cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).

Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years, \<85 years, life expectancy \>3yrs.
* Documented history of severe fecal incontinence for at least 6 months
* Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage
* Subject has failed standard conservative and medical therapy
* Subject is a surgical candidate.
* Subject is willing and able to cooperate with follow-up examinations.
* Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.

Exclusion Criteria:

* Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders
* Subject has current, external full thickness rectal prolapse or vaginal prolapse
* Subject has an electric or metallic implant within 10cm of the area of device placement
* Subject has Inflammatory Bowel Disease
* Subject has Irritable Bowel Syndrome
* Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
* Subject has active pelvic infection
* Subject has chronic diarrhea
* Subject diagnosed with anal, rectal, or colon cancer within 2 years
* Subject has had prior anterior resection of the rectum
* Subject has undergone pelvic radiation therapy
* Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula
* Subject has had previous anorectal posterior compartment surgery
* The procedure is an emergency procedure
* Subject is currently being treated with another investigational drug or investigational device.
* Subject cannot understand trial requirements or is unable to comply with follow-up schedule.
* Subject is pregnant or nursing, or plans to become pregnant.
* Subject has history of complex anal fistula
Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer

CA19-9 is an acidic glycoside containing sialic acid, called ganglioside. Lewis blood group antigen is the precursor for the synthesis of CA19-9, which is formed by the combined action of sialic acid transferase and fucosyltransferase (FUT3). The ability to produce soluble blood group substances is determined by the alpha (1,2) fucosyltransferase gene (FUT2), which can be divided into secretory Se, weakly secretory Sew, and non secretory SE. The Lewis antigen positive (Lewis+) population has normal CA19-9 secretion function, while the Lewis antigen negative (Lewis -) population (about 7%) usually shows no or low secretion of CA19-9. Therefore, when CA19-9 is used as a biomarker, the combined detection of Lewis antigen status is a marker to judge the prognosis of pancreatic cancer, which can divide pancreatic cancer patients into high/medium/low malignant phenotypes.

1. This study adopts a prospective, multicenter design, and classifies pancreatic cancer patients and predicts their prognosis through Lewis antigen detection and CA19-9 detection.
2. Observe the survival time of pancreatic cancer subjects to observe the consistency between Lewis typing and prognosis, and evaluate the sensitivity of Lewis antigen detection.
3. Evaluate the specificity of Lewis antigen detection by observing the distribution of Lewis subtypes in non pancreatic cancer subjects.
4. Explore the prognostic distribution of age, different Lewis subtypes, and overall survival cycle for Lewis antigen detection.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily enrolled, regardless of gender, aged ≥ 18 and ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form;
2. ECOG 0-2
3. Pathologically confirmed as pancreatic ductal adenocarcinoma; Or confirmed by pathology and clinical examination as pancreatic ductal adenocarcinoma.
4. Willing to accept routine CA19-9 testing, Lewis antigen sample collection and testing (2-3ml), and follow-up Non pancreatic cancer subjects enrolled in this study must meet all the following criteria

1. Voluntary enrollment, regardless of gender, age ≥ 18 years, ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form 2. Willing to accept Lewis antigen sample collection and testing (2-3ml)

Exclusion Criteria:

1. Suffering from the second or double primary malignant tumor besides pancreatic cancer at the same time
2. Patients with pancreatic cancer who cannot trace the specific anti-cancer treatment plan
3. HIV positive
4. Other situations that researchers believe need to be excluded
Daratumumab in Treating Patients With Multiple Myeloma

This phase II trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab.

II. Estimate the time savings versus (vs) predicted infusion time.

OUTLINE:

Patients receive daratumumab intravenously (IV) over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have received \>= 2 daratumumab infusions and be scheduled to receive another dose
* All races and ethnic groups are eligible for this study
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
* Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
* Prisoner
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine

This study is designed to investigate the pharmacokinetic drug interaction between Udenafil and Dapoxetine in healthy male subjects

Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study

Investigational Product : Udenafil, Dapoxetine


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old at screening
* Body mass index(BMI) in the range of 19 to 27 ㎏/㎡
* Sitting position blood pressure down to meet the criteria at the time of screening (90mmHg≤Systolic blood pressure≤140mmHg)

Exclusion Criteria:

* History of clinically significant disease or kidney, liver and biliary system, digestive system, respiratory, musculoskeletal, endocrine, neurological psychiatric blood and tumor system, cardiovascular system, etc.
* History of gastrointestinal diseases or gastrointestinal operation which might affect the study drug absorption
* Clinically significant hypersensitivity or with a history of hypersensitivity reactions to Udenafil, Dapoxetine ingredients that included elements of the same family of drugs, or other medications
* ≥ 1.5 fold of normal upper limit(UNL) in the level of ALT, AST
* Alcohol, excessive intake (\>21 units/week)
* Excessive smoker (\>10 cigarette/day)
Post-bariatric Abdominoplasty: Skin Sensation Evaluation

The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.

Additional purposes were: quantify topographically the abdominal skin sensation of the Normal weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the abdominoplasty - excess skin surgical removal without flap undermining -\> Anchor Line Abdominoplasty).

Abdominoplasty performed in post-bariatric patients presents more post-operative complications than in non post-bariatric patients. Surgical techniques that provokes less complications are required.

Anchor-line abdominoplasty is a technique published in the years 1950 as well the first bariatric proceedings. Abdominoplasty without flap undermining is feasible in pendular abdominal wall of the former morbidly obese women with scarred abdomen.

Classical abdominoplasty (with flap undermining) is known to impair significantly the skin sensation. Post-bariatric abdominoplasty without flap undermining keeps the skin sensation unaltered since the early post-operative period.

Now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves. Could this technique improve the skin sensation of the anterior abdominal wall of the post-bariatric patients?

Eligibility Criteria:
Inclusion Criteria:

* Former morbidly obese women with Body Mass Index superior of 40kg/m2.
* Post-bariatric surgery: Roux en Y gastric bypass.
* Clinical conditions to perform a plastic surgery.

Exclusion Criteria:

* Diabetes.
* Peripheral neuropathy.
* Deny to sign the Informed Consent Term.
Focus on Fibre Study

The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.


Eligibility Criteria:
Inclusion Criteria:

* healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
* low habitual fibre intake (\<10g/day)

Exclusion Criteria:

Medication exclusion criteria:

* antibiotic use (within the past 3 months due to impact on gut microbiota)
* statins (current)
* aspirin or other NSAIDs or anti-coagulants (current)
* anti-depressants (current)
* smoking or vaping

Medical exclusion criteria:

* Females who are planning to be pregnant, are pregnant or are breastfeeding
* Anyone with food allergies, self-reported food sensitivity or intolerance
* Anyone with coeliac disease or gluten intolerance
* Anyone taking medication which may affect their appetite
* Anyone with an eating disorder
* Anyone with diabetes
* Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout
* Anyone suffering from a psychiatric disorder or any type of substance abuse
* Anyone suffering from unregulated thyroid disease

Other exclusion criteria:

* Anyone following a vegetarian or vegan diet
* Anyone following a weight loss programme (that may be affecting lifestyle, physical activity \& diet)
* Anyone with unsuitable veins for blood sampling
* Anyone who is unable to fluently speak, read and understand English
* Anyone who is unable to comply to an alcohol-free diet for 6 weeks
Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis

Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis


Eligibility Criteria:
Inclusion Criteria:

* Active ankylosing spondylitis (pain rated \>= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease

Exclusion Criteria:

* none
Executive Function in Learning in Children With Attention Deficit Hyperactivity Disorder (ADHD) Receiving Medical Treatment Alone Compared to Children Receiving Additional Treatment to Improve Learning Strategies

The purpose of this study is to determine whether there is a difference in executive function in learning in children with ADHD receiving medical treatment alone to the executive function in children receiving, in addition to medical treatment in learning strategies.


Eligibility Criteria:
Inclusion Criteria:

* Normal development for age
* ADHD

Exclusion Criteria:

* Low compliance
* Developmental delay
* Chronic disease
Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study

The goal of this observational study is to learn about the brain imaging changes associated with concussion using a very detailed (7T) MRI scanner.

To do this, the investigators will study 7T MRI brain imaging in patients aged 18-40 who present to the Emergency Department within 96 hours of a head injury. Patients will be eligible if they have had a normal CT brain as part of their usual care.

The investigators will compare brain imaging from patients who have completely recovered from an episode of concussion to patients who still have significant symptoms at approximately 28 days after a head injury.

The study attempts to answer the following questions:

1. Do patients with ongoing symptoms after concussion show greater 7T MRI brain imaging evidence of changes to the blood vessels at approximately 28 days after their injury in comparison to patients who have recovered fully?
2. Do patients with ongoing symptoms after concussion show greater 7T MRI brain imaging evidence of changes in brain signaling pathways at approximately 28 days after their injury, in comparison to patients who have recovered fully?

Evaluation of symptoms will be conducted at presentation in the Emergency Department and at 25 +/- 3 days after head injury. This will be assessed using 2 validated questionnaires: the Neurological Assessment Questionnaire (NAQ) and the Post Concussion Symptom Scale (PCSS).

Lifetime incidence of concussion will be assessed at 7T MRI using the a modified version of the Brain Injury Screening Questionnaire (BISQ).

Information will also be collected regarding painkiller use, anticoagulation, return to work, and any related further unscheduled care admissions or CT head imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Isolated head trauma
2. Initial review within 96h of injury
3. No acute findings on CT head
4. Aged 18-40 years

Exclusion Criteria:

1. Patient unable to give informed consent
2. Patient unable to speak and understand English
3. Patients where alternative diagnosis cannot be excluded
4. Polytrauma
5. Contra-indication to MRI
6. BMI \>40 or unable to comfortably lie on MRI scanner
7. Pregnant
8. Major confounding neurological disease e.g Multiple sclerosis, Stroke, Parkinson's Disease.
9. Patient participation in other research studies concurrently
Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

This project has focus on patients in palliation testing a digital platform TelePal.dk.

The aim of the RCT study is to:

• Test, implement, and evaluate a telepalliation program for patients receiving palliative care (cancer, heart failure (HF), COPD, and motor neuron disease) from a clinical, psychosocial, inter-organizational, and health economic perspective.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Live in Esbjerg, Varde, Billund, Fanø or Vejen Municipality
* Cancer, heart failure, chronic obstructive pulmonary disease (COPD), and motor neuron disease (neurological diseases) referred to the Palliation Team at Southwest Jutland Hospital
* Basic computer skills or a relative who has basic computer skills

Exclusion Criteria:

* Delirium at enrolment based on CAM score
* Active psychiatric history (as noted in the medical record) other than depression or anxiety related to the main diagnosis referred to palliative care
* Lack of ability to cooperate
Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils

The purpose of this study is to determine if aromatherapy (essential oil) is effective at reducing up-set stomach and vomiting after surgery and in reducing the need for up-set stomach medications

If participants decide to take part in this study, they will be asked to use choose a small nasal inhaler from a bag, open the sealed package, and inhale from the nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth, just prior to entering the operating room. During recovery in the Post-operative acute care unit (PACU), nausea severity will be rated using a 0-3 scale where zero indicates no nausea.

If your score is 1-3, participants will be instructed/assisted in using a nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth. After 5 minutes, nausea scores will be collected again and if the score is the same or higher, participants will be asked to use the nasal inhaler again in the same manner as before. If their nausea has not resolved after the second use, they will be give anti-nausea medication that a surgeon ordered. This process will be repeated again whenever you complain of nausea, until they are discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* post-op surgical patients at least 18 years of age or older
* the ability to understand and follow directions for use of essential oils
* the ability to understand and give informed consent to study
* the ability to understand, read and write English
* ambulatory or short-stay/23-hour patients

Exclusion Criteria:

* History of any pulmonary disease, including but not limited to: asthma, COPD, OSA, chronic bronchitis, pulmonary and ear, nose, throat (ENT) surgery patients
* Allergy to any of the ingredients in the essential oils
* Sensitivity to strong odors
The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus

This randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lichen planus (OLP). The study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.

Oral lichen planus (OLP) is a chronic, immune-mediated inflammatory condition that causes painful mucosal lesions and significantly impairs patients' quality of life. Although topical corticosteroids are the standard treatment, their long-term use is associated with adverse effects. Curcumin, a natural compound with anti-inflammatory and antioxidant properties, has shown promise as an alternative treatment. However, its clinical application is limited by poor bioavailability.

This randomized, double-blind, controlled clinical trial aims to compare the therapeutic effects of curcumin in nanogels and 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive OLP. Thirty eligible participants will be randomly assigned to either the curcumin nanogel or fluocinolone group, and treatment outcomes will be evaluated using the Oral Lichen Planus Disease Activity Scale (OLP-DAS) and a patient satisfaction questionnaire over a 4-week period.

The study is conducted at the Faculty of Dentistry, Chulalongkorn University, and seeks to evaluate whether curcumin nanogels offer comparable therapeutic efficacy to corticosteroids, with potentially fewer side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability to provide written informed consent
* Clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (OLP)
* Presence of symptoms (NRS pain score \> 0 at baseline)
* Ability to communicate and follow instructions
* Willingness to apply oral paste treatment and comply with study protocol

Exclusion Criteria:

* Pregnancy or lactation
* Current orthodontic treatment
* Uncontrolled diabetes mellitus (HbA1c \> 7% or FPG \> 130 mg/dL)
* Use of anticoagulants or antiplatelet agents
* Severe dry mouth (Challacombe score \> 7)
* History of gastric ulcers, duodenal ulcers, or gallstones
* Presence of any active malignancy or infection
* Use of topical/systemic treatment for OLP in the past 2 weeks
* Current use of immunosuppressants
* Known allergy to corticosteroids or herbal agents such as turmeric
* Diagnosis of oral lichenoid contact lesion or graft-versus-host disease (GVHD)
* History of allogeneic bone marrow transplantation
* Current smokers
Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults with Type 1 or 2 diabetes
* Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion Criteria:

* Patients must not be in poor or unstable health.
Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.

To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.

Given that this is the first study to explore the potential effects of exercise training on exercise capacity, tumor vascularity and response in women undergoing neoadjuvant chemotherapy for operable breast cancer, prior to the initiation of the full investigation, we will conduct a small vanguard study to ensure we can achieve acceptable exercise adherence rates in the absence of dose-limiting toxicities (DLTs). Specifically, three operable breast cancer patients will be recruited and enrolled as described below and perform exercise training for a minimum of six weeks. If acceptable exercise rates are observed in the absence of severe DLTs during this time, we will proceed with the full investigation (recruitment of additional 20 patients) (see Figure 2). Using a prospective, randomized design, potential participants will be identified and screened for eligibility by an assigned Breast Protocol Nurse (TBD) via medical record review of patients scheduled for their primary neoadjuvant chemotherapy consultation at DCCC

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed operable primary breast cancer
* Age 18 or older
* Karnofsky performance status greater than 70
* No previous malignancy
* Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%)
* No hormonal replacement therapy use within the past month
* Not pregnant
* Ability to read and understand English
* Signed written informed consent prior to beginning protocol specific procedures
* Willing to travel to DUMC to exercise three times per week
* Primary treating oncologist approval