louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03823768: Envarsus Neurotoxicity Burden in Liver Transplant Patients
Official title: The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurotoxicity
Liver Transplant; Complications
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2019-01-30
Enrollment: 30
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: This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

Exclusion Criteria:

1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
2. HIV positive (HIV ab +)
3. Unable to tolerate oral medications
4. Use of another investigational product within thirty days prior to receiving study medication
5. Moderate acute cellular rejection (RAI ≥ 5) within the past month
6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
7. Patients taking medications known to induce tremors or dopamine blocking agents
8. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject

Primary outcomes:
measure: Change in Neurotoxicity Burden
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Derek Dubay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645668: Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients
Official title: Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: sepsis，meropenem，2 steps administration
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 80
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 experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data

Detailed description: This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.

Eligibility criteria: Inclusion Criteria:

1. Inpatients, whose informed consent has been obtained;
2. Clinical diagnosis of Sepsis

Exclusion Criteria:

1. Pregnancy or lactation;
2. Treated with other carbapenems;
3. Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;
4. Allergy to meropenem or other β-lactams, or the history of allergy;
5. Resistant to meropenem according to the antimicrobial susceptibility test;
6. Epilepsy or history of epilepsy;
7. History of seizures;
8. Combined medicine with sodium valproate;
9. Combined medicine with anti-MRSA, anti-fungal drugs;
10. with severe liver or renal dysfunction;
11. Terminal cancer;
12. Septic shock;
13. APACH II ≥20;
14. Inappropriate to participate in the trial evaluated by investigator.

Primary outcomes:
measure: T>MIC
timeFrame: Day 1
Secondary outcomes:
measure: APACHE II score
timeFrame: Day 0,Day 4,Day 8
measure: SOFA
timeFrame: Day 0,Day 4,Day 8
measure: Mortality
timeFrame: Day 28
measure: highest temperature
timeFrame: Day 0,Day 4,Day 8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Aihua FEI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270368: Children Born Preterm: Sustainable Health Monitoring
Official title: Children Born Preterm: Sustainable Health Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Birth
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: IRCCS Fondazione Stella Maris
First posted: 2024-02-21
Enrollment: 650
Sex: ALL
Minimum age (years): 20
Maximum age (years): 66
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants who were born and reside in the Tuscany region.

Brief summary: Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.


Eligibility criteria: Inclusion Criteria:

* Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
* Acquisition of the informed consent

Exclusion Criteria:

* Residing outside Tuscany region

Primary outcomes:
measure: Infant development
timeFrame: The measurements will be assessed at 20-28 months of age
measure: Childhood development
timeFrame: The measurements will be assessed at 56-66 months of age
Secondary outcomes:
measure: Presence of visual or hearing impairement
timeFrame: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
measure: Presence of asthma
timeFrame: The measurements will be assessed at 56-66 months of age
measure: Access to care
timeFrame: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi (AOUC)
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana (AOUP)
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese (AOUS)
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Vieri Lastrucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01013246: Effects of Playing Video Games on Energy Balance
Official title: Effects of Playing Video Games on Energy Balance: a Randomized, 2-condition, Crossover Study in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Video games
Energy balance
Metabolism
Appetite control
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 22
Sex: MALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effects of playing video games on various components of energy balance and substrate metabolism as well as on glucose homeostasis and relevant hormonal systems that might be involved in the underlying mechanisms.


Eligibility criteria: Inclusion Criteria:

* Male adolescents between 15 and 19 years of age
* Normal weight (5th percentile to less than the 85th percentile)

Exclusion Criteria:

* Smoking
* Unstable body weight (±4 kg) during the 6 months preceding testing
* Regular physical exercise (\>3 hours/week)
* Excessive intake of alcohol (\>7 drinks/week)
* Substance abuse
* Metabolic disease (e.g. thyroid disease, heart disease, diabetes, etc.)
* Medication that could interfere with the outcome variables
* Eating disorder
* High restraint eating behavior (score ≥8 for cognitive dietary restraint in the Three-Factor Eating Questionnaire)
* Irregular eating schedule (e.g. skipping breakfast)
* Unfamiliar with the use of video games
* Unable to comply with the protocol

Primary outcomes:
measure: Energy intake and energy expenditure
timeFrame: 1 time point
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
citation: Chaput JP, Visby T, Nyby S, Klingenberg L, Gregersen NT, Tremblay A, Astrup A, Sjodin A. Video game playing increases food intake in adolescents: a randomized crossover study. Am J Clin Nutr. 2011 Jun;93(6):1196-203. doi: 10.3945/ajcn.110.008680. Epub 2011 Apr 13.
Clinical trial NCT00762346: Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Official title: Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Small Cell Lung Cancer
Bone Metastases
High NTX Level
Keywords: non small cell lung cancer
NTX
zometa
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-09-30
Enrollment: 156
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: A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Histologically confirmed non-small cell cancer
* One bone metastasis at least confirmed by image(X ray, CT or others)
* NTX \> 50nM BCE/mM creatinine
* Life expectancy \> 6 M
* ECOG \<= 2
* Signed ICF

Exclusion Criteria:

* Women who are pregnant or in lactation
* Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
* Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
* Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Primary outcomes:
measure: Skeleton-related event
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: cancer center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05257746: Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
Official title: Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Surgery
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 500
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: All patients undergoing rectal resection with total mesorectal excision

Brief summary: The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing rectal resection with total mesorectal excision

Exclusion Criteria:

* primary or secondary removal of rectal sphincter apparatus
* patients with enterostomy persisting 12 months after initial rectal resection

Primary outcomes:
measure: Assessment of pelvic function before and after rectal resection
timeFrame: 5 years
measure: Rectal sphincter function before and after rectal resection
timeFrame: 5 years
measure: Assessment of stool continence before and after rectal resection
timeFrame: 5 years
Secondary outcomes:
measure: Operating time [min]
timeFrame: during surgery
measure: Intraoperative blood loss [mL]
timeFrame: during surgery
measure: Duration of postoperative hospital stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Duration of postoperative intermediate/intensive care unit stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Frequency of peri-operative morbidity after resection
timeFrame: 90 days after surgery
measure: Kind of peri-operative morbidity after resection
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
state: Saxony
Study officials:
affiliation: Technical University Dresden
name: Johannes Fritzmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04909346: Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Official title: Observational Clinical Study of Anti-AAV Seroprevalence in Subjects With Ornithine Transcarbamylase Deficiency, Glycogen Storage Disorder Type Ia, and Wilson Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ornithine Transcarbamylase Deficiency
Wilson Disease
Glycogen Storage Disease Type IA
Lead sponsor: Ultragenyx Pharmaceutical Inc
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 51
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: Study population will include approximately equal proportions of subjects with OTC deficiency, GSDIa, and Wilson Disease

Brief summary: The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease

Detailed description: The study is primarily designed to follow a virtual model, in which Screening will take place over a telephone/video call. The study will comprise a single home health visit, either on the same day as Screening or within 30 days of enrollment. A safety follow-up may occur up to 5 days after Day 1 assessments are completed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OTC deficiency, GSDIa, or Wilson Disease.
* Provide informed consent after the nature of the study has been explained, and prior to any research-related procedures.

Exclusion Criteria:

* Prior exposure to an AAV-based gene therapy.
* Concurrent or previous participation in another Ultragenyx clinical study.
* Recipient of a liver transplant.
* Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results.

Primary outcomes:
measure: Prevalence of Anti-AAV8 Antibodies in Subjects with OTC Deficiency or GSDIa
timeFrame: Up to 35 days
measure: Prevalence of Anti-AAV9 Antibodies in Subjects with Wilson Disease
timeFrame: Up to 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Synexus Clinical Research US (Virtual Trial)
state: Ohio
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre
Study officials:
affiliation: Ultragenyx Pharmaceutical Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00948246: European Union (EU) Post-Market Study on Easyband®
Official title: EU Post-Market Study on Easyband®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Weight loss clinic and bariatric surgeon clinics within a hospital

Brief summary: The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.


Eligibility criteria: Inclusion Criteria:

* Demonstrated failure in losing weight with non-invasive therapies
* BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and \< 40 kg/m2 with one or more significant medical conditions related to obesity

Exclusion Criteria:

* patients with BMI greater than 60 kg/m2
* patients who are not indicated for laparoscopic bariatric surgery
* patients with known allergies to implant materials such as silicone and PEEK
* patients whose abdominal structures have been damaged during preceding surgical procedures
* pregnant women
* patients under the age of 18 years
* patients treated with steroids
* patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
* patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc

Primary outcomes:
measure: Feasibility and Ease of Implantation
timeFrame: < 1day
Secondary outcomes:
measure: % Excess Weight Loss
timeFrame: 12 months
measure: Change in BMI
timeFrame: 12 months
measure: Change in Weight
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Peschiera
country: Italy
city: Nieuwegein
country: Netherlands
city: Cheshire
country: United Kingdom
Study officials:
References:
Clinical trial NCT01966146: Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI
Official title: Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography
Aortic Stenosis
Mitral Valve Insufficiency
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.

Detailed description: Echocardiography: GE Healthcare Vivid E9

Eligibility criteria: Inclusion Criteria:

* patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
* patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
* Patients who are aged above 18 years and legally competent
* signed informed consent

Exclusion Criteria:

* patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities \> stage 1
* patients with atrial fibrillation
* pregnant and breast-feeding women
* patients with disturbed central nerve system
* patients with pacemaker, implants, ferrous clamps,insulin pump
* patients with tattoo
* patients with claustrophobia
* patiens with asthma

Primary outcomes:
measure: Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
timeFrame: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen
state: NRW
Study officials:
References:
Clinical trial NCT00958646: Biomarkers of the Response to Osteopathic Manipulation
Official title: Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: OMT
biomarker
Manipulation, osteopathic
Lead sponsor: West Virginia School of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2009-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).


Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 21 and 60

Exclusion Criteria:

* Eating or drinking anything but water or chewing gum within an hour of the appointment
* Rib fracture
* History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain)
* Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea)
* Pregnancy
* History of Sjogren's Syndrome

Primary outcomes:
measure: Salivary amylase levels
timeFrame: baseline, 10 minutes post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: West Virginia School of Osteopathic Medicine
state: West Virginia
Study officials:
affiliation: West Virginia School of Osteopathic Medicine
name: Kristie G Bridges, PhD
role: PRINCIPAL_INVESTIGATOR
References: