cyrilzakka/clinical-trials huggingface dataset:
Electrostimulation and PFMT for Stress Urinary Incontinence

The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. The main questions are:

What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone?

Participants will be evaluated before and after the interventions with the following methods:

International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF) Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.

The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave at least one birth vaginally and signed the consent form. Subjects were excluded if they were pregnant, were diagnosed with vaginismus, urinary tract infections, cancer, epilepsy, pelvic organ prolapse greater than stage I, skin diseases, had undergone previous pelvic floor surgeries, had heart stimulator, or metal implant and were unable to contract the PFM. Study participants were randomly divided into two groups: the I group (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's quality of life (QoL) was assessed according to the International Incontinence Counseling Questionnaire - Short Form. Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.

Eligibility Criteria:
Inclusion Criteria:

* Have given birth at least once
* Voluntary consent to participate in the study
* Do not have concomitant diseases
* Do not use hormonal drugs.

Exclusion Criteria:

* Less than three months have passed after childbirth
* Have heart implants or other metal implants
* Pregnancy
Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma

This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the bile ducts, gallbladder, or cholangiocellular carcinoma, with primary tumors located in the intrahepatic bile ducts, hilar bile ducts, distal bile ducts, or gallbladder;
2. Progression after prior gemcitabine-based systemic chemotherapy and refused or were intolerable to initial treatment with gemcitabine-based chemotherapy regimens;
3. At least one measurable objective lesion of the tumor according to the RECIST version 1.1 criteria, which must have a maximum diameter of ≥1 cm for spiral CT or ≥2 cm for plain CT or MRI; and should be performed within 28 days prior to enrollment;
4. Aged 18 to 75 years old;
5. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1;
6. Life expectancy of greater than 3 months;
7. Must be able to participate the study voluntarily and sign the informed consent document;
8. Adequate organ and bone marrow function as below:

Absolute neutrophil count ≥1.5\*109/L , platelet count ≥75\*109/L , hemoglobin ≥90g/L; Alanine aminotransferase, and aspartate aminotransferase ≤2.5 × upper limit of normal; Total bilirubin and serum creatinine ≤1.5 × upper limit of normal.

Exclusion Criteria:

1. Disease-free survival within 5 years due to other malignancies (except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix);
2. Serious or uncontrolled infectious disease (HIV, HBV DNA \> 500IU/ml);
3. Severe uncontrolled acute infection (infection causing a fever of 38℃ or higher)；
4. Severe hepatic or renal insufficiency; or recent history of myocardial infarction (within 3 months)；
5. Current or past autoimmune disease and susceptibility to its reoccurrence;
6. Serious or uncontrolled pleural effusion or ascites;
7. Subjects with a history of active tuberculosis infection within 1 year prior to the first administration of study drug. If in the judgment of the investigator, subjects with more than 1 year prior to the first administration of study drug were considered suitable for enrollment; Subjects with a long history of chronic diarrhea or the presence of complete intestinal obstruction;
8. Subjects requiring systemic therapy with corticosteroids (\> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of study drug.
9. Combined with other serious medical and surgical conditions that affected organ function;
10. Participated in other clinical trial within 4 weeks;
11. Pregnant or breastfeeding women or subjects of childbearing potential (males or females with less than 1 year of menopause) who were unwilling to use contraception;
12. Subjects with a history of allergic or hypersensitivity reactions to components of the study drug;
Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision

This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.

This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years of age undergoing circumcision will be included.

Exclusion Criteria:

* Patients \<18 years of age who did not provide consent to be randomized.
Annexin A5 in Patients With Severe COVID-19 Disease

Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 19 years
2. Positive test for SARS-CoV-2 virus (anytime during current illness episode)
3. Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)

Exclusion Criteria:

1. Known allergy to any of the ingredients or components of the investigational product
2. Known pregnancy
3. Moribund and not expected to survive beyond 24 hours
4. Known or suspected risk for serious bleeding complications (note that Disseminated Intravascular Coagulopathy (DIC) is an expected finding in patient with sepsis and COVID-19 disease and is not an exclusion criterion on its own)
5. Acute or chronic renal failure (dialysis dependent)
Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

Argonaute (AGO) proteins have been described as the target of antibodies in several autoimmune diseases including Sjögren Syndrome (SS). Sensory neuronopathies (SNN) are disorders affecting neurons in the dorsal root ganglia that may depend on an inflammatory process. However, identifying these cases needs the availability of specific biomarkers. The aim of this study is to test the prevalence of anti-AGO antibodies in a population of patients with Sensory neuronopathies (SNN) with and without associated autoimmune disease in comparison with other peripheral neuropathies to determine how anti-AGO antibodies may help the identification of potentially dysimmune Sensory neuronopathies (SNN).

Sensory neuronopathies (SNN) are rare and debilitating diseases that fall under several etiologies. Among them, dysimmune forms are the most frequent but very difficult to identify when they do not occur in the context of associated systemic dysimmune disease (Sjögren Syndrome (SS) syndrome) because only a biopsy of the epiphytically unthinkable posterior spinal node would support the diagnosis. It is therefore necessary to have diagnostic biological markers of these forms to consider rapid treatment before irreversible neuronal degeneration.Using a protein-array technique, it has been showed that anti-FGFR3 antibodies was one of these markers and that it was associated with a clinical picture that differentiated from Sensory neuronopathies (SNN) without this antibody. Protein-array also allowed to identify another potentially interesting antibody for the diagnosis of Sensitive neuronopathies (NNS). This antibody recognizes the AGO1 protein. Anti-AGO1 antibodies have been described in association with system autoimmune diseases and in particular lupus but not in neurological diseases and more particularly in Sensory neuronopathies (SNN). The study want to validate the diagnostic interest of these antibodies by testing the collection of serums performed for studies on the anti-FGFR3 antibody and including patients with Sensory neuronopathies (SNN) and as controls of patients with another form of neuropathy and subjects with systemic autoimmune disease without peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sensory neuropathy

Exclusion Criteria:

* Patient not tested for anti-AGO antibody
The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles

The purpose of this experiment is to analyze wrinkle severity, the skin barrier and facial pigmentation level after topical almond oil application, compared to the use of topical retinol. Both the almond oil and the 0.5% topical retinol studied is investigational.

The natural cosmetic market is a multi-billion-dollar industry. Nutraceuticals and foodbased cosmetics are a growing trend within dermatology. Almonds are a rich dietary source of a range of fatty acids, phytochemical polyphenols, and antioxidants \[1\]. The previous study done by Dr. Raja Sivamani was a double blinded study that compared oral almond intake to a calorie matched non-nut-based intake over 12 weeks.The study determined that that there was a statistically significant improvement in wrinkle severity and pigment intensity in the women that received almond supplementation. This proposal aims to now understand how the topical application of almond oil may influence the appearance of wrinkles and facial tone in post-menopausal women. Almond oil is rich in fatty acids and alpha-tocopherol \[2\]. Tocopherol inhibits melanogenesis in melanocytes \[3\] and topical alpha tocopherol has been shown to improve skin antioxidants and hyperpigmentation \[4, 5\].

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women of Fitzpatrick skin types 1 and 2

Exclusion Criteria:

* Those with a nut allergy
* Smoking is an independent risk factor and serves as a confounder for the development of facial wrinkles and photoaging \[14\]. Therefore, current smokers, those that have smoked within the past year, and former smokers with greater than a 20-pack year history of smoking will be excluded.
* Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes) will be excluded as this can be a confounder for facial wrinkles.
* Those who have undergone any cosmetic procedures to the face in the 4 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment will also not be eligible.
* Individuals who are unwilling to discontinue vitamin E food sources during the washout and intervention. This includes

  * Vitamin E containing supplements.
  * Sunflower seeds or sunflower oil.
  * All nuts.
* Individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment:

  * Retinoids such as tretinoin, adapalene, retinol, except as provided by the study.
  * Antioxidant ingredients such as vitamin C or vitamin E.
  * Pigment reducing agents such as hydroquinone, a retinoid, azelaic acid, kojic acid, pomegranate seed oil, and other similar agents per the discretion of the investigator, except for the retinol that is provided in this study.
  * Topicals that contain a nut oil or nut extract as part of their ingredient list.
Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

In 2016, a systematic review and meta-analysis assessing the effects of systematic high FiO2 (80%) compared with standard FiO2 (30%) concluded that high FiO2 was associated with a reduction of SSI in patients undergoing surgery under general anesthesia. Consequently, the WHO recommended that "adult patients undergoing general anesthesia should receive an 80% FiO2 intra-operatively to reduce the risk of SSI".These recommendations have sparked a large debate on the benefits and harms of hyperoxemia. From the theoretical point-of-view, several pro (prevention of hypoxemia, SSI, and postoperative nausea and vomiting) and con (respiratory adverse events, increased production of harmful "reactive oxygen species") arguments have been raised by believers and detractors of high FiO2. Accordingly, and despite these recommendations, anesthetists still used a wide range of intraoperative FiO2 in daily practice and frequently changed FiO2 settings during surgery unrelated to patients' PaO2 or SpO2.

The PROXI study, the largest multicenter randomized controlled trial specifically designed to assess the role of high vs. low intraoperative FiO2 on SSI, did not report any reduction of the incidence of SSI with the administration of 80% FiO2 during colorectal surgery. Similarly, the recent multicenter randomized iPROVE-O2 trial that included 740 patients undergoing major abdominal surgery, ventilated intraoperatively with an evidence-based protective strategy, reported a similar SSI rate between the 30% and 80% FiO2 groups.

Eligibility Criteria:
Inclusion Criteria:

* - BMI of \<35 kg/m2
* scheduled for elective abdominal laparotomy/ laparoscopy under general anesthesia with an expected surgical time longer than 2 h.
* ASA I and II

Exclusion Criteria:

* - Patients undergoing minor procedures, where the expected duration of surgery will be less than 1 hour.
* emergency surgeries for bowel obstruction.
* abdominal surgery for vascular or plastic indications.
* patients with a recent history of fever,
* patients with uncontrolled diabetes mellitus,
* patient with known immunological dysfunction (on steroids, decompensated liver disease, HIV, etc.).
The Randomized Controlled Cocoa-Appetite Trial

The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite in humans. In addition the study is designed to test epicatechin, a compound found in cocoa and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite in humans.

The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.

Eligibility Criteria:
Inclusion Criteria:

* stable-weight, as indicated by weight gain or loss of \<2% in the past 6 months;
* engaging in only mild exercise\< twice a week;
* moderate alcohol users, \<2 drinks/day;
* willing to eat pizza.
* mentally and physically healthy.

Exclusion Criteria:

* smokers regular;
* frequent drinkers of coffee, tea or cola sodas, \>daily;
* underweight or obese (BMI: \<18.5 or \>30 Kg/m2);
* allergies to chocolate, cocoa, green tea, coffee or pizza;
* using medication;
* interested in registering in the future for the course Health \& Nutrition Sciences 2140, Introduction to the U.S. Health Care System, that is often taught by the PI of the proposed study
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-13 years old
* A history of cancer
* Treatment with a chemotherapy regimen including VCR and/or DOX
* Completion of chemotherapy at least one year prior to study enrollment and survey completion.

Exclusion Criteria:

* Patients with a:
* Primary pelvic tumor
* Pelvic irradiation
* Pre-existing bladder/bowel dysfunction
* Spinal defects
* Neurologic disorder
* Neuro-oncologic tumor or brain metastasis
* Cyclophosphamide or ifosfamide therapy
Comparative Study of Empathy and Anxiety in the Different Academic Years, at the Beginning of Academic Year and Exam Period in Healthy Students.

Students from different health science degrees will carry out a study on the variables of empathy, anxiety and personality profile.

Students from different health science degrees will carry out a study on the variables of empathy, anxiety and personality profile by means of validated questionnaires in order to compare them between different Spanish regions and in different courses to be able to see their evolution and characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are studying a health grade.
* Subjects that wish to participate in the study.

Exclusion Criteria:

* Students who do not wish to participate in the study.
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Sexually active at risk of pregnancy

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day
Mastectomy Flap Temperature Study

The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order to enable and facilitate the evaluation of important and novel research questions - and quality improvement (QI) ideas/objectives - that may improve the care of breast surgery patients.

Primary Objective(s)

* Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure).
* Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant.

Secondary Objective: To measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System.
* Aged 18 or older.
* Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria: Those who are male.