arterial hypertension (systolic pressure \> 180 mmHg; diastolic pressure \> 110 mmHg)
* treatment with anti-hypertensive drugs
* cardiovascular disorder other than mild hypertension
* severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
* contra-indication to nCPAP treatment
* known allergy to bosentan
* active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
* active treatment with a drug acting on systemic arterial blood pressure or endothelial function
* liver or kidney dysfunction
A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies

142 cases of patients with iRBD will be recruited from the neurology department of Ruijin Hospital, th second Affiliated Hospital of Soochow University and wuhan Union Hospital. After the informed consent was signed, they were divided into a trial group and a control group randomly. Each group contains 71 cases. The patients in the trial group will be treated with Idebenone, while the patients in the control group was treated with placebo. Both groups of subjects will be treated for 5 years, and patients will be followed-up and evaluated in the first year, 3 years and 5 years after treatment. The observations include the MDS-UPDRS questionnaires evaluation, blood biomarker measurements and fMRI or PET-MR examination to make sure whether the patients has converted to synucleinopathies. Study hypothesis: Idebenone therapy for patients with iRBD is safe and effective in delaying disease progression into synucleinopathies.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed of iRBD.
2. Age between 40 and 75.
3. Be voluntarily to participate in the experiment by signing an informed consent form.

Exclusion Criteria:

1. Sleep apnea hypopnea syndrome
2. Slow movement, muscle rigidity, tremor or postural instability.
3. Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection.
4. Other sleep disorders or seizures.
5. Alcoholism or drug addiction patients.
Validity and Reliability of Perceived Exertion Rating Scale in Children With Brain Damage

The purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.

walking on a treadmill twice- one weeks interval five intensity level in each session

Eligibility Criteria:
Inclusion Criteria:

* Children post severe closed head injury (Glasgow Coma Scale \[GCS\] score at admission to emergency room of ≤8, at least one year post trauma
* Ages 7 to 12 years
* (3) independent ambulation (foot orthoses permitted).
* Children with Cerebral palsy, GMFCS 1 or 2, ages 7 to 12 years. Typically developed controls.

Exclusion criteria:

* Cannot understand simple instructions
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder

Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.

Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible. However, this is currently not the case for the majority of families. There are no empirically validated treatment programs for infants showing ASD risk. The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.

Eligibility Criteria:
Inclusion Criteria:

* Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
* and Infant Toddler Checklist (ITC) scores in the autism concern range
* Expression of clinical concern about ASD risk by the assessor and caregiver
* Caregivers must be identified as the infants' primary caregivers
* Caregivers be English speaking
* Caregivers must have access to wired or wireless network technology to access the internet in their homes.

Exclusion Criteria:

* Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
* Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
* Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
* Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
* A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).