louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06353672: A Study to Evaluate Safety and Feasibility of Robotic Liver Resection
Official title: A Study to Evaluate Safety and Feasibility of Robotic Liver Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Surgery
Keywords: Robotic liver resection
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.

This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR.


Eligibility criteria: Inclusion Criteria:

* The patients were diagnosed with a liver tumor.
* The patients underwent robotic liver resection.

Exclusion Criteria:

* The patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).

Primary outcomes:
measure: Postoperative complications
timeFrame: with in 90 days after surgery
measure: Postoperative hospital stay
timeFrame: with in 90 days after surgery
measure: Postoperative unplanned reoperation
timeFrame: with in 90 days after surgery
measure: Unplanned readmission
timeFrame: with in 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital, Medical College of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02766504: Ultrasound in Airway Assessment of Morbidly Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Anesthesia of Morbid Obese Patients
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: surgical list patients with indicated endotracheal tube insertion for general anesthesia

Brief summary: the study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients


Eligibility criteria: Inclusion Criteria:

* all surgical list patients planned for general anesthesia from october 2015 to may 2016

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: prediction of difficult intubation in morbid obese patients
timeFrame: during endotracheal tube insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT04833504: Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
Official title: Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Transformed Follicular Lymphoma
Primary Mediastinal Large B-cell Lymphoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 39 patients meet including and excluding criteria criteria

Brief summary: This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).

Detailed description: Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.

Eligibility criteria: Inclusion Criteria:

* All patients who have received the CD19-IL7/CCL19 CAR-T therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (NCT0325847) Patients who have provided informed consent for the long term follow up study prior to their study participation .

Exclusion Criteria:

* There are no specific exclusion criteria for this study.

Primary outcomes:
measure: Evaluate the efficacy of CD19-IL7/CCL19 CAR-T
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate the persistence of CAR-T cells
timeFrame: 5 years
measure: Evaluate the incidence of adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hui Liu
state: State...
Study officials:
affiliation: Zhejiang University
name: Wenbin Qian, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01353404: Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)
Official title: Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 20-50 years of age
* Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
* Voluntary written informed consent

Exclusion Criteria:

* History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
* Drug allergies to fenofibrate
* Recent history or evidence of drug abuse
* Recent participation(within 2months) in other clinical studies
* Recent donation of blood(within 2months) or plasma(within 1months)

Primary outcomes:
measure: Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
timeFrame: 23 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Institute, Seoul National University Hospital
Study officials:
affiliation: Clinical Research Institute, Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228604: Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
Official title: COST-EFFECTIVENESS STUDY OF THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER IN BRAZIL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: open label
Ritalin®
ADHD
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-10-26
Enrollment: 23
Sex: MALE
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for children with ADHD aimed at assessing whether the observable behavioral changes seen during treatment are associated with potentially more stable underlying modifications in brain functioning (resting-state functional connectivity). Additionally, we will also be looking at treatment effects on neuropsychological processes and reading skills. This information will contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of typically developing children.


Eligibility criteria: Inclusion Criteria:

The study will include 20 boys aged 8 to 10 years old, regularly enrolled in local schools and directed to the research through advertisement in the media, contact with schools or directly referred to the Attention Deficit/Hyperactivity Program (ProDAH/HCPA) by primary care services for assessment and treatment. Only children with a primary diagnosis of ADHD or with the comorbidity ADHD + reading disorder or ADHD + ODD will be included. Only drug-naïve subjects will be apt to participate in the study.

Exclusion Criteria:

Children who fit into one or more of the following conditions will not be considered eligible to take part in the study: (1) they are outside the age range specified; (2) they are not regularly enrolled and attending school; (3) they have a history of prior or current treatment with psychoactive drugs or psychotherapy; (4) they are mentally retarded (Overall IQ\<80); (5) they have a main diagnosis differing from ADHD, including children with other psychiatric or neurological diagnoses

Primary outcomes:
measure: Resting-state functional connectivity
timeFrame: After 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT01011504: Utilisation of Angiox® in European Practice
Official title: A Registry Study to Determine Utilisation Patterns in Patients Receiving Angiox®, and Collect Descriptive Safety and Outcome Data to Inform the Risk Management Strategy for Europe.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina (SA)
NSTE-ACS (NSTEMI and UA)
STEMI (STE-ACS)
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 2019
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately, 2,000 patients will be included at centres throughout Europe

Brief summary: The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe


Eligibility criteria: Inclusion Criteria:

* Eligible for, and receive treatment with Angiox®.
* Willing and able to provide written informed consent to the use of their data in accordance with relevant local Data Protection laws, policies and regulations

Exclusion Criteria:

* Participation in other interventional clinical research studies involving the evaluation of investigational drugs, including Angiox®, or devices at the time of enrolment.
* Patients not eligible for treatment for Angiox®.

Primary outcomes:
measure: Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered
timeFrame: from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).
Secondary outcomes:
measure: Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events
timeFrame: measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Rostock
country: Germany
facility: Medizinische Klinik I Kardiologie/Pneumologie/Internistische
Study officials:
name: Christoph Nienaber, Prof.
role: PRINCIPAL_INVESTIGATOR
name: Martial Hamon, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597904: Background of Different Phenotypes of Coeliac Disease
Official title: Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Celiac Disease
Dermatitis Herpetiformis
Keywords: coeliac disease
dermatitis herpetiformis
gluten-free diet
transglutaminase
microbiata
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
name: University of Turku
name: Oulu University Hospital
name: University of Debrecen
name: University of Trieste
name: Oslo University Hospital
First posted: 2022-10-28
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National and also focused recruitment for patients with coeliac disease or dermatitis herpetiformis diagnosis. Healthy controls recruited via volunteered subjects with coeliac disease or dermatitis herpetiformis

Brief summary: The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

Detailed description: The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines.

In this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

Eligibility criteria: Inclusion Criteria:

* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis
* Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient

Exclusion Criteria:

* Cohorts 1-3: Age \<18 years
* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed
* Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis

Primary outcomes:
measure: Non-HLA variant association
timeFrame: baseline
Secondary outcomes:
measure: serum transglutaminase antibodies
timeFrame: baseline
measure: microbiata
timeFrame: baseline
measure: quality of life measure
timeFrame: baseline
measure: gastrointestinal symptoms
timeFrame: baseline
measure: dietary adherence
timeFrame: baseline
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT00876304: Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia
Official title: Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF-04802540 multiple dose safety study
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Males or females of non-childbearing capacity aged 18 to 55 years inclusive
* DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months
* Body mass index in the range of 18 to 40 kg/m2 and body weight\>45 kg.

Exclusion Criteria:

* Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
timeFrame: 22 days
measure: Adverse Events
timeFrame: 22 Days
measure: Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
timeFrame: 12 Days
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: 16 days
measure: Clinical Global Impression of Severity and Improvement
timeFrame: 16 days
measure: Extrapyramidal Symptom Rating Scale - Abbreviated
timeFrame: 16 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04533204: Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment
Official title: Comparing Mnemonic Strategy With Spaced Retrieval Training in Patients With Mild Cognitive Impairment (B6366-W)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: MCI
cognitive training
memory training
dementia
Alzheimer's disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-08-31
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to Mnemonic strategy or spaced retrieval training
Primary purpose: TREATMENT

Brief summary: This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.

Detailed description: Individuals with MCI were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. Across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. Task-fMRI was acquired before and after training. Memory was again evaluated 1 month after the last training session. The primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the MRI environment.

Eligibility criteria: Inclusion Criteria:

-Diagnosis of MCI according to Petersen (2004) criteria, right handed

Exclusion Criteria:

* Diagnosis of other neurological condition,
* active drug/alcohol abuse/dependence,
* moderate-severe depression or other Axis I diagnoses.

Primary outcomes:
measure: Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment
timeFrame: up to 1 month after last training session
Secondary outcomes:
measure: Change in Accuracy (vs. Baseline) on Novel Object Location Associations
timeFrame: up to 1 month after last training session
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Benjamin M. Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05973604: Prevalence of Primary Aldosteronism in Atrial Fibrillation
Official title: Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Primary Aldosteronism
Keywords: Atrial Fibrillation
Primary Aldosteronism
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation

Brief summary: This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).

Exclusion Criteria:

* Diagnosis of primary aldosteronism
* Diagnosis of heart failure, treated with mineralocorticoid receptor antagonists
* Inability to be subjected to any confirmatory tests for primary aldosteronism
* Acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular event) within last 6 months
* Renal replacement therapy
* Incompetence of unwillingness to provide written informed consent

Primary outcomes:
measure: Prevalence of primary aldosteronism in patients with atrial fibrillation
timeFrame: Baseline
Secondary outcomes:
measure: Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation
timeFrame: Baseline
measure: Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.
timeFrame: Baseline
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Ippokratio General Hospital
Study officials:
affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
name: Maria Toumpourleka, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
name: Vassilios P Vassilikos, PhD
role: STUDY_DIRECTOR
affiliation: Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
name: Michael Doumas, PhD
role: STUDY_DIRECTOR
affiliation: Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
name: Christodoulos E Papadoupoulos
role: STUDY_CHAIR
References: