cyrilzakka/clinical-trials huggingface dataset:
To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT

The increasing survival rate of gynaecological cancer patients highlights the need to improve their Quality of Life (QoL) after treatment. Among all QoL factors, sexuality is unfortunately often neglected, especially vaginal dryness and fibrosis/stenosis. Currently, the latter is standardly treated by vaginal dilators, which may induce pain and discomfort (1). A new possibility, already used in some centers, is the MonaLisa Touch® system, a microablative CO2 laser (2). Its efficiency to improve sexual QoL has already been demonstrated in breast cancer patients treated with chemotherapy and/or hormonotherapy and in menopausal women (3). Unfortunately, almost no study have been conducted yet for patients undergoing radiotherapy to the pelvic area to prevent vaginal morbidity. Our randomised study will explore the benefits of the MonaLisa Touch® device for the prevention of sexual adverse events induced by pelvic (chemo-) radiotherapy for pelvic cancers.

Patients will be randomly (1:1) assigned to the dilators (standard of care) or MonaLisa Touch® system (2 arms). Patients will be stratified for endometrial or cervix cancer, radiotherapy dose and techniques, menopausal status, tumor stage, chemotherapy or not, surgery or not. Patients will begin the Mona Lisa at 3 months, once per month during 6 months while the follow-up assessment will continue until 12M after end of RT treatment. Patients randomized in dilator arm will also begin 3 months post end of RT and will use them twice every 2 weeks for 12M (as standard of care).

Questionnaires (FSFI- Female Sexual Function Index \[10\], SHQ-22) and VHI (Vaginal Health Index \[11\]) will be performed before treatment, at 3, 6, 9, 12 and 15M. Partners will also be asked to fill the sexual quality of life questionnaire EORTC SHQ-22 before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
* complete response on the imagery at 3 months (PET scan/MRI).
* Stades I-III

Exclusion Criteria:

* M1
* Stade IV
* No complete response under imagery at 3months
* Relapse of gynaecological cancer
* Active gynaecological infection
* Pelvic organ prolapse more than stage II
* Local vaginal hormone therapy within 6 weeks prior to enrolment
Contraceptive Awareness and Reproductive Education

The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.

This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age 14-21;
* 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
* 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
* 4) Fluent in English.

Exclusion Criteria:

* 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
* 2) Girls who are not sexually active; or
* 3) Currently pregnant.
In the Mirror: Functional Appreciated Bodies (IM FAB)

The current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and decrease eating disorder symptoms in a sample of undergraduate females, a population at particularly high risk of body image dissatisfaction and consequent eating disorder development.

Specific Aim 1. First, the project aims to test a gratitude-based body functionality primary prevention program, In the Mirror: Functional Appreciated Bodies (IM FAB), that incorporates mirror exposure with a greater intervention "dose" than that piloted by Brooks and Walker. The increased dose should allow for greater ability for participants to consolidate exposure-based learning. Specifically, more time instructed to appreciate the body's functionality allows for more occasions to redirect critical appearance-oriented cognitions to appreciative, function-based cognitions.

Specific Aim 2. Second, the project aims to pilot test a relatively minimalistic intervention that would be easily translated to app-based delivery format, to help overcome the most-cited barriers to prevention program participation noted by undergraduate students in universal prevention research. Specifically, undergraduate participants who were assigned to a prevention program but did not enroll questioned a need for counseling/therapy, reported preferring to deal with issues on their own, and cited a lack of time as reasons they did not enroll.

Specific Aim 3. Third, the project aims to test this specific functionality mirror exposure approach largely on its own, rather than as part of a multicomponent treatment program, so that its unique contribution in preventing body image dissatisfaction, and ultimately eating disorders, can be assessed. A main goal in prevention and treatment development remains to continuously test components of body-image interventions separately for efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate female aged 18-23 years.

Exclusion Criteria:

* Self-definition as having an active eating disorder
* Participation in the Body Project
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation

The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs. symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity and improve quality of life for AF patients. The study will involve randomizing almost 500 paroxysmal AF patients to either AF episode tracking versus engaging in testing the relationship between participant-selected triggers and AF episodes utilizing a mobile-app based N-of-1 study design. Both groups will complete a validated survey to assess AF severity, essentially a measure of quality of life while living with AF, before and after a 3 month testing period.

N-of-1 Trial arm: Participants will use the Eureka mobile application and AliveCor device to execute at least one N-of-1 trial with the goal of identifying and better controlling their AF triggers. Each N-of-1 trial will last a total of 6 weeks and will include up to 3 periods of trigger exposure and 3 periods of trigger elimination with each exposure/elimination period lasting 1 week. Participants will be randomly assigned to start their trial with a period of either trigger exposure or elimination. During each N-of-1 trial, participants will track daily AF duration and severity, daily mood and sleep quality, daily AliveCor tracings and daily trigger exposure. At the end of each trial, participants will be able to review their trial results which will include visualizations of their daily AF symptom and trigger tracking over time. After completing a trial, participants will be instructed to implement any lifestyle changes they deem appropriate based on what they learned from the results of their trial. Participants will implement these changes for a period of 4 weeks during which they will continue to track AF episode duration and severity via the app. At the end of the 4-week lifestyle change period, participants will complete the Atrial Fibrillation Effect on QualiTy of Life survey (AFEQT) and will then have the option of testing another trigger or ending their study participation.

Symptom Surveillance arm: Participants will use the Eureka app and AliveCor device to record daily AF duration and severity, daily AliveCor readings and daily mood and sleep quality for a period of 10 weeks. Participants will be able to visualize their AF, sleep and mood data in real time and will receive a weekly summary of their data via the Eureka app.At the end of the 10-week data tracking period, participants will complete the AFEQT survey and will then have the option of either ending their study participation or crossing over to the N-of-1 trial arm to test their triggers.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic paroxysmal AF
* a smartphone

Exclusion Criteria:

* Non-English speakers
* Children (age \< 18 years)
* Patients with plans to substantially change AF management (such as with ablation or change in antiarrhythmic drugs) over the ensuing 6 months
* Unwillingness to test AF triggers.
* Patients who have had an AV node or AV Junction ablation
Intrathecal Opioid Study

This is an interventional drug trail to evaluate the effect of different intrathecal opioids on post-operative pain experiences in women who have undergone caesarean section surgery.

1. To evaluate the effect of three different intrathecal opioid mixtures on post-operative pain experiences in women who have undergone caesarean section surgery, relating specifically to:

   1. Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery
   2. Pain scores at two time points (12 hours and 24 hours) after surgery
   3. Sedation scores at two time points (12 hours and 24 hours) after surgery
   4. Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery
   5. Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery
2. To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital

Exclusion Criteria:

* Pre-operative:

  b) Patient refusal or inability to give informed consent c) Severe pre-eclampsia d) Eclampsia e) Patient unable to understand how to use the Patient Controlled Analgesia (PCA) pump, after appropriate counselling and training
* Intra-operative:

  a) Obstetric Complications: i) Post-partum Haemorrhage ii) Ruptured Uterus iii) Still Birth b) Conversion to general anaesthesia intra-operatively c) Administration of supplementary intravenous opioid analgesics
* Post-operative:

  1. Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities
  2. Patients who require ICU or High care admission postoperatively for any intra-operative complications
Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds

This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 160 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor site wounds compared to standard of care.

This is a clinical study of a new wound dressing for superficial partial thickness (SPT) wounds. The dressing consists of 2 stable layers that when placed together release Nitric Oxide. In preclinical studies NOx delivery has caused significant vasodilation, angiogenesis and demonstrated potent anti-microbial activity.

This is a multi-centre, 160 patient, randomised, controlled study. There are 2 arms to the study. 80 patients will have treatment applied to a SPT burn wound and 80 patients will have treatment applied to a SPT graft donor site wound.

The controls will be intra-individual. Each patient will have their wound divided into 2, half of the wound being treated with the NOx dressing, the other half treated with standard of care. The positioning of the dressings will be randomised.

The NOx dressing will be changed at least every 2 days and the standard of care changed according to normal clinical practice and patients will be treated until the wound is healed.

The study will evaluate:

* The size of the wound
* Eepithelialisation
* Trans-epidermal water loss
* Infection status.

There will be 3 and 12 month follow up with assessment of scarring.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a Superficial Partial Thickness wound (2a) either from a thermal injury or from a skin graft donor site under the care of St. Andrews service, within the recruitment timeline.
* Wound area to be treated in study must be less than 5% of total body surface area (TBSA).
* Patients aged over 12 months and up to and including 80 years old.
* Informed Consent

Exclusion Criteria:

* Any inclusion criteria not met
* Unwilling to consent to investigation/ unable to provide consent
* Wounds deeper than superficial partial thickness (2b, 3 and 4)
* Chemical /Electrical burns
* Already having received silver sulfadiazine
* Disease that could affect wound healing
* Previous participation in the study
* Females who are pregnant or breast-feeding.
* Relative, spouse or employee of the investigational site
* Known multiple allergic disorders
* Skin disorders
* Facial burns
* Patients who have taken part in any investigational studies within the last 30 days prior to participation.
Comparison of Intercostal and Quadriceps Femoris Muscle Oxygenation in Women and Men

The differences in physiological responses due to gender during exercise tests have recently begun to be investigated. The oxygen use of respiratory muscles and lower extremity muscles may differ during upper and lower extremity exercise tests, but there is no study on this subject in the literature. The primary aim of this study was to compare intercostal and quadriceps femoris muscle oxygenation during upper extremity and lower extremity maximal exercise tests in women and men. The secondary aim of the study was to investigate the relationship between intercostal and quadriceps femoris muscle oxygenation and upper extremity and lower extremity exercise capacity, body composition, respiratory muscle strength, and respiratory muscle endurance in women and men.

Differences in physiological responses due to gender during exercise tests have recently been investigated. In a study, it was determined that respiratory muscles such as intercostals use more oxygen during exercise tests in women. It was shown that this situation is related to the smaller rib cage, mechanical disadvantage of the diaphragm, narrower airway diameter and greater activation of accessory respiratory muscles in women. The fact that respiratory muscles consume more oxygen in women causes blood flow to the respiratory muscles to be higher. This situation causes a decrease in the amount of oxygen carried to the peripheral muscles, which may cause early fatigue in the peripheral muscles during the exercise test. Muscle oxygen saturation (SmO2) indicates the oxygen uptake and oxygen consumption of the muscle. This can be determined using continuous wave near infrared spectroscopy (NIRS, 630-850 nm) device, which measures changes in the amount of hemoglobin bound to oxygen at the microvascular level. Research on gender-related differences and how SmO2 levels in these muscles change during exercise in women is limited. The aim of the study was to compare intercostal and quadriceps femoris muscle oxygenation during upper extremity and lower extremity maximal exercise tests in women and men.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35 years,
* Physically active (doing moderate intensity physical activity 3 days a week for 150 minutes / week)
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Healthy individuals with any diagnosed chronic or systemic disease,
* Those who smoke 10 packs x years or more,
* Those with pneumonia or any acute infection,
* Those with any psychiatric disorder will not be included in the study.
A Long-Term Safety Study of ALKS 5461

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Agree to use an approved method of contraception for the duration of the study
* Have the potential to safely benefit from the administration of ALKS 5461
* Have a diagnosis of major depressive disorder (MDD)
* Additional criteria may apply

Exclusion Criteria:

* Have a positive test for drugs of abuse
* Currently pregnant or breastfeeding
* Have a current primary Axis-I disorder other than MDD
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
* Have attempted suicide within the past 2 years
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation within the past 60 days
* Additional criteria may apply
Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis

The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.

Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed endometriosis with ultrasound or surgery
* no metabolic diseases
* no rheumatological diseases

Exclusion Criteria:

* Immune modulator, hormonal, anti-inflammatory use history in the last 3 months
Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan

Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past.

Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan.

Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist t at the time of recruitment.
* Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
* Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan.

Exclusion Criteria:

- Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.