louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05134064: 68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer
Official title: 68Ga-PSMA PET/CT Imaging in Assessment of PCa: Feasibility of Delayed Acquisition on Total-body PET/CT Scanner?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PET/CT
Prostate Specific Membrane Antigen
IMAGE
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 66
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The prospective study consisted of 56 patients for 68Ga-PSMA-11 total-body PET/CT examination between December 2020 and July 2021.

Brief summary: Dual-time point 68Ga-PSMA PET/CT could increase the lesion detection in PCa patients, it remains difficult to perform in clinical practice. The possibility of one-time point 68Ga-PSMA PET/CT imaging could be achieved using a total-body PET/CT.


Eligibility criteria: Inclusion Criteria:

* primary staging of pathology-confirmed PCa or evidence of BCR with PSA value \> 0.2 ng/ml
* positive 68Ga-PSMA findings
* both standard and delayed scans were performed on the total-body PET/CT

Exclusion Criteria:

* only one scan was performed
* negative PSMA results

Primary outcomes:
measure: Only one-time point scan is possible for PSMA PET/CT
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05743764: HU007 in Patients with Dry Eye Syndrome
Official title: A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 328
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria

* Age over 19
* Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 in at least one of both eyes
* Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
* Best corrected visual acuity of 0.2 or higher in both eyes
* Those who voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

* Patients with clinically significant ocular disorders affected the test result
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c \> 9%
* Wearing contact lenses within 72 hr prior to screening visit or during clinical trial
* Pregnancy or Breastfeeding
* Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
* Patient with autoimmune disease (e.g. sjogren's syndrome)
* Patients with a history of corneal transplant or neurotrophic keratitis

Primary outcomes:
measure: Change from baseline in corneal staining score
timeFrame: 12weeks
Secondary outcomes:
measure: Change from baseline in corneal staining score
timeFrame: 4, 8weeks
measure: Change from baseline in conjuctival staining score
timeFrame: 4, 8, 12weeks
measure: Change from baseline in strip meniscometry score
timeFrame: 4, 8, 12weeks
measure: Change from baseline in TBUT score
timeFrame: 4, 8, 12weeks
measure: Change from baseline in SPEED dry eye questionnaire score
timeFrame: 4, 8, 12weeks
measure: Time to achieve 100% clearance in corneal staining
timeFrame: 12weeks
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jun young Hyun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780764: Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage
Official title: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliances
Keywords: Pulpal blood flow
self ligating brackets
orthodontics
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients).
Primary purpose: TREATMENT

Brief summary: - Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.

Detailed description: Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.

Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects
* 6 or more years old
* Class I skeletal malocclusion
* mild lower arch crowding.

Exclusion Criteria:

* Poor oral hygiene
* Previous orthodontic treatment
* Active periodontal disease
* Missing teeth, deep carious teeth
* Teeth with root resorption
* Endodontically treated teeth
* History of previous trauma
* Restoration on measured teeth
* Medical conditions affecting blood vessels and
* smoking

Primary outcomes:
measure: Pulpal blood flow changes by the use of Laser Doppler Flowmeter
timeFrame: 20 minutes ,48 hours, 72 hours and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of science and technology Dental Teaching Clinics
Study officials:
References:
Clinical trial NCT00532064: Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
Official title: Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MDACC Cancer Participants

Brief summary: This trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Testing for cardiac biomarkers, such as troponin I and/or T and B-type natriuretic peptide (BNP), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).

Detailed description: PRIMARY OBJECTIVES:

I. To determine if specific biomarkers (troponin I and B-type natriuretic peptide \[BNP\]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy.

SECONDARY OBJECTIVES:

I. To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.

OUTLINE:

Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP.

Eligibility criteria: Inclusion Criteria:

* Patient age 18-85 years
* Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib
* Has a life expectancy of greater than 6 months

Exclusion Criteria:

* Unstable angina within the last 3 months
* Myocardial infarction within the last 3 months
* Left ventricular ejection fraction (LVEF) less than 40%
* Decompensated heart failure (HF) in the last 3 months

Primary outcomes:
measure: Sensitivity of each biomarker for detecting cardiotoxicity
timeFrame: Up to 6 months
measure: Specificity of each biomarker for detecting cardiotoxicity
timeFrame: Up to 6 months
Secondary outcomes:
measure: Incidence of cardiotoxicity
timeFrame: Up to 6 months
measure: MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elie Mouhayar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03720964: Mitochondrial Genetics of Presbycusis
Official title: Mitochondrial Genetics of Presbycusis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbycusis
Age Related Hearing Loss
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is proposed to patients consulting for hearing evaluation in ENT department of University Hospital of Angers.

Brief summary: The main goal of this study is to identify mitochondrial mutations associated with presbycusis. Patients affected by severe presbycusis and normal hearing controls (according to ISO7029 norm) will be enrolled if satisfying inclusion criteria (aged from 40 to 80 years old) in existing biocollections in the University Hospital of Angers. After DNA extraction, the mitochondrial genome will be sequenced and data in silico analysed.

Detailed description: The study will be proposed to patients consulting in the ENT department of the University Hospital of Angers. After clinical examination and audiometry recording, the eligibility criteria will be checked and inclusion in biocollections proposed. Presbycusis affected subjects will be enrolled in "Mitochondrial Disease biocollection" and normal hearing controls in "Healthy Volunteer biocollection". These biocollections have been approved by the board comitee "Centre de Protection des Personnes".

After DNA extraction and mitochondrial sequencing, candidate variants will be selected by in silico analysis. The presence of mitochondrial variants in both groups (presbycusis and control) will be compared in multivariate analysis if needed.

The nuclear DNA may be sequenced in order to complete the previous analysis and look for any candidate variant .

Eligibility criteria: Inclusion Criteria:

* age related hearing loss more severe than the predicted hearing thresholds according to the norm ISO7029, for the presbycusis population;
* normal hearing according to norm ISO7029 for the control population

Exclusion Criteria:

* deafness diagnosed before 40 years old
* exclusion criteria of one of the biocollection

Primary outcomes:
measure: identification of mitochondrial mutations associated with presbycusis
timeFrame: the analysis will be conducted at the end of the inclusion of the 200 patients
Secondary outcomes:
measure: identification of genomic variants associated with presbycusis
timeFrame: the analysis will be conducted at the end of the inclusion of the 200 patients
measure: identification of DNA variants associated with environmental susceptibility
timeFrame: the analysis will be conducted at the end of the inclusion of the 200 patients
Other outcomes:
measure: identification of clinical features predicting some presbycusis forms
timeFrame: the analysis will be conducted at the end of the inclusion of the 200 patients
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
References:
Clinical trial NCT01612364: RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Official title: Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome I of Upper Limb
Keywords: CRPS I
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo General Hospital
First posted: 2012-06-05
Enrollment: 60
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 is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).


Eligibility criteria: Inclusion Criteria:

* Complex regional pain syndrome (IASP, 1994) involving an upper limb;
* Pain scores in excess of five visual analog scale (VAS);
* Poor outcome to treatment (less than 50% reduction in VAS scores) -

Exclusion Criteria:

* History of severe brain injury, epilepsy and stroke
* Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
* Severe systemic disease
* Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
* Refusal to participate or not initial adherence to orientations
* Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.

Primary outcomes:
measure: Analgesia after block
timeFrame: 1 month
Secondary outcomes:
measure: analgesia quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Study officials:
affiliation: Hospital das Clinicas Faculty of Medicine University Sao Paulo
name: Roberto O Rocha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175264: Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia
Official title: Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isolated Non Syndromic Left CDH With Postero Lateral Diaphragmatic Defect With Good Perinatal Outcome
Keywords: Isolated non syndromic CDH
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies with CDH who delivered if centers included in the "Centre For Rare Disease for Congenital Diaphragmatic Hernia"

Brief summary: In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). Our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

Detailed description: To elucidate the genetic basis of non syndromic congenital diaphragmatic hernia in a sub group of individuals with similar phenotype: Isolated CDH presenting with postero-lateral-left diaphragmatic defect with good perinatal outcome (n=16) To establish the prevalence of the identified gene(s) in a cohort of identical patients (n=30)

Two complementary approaches will be used:

* Search for pathogenic genomic alterations using microarrays (\~2.106 markers (SNP and CNV) in 16 trios (affected child and 2 parents).
* Sequencing of the whole exome from patient genomic DNA (n=16)
* Selection of unknown or very rare variants according to different criteria: recessive or dominant model, prediction of their pathogenicity, filtered on genes already known in CDH or involved in diaphragmatic development and non annotated CNV or variants of new gene(s) shared by different patients.
* Variants will be validated by Sanger sequencing (for intragenic variants) or quantitative PCR (for CNV) on CDH cases and their parents as well as their absence on 100 controls.

Eligibility criteria: Inclusion Criteria:

* Families with one (or more) non syndromic CDH child
* Signed consent form

Exclusion Criteria:

* Syndromic CDH or associated with a known karyotype anomaly
* No signed consent form
* Not affiliated to French social security

Primary outcomes:
measure: genes responsible for isolated CDH
timeFrame: One year
Secondary outcomes:
measure: prevalence of new identified genes in a cohort of CDH
timeFrame: One year
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital béclère
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Judith Melki, MD-PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02667964: FGF-21 and Exercise in Relation to Insulin Secretion
Official title: FGF-21 During Physical Exercise in Patients With Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore, both hormones are influenced by physical activity. The following hypothesis will be tested: FGF-21 is regulated insulin-dependent during exercise.

Detailed description: Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by rising global importance. In Germany alone, more than seven million people are being treated currently. T2DM is characterized by permanently elevated blood glucose levels, based on insulin resistance and followed by associated beta cell failure. In our previous work the investigators could already shown that increased FGF-21 levels are accompanied by an increased risk of T2DM. Physical activity is essential in the treatment and the prevention of T2DM. Interestingly, it was shown that acute physical exercise was leading to decreased insulin levels and increased FGF-21 values. In this study the effects of acute physical activity on FGF-21 values should be investigated in 3 groups: a) Healthy volunteers b) persons with T2DM c) persons with T1DM.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers,persons with T2DM, persons with T1DM

Exclusion Criteria:

* Patients with contraindications to an exercise ECG or spirometry be excluded from participation in the study.

Primary outcomes:
measure: FGF-21 change after physical activity
timeFrame: FGF-21 before and 1 h after spiroergometry
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charité
name: Thomas Bobbert, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614664: Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congenital Heart Disease
Single Ventricle
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with single ventricle anatomy

Brief summary: Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement. With advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. Although generally safe and effective, the increase in IAP during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. This prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).


Eligibility criteria: Inclusion Criteria:

* Patients with single ventricle physiology presenting for laparoscopic procedures.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in cerebral oxygenation values
timeFrame: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Roby Sebastian, MD
role: PRINCIPAL_INVESTIGATOR
References: