louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04216914: BASIC Study: Bone Age Study In Children
Official title: Bone Age Study In Children (BASIC): A Simple Intervention to Improve the Quality of Bone Age X-rays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Age Maturation
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 56
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

Detailed description: The study of left wrist/hand Xrays can help children's doctors to ascertain the age of a child's skeleton, know how much growing they still have to do and predict how tall they will be as an adult. The Xray requires the child to keep their hand flat and still and in the correct orientation. Some children, especially young ones, find this difficult and therefore the quality of the Xray can mean that aging the skeleton is difficult and may require the Xray to be taken again.

This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

Eligibility criteria: Inclusion Criteria:

* Children who are having a bone age Xray as part of their endocrinological hospital management.

Exclusion Criteria:

* Patients who do not give informed consent to be included in the study.
* As this study is very small and non externally funded, we will not be able to produce translations of the information sheets and consent/assent forms. This means that where patients are unable to fully give informed consent due to language barriers, they will be excluded from the study.
* )Any child with a left hand abnormality making them unable to place their hand flat e.g. contractures will be excluded.
* Any child too young or with significant enough learning difficulties making their compliance with the instructions too problematic. This will be at the discretion of the medical professional consenting the patient and the radiographer.

Primary outcomes:
measure: Change in X-ray quality score with use of hand outline for TW3 x-rays
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire District)
Study officials:
affiliation: Investigator
name: Charlotte Elder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06191614: DEXINEURO® Tab on Blood Glucose Reduction in Patients With Type 2 Diabetes Accompanied by Diabetic Peripheral Neuropathy
Official title: Multi-center, Single-group, Prospective Observational Study to Evaluate the Efficacy of DEXINEURO Tab on Blood Glucose Reduction in Type 2 Diabetic Patients With Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Keywords: R-thioctic acid tromethamine
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 528
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Prescribed DEXINEURO® tab for the treatment of diabetic peripheral neuropathy

Brief summary: This study is to evaluate the efficacy of DEXINEURO® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type 2 diabetes accompanied by diabetic peripheral neuropathy.

Detailed description: This clinical trial is a multi-center, single-group, prospective observational study conducted to investigate the interaction with concomitant insulin or oral antidiabetic agents and assess the influence on blood glucose reduction when administering DEXINEURO® tab to patients with type 2 diabetes and diabetic peripheral neuropathy.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 years and older of both genders.
2. Type 2 diabetes patients with HbA1c ≤ 10% at screening.
3. Patients diagnosed with diabetic peripheral neuropathy who are scheduled to receive DEXINEURO® tab.
4. Individuals who have voluntarily provided written consent to participate in this study.

Exclusion Criteria:

1. Individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening.
2. Individuals contraindicated according to the approval conditions of DEXINEURO® tab.
3. Pregnant or breastfeeding women.
4. Individuals participating in other clinical trials (except for non-interventional observational studies, if they have not received investigational drugs, or are participating in other non-interventional observational studies).
5. Individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.

Primary outcomes:
measure: Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline
timeFrame: after 12 weeks of prescription for DEXINEURO tab compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Ho-chan Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01479114: Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
Official title: In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Sepsis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 90
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.

Detailed description: Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte-colony stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.

Eligibility criteria: Inclusion Criteria:

* newborn infants with postnatal age \< 28 day,
* minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis,
* with or without neutropenia

Exclusion Criteria:

* neonates with congenital malformation,
* major chromosomal abnormalities,
* prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion

Primary outcomes:
measure: all cause mortality
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01860014: Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Official title: Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hemorrhage
Keywords: Pulmonary hemorrhage
Mortality
Newborn
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Detailed description: The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Eligibility criteria: Inclusion Criteria:

* Premature infants \<1500 g
* Within first week of life

Exclusion Criteria:

* Major congenital abnormalities
* Without parental consent

Primary outcomes:
measure: Oxygen requirement
timeFrame: 6 hour
Secondary outcomes:
measure: Mortality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Hospital
Study officials:
affiliation: Zekai Tahir Burak Hospital
name: Şenol Bozdağ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. doi: 10.1016/0140-6736(93)90469-w. No abstract available.
Clinical trial NCT01941914: Calcium Electroporation for the Treatment of Keloids
Official title: Calcium Electroporation for the Treatment of Keloids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keloid
Keywords: Calcium electroporation
calcium
electroporation
electrotransfer
keloid
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Detailed description: The keloids wil be treated with intratumoral injection of calcium followed by electroporation. It is a once only treatment and the patients will be followed up for 24 months.

Eligibility criteria: Inclusion Criteria:

* At least 1 keloid available to electroporation.
* Patient should have been offered standard treatment.
* At least 8 weeks since other keloid treatment.
* Performance status \<2 (ECOG).
* Platelet count \>50 mia/l
* International Normalized Ratio (INR) \<1,2.
* Age \>18.
* Patient should be able to understand participants information.
* Signed, informed consent.

Exclusion Criteria:

* Clinically significant coagulopathy.
* Pregnancy or lactation.
* Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Primary outcomes:
measure: Response evaluated by Vancouver Scar Scale
timeFrame: After 6 months
Secondary outcomes:
measure: Adverse events to calcium electroporation.
timeFrame: After 6 months.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University hospital, Herlev
Study officials:
affiliation: University of Copenhagen
name: Julie Gehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324114: Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer
Official title: Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer
Lead sponsor: Protgen Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

Detailed description: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility criteria: Inclusion Criteria:

* colorectal cancer patients, healthy volunteers, benign colorectal diseases patients

Exclusion Criteria:

* Patients who previously accepted radiotherapy

Primary outcomes:
measure: Hsp90α Concentration(ng/ml) of plasma
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong province cancer hospital
state: Shandong
Study officials:
affiliation: Shandong province cancer hospital
name: Jinming Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04171414: A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Official title: A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2019-11-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Detailed description: CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to evaluate usability of subcutaneous auto-injector of CT-P17 in patients with moderate to severe rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

* Male or female patient aged 18 to 70 years, inclusive.
* Patient must be able and willing to self-administer subcutaneous (SC) injections via auto injector (AI).

Exclusion Criteria:

* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Primary outcomes:
measure: The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
timeFrame: Week 0
measure: Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
timeFrame: Week 0,2,4,24
measure: Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
timeFrame: Week 8,16,24
measure: Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
timeFrame: Week 2
measure: Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
Study officials:
affiliation: Celltrion, Inc.
name: MinJi Ma
role: STUDY_CHAIR
References:
Clinical trial NCT04821414: Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children
Official title: Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Critical Illness
Sepsis, Severe
Keywords: Critical Illness
Sepsis
anakinra
canakinumab
children
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

Brief summary: In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of IL-1β and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-1β and its receptor antagonists in children with severe infection is not fully evaluated.

Detailed description: The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded. Patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

Eligibility criteria: Inclusion Criteria:

* Children between 29 days and 18 years old.
* Severe pneumonia and/or sepsis.
* Patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children.

Exclusion Criteria:

* Notifiable infectious diseases.
* The researcher believes that he is not suitable to participate in other situations in this study.
* Participants in other clinical trials in the same period.
* Discharge within 48 hours

Primary outcomes:
measure: survival rate
timeFrame: within 28 days after they discharged from PICU
Secondary outcomes:
measure: length of stay in PICU
timeFrame: within 28 days after they discharged from PICU
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03460314: Bariatric Surgery and Pharmacokinetics of Buprenorphine
Official title: Bariatric Surgery and Pharmacokinetics Buprenorphine: BAR-MEDS Buprenorphine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Buprenorphine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on buprenorphine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Buprenorphine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554314: Effect of Probiotics on Regulating Gut Health and Blood Lipid in Adults
Official title: Effect of Probiotics on Regulating Gut Health and Blood Lipid in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Nutrarex Biotech Ltd.
First posted: 2024-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of Nutrarex Probiotic Capsules per day in regulating gut health and blood lipid in adults by clinical trial.

Detailed description: This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 50 subjects were randomized, 25 to placebo and 25 to probiotics. The subjects took one capsules of Nutrarex probiotics daily, a total of 300 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Eligibility criteria: Inclusion Criteria:

* male or female participants
* aged 20-65 years old
* body mass index in 25-27 kg/m2 or body fat \> 25% for men and \> 30% for women

Exclusion Criteria:

* cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity having systemic infections
* using probiotics.

Primary outcomes:
measure: Change from baseline serum lipids at week 4
timeFrame: Week0, Week4
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Yin-Chin Liu, MS student
role: PRINCIPAL_INVESTIGATOR
References: