cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women

Evaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.

This United Kingdom study will comprise a single blind, primary care, post-market evaluation of a novel neuromuscular electrical stimulation treatment for urinary incontinence . Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two groups (intervention or control). The control group will receive routine care via their GP practice. The intervention group will receive the electrical stimulation device. Treatment will last for 12 weeks with a Quality of Life (QoL) primary end point immediately post treatment with a second phase to explore the impact of a further 12 weeks maintenance programme in the intervention group compared to routine care. There will be a further two year follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged between 18 and 65
* GP determined urinary incontinence

Exclusion Criteria:

* Abnormal abdominal mass
* Clinical history of urinary retention problems
* Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia
* Pregnancy or given birth within the last three months
* Implanted pacemaker
* Recent pelvic surgery (within the last 12 months)
* Recent haemorrhage, haematoma and/or tissue damage to the vagina
* Undergoing any active therapy or review appointments for pelvic malignancy
* Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
* Manual dexterity insufficient to place the electrical stimulation device in the vagina
* Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease
* Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
* Insufficient cognitive ability to provide informed consent and/or participate in the study
* Unwillingness to participate in the study
Mental Health and Sexuality in Adolescents and Young Adults

According to the World Health Organization (WHO), "Sexual health is a state of physical, emotional, mental and social well-being in relation to sexuality, not merely the absence of disease, dysfunction or of infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships \[...\]".

The main objective is to show that a training intervention intended for psychiatric care teams and targeted on the question of the impact of psychiatric disorders and psychotropic drugs on the sexuality of young people, increases the proportion of young people with whom the question of sexual health is discussed (in connection with psychiatric disorders and, if applicable, with the taking of psychotropic treatment, while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, psychotropic treatment ).

Non-interventional multicenter prospective mixed study (quantitative and qualitative).

Research process in 3 phases:

1. Inventory with a mixed method evaluation (quantitative survey and qualitative survey),

   * Step 1: quantitative survey with self-administered questionnaire offered to all patients attending psychiatric study care during the month of the assessment.
   * Step 2: qualitative survey of young people and caregivers.
2. Design and implementation of an intervention adapted to the needs of the field (training for caregivers and tools for young people).

   * Step 3: implementation of training programs for professionals based on data from phase 1 and preparation for interventions for young people.
   * Step 4: Interventions (interventions with young people in groups and individually).
3. Reassessment after the deployment of the intervention - Step 5: Finally, the quantitative survey of stage 1 with a self-questionnaire offered to all patients present in psychiatric care-study will be repeated during one month of the evaluation in order to measure the impact of the action taken.

Eligibility Criteria:
Inclusion Criteria:

* Young people hospitalized in psychiatric care-studies in one of the establishments of the FSEF,
* Age ≥ 15 years (age of sexual majority),
* Receiving or not a psychotropic treatment,
* No opposition to participation (or parents for minors) in the study and use of data

Exclusion Criteria:

* Refusal to participate
* Patient under 15 years old
* Need for emergency care (medicine or psychiatry).
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD.
* HbA1c between 7.1% and 10.0%, inclusive.
* Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2

Exclusion Criteria:

* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
* Have characteristics contraindicating metformin, SU, or TZD use.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
* Have used any prescription drug to promote weight loss within 3 months prior to screening.
* Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with T1D and continuously using insulin for at least 1 year
* Have been using CSII therapy for a minimum of 6 months
* Currently treated with \<100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
* Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days

Exclusion Criteria:

* Have hypoglycemia unawareness
* Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects referred to the PI for management of TBI
* Subject is at least 3 months post-injury at the time of consent
* Ages 25-70

Exclusion Criteria:

* Subjects with the inability to consent for themselves
* Subjects with body habitus that does not allow the EEG cap to be properly placed
* Presence of scalp injury or disease
* Allergic reaction to topical lidocaine jelly
* Prior intracranial surgery or skull-fracture over VLPFC
* Presence of hemorrhage on intracranial imaging
* Prior brain radiotherapy
* Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation
* Subjects with the inability to see and read from a computer screen
* History of any form of seizures prior to TBI or within 6 months of study participation
* Pregnancy
The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
* ASA class I and II

Exclusion Criteria:

* Coagulopathy
* Neurological disease
* Allergy to local anesthetics or contraindication to use of ropivacaine
* Infection at the site of epidural catheter insertion
A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants

The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).

BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.

Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given a BOTOX injection on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participant meets the following criteria:

  * Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS).
  * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P).
  * Investigator and participant scoring of MMPS and MMPS-P must be the same.
* Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2.

Exclusion Criteria:

* Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading.
* Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face.
* History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.
Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study

Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:

Many patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.

Preliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.

There is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients\&amp;#39; health issues.


Eligibility Criteria:
Inclusion Criteria:

* The participant certifies that they have undergone a medical assessment for their physical symptoms (see separate certificate).
* The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
* The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
* Any prescribed medications must have been stable for at least one month.

Exclusion Criteria:

* Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
* Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
* Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are permitted as long as the supportive therapy does not occur more than once a month.
* Participants do not have sufficient proficiency in the Swedish language.

Please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.
Bioavailability Study for New Atorvastatin Formulation

The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.

Estimation of Relative Bioavailability

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening
Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Common urinary urgency syndromes may be related to over-activation of bladder afferent pathways involving CGRP signaling. CGRP (calcitonin gene related protein) is a neurotransmitter in afferent pathways also involved in central nociception and hypersensitization. CGRP-targeted therapies, approved for migraine treatment, have the potential to alleviate lower urinary tract symptoms, but these possible effects have not been studied in humans.

This is a prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Eligibility Criteria:
Inclusion Criteria:

* Female Patients \> 18 years
* Refractory migraine, planned treatment with either:
* CGRP inhibitors, including:

  * CGRP small molecule receptor antagonists ("gepants"): Ubrogepant, Rimegepant, Atogepant.
  * CGRP monoclonal antibodies: Eptinezumab, Fremanezumab, Galcanezumab.
  * CGRP receptor monoclonal antibodies: Erenumab.
* BoNTA extracranial muscle injections
* Any of the following symptoms during the last month:

  * Urinating too often (frequency).
  * Having a sudden urge to urinate that's difficult to hold back (urgency).
  * Having a sudden urge to urinate and urine leaking before you make it to the toilet (urge incontinence).

Exclusion Criteria:

* Age \< 18 years
* CGRP treatment within the last 12 months or BoNTA (head / bladder) last 6 months.
* Patient (or medical decision-maker) unable to provide informed consent or unable to answer questionnaire.
* Unable to urinate, eg: post cystectomy, indwelling catheter, on intermittent self catheterization, ESRD w/ anuria.
* Prior bladder BoNTA in last 12 months.
The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'

The purpose of this study is to identify medical conditions that may cause particular problems to individuals receiving care for HIV infection over the age of 50. In addition, as the effects and potentially the side effects, of HIV medication may change with age, this study will also investigate the association between age and differing effects of antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in blood.

Results from this study may inform future HIV treatment guidelines on how we monitor individuals with HIV infection. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.

Multicentre, prospective, observational study over 3 years.

Our study will describe the impact of advancing age on the experience of living with HIV in England and Ireland. To address this we will establish cohorts of HIV-positive people aged \>50 and \<50 years as well as demographically matched HIV-negative people aged \>50 years.

1. To analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.
2. To evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities.
3. To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.

2000 will be recruited in all either white or black african individuals (self reported) 1000 will be Over 50 years of age and HIV positive, 500 will be under the age of 50 and will be HIV positive and 500 will be over the age of 50 and be HIV negative.

Eligibility Criteria:
Inclusion Criteria:

Older HIV-positive cohort (n=1000):

* documented HIV infection
* age \>50 years at study entry
* self defined white or black African ethnicity
* likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African
* able to comprehend study patient information leaflet

  -Younger HIV-positive cohort (n=500):
* documented HIV infection
* age \<50 at study entry\*
* self defined white or black African ethnicity
* likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African.
* able to comprehend study patient information leaflet

  * this group will comprise of at least 150 subjects in each of the following age groups: 20-29, 30-39, 40-49 years. Recruitment will be monitored by the Study Monitoring Team.

HIV-negative cohort (n=500):

* documented negative HIV test at screening
* age \>50 years at study entry
* self defined white or black African ethnicity
* registered with a General Practitioner and gives permission for contact with that General Practitioner.

Exclusion Criteria:

* in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
* life expectancy less than 6 months