cyrilzakka/clinical-trials huggingface dataset:
Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool

This study aimed to evaluate the effectiveness of LactApp in improving breastfeeding self-efficacy among Filipino mothers.

Breastfeeding is crucial for maternal and child health, but Filipino mothers face significant challenges, worsened by the COVID-19 pandemic, which has limited access to traditional breastfeeding support. This study proposes evaluating the LactApp mobile application as a tool to enhance breastfeeding self-efficacy among Filipino mothers and improve nursing education.

The study's objectives include assessing LactApp's effectiveness in boosting mothers' confidence in breastfeeding and identifying gaps in nursing students' breastfeeding education. A mixed-methods approach will be used, combining quantitative assessments (via the Breastfeeding Self-Efficacy Scale-Short Form) and qualitative focus group discussions with mothers and nursing students. The study will also analyze user engagement and common breastfeeding queries to tailor educational content.

Expected outcomes include empowering nursing students with better breastfeeding knowledge, improving maternal support, and integrating digital tools like LactApp into nursing curricula. Ultimately, the study aims to enhance breastfeeding outcomes for Filipino mothers and contribute to improved maternal and child health in the community.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 16-45, including those who are pregnant or have recently given birth (within the last 12 months).
* Females who are currently seeking breastfeeding support and are open to using the LactApp tool.
* Females who are willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Females who are not intending to breastfeed.
* Females with significant health issues that may impair their ability to use the LactApp tool or participate in the study.
* Females who are not fluent in the language in which the LactApp tool is provided, making it difficult for them to engage with the content.
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia

Staphylococcus aureus bacteremia is a serious infection associated with a high mortality rate (with or without associated infective endocarditis (IE)), long hospital stays and multiple complications, due to the terrain in which it occurs and its secondary localization. They may be community-acquired or healthcare-associated infections. Being a carrier of S. aureus is a known risk factor for S. aureus bacteremia. Although several mucosal sites of carriage have been described, screening for carriage is most often carried out at the nasal level, both for reasons of simplicity and because it is the predominant site of carriage of this bacterium. However, S. aureus carriage is a frequent occurrence, affecting around 1/3 of the general population.

Long considered an extracellular bacterium, the investigators now know that S. aureus can have an intracellular reservoir. This was initially described in situations of infection (bone infections, vascular infections) and more recently in situations of nasal carriage without associated infection. Among S. aureus carriers, between 15% and 30% have an intracellular reservoir of this bacterium, depending on the study, in patients with no S. aureus infection. For S. aureus carriers with S. aureus infection, there are no data in the literature. The clinical significance of this intracellular reservoir in a carrier situation is currently unknown. The study team was able to demonstrate in vitro that this reservoir was not affected by the mupirocin used in decolonization, and preliminary results suggest that in vivo this reservoir may also be associated with decolonization failure.

Moreover, in vitro, it has been suggested that S. aureus may act on autophagy to promote intracellular survival. Is the intracellular reservoir more frequent in patients with S. aureus bacteremia? Is it associated with a poorer prognosis in S. aureus bacteremia? Is it associated with the production of certain S. aureus intracellular persistence factors? Is it associated with a slowdown in autophagic flow in nasal cells or phagocytes? These questions remain unanswered to this day.

To explore these questions, the investigators plan to conduct a study to assess the frequency of the intracellular S. aureus reservoir (within carriers) in S. aureus bacteremia and in bacteremia to another pathogen (control group). They would also like to study the impact of this reservoir on the persistence of carriage and prognosis (death, duration of bacteremia, length of stay, presence of secondary localizations of bacteremia or endocarditis in the case of S. aureus bacteremia).

Eligibility Criteria:
Inclusion Criteria:

* Bacteremia
* Patient affiliated or entitled to a social security plan
* Patient who has signed a consent form to participate in the study.

Exclusion Criteria:

* Antibiotic therapy in place for more than 5 days at the time of inclusion
* Nasal decolonization of S. aureus within 12 months
* Pregnant or breast-feeding women
* Patients under guardianship
* Polymicrobial bacteremia including S. aureus
Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers

Primary Objective:

To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.

Secondary Objective:

To investigate the safety and tolerability of meloxicam following a single dose of meloxicam capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study
2. Healthy adult male, aged between 20 and 40 years old
3. Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from biochemistry including: aspartate transaminase (SGOT/AST), alanine transaminase (SGPT/ALT), gamma-glutamyl-transferase (GGT), alkaline phosphatase, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, total cholesterol and triglyceride.
6. No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
7. No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past one year
2. Medical history of allergic asthma or sensitivity to analogous drug
3. Evidence of chronic or acute infectious diseases from 4 weeks before the study
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 3 months before the study
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study
9. Blood donation of more than 500 ml within the past 3 months
10. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
11. A positive test for HIV antibody
Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients with Hematologic Malignancies.

Primary end points are treatment-related mortality and engraftment. Secondary end points are regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

-Patients should have an unrelated donor who is matched for HLA-A and -B by serology and for -DRB1 by molecular typing.

Exclusion Criteria:

* Patients should not have major illness or organ failure
* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
* Patients must not be pregnant or lactating.
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Adults \>18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy.
2. Individuals with healthy mucosa.
3. Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
4. Patients with ECOG performance ≤2

Exclusion Criteria:

1. History of chemotherapy or radiotherapy.
2. Signs of systemic infections.
3. Pregnant and lactating women.
4. Individuals receiving systemic analgesics.
5. Liver disorders and renal failure with eGFR \<30 ml/min/1.73m2 (by the MDRD equation).
6. Inability to follow instructions and complete the questionnaires.
Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial

This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy

Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence

Gastric cancer is the second most common cause of cancer death worldwide. Surgery is the mainstay treatment for cure. Peritoneum is a common site of recurrence and the prognosis in patients with peritoneal recurrence is dismal. Hence, prevention is essential to patient's outcomes. In patients with serosal invasion, about half experience peritoneal recurrence within first 2 years after surgery, even after curative surgery. Peritoneal metastasis is caused by the implantation of free cancer cells in the peritoneal cavity exfoliated from the primary tumor before or during curative surgery. It is well known that cancer cells spillage could occur during surgery due to manipulation or even after lymph node dissection. If we can remove these free exfoliated cancer cells on the peritoneal lining, we may reduce the risk of tumor recurrence.

Recently, a study has demonstrated a dramatic reduction of peritoneal recurrence with extensive peritoneal lavage (EPL) in patients who underwent curative resection of gastric cancer. EPL was performed after the curative operation . The peritoneal cavity was washed with normal saline which is then followed by the complete aspiration of the fluid. This procedure was done 10 times using 1 liter of normal saline. The method was based on the 'limiting dilution theory' in which the method can dilute the number of free cancer cells to minimal hence reduce the risk of tumor implantation. In this study, among patients with microscopic peritoneal metastasis, peritoneal recurrence developed in 40% of patients with EPL and surgery, compared to 89.7% in patients with surgery alone. EPL carries minimal risk to patients. It is simple and inexpensive, and it is not time consuming. Hence, it may be an effective strategy for treatment of gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer.
* Patients planned for open or laparoscopic gastrectomy.
* Patients undergoing gastrectomy with curative intent.
* Lower age limit of research subjects 21 years old and upper age limit of 80 years old.
* Ability to provide informed consent

Exclusion Criteria:

* Patients who undergo a palliative gastrectomy.
* Patients who undergo a gastrectomy as emergency.
* Vulnerable persons under age of 21.
* Patients receiving neoadjuvant therapy.
* Patients presented with life-threatening bleeding from tumour
* ASA score of 4 \& 5
* Patients with another primary cancer within last 5 years
* Patients with gross peritoneal and liver metastasis at surgery.
Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury

The purpose of our study is to determine the safety and efficacy of the combination of erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with neurological diseases. To be specific, our clinical study is expected that the combination injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating endogenous repair process in patients with neurological diseases including stroke, cerebral palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in patients with neurological diseases, which is expected to overcome current ethical and technical limitations of less evidenced functional recovery, hematological changes, and side effects. Eventually, We will establish a comprehensive clinical background about neurotrophic and neuroprotective effects of this hematopoietic growth factors therapy.


Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* Voluntary participants
* Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset
* Participants who got previous EPO+GCSF injection at least 6 months ago.

Exclusion Criteria:

* Under 20 years old
* Participants who can not voluntarily consent
* Encephalopathy including brain tumor and infection
* Warfarin (coumadin) medications
* Leukopenia, Thrombocytopenia, Polycythemia
* Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia
* Hepatic or Renal dysfunction, Serum creatinine\>3mg/dl
* Allergic reactions against to exogenous EPO and G-CSF
* Involved in a exclusion criteria for MRI test
* A women who is pregnant or on breast feeding
* Body temperature over 38°C
* Blood pressure over 140/90 mmHg at pre-treatment
* Blood pressure over 160/100 mmHg during intervention
* Hb \> 15 g/dL at pre-treatment
* Hb \> 17 g/dL during intervention
* Pneumonia detected by X-ray test
* Recurrent history of aspiration pneumonia
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN

The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).

The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).

Eligibility Criteria:
Inclusion Criteria:

* The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
* The subject has documented chronic kidney disease (CKD)

Exclusion Criteria:

* Subject is in acute renal failure
* Assessment of ventricular function that cannot be accomplished without the use of the CM.
* Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.
* Subject is unable to undergo peri-procedural hydration.
Chronic Inflammation After Obesity Surgery

To evaluate the impact of obesity surgery on chronic inflammation.

A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass (LOLGB) on chronic inflammation and metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35kg/m² and obesity-related disease or BMI \> 40kg/m²

Exclusion Criteria:

* acute inflammation during laboratory examination
The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus

A total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. The experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. Four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.

To explore the effectiveness of two types health education on knowledge in diabetes and insulin injection, skills in insulin injection, self-efficacy in insulin injection, injection performance rate, satisfaction with health education,nursing hours, and biophysical indicators among the type 2 diabetes who began insulin therapy using a pen injector.With a repeated measures experimental study design, a total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. The experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. Four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 2 diabetes.
2. First received insulin injection with Lantus, Levemir or Novomix.
3. Ability to communicate in Mandarin or Taiwanese.
4. Ability to self-inject insulin.

Exclusion Criteria:

1. Cognitive impairment or dementia, inability to manage self-care.
2. Severe or unstable medical conditions.
Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

1. Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
2. Tumor size is 5 cm or less in the longest diameter
3. Age 18 years or older
4. Eastern Cooperative Oncology Group performance status is 2 or less
5. Life expectancy: 6 months or longer
6. Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
7. Platelet count \>= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio \<= 1.8
8. Women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.
9. Having received explanation about the study, consented to participate in the study and signed the informed consent form.
10. Measurable disease according to RECIST v1.1

Exclusion Criteria:

1. The size of the tumor more than 5 cm in the maximum diameter.
2. ECOG performance status is 3 or higher
3. Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
4. History of serious allergy to the medicine for the treatments like anesthesia.
5. There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
6. Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
7. Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
8. Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy
9. Pregnant women or breast-feeding mothers
10. Those who do not wish to sign the informed consent form
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to provide a written informed consent
* Females of childbearing potential must have a negative pregnancy test at screening and baseline
* Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
* Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
* Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:

  * Corticosteroids
  * Immunomodulators
  * Tumor necrosis factor-alpha (TNFα) antagonists
  * Vedolizumab
* May be receiving the following drugs:

  * Oral 5-aminosalicylate (5-ASA)
  * Oral corticosteroid therapy
  * Antidiarrheals for chronic diarrhea
  * Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
  * Antibiotics for the treatment of Crohn's disease
* Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements

Key Exclusion Criteria:

* Evidence of abscess at screening
* Extensive colonic resection (subtotal or total colectomy) or history of \> 2 small bowel resections
* Ileostomy, colostomy, or symptomatic stenosis of the intestine
* Current use of oral corticosteroids at a dose equivalent to \> 30 mg/day of prednisone
* Ulcerative colitis or indeterminate colitis
* Short bowel syndrome
* Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
* Treatment with any monoclonal antibody within 4 weeks of screening
* History or evidence of colonic mucosal dysplasia
* HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.