cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer

To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.

This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of 1 or more active gastric ulcers (≥3 mm \~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.

Exclusion Criteria:

1. Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of \>3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
2. Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
3. Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
4. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
5. Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery

Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.

Seventy patients indicated for induction of labor will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, transvaginal ultrasound will be done to assess the posterior angle and the length of the cervix. Then vaginal examination will be done to measure the Bishop score. Analysis will be done to identify the best predictor of successful induction of labour.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 35 and 42
* Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
* The fetus is living
* Cephalic presentation

Exclusion Criteria:

* Estimated fetal weight more than 4 kilograms
* Malpresentation
* Oligohydramnios
* Polyhydramnios
* Non-reassuring non-stress test before induction of labor
* Cephalo-pelvic disproportion
* Previous operation on the cervix as cautery or cerclage
* Previous cesarean section
* Any contraindication to vaginal delivery including placenta previa
* Anomalous fetus
* Morbid obesity
Poznan Prospective Study of Type 1 Diabetic Patients

The purpose of this study is to evaluate the development and progression of chronic complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular events) in patients with type 1 diabetes treated from the onset of the disease with recommended method of intensive insulin therapy. All patients attended a five-day structured training program during first hospitalization and re-education once year during the observation. After five years of observation and next - once a year chronic complications are assessed. The investigators would like to evaluate also the relationship of the management of the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory markers with development and progression of chronic complications.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency (serum C-peptide level \<0.05 ng/ml, acetonuria, blood gases disturbances such as: pH \<7.30, BE\< -6 mmol/l, HCO3 \<18 mmol/l)
* Age \< 35 years old
* Educational course in intensive insulin therapy started at the onset of the disease after treatment of ketoacidosis
* Written consent

Exclusion Criteria:

* Uncertain type of diabetes mellitus
* Kidney failure (serum creatinine level \> 1.1 mg/dl)
* Liver dysfunction (AspAt \> 31 U/l, AlAt \> 34 U/l)
* Acute inflammatory process
* Other concomitant diseases (i.e. neoplasm)
Lumbar Paraspinal Muscular Properties After Cesarean Delivery

The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.

Stiffness and elasticity are two mechanical characteristics of the muscles, whereas relaxation time and creeping are two viscoelastic characteristics.

Different studies investigated the mechanical properties of lumbar paraspinal muscles in numerous musculoskeletal conditions, however, no previous studies investigated these characteristics after cesarean section, which is associated with high prevalence of lower back pain when compared with normal delivery.

Eligibility Criteria:
Inclusion Criteria:

* Women who experienced cesarean section at least for one time
* Women Who are free of specific lower back disorders
* Women who are below 34 years old and above 20 years old

Exclusion Criteria:

* Women who experienced normal vaginal birth
* Women who complain of a specific lower back disorder
* Women who are above 34 years old or below 20 years old
* Women who have a body mass index above 30 Kg/m2
Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

This trial studies cardiac changes after radiation or chemo-radiation for the treatment of lung or esophageal cancer that has not spread to other places in the body (non-metastatic) or has not come back (non-recurrent). Continuous cardiac monitoring with an implanted device may help to identify cardiac changes that would remain unnoticed, and facilitate the treatment of these early cardiac changes as part of standard care.

PRIMARY OBJECTIVE:

I. To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.

EXPLORATORY OBJECTIVES:

I. Define the spectrum of cardiac toxicity among chemoradiotherapy (CRT) patients at highest risk of cardiac toxicity.

II. Establish the timeline of cardiac toxicity development and identify early predictive findings of permanent damage.

III. Characterize the areas of the heart at highest risk for persistent cardiac damage.

IV. Identify a dose response threshold for radiotherapy (RT) damage in different areas of the heart.

V. Improve survival by alerting the cardiology team of the need for life-saving standard of care interventions.

VI. Describe medical interventions employed for the cardiac events identified in the study.

OUTLINE:

Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.

After completion of study treatment, patients are followed up at 4 weeks, 3, 9 and 12 months post RT.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Planned standard of care curative thoracic RT or CRT with anticipated heart V40 \> 20 cc (At least 20 cc of the heart should receive a dose of 40 gray \[Gy\] or higher)
* Able to follow-up at all specified standard of care time-points
* Patients can receive treatment as part of the standard of care or in a different study
* Receiving radiation treatment to an area close to the heart, for example gastroesophageal junction cancer, hilar lung cancer, or mainstem bronchus lung cancer
* Any type of systemic therapy or surgery before during or after radiation is acceptable
* Prior radiation to other areas is acceptable
* Planned radiation doses equal or higher than 40 Gy

Exclusion Criteria:

* Metastatic disease
* Recurrent disease
* Patient receiving radiation prescription doses lower than 40 Gy
* No prior radiation that included any part of the heart is acceptable
* No thoracic re-irradiation
Platelets Antiaggregation Control Enhancement (PACE) Study

Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

* none.
Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs

Pressure injuries (PIs) represent a significant clinical complication for patients worldwide and pose financial and quality challenges for healthcare systems. These wounds, which are highly challenging to treat and care for both patients and caregivers, lead to physical and psychological trauma, negatively affect daily life activities, reduce quality of life, and increase care costs (Padula et al., 2019; Yilmazer \& Tüzer, 2022). Moreover, the expenses associated with treatment are 2.5 times higher than those for prevention (Lyder \& Ayello, 2007). Additionally, they often prolong hospital stays and increase the time nurses spend on care (Yilmazer \& Tüzer, 2022).

According to the National Pressure Injury Advisory Panel (NPIAP, 2019), providing high-quality care for patients with PIs requires adopting a multidisciplinary, standardized care approach tailored to the specific needs of patients (Heasler, 2019). Past and current literature supports the use of evidence-based care bundles to reduce PIs (Coyer et al., 2015; Chaboyer et al., 2015; Amr et al., 2017; Deakin et al., 2020; Yilmazer \& Tüzer, 2022; Wang et al., 2023). A care bundle is a critical element for standardizing and enhancing the quality of nursing care through the utilization of evidence-based clinical practice guidelines by healthcare professionals. Therefore, adopting these evidence-based approaches will improve the consistency and quality of nursing care, enhance patient outcomes, and reduce institutional costs. Moreover, the use of care bundles during interventions promotes teamwork and collaboration while supporting the development of a common language (Anderson et al., 2015; Institute for Healthcare Improvement, 2021).

This study aims to reduce PIs, enhance the quality of patient care, lower healthcare costs, and improve overall patient outcomes through the development and implementation of a nursing care bundle based on evidence in the literature. The widespread use of the care bundle, grounded in achieved outcomes, will contribute to the prevention of PIs. Additionally, it will serve as a supportive tool for nurses to improve the quality of care.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Patients who fall into all risk categories assessed by the Braden scale
* Not having developed a pressure injury anywhere on their body
* Expectation of a minimum of 24 hours or more in the intensive care unit

Exclusion Criteria:

* Being 18 years of age or younger
* Having and developing a pressure injury anywhere on their body
* Expectation of a less than 24-hour stay in the intensive care unit
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome

Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI microbiota and well being are analysed in subjects claiming GI inconveniences due to Irritable Bowel Syndrome or food intolerances.

Study objectives: Analysis of consequences of Hydro Colon Therapy plus probiotic intervention on GI microbiota and well being.

Study group: 78 subjects, inclusion criteria: 20-50yrs; under consultation at doctors or nutritionists because of claimed food inconveniences or Irritable Bowel Syndrome. exclusion criteria: antibiotics treatment and specified complex diseases.

Intervention: Hydro colon therapy 2- 5 washes within 3 weeks. probiotic intervention after end of Hydro colon therapy for 6 weeks ( DUOLAC® bacterial strains per capsule: Lactobacillus plantarum, Streptococcus thermophiles, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium breve, fructooligosaccharides, 200 µg folic acid, 2.50 µg vitamin B12 and 55 µg selenium (all amounts corresponding to 100% of daily requirement). Control group: Vitamin B complex: 10µg cobalamin, 450µg folic acid, and 55 µg selenium.

Sample collection: standardized Feces collection, T1, before colon hydrotherapy, T2, immediately after colon hydrotherapy 2-5 washes of fasting ; T3, after six weeks of probiotic or Control intervention Analysis: standardizes food frequency questionnaire before and after intervention.

Feces analysis based on 16 S ribosomal DNA (rDNA) PCR DGGE and quantitative PCR (qPCR) and bioinformatic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances

Exclusion Criteria:

* Pregnancy
* Antibiotic therapy 0,5 yrs before start
* Hormone therapies
* Malignant diseases
* Subjects were asked to avoid dietary supplements 4 weeks before and during the study.
A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

The goal of the present study is to use computationally driven models of speech understanding in CI users to guide the search for which combination of active electrodes can yield the best speech understanding for a specific patient. It is hypothesized that model-recommended settings will result in significantly better speech understanding than standard-of-care settings.

Aim 1 is to quantify speech understanding and sound quality with model-recommended combinations of active electrodes compared to standard settings, and compared to two control active electrode combinations. Aim 2 is to translate the model-driven recommendations from Aim 1 into practical guidance about how many (and possibly which) CI electrodes to deactivate.

Eligibility Criteria:
Inclusion Criteria:

Cochlear implant subjects

* must be older than the age of 18
* implanted unilaterally with CI with at least 1 year of experience
* no diagnosis of any other communicative or cognitive disorder.
* English-speaking
* willingness and ability to provide informed consent

Normal hearing subjects

* must be older than age of 18
* no diagnosis of any other communicative or cognitive disorder.
* English-speaking
* willingness and ability to provide informed consent

Exclusion Criteria:

not meeting the inclusion criteria above
Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles

This study investigates the evolution of sensory, motor and tissue variables following exercise-induced pain in wrist extensor muscles in healthy subjects.

The aim of this study is to determine how is the normalization process of sensory (pressure pain thresholds, subjective pain sensation, self-recovery perception), motor (maximal isometric strength, active range of motion, manual dexterity) and tissue (myotonometer) variables after an experimental pain model in the extensor forearms muscles, by delayed onset muscle soreness after an eccentric exercise in healthy subjects. This way will be possible to establish 1) if there are differences in the time of normalization for each variable; 2) if there is a correlation between each variable and self-recovery perception.

Seven assessment sessions are performed in a 14-days period. Day 0 (baseline assessment 1), Day 7 (baseline assessment 2, pre exercise), Day 7 (post exercise), Day 8 (24-hours post exercise), Day 9 (48-hours post exercise), Day 10 (72-hours post exercise), Day 14 (1-week post exercise).

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy subjects of both sexes.
* Age: 18-50.
* Being free from any pain specific to the upper limb and/or in general.

Exclusion Criteria:

* History of acute or chronic painful condition in the previous 3 months.
* Regular medication intake for any reason.
* History of severe injury in the upper extremity (e.i. fracture).
* Prior surgery in the upper limb.
* Diagnosed of any chronic pain syndrome (fibromyalgia, migraine, etc.) or severe disease.

Withdrawal Criteria:

* Being involved in new physical stimulus, which volunteer is not used to.
* Micronutrient supplementation intake.
* NSAIDs or other medication intake.
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
* Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
* HIV ribonucleic acid (RNA) \< 50 copies/mL at the screening visit.
* Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
* Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
* Active tuberculosis infection.
* Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
* Females who are pregnant.
* Females who are breastfeeding.
* Acute hepatitis in the 30 days prior to study entry.
* Chronic Hepatitis B Virus (HBV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
eCEASE to Support Treatment for Parental Tobacco Use

The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.


Eligibility Criteria:
Inclusion Criteria:

* Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. "Smoker" will be defined as answering "yes" to either of the screening questions: "Have you smoked a cigarette, even a puff, in the past 7 days?" and "Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?"

Exclusion Criteria:

1. Parent/legal guardian does not speak English;
2. No telephone; and
3. Prior enrollment in the study during a previous visit.
Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:

* Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
* Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.

Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated.

A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:

* Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
* Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.

Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated by a blined epidemiology nurse.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain).
* Haemorrhoids grade III and IV
* The patients sign an Informed Consent Form agreeing their participation in the study.

Exclusion Criteria:

* Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan
* Haemorrhoids grade I and II
* Patients with medical or surgical pathologies that do not allow the participation in the study
* Disability to understand and accept the entry in the study
Women With Migraine With Aura Neuroimaging Study

The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain


Eligibility Criteria:
Inclusion Criteria:

* female
* case (migraine with aura), co-twin to case, or control (migraine-free)
* residency in Denmark
* no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders

Exclusion Criteria:

* male
* residency outside Denmark
* registered in Civil Registry as not to be contacted by researchers
* severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
* mobile metal parts or other contraindication for MRI
* weight of 130+ kilograms
* pregnancy
* subjects that wished not to be informed about abnormal findings on MRI
* chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview)
* frequent tension-type headache (control group only, self-reported or diagnosed through physician interview)
DAratumumab and REvlimid REfractory MM

Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.


Eligibility Criteria:
Inclusion Criteria:

Phase I

* Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
* Patients aged ≥ 18 years
* Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

Phase II

* Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes
* Patients aged ≥ 18 years
* Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

Exclusion Criteria:

* Patients not willing to consent to review of clinical data