cyrilzakka/clinical-trials huggingface dataset:
Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.

An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.

Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* male or female patient at an age of 18 years or older
* patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
* TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
* indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
* intended curative gastrectomy
* Karnofsky index \> 70

Exclusion Criteria:

* Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
* prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
* previous use of non-humanized monoclonal mouse or rat antibodies
* treatment with another investigational product during this study or during the last 30 days prior to study start
* presence of distant metastases
* presence of constant immunosuppressive therapy
* history of pancreas resection (also partial) or thoracotomy
* presence of any acute or chronic systemic infection
* patient with a bowel obstruction within the last 30 days
* known contraindications to any of the planned ECX chemotherapeutics
The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study

Observe the changes of type II inflammation markers, lung function, and symptom scores in asthmatic patients aged 6 to 14 during the use of dupilumab to analyze its efficacy.


Eligibility Criteria:
Inclusion Criteria:

Enrolled patients were required to have been on regular ICS-LABA therapy for at least 3-6 months without adequate control. The attending physician evaluated these patients as having type 2 inflammatory asthma based on factors such as FeNO (fractional exhaled nitric oxide) levels ≥ 20, sputum eosinophils (EOS) percentage ≥ 2%, and/or blood EOS count ≥ 300/μl. All children were prescribed with dupilumab during the study period.

Exclusion Criteria:

Patients with conditions other than asthma receiving treatment with dupilumab, individuals currently using other biologics or undergoing sublingual or subcutaneous immunotherapy, active parasitic infections, and children with immunodeficiency were excluded.
Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Therapy in Patients With HFrEF.

The goal of this observational study is to investigate the effects of combination therapy with ARNI and inhibitors of SGLT2 in patients affected by HFrEF.

The main questions it aims to answer are:

* What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied by speckle tracking echocardiography (GLS%) and by variation of volumetric indices and contractile function (LVEDV, LVEDD, FE%)?
* What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (NT-pro-BNP)?
* What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of major cardiovascular events (MACVE)?
* What are the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling? Participants will undergo, at the time of enrollment and after approximately 3 and 12 months from the introduction of SGLT-2 inhibitor therapy, at clinical, echocardiographic and biohumoral investigations.

According to the 2021 ESC guidelines for heart failure, iSGLT2 has become the cornerstone of the treatment of heart failure with reduced ejection (HFrEF) fraction, with a class of recommendation IA (1).

However, the mechanisms of action of iSGLT2 remain still little known. In particular, if the combined therapy with ARNI and iSGLT2 may have an effect in terms of left ventricular remodeling evaluated by speckle tracking echocardiography (GLS%) in patients with HFrEF at a medium-long term (3-12 months) is still to be defined (primary objective).

Furthermore, our study will aim to evaluate the clinical and echocardiographic impact of the combined therapy with ARNI + iSGLT2 in terms of left ventricular remodeling evaluated through volumetric and contractile function indices (LVEDV, LVEDD, FE%) and in terms of variation of laboratory data suggestive of decompensated heart failure (NT-pro-BNP) in patients with HFrEF at a medium-long term follow-up (3-12 months) (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* HFrEF on ARNI
* Ability to express written informed consent to participate in the study

Exclusion Criteria:

* Contraindication to glyphozine therapy (i.e., severe renal insufficiency with filtration estimated glomerular \<30ml/min/m2 or history of recurrent urinary tract infections);
* Comorbidities with expected survival of less than 1 year;
* Limited or legal inability to give written informed consent
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
* Subjects who have failed conservative care for at least 6 weeks.

Exclusion Criteria:

* Contraindication to MRI
* Instrumented fusion
Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss

This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 to 65 years of age
* Body Mass Index \>35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index \>40 with or without comorbidity
* Undergoing primary sleeve gastrectomy

Exclusion Criteria:

* Prior metabolic and bariatric surgery
* Prior use of GLP-1 agonist
* Prior history of pancreatitis
* Personal/family history of medullary thyroid cancer or MEN type 2
* Secondary cause of obesity
* Any eating disorder
* Pregnancy/lactation
* History of acute coronary syndrome or myocardial infarction
* History of stroke
* Hepatic dysfunction: AST/ALT \>3 ULN
* Renal dysfunction eGFR\<45ml/min/1.73m2
* Active malignancy
* History of diabetic retinopathy
* History of gastroparesis
Energy Requirements in Mitochondrial Disease

Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to disruptions in energy producing pathways in our body. Enough energy or calories must be given in the diet to ensure normal growth and development. Currently, energy needs for patients with metabolic and mitochondrial diseases are not measured, but is estimated using a mathematical equation based on healthy children. This may lead to under feeding or overfeeding of calories, and has negative nutritional implications.

The clinical standard for measuring energy needs is the use of indirect calorimeter.The indirect calorimeter takes individualized measurements for each patient and therefore will enable dietitians and clinicians to provide sufficient calories in the diet to better manage the disease and promote normal growth and development.

We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria) and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation etc.).

The objective of this preliminary study is to measure resting energy expenditure in children living with metabolic and mitochondrial conditions and data obtained will be used to generate future hypothesis and will form a basis for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Children(1-18y) who are diagnosed with either Phenylketonuria (PKU) or a mitochondrial disorder

Exclusion Criteria:

* Children, less than 1y old, who are diagnosed with PKU or a mitochondrial disorder, as it is difficult to perform indirect calorimeter on them.
* Children(1-18y) who are not diagnosed with PKU or a mitochondrial disorder
* Children(1-18y) who are diagnosed with either PKU or a mitochondrial disorder, but are currently experiencing illness such as fever, cold, vomiting or diarrhea
APOL1 Genotyping CTA Clinical Performance Study

Clinical Performance Study SP2024001, is a prospective, interventional study to assess the clinical performance of the APOL1 Genotyping Clinical Trial Assay (CTA) in the intended use population and environment. The study will use the APOL1 Genotyping CTA to test deoxyribonucleic acid (DNA) extracted from blood specimens to identify individuals who are homozygous or compound heterozygous for apolipoprotein L1 (APOL1) high-risk genotypes (G1 and G2).The individuals who are identified as being homozygous or compound heterozygous for the APOL1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, Phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (ASO) for the treatment of APOL1-mediated kidney disease (AMKD).


Eligibility Criteria:
Inclusion Criteria:

* Study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria.
* Study participant has agreed to and signed the clinical trial Informed Consent Form (inclusive of risks related to the APOL1 Genotyping CTA).
* The study participant's specimen must be distributed to the device test site accompanied by a complete Test Request Form signed by the appropriate clinical trial site personnel.
* All participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures.

Exclusion Criteria:

* Study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit 1.
* The study participant has not agreed to and signed the (Clinical Trial) Informed Consent Form.
* The study participant's specimen is distributed to the device test site without a complete Test Request Form.
* The study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.
The Effects of AR and VR Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students

The aim of this study is to assess the effectiveness of an AR/VR oral care training system on the knowledge, attitudes, self-efficacy, and behavioral intentions of students majoring in geriatric care.

A randomized controlled trial design will be employed, students randomly assigned to either the experimental group or the control group. The experimental group will receive a total of two sessions of AR/VR oral care training, each lasting two hours, with the intervention taking place two weeks and four weeks after completing the pre-test questionnaire. The control group, on the other hand, will receive traditional oral care instruction for thirty minutes.

Each student collected the data by a self-administered questionnaire before and immediately after each intervention.

Linear regression in generalized estimating equations (GEE) compares the differences between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-30 years
* Students majoring in geriatric care
* Fooyin University of Technology

Exclusion Criteria:

* Transfer student
Early Group Based Parental Support Within Child Health Service - Group Leadership

All parents in Sweden are offered group based parental support within Child Health Service (CHS) but only 40% participate. Nurses feel insecure in their group leadership and express a need for education in group leadership and group dynamics. Most CHC nurses do not have formal education or training in group leadership and the aim of this study was to evaluate a group based education program in group leadership for Child Health Care (CHC) nurses.

The study follows the guidelines for complex interventions (MRC) and was set up as a randomized controlled trial (RCT) evaluated with questionnaires before and after the intervention. Focus group interviews 6 months after the intervention will be performed with the CHC nurses participating in intervention group. 3 groups with 25 CHC nurses in each group are to participate in a three day education in group leadership and group processes. The education aims to provide knowledge and awareness about group dynamics, group processes and group leadership and also aims towards increased self-awareness in the role as group leader.

Eligibility Criteria:
Inclusion Criteria:

* working within child health service in Skåne, Sweden
* managing at least 2 parental groups/year

Exclusion Criteria:

* no parental groups
Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Background: The actual literature is consistent in considering potential negative effects of sub-gingival prosthetic margins on the periodontal health, but no research has focused the attention on the type of prosthetic margin designs. Hence, the aim of the present study is to evaluate if a horizontal finishing line (deep chamfer preparation) may have a different influence on periodontal soft tissue in comparison with a vertical finishing line (feather edge preparation).

Methods: A prospective randomized controlled double blind clinical trial with one single operator and three experienced examiners was performed. One hundred and six crowns were prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation. All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12 months follow-up, the gingival margin position was related to the crown margin position.


Eligibility Criteria:
Inclusion Criteria:

The patient inclusion criteria were as follows:

1. dentate patients treatment planned for single unit restorations in the esthetic zone (from 1st premolar forward)
2. periodontal probing depth prior to tooth preparation ≤4mm, with no bleeding on probing and no plaque
3. \>30 years of age
4. full mouth plaque score (FMPS) and full mouth bleeding scores (FMBS) \<20% at study baseline
5. eventual loss of attachment limited only to areas different from the sites included in the study.

The patient exclusion criteria were as follows:

1. patient with medical history in which any dental intervention would be contraindicated
2. any local or systemic disease, condition or medication that might compromise healing and affect the periodontium
3. dental caries or periodontal disease in the remaining teeth
4. inability or unwillingness to return for follow-up visit.

Exlusion Criteria:

1. patients with systemic diseases (such as heart, coagulation, and leukocyte diseases or metabolic disorders)
2. history of radiation therapy in the head and neck region within 12 months prior to surgical phase
3. current treatment with steroids
4. neurological or psychiatric condition that could interfere with good oral hygiene
5. immunocompromised status, including infection with human immunodeficiency virus
6. smoking habit (more than 10 cigarettes/day)
7. drug or alcohol abuse
8. inadequate compliance
9. patients who received bone regeneration procedure
Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer

Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE). This study aimed at identifying the recurrence rate of the same AE after a BRAFi +/- MEKi rechallenge in patients with cancer and the factors associated to the recurrence.

This is an observational, cross-sectional, pharmacovigilance cohort study. AEs were extracted from safety reports from the World Health Organization database VigiBase®, to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE) in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive AE cases associated with BRAFi and MEKi therapy. Combination therapy cases, where BRAFi were concurrently reported with MEKi will be identified, as well as the combination therapy regimen (V+C, D+T, E+B). We will not study MEKi monotherapy cases

Exclusion Criteria:

* MEKi monotherapy cases
* Cases concurrently reporting on immune checkpoint inhibitor therapies
Identification of Ventricular Fibrillation and Optimization of Defibrillation During CPR

It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Both the guidelines by American Heart Association and the guidelines by European Resuscitation Council emphasize the importance of minimizing interruptions in chest compressions, specifically, duration of the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF during chest compression, which has high sensitivity and specificity. And the investigators can identify VF and defibrillate earlier.

The aim of this study is to verify that if Sherlock algorithm of Philips MRx monitor/defibrillator can identify shockable rhythms during chest compression accurately.


Eligibility Criteria:
Inclusion Criteria:

1. Cardiac arrest patients
2. The length from cardia arrest to be rescued is less than 10 minutes
3. age≥14
4. Complied with ethical requirements
5. signing the informed consent form.

Exclusion Criteria:

1. DNR
2. Pregnant women
The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients

Endometriosis is a common gynecological problem, with pain as the main problem. Pain can be felt for years, in high intensity, continuous, unpredictable, and disrupts the patient's daily life, thereby reducing the quality of life. Dienogest is a progestin-derived drug, the first line therapy for endometriosis pain. Other therapy options include hormonal, non-hormonal therapy, and surgery, but they have a high risk of side effects and recurrence.

In cases of endometriosis, acupuncture has an analgesic effect, modulates hormones and neurotransmitters, strengthens immune cells, and reduces inflammation, therefore improves quality of life. However, the effectiveness of thread embedding acupuncture for endometriosis pain is still rarely published. This research was conducted to determine the effectiveness of thread embedding acupuncture for pain and quality of life in endometriosis patients.

This study is a one-group pretest-posttest clinical trial. Research subjects will receive a one-time thread embedding acupuncture (TEA) combined with dienogest as standard therapy for 8 weeks. The outcomes assessed will be pain intensity (NRS score) and quality of life score (Endometriosis Health Profile-30 core score) 4 and 8 weeks after receiving TEA combined with standard therapy (posttest), compared with standard therapy alone (pretest).

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-45 years.
2. Subjects diagnosed with endometriosis from laparoscopy, ultrasound, or histopathology.
3. Subjects experience at least one type of pain including pelvic pain, dysmenorrhoea, dyspareunia, dyschezia, or dysuria with a minimum NRS score of 4.
4. The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4.
5. Subjects are willing to follow research procedures and sign the informed consent form.

Exclusion Criteria:

1. Subjects who have wounds, inflammation, infection, lumps, or eczema at the puncture site.
2. Pregnant or breastfeeding women.
3. Subjects with blood clotting disorders or who are taking blood thinning medication.
4. Have a history of diabetes mellitus, malignancy, psychiatric disorders, keloids, allergies to stainless steel or PDO threads.
5. Subjects who received surgical therapy in the last 3 months.
6. Subjects who have been undergoing acupuncture therapy in the last 2 weeks or TEA in the last 6 months.