louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02149017: Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
Official title: Phase 1 and Phase 2 Clinical Trials for the Evaluation of Pharmacokinetics, Safety, and Efficacy of SNUBH-NM-333(18F) in Alzheimer's Disease Patients and Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Alzheimer Disease
Keywords: amyloid plaque
Positron-Emission Tomography
radiopharmaceuticals
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.

Detailed description: The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure.

Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling.

The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.

Eligibility criteria: Inclusion Criteria:

* Healthy young controls who are 20 - 30 years old and have no subjective memrory complaints
* Cognitively normal elderly who have Clinical Dementia Rating score of 0
* Alzheimer's disease (AD) patients who met both the DSM-IV criteria for dementia and NINCDS-ADRDA criteria for probable AD

Exclusion Criteria:

* any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on MRI; the presence of severe behavioral or communication problems

Primary outcomes:
measure: Distribution volume ratio (DVR)
timeFrame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Secondary outcomes:
measure: Standardized uptake value ratio (SUVr)
timeFrame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang Eun Kim, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06436417: Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery
Official title: Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty in Adult Surgery
Keywords: Heart rate variability, prehabilitation, major surgery, frailty, physiological reserve
Lead sponsor: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Sponsor class: NETWORK
First posted: 2024-05-31
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.

Brief summary: This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

Detailed description: The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Scheduled for major adult surgery
* Any ASA classification
* Signed informed consent

Exclusion Criteria:

* Urgent surgery
* Severe cognitive impairment
* Patient refusal to participate
* Pediatric patients
* Cardiac arrhythmia or atrial fibrillation

Primary outcomes:
measure: Correlation of HRV indices with functional capacity and frailty
timeFrame: From initial pre-anesthesia consultation to 30 days postoperatively
Secondary outcomes:
measure: Reduction of postoperative complications
timeFrame: 30 days postoperatively
measure: Intraoperative decisions based on HRV
timeFrame: During the perioperative period
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet University Hospital
name: Cristian Aragón-Benedí, M.D., Ph.D.,
role: STUDY_CHAIR
References:
Clinical trial NCT06466317: Is There Effect of Adding Honey Intake to Free Walking in Metabolic Syndrome Children
Official title: Response of Metabolic Syndrome Components to Adding Honey Consumption to Free Walking Exercise in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.

Detailed description: Forty Children with metabolic syndrome will Assigned to group of free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking was supervised by authors via Videoconferencing Imo Program) and this group also will receive healthy dietary guidelines in addition to consuming natural honey for 12 weeks.. The other group that will contain 20 patients will take only free walking exercise and healthy diet guidelines for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 40 metabolic syndrome children

Exclusion Criteria:

* respiratory, cardiac , renal , liver problems

Primary outcomes:
measure: high density lipoprotein
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: triglycrides
timeFrame: it will be assessed after 12 weeks
measure: body mass index
timeFrame: it will be assessed after 12 weeks
measure: waist circumference
timeFrame: it will be assessed after 12 weeks
measure: systolic blood pressure
timeFrame: it will be assessed after 12 weeks
measure: diastolic blood pressure
timeFrame: it will be assessed after 12 weeks
measure: fasting blood glucose
timeFrame: it will be assessed after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram canadian university
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
name: hagar el-hadidy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02442817: Linagliptin and Mesenchymal Stem Cells: A Pilot Study
Official title: Linagliptin and Mesenchymal Stem Cells: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: DPP-4 Inhibitor
Linagliptin
SDF1-α
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: Augusta University
First posted: 2015-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.

Detailed description: This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.

Eligibility criteria: Inclusion Criteria:

* Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia.
* Considered clinically stable, and on the same dose of antipsychotic for two weeks.
* A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item.
* Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine.
* Age 18-45 years.
* Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays.

Exclusion Criteria:

* Does not meet DSM criteria for substance abuse or dependence.
* No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.

Primary outcomes:
measure: SDF1-α (stromal cell-derived factor alpha) Concentration
timeFrame: Blood will be collected on the first week and then biweekly for 12 weeks.
Secondary outcomes:
measure: DPP-4 (Dipeptidyl peptidase-4) Activity
timeFrame: Blood will be collected on the first week and then biweekly for 12 weeks.
measure: Monocyte State
timeFrame: Blood will be collected on the first week and then biweekly for 12 weeks.
measure: Absolute/Differential leukocyte count
timeFrame: Blood will be collected on the first week and then biweekly for 12 weeks.
measure: CD271+ cells
timeFrame: Blood will be collected on the first week and then biweekly for 12 weeks.
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada School of Medicine
state: Nevada
Study officials:
affiliation: University of Nevada School of Medicine
name: Brian Kirkpatrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889017: Generic Immunosuppressive Drugs After Lung Transplantation
Official title: Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunosuppressive After Lung Transplantation
Keywords: generic immunosuppressive
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients after lung transplantation (single, double or combined) with an immunosuppressive therapy with tacrolimus or ciclosporin

Brief summary: Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation

Detailed description: Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors.

For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.

Eligibility criteria: Inclusion Criteria:

* patients after lung transplantation (single, double or combined)
* informed consent
* patient with an immunosuppressive therapy with tacrolimus or ciclosporin

Exclusion Criteria:

* immunosuppressive therapy without calcineurin inhibitors
* need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus\[MRSA), B. cenocepacia)
* limited German language skills or other reasons which might impair patient communication or computer handling

Primary outcomes:
measure: Frequency of use of generic immunosuppressive drugs
timeFrame: baseline
Secondary outcomes:
measure: Calcineurin inhibitor through levels
timeFrame: baseline, retrospective 6 months
measure: Dose of calcineurin inhibitors
timeFrame: baseline
measure: Therapy adherence
timeFrame: baseline
measure: Satisfaction with immunosuppression
timeFrame: baseline
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
References:
citation: Drick N, Seeliger B, Fuge J, Tudorache I, Greer M, Welte T, Haverich A, Gottlieb J. Self-reported non-adherence to immunosuppressive medication in adult lung transplant recipients-A single-center cross-sectional study. Clin Transplant. 2018 Apr;32(4):e13214. doi: 10.1111/ctr.13214. Epub 2018 Feb 23.
Clinical trial NCT00065117: Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Metastases, Neoplasm
Keywords: metastatic
colorectal
first-line
adjuvant
cancer
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-07-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.


Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal carcinoma
* Suitable for first-line treatment of metastatic disease

Exclusion Criteria:

* Peripheral neuropathy greater than Grade 1
* Adjuvant therapy within 6 months prior to study treatment
* Prior oxaliplatin
* Prior pelvic or whole abdomen radiation
* Any history of coronary angioplasty or history of myocardial infarction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: New York
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01362517: Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Official title: Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae Infections
Keywords: Vaccination
Immunisation
Virus
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 131
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule


Eligibility criteria: Inclusion Criteria:

* Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
* Have a normal gestational age (≥ 37 weeks); birth weight \> 2.5 kg
* There is no congenital disease detected through interview and clinical examination
* Already had or not yet received Hepatitis B vaccination at birth
* Do not have dermatological diseases such as eczema, allergies
* Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures

Exclusion Criteria:

* Already vaccinated with DTP vaccine
* Have an acute infection at the time of study vaccination
* Contraindications to Quinvaxem
* Receiving treatment with systemic corticosteroids
* Currently participating in another clinical trial
* In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
* Parents intend to move to another location during the study (the next 12 months)

Primary outcomes:
measure: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
timeFrame: at 5 months (equivalent to 1 month after the third vaccination)
measure: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
timeFrame: at 14 months (equivalent to 12 months after the first vaccination
Secondary outcomes:
measure: Safety: Adverse and Serious Adverse Events
timeFrame: From Day 1 up to 30 days after the third vaccination
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Pasteur Institute
Study officials:
affiliation: Pasteur Institute of Ho Chi Minh City
name: Tran Ngoc Huu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06606834: Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea
Official title: Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea
Sonoelastography
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: dysmenorrhea patient group

Brief summary: The aim of this study is to perform sonoelastographic assessment of the uterus in patients diagnosed with primary dysmenorrhea and to compare these measurements with sonoelastographic evaluations of the uteri in asymptomatic individuals. This will enable, for the first time, the demonstration of whether the elasticity of the myometrial tissue contributes to the etiology of primary dysmenorrhea.

Secondary Objectives: To determine whether there is a correlation between the severity of primary dysmenorrhea and ultrasonographic markers.


Eligibility criteria: Inclusion Criteria:

1. Women aged 18-40 years.
2. Women with primary dysmenorrhea who are willing to participate in the study.
3. Women without primary or secondary dysmenorrhea who agree to participate as a control group.

Exclusion Criteria:

1. Women with secondary dysmenorrhea.
2. Patients with underlying uterine or adnexal pathologies (e.g., endometrial polyps, adenomyosis, uterine fibroids, adnexal masses, ovarian pathologies and cysts) identified via ultrasonography.
3. Individuals with a history of uterine surgery.
4. Individuals with a history of pelvic surgery.
5. Individuals who have delivered via normal spontaneous vaginal delivery or cesarean section.

Primary outcomes:
measure: SWE Tecnique
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
References:
Clinical trial NCT01664234: Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants
Difficult Airway
Keywords: infants with cleft palate
Pierre Robin
Treacher Collins
trisomy 21
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.


Eligibility criteria: Inclusion Criteria:

* infants (0-2) difficult airways

Exclusion Criteria:

* . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

Primary outcomes:
measure: time to oxygen saturation
timeFrame: Day 1
Secondary outcomes:
measure: mean oxygenation comparison
timeFrame: Day 1
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinischen Universität Wien
state: Borschkegasse
Study officials:
affiliation: Medizinischen Universität Wien Vienna
name: Olga Plattner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: