louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06227741: Concept Mapping: as a Tool for Problem Based Learning
Official title: Concept Mapping: as a Tool for Problem Based Learning on Students Problem Solving Skills, Metacognitive Awareness, and Self-directed Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Problem;Learning
Keywords: education
concept mapping
Problem Solving skills
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: concept mapping
Primary purpose: OTHER

Brief summary: This study delves into the utilization of concept mapping as a strategic tool within problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive awareness, and self-directed learning abilities. Concept mapping, a visual representation of knowledge structures, is explored as a means to cultivate and refine students' problem-solving capabilities, preparing them for challenges in various domains.

Detailed description: This study delves into the utilization of concept mapping as a strategic tool within problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive awareness, and self-directed learning abilities. Concept mapping, a visual representation of knowledge structures, is explored as a means to cultivate and refine students' problem-solving capabilities, preparing them for challenges in various domains. Additionally, the research investigates how concept mapping within a PBL context promotes metacognitive awareness, helping students become more conscious of their learning strategies and enabling them to identify gaps in understanding. Moreover, the study explores the role of concept mapping in empowering self-directed learning, fostering autonomy and a deeper sense of ownership over students' educational journeys. The insights gained from this research not only inform instructional design practices, providing evidence-based strategies for enhancing problem-based learning through concept mapping but also contribute to the broader educational research discourse, offering valuable perspectives on effective teaching and learning strategies.

Eligibility criteria: Inclusion Criteria:

* from 2 -4th academic year
* accept to participate in this study

Exclusion Criteria:

* first academic year
* psychological or mental disorder

Primary outcomes:
measure: improving students' metacognitive awareness
timeFrame: 2 months
measure: improving students' Problem-Based Learning
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Masjid Al Khiḑr
country: Egypt
facility: Faculty of Nursing
state: Semoha
Study officials:
affiliation: Faculty of nursing, Alexandria university, Egypt
name: mohamed H atta
role: STUDY_CHAIR
References:
Clinical trial NCT02032641: Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
Official title: Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keywords: Non-ablative laser
Scar revision
direct brow lift
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar after direct brow lift.

Detailed description: Patients who undergo a direct brow lift may participate in this study. Participants will receive laser treatment on one of the two surgical wounds (side of treatment will be chosen randomly by an independent source). Treatment parameters will be 500 spots and 10-14 megajoules (mJ) depending on skin type. The opposite side brow scar will not be treated until 1 month after the study is completed (if the patient elects to treat the contralateral brow after study completion this will be done at no charge to the patient). This treatment will be given at 2-4 week intervals for 6 treatments. Photographs will be taken at each visit, and they will be assessed based on different parameters by an examiner, as well as judged by the patient based on overall appearance.

Eligibility criteria: Inclusion Criteria:

* Undergoing or have undergone direct brow lift

Exclusion Criteria:

* under 18 years old
* history of photodermatoses
* receiving systemic isotretinoin within the preceding 6 months
* undergoing other scar treatment in the brow area
* pregnant patients
* history of adverse outcomes related to non-ablative laser

Primary outcomes:
measure: Relative Improvement
timeFrame: 1 month after final treatment
Secondary outcomes:
measure: Overall Appearance
timeFrame: 10 minutes before first treatment and at the final visit
measure: Hair Loss
timeFrame: within 1 hour after final treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Plantation
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Sara Wester, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04227041: A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
Official title: Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: HER-2 Positive Colorectal Cancer
Lead sponsor: Qingdao Zhixin Health Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
First posted: 2020-01-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
2. Patients with HER2 positive；
3. Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
4. Life expectancy is at least 6 months
5. ECOG score 0-1；
6. The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：

Exclusion Criteria:

1. The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
2. Patients who have previously been treated with anti-Her2-targeted drugs；
3. Patients with surgical opportunity or potential for surgical treatment；
4. Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
5. Patients with any severe and/or uncontrolled disease;
6. Patients with any or present brain metastases；
7. Women who were pregnant or breast-feeding.

Primary outcomes:
measure: Maximally Tolerated Dose (MTD)
timeFrame: up to 36 months
measure: Progression-free survival (PFS)
timeFrame: up to 36 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 36 months
measure: Duration Of Response (DOR)
timeFrame: up to 36 months
measure: Disease Control Rate (DCR)
timeFrame: up to 36 months
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao University Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT07007156: Is a Positive NECPAL in ICU Patients Associated With Higher Mortality
Official title: Is a Positive NECPAL in ICU Patients Associated With Higher Mortality
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Disease
Keywords: Acute Disease
Intensive Care Unit
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 199
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 75 years or older who are admitted to an ICU

Brief summary: The aim of the present study is to evaluate the usefulness of the NECPAL scale in identifying Intensive Care Unit (ICU)-admitted patients at higher risk of dying within 90 days of ICU admission


Eligibility criteria: Inclusion Criteria:

* Patients who meet all of the following inclusion criteria may be included in the study:
* Men and women aged 75 years or older.
* Admission to the ICU of the study center.
* Legal capacity to provide informed consent.
* Signed informed consent for study inclusion, either by the participant or their legal representative.

Exclusion Criteria:

Participants who meet any of the following exclusion criteria may not be included in the study:

-Death within the first 24 hours of ICU admission.

Primary outcomes:
measure: Mortality
timeFrame: From baseline to 90-day
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere de Ribes
country: Spain
facility: CSAPG
state: Barcelona
Study officials:
affiliation: CSAPG
name: Diana Gutiérrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877656: HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
Official title: An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Relapsed Non-Cutaneous CD4+ T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: T Cell Lymphoma
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.

Detailed description: The study is closed and all subjects have completed treatment.

The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.

Eligibility criteria: Inclusion Criteria:

* Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype
* Relapsed or refractory to minimum of one course of chemotherapy
* Study is closed to enrollment.

Primary outcomes:
measure: Efficacy as measured by survival and time to disease progression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genmab
name: Abhay Patki, PhD
role: STUDY_CHAIR
References:
citation: d'Amore F, Radford J, Relander T, Jerkeman M, Tilly H, Osterborg A, Morschhauser F, Gramatzki M, Dreyling M, Bang B, Hagberg H. Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma. Br J Haematol. 2010 Sep;150(5):565-73. doi: 10.1111/j.1365-2141.2010.08298.x. Epub 2010 Jul 14.
Clinical trial NCT04603456: miRNA-155 Assay Before and After Immunotherapy and Probiotics
Official title: MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-10-26
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I included 15 cases who received probiotics only. Group II included 15 children who received SLIT. Group III included 15 children who received probiotics and SLIT.
Primary purpose: OTHER

Brief summary: The investigators aimed to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.

Detailed description: Allergic rhinitis (AR) is an inflammatory state characterized by a disturbance of immunoregulatory mechanisms that leads to an amplified T helper "Th-2" response. Micro-RNAs (miRNAs) are short single-stranded RNA molecules that post transcriptionally control gene expression and can mediate allergic process. The aim of this study was to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.

Eligibility criteria: Inclusion Criteria:

* Children aged 5-18 years
* Diagnosed as having AR
* With positive skin test to grass pollen

Exclusion Criteria:

* Anatomical abnormalities of upper respiratory tract,
* Previous immunotherapy,
* Clinically significant inﬂammatory diseases,
* Malignancies,
* Chronic treatment with systemic corticosteroids or immune suppressive drugs

Primary outcomes:
measure: Total nasal symptom score between before and after treatment
timeFrame: 6 months
Secondary outcomes:
measure: Serum miR-155 expression at the start and end of the study
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
affiliation: Medical Microbiology and Immunology
name: Randa Sedeek
role: STUDY_CHAIR
References:
citation: Livak KJ, Schmittgen TD. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-Delta Delta C(T)) Method. Methods. 2001 Dec;25(4):402-8. doi: 10.1006/meth.2001.1262.
citation: Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.
Clinical trial NCT06936956: The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality
Official title: The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Acupressure, diabetes, nursing, polyneuropathy, sleep quality
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Were between the ages of 18-65 years old
* Resided in the city center
* Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
* Had no clotting or bleeding disorders
* Were not undergoing dialysis treatment during the study period
* Had no ulcers, physical deformities or foot calluses
* Had no history of analgesic medication, except for medication used for DPN
* Had no physical diseases, cognitive deficiencies or psychiatric disease diagnosis that would prevent understanding of the questions on the scales used for data collection.

Primary outcomes:
measure: Pain Quality Assessment Scale (PQAS)
timeFrame: 6 days
measure: Pittsburgh Quality of Sleep Index (PQSI)
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Endocrinology Clinic and Outpatient Clinic of a Atatürk University Hospital
Study officials:
affiliation: Erzurum Technical University
name: Elanur YILMAZ KARABULUTLU Professör, pHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01937156: A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
Official title: A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Solasia Pharma K.K.
Sponsor class: INDUSTRY
Collaborators: name: Proswell Medical Corporation
First posted: 2013-09-09
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide scientific and reliable clinical data in the drug registration in China.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 18years
* Histologically and/or cytologically confirmed cancer
* The physical status score ECOG ≤ 2
* Life expectancy of ≥3 months
* Will receive multi-day ME/HE chemotherapy (≥2 days) with the emetogenic potential of level 3-5
* In accordance with the indication of chemotherapy and basic requirements;

  * Peripheral Haematology: Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5×10e9/L, platelet count ≥ 80×10e9/L
  * Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)
  * Other important organs function normally
* Subjects voluntarily participate and signed the informed consent form

Primary outcomes:
measure: Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The 81st Hospital of P.L.A.
state: Jiangsu
Study officials:
affiliation: The 81st hospital of P.L.A.
name: Shukui Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259656: Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
Official title: Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Keywords: Anti SARs-CoV
Pregnancy
Cordblood
Vaccine
Lead sponsor: Vachira Phuket Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Thai term pregnant women are recruited at labor room, after informed consent was done. Characteristic data (such as vaccination type and time) and Maternal Blood was collected then cord blood was collected after birth. All blood was sent to test Anti SARs CoV antibody level. Then all data and 80 test result will analyzed.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.

Detailed description: The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.

Eligibility criteria: Inclusion Criteria:

* Thai term pregnant women
* 18-45 year old
* At least 1 covid vaccination received
* admission at Vachira Phuket Hospital Labor Room

Exclusion Criteria:

* Do not want to participate
* Unstable or Emergency condition

Primary outcomes:
measure: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level
timeFrame: 1 month
Secondary outcomes:
measure: Analysed time effect from last vaccination and type.
timeFrame: 1 month
Other outcomes:
Locations:
city: Phuket
country: Thailand
facility: Vachira Phuket Hospital
Study officials:
References: