louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02389335: Roles of T Helper 1 Cytokines in Type 1 Diabetes
Official title: Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1diabetes
IFN γ
IL-2
TNF α
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 98 T1DPs and 30 healthy subjects (CG). All subjects

were matched on age and gender. β-cell function of 98 T1DPS was assesseed by measuring C-Peptide levels

after mixed-meal tolarence test (MMTT)s. T1DPs were divided into 3

groups according to the C-Peptide levels after MMTTs and the groups

were as follows: patients with undetectable ≤0.1 ng/mL(group 1a, n=30)

C-Peptide levels; minimal 0.1-0.8 ng/mL(group1b, n=30); and sustained

≥0.8ng/mL(group1c, n=38) C-peptide levels which increased at the 90th

minute after the meal ≥150% of fasting C-peptide level.

Brief summary: The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.

Detailed description: T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.

Eligibility criteria: Inclusion Criteria:

* Patients giving consent to participate the study
* Patients with type 1 diabetes according to WHO definiton

Exclusion Criteria:

* Acute and chronic inflammatory diseases,
* significant concomitant diseases which may interfere with glucose metabolism
* cancers,
* hemoglobinopathies,
* recently received antibiotics,
* drugs influencing β-cell function and
* insulin sensitivity or anti-inflammatory drugs
* recent history of trauma

Primary outcomes:
measure: Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes
timeFrame: 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital
Study officials:
References:
Clinical trial NCT05706935: MeMed BV® Test Evaluation in Adult Emergency Department Patients
Official title: Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Infection
Respiratory Infections in Old Age
Respiratory Infection Virus
Respiratory Infection Bacterial
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.

Brief summary: The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.

Detailed description: The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.

Eligibility criteria: Inclusion Criteria:

* Adults presenting to the emergency department
* Subjective or objective fever within the past 7 days
* Signs or symptoms of upper or lower respiratory tract infection within the past 7 days

Exclusion Criteria:

* Prisoner
* Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
* Active inflammatory disease
* Congenital or acquired immune deficiency
* Chronic fungal or parasitic infection
* Infection with human immunodeficiency virus (HIV)
* Hepatitis B virus (HBV)
* Hepatitis C virus (HCV)
* Infection with active tuberculosis (TB)
* Significant trauma or burns in the last 7 days
* Patients that have undergone major surgery in the last 7 days
* Pregnancy
* Active malignancy

Primary outcomes:
measure: MeMed BV® test result and diagnostic concordance
timeFrame: Emergency department 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Pulia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349635: A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Official title: A Double-Blind, 3-Arm Study on Weight Loss With a Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Per Day Compared to Metformin 1,700 mg and to Placebo, at 6 Months, in Obese Patients, Followed by: A Double-Blind, 2-Arm Investigation of Weight-Loss Maintenance With the Same Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Compared to Placebo, at 6 Months, in the Responders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Weight loss and diet.
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-07
Enrollment: 148
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.


Eligibility criteria: Inclusion Criteria:

* Both genders, BMI ≥ 30 kg/m² and \<40 kg/m².

Exclusion Criteria:

* Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.

Primary outcomes:
measure: Weight
Secondary outcomes:
measure: Waist and hip circumference
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Site 1
city: Kuopio
country: Finland
facility: Site 3
city: Oulu
country: Finland
facility: Site 2
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT03707535: To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
Official title: A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.


Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of rheumatoid arthritis
* Has active disease as defined in DAS28 Criteria

Exclusion Criteria:

* Has a history of tuberculosis (TB) or a current diagnosis of TB
* Has previously received a biological agent
* Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
* Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
* Pregnant or lactating

Primary outcomes:
measure: Efficacy assessment: DAS28 (CRP) at Week 14
timeFrame: Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT01570335: The SBAR Effect on Safety Attitudes in the Perinatal Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Distress
Keywords: SBAR,
SAQ,
Team Resource Management
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Physicians and Nurses in the Perinatal Department

Brief summary: The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the perinatal department.


Eligibility criteria: Inclusion Criteria:

* All Physicians and Nurses in the Perinatal Department

Exclusion Criteria:

* nil

Primary outcomes:
measure: Changes of patient safety attitude after introducing SBAR
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT04412135: The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality
Official title: The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality During the Initial Healing Phase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hematologic cancer patient and family member

Brief summary: The management of patients with malignant hemopathy is based on comprehensive management. In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment;
* Patients who speak and read French;
* Patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires;
* Patients benefiting from a social security scheme,
* Patients who signed the non-objection form after being informed of the study,

family person:

* Have been designated by the patient as being the loved one they wish to include with them;
* Aged ≥ 18 years;
* Fluent in and reading French;
* Having signed the non-objection form after being informed of the study.

Exclusion Criteria:

* Patients in recurrence / progress or in remission of cancer;
* Patients in the terminal phase of the disease.

Family person:

person in the curative phase of cancer

Primary outcomes:
measure: FACIT-Sp questionnaire
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00993135: Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia
Official title: Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Renal Toxicity
Keywords: renal toxicity
childhood acute lymphoblastic leukemia
adult acute lymphoblastic leukemia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-12
Enrollment: 10
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.

OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia

  * Receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at Vanderbilt Children's Hospital

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Pinki Prasad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800435: A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Official title: Whole Blood Clot Stability and Thrombin Generating Capacity Following Treatment With Bypassing Agents (BPA) With and Without and Tranexamic Acid (TXA) in Haemophilia A Patients With inhibitor-an In-vivo Prospective Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hereditary Factor VIII Deficiency Disease With Inhibitor
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients with high titer inhibitors. However, management of bleeds in these patients can be challenging due to variation in response and lack of standardized methods to monitor the effect. We hypothesized that significant increase in whole blood clot stability could be achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin generation remains unaffected. In this prospective crossover study the effect of aPCC and rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively. In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was assessed.

Detailed description: Patients receive the first day aPCC (75IU/kg) and aPCC in addition to TXA (20mg/kg orally) the second day. After a 14 days washout period they crosse over using rFVIIa (90 µg/kg) otherwise the same experimental setup. Blood sampling is performed at baseline, 15, 30, 60, 120, 180 and 240 minutes post-treatment.

Eligibility criteria: Inclusion Criteria:

* Haemophilia patients with high titer inhibitors or high-responding inhibitors, aged between 18-65 and no history of aspirin or NSAID use within the last 14 days were eligible for the study.

Exclusion Criteria:

* Patients with renal failure, liver disease, infected with immune deficiency virus (HIV), platelet count \<150x109/L, acquired haemophilia, ongoing bleeding, hypersensitivity to TXA or a history of arterial or venous thrombosis were excluded from the study.

Primary outcomes:
measure: Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid.
timeFrame: 2 years
Secondary outcomes:
measure: DIC or thrombosis events associated with different treatment regimens.
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: PÅL A Holme, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05188235: Sound Conduction of Infant Hips
Official title: Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: University of Central Florida
First posted: 2022-01-12
Enrollment: 61
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).

Detailed description: This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH.

For both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.

Eligibility criteria: Inclusion Criteria:

* Infants included in this study must be born at full term with a gestational age of 0-6 months
* Infants of both genders will be included
* Infants must have been screened for DDH.

Exclusion Criteria:

* Infants born prematurely
* Infants greater than six months of age.
* Nonviable neonates and neonates of uncertain viability

Primary outcomes:
measure: Difference in soundwaves on the Actuator on patella, sensor on sacrum
timeFrame: Study visit 1 (Day 1)
measure: Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis
timeFrame: Study visit 1 (Day 1)
measure: Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum
timeFrame: Study visit 1 (Day 1)
measure: Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest
timeFrame: Study visit 1 (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Lagone Health
name: Pablo Castaneda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090635: Imaging the Uterine Cervix - UltraSightHD™
Official title: Imaging the Uterine Cervix - UltraSightHD™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Keywords: Cervical Intraepithelial Neoplasia
Lead sponsor: STI-Medical Systems
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy non-pregnant females over 18 years old.

Brief summary: The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.

The primary objectives of this study are to:

* Determine if the light source provides sufficient illumination of the cervix.
* Assess focus and overall image quality.
* Assess the functionality and ergonomics of the instrument's design.


Eligibility criteria: Inclusion Criteria:

* Healthy Female
* 18 years old or older
* Not pregnant
* Ability to give consent

Exclusion Criteria:

* Male
* Less than 18 years old
* Pregnant or suspected pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Dr. Nathan Fujita
state: Hawaii
Study officials:
name: Nathan Fujita, M.D.
role: PRINCIPAL_INVESTIGATOR
References: