louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03932058: Proteomics Research of Osteosarcoma
Official title: Establishment of New Molecular Prototyping Based on Proteomics for Predicting Osteosarcoma Chemotherapy Response and Risk of Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteosarcoma
Proteomics
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Retrospectively collected 400 cases of clinical data and pathological paraffin specimens of osteosarcoma, chondrosarcoma (control) and endogenous chondroma (control) in our hospital from 2008 to 2014, combined with high-pressure cycle-satellite scanning mass spectrometry (PCT-SWATH) Molecular typing of osteosarcoma and prediction of targeted therapy, the establishment of a new molecular classification based on proteomics for osteosarcoma to predict the chemotherapy response and recurrence risk of osteosarcoma. Clinical osteosarcoma patients include as many types as possible: pre-chemotherapy, post-chemotherapy, recurrence, and metastasis. The study did not involve vulnerable groups, and it was taken as a postoperative wax specimen for patients, which had no health, life and other effects on patients. Study application exemption from informed consent.


Eligibility criteria: Inclusion Criteria:

* all osteosarcoma patients in our hospital
* received Methotrexate+Doxorubicin+Cisplatin protocol chemotherapy

Exclusion Criteria:

* non-chemotherapy patients
* bio-specimen not completed

Primary outcomes:
measure: proteomics changes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital Of Zhejiang University
name: zhaoming Ye, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270758: Clinical Validation of BBCT-hip
Official title: Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Keywords: hip fracture
fracture prediction
finite element
in silico
osteoporotic fracture
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resident in Emilia Romagna, Italy

Brief summary: The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.


Eligibility criteria: Inclusion Criteria:

* caucasic post-menopausal women resident in Emilia-Romagna
* menopause (\>= 45 years)

Exclusion Criteria:

* tumours
* not free living
* Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
* Long-term continuous therapy (\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
* Previous femur fractures
* Presence of hip/knee prosthesis

only for the fracturegroup:

* presence of fixation devices after the fracture
* femur fracture due to high energy trauma

Primary outcomes:
measure: Femoral fracture event
timeFrame: 5 years
measure: BBCT-hip risk prediction
timeFrame: 5 years
Secondary outcomes:
measure: T-score
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
References:
Clinical trial NCT02820558: Neuropeptide Therapy of Recent Onset Type 1 Diabetes
Official title: A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Neuropeptide
Therapy
Onset
Lead sponsor: Vanilloid Genetics Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Recent onset T1D (CDA 2013 guidelines: See link in links section
* Age 10-18 years
* Disease Duration 3-30 months
* Fasting C-Peptide (measured at screening) greater than or equal to 33 pmol/L
* Post honeymoon phase based on the following criteria: History of HbA1c values and insulin requirements from diagnosis indicating a honeymoon period followed by increased insulin requirements which at time of recruitment are \> 0.50 units/Kg together with an HbA1c value \> 7.2 %; Patients with diabetes duration \> 3 months who never experienced a honeymoon period as reflected by consistent HbA1c values \> 7.2 % from the time of diagnosis and at the time of recruitment are using an insulin dose \> 0.50 units/Kg.
* The presence of one or more of the TRPV1 alleles similar to those found in patients currently enrolled in the TRPV1-North American - European Study.
* Stimulated C-Peptide (measured at mixed meal tolerance at Stage A and Stage B of sP trial) ≥ 200 pmol/L and less than or equal to 1500 pmol/L.

Exclusion Criteria:

* Patients with known co-morbidities, including ACE-inhibitor treated hypertension as well as chromosomal abnormalities, involving one or more organ systems.
* Type 2 Diabetes Mellitus
* Patients with a known radiographic contrast allergy
* Pregnancy.

Primary outcomes:
measure: Stage A Safety: Side effects reported for entire cohort
timeFrame: Reported during the first 20-27 days following sP administration
Secondary outcomes:
measure: C-Peptide Levels (small cohort)
timeFrame: Day 20-27 post sP injection
measure: C-Peptide Levels (large cohort)
timeFrame: Day 20-27 post sP injection
Other outcomes:
measure: sP Longevity
timeFrame: 3 and 6 months
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Hospital for Sick Children, Toronto Ontario
name: Etienne Sochett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399658: Image-Guided Gynecologic Brachytherapy
Official title: A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Uterine Cancer
Vaginal Cancer
Carcinoma of the Vulva
Keywords: Brachytherapy
Gynecological cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.

Detailed description: The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
* Life expectancy \> 6 months
* MRI of the pelvis and/or PET-CT within 4 months prior to entering study

Exclusion Criteria:

* Uncontrolled intercurrent illness
* Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye

Primary outcomes:
measure: Mean Doses Given
timeFrame: Measured while on treatment, up to 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Martin King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02366858: Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures
Official title: Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: 19 gauge
22 gauge
core tissue
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.

Detailed description: Inclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Exclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Eligibility criteria: Inclusion Criteria:

* All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)

Exclusion Criteria:

* Age under 19 years
* Pregnant women will be excluded. This will be confirmed by self-report

Primary outcomes:
measure: 22 gauge needle
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812758: Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence?
Official title: Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Keywords: sedation depth
indices of preload dependence
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 45
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: All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)

Brief summary: Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.


Eligibility criteria: Inclusion Criteria:

* All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)
* Good echogenicity
* Social security coverage

Exclusion Criteria:

* Pregnancy, legal guardianship
* Subjects with black skin (a known technical limitation of plethysmography)
* Cardiac arrhythmia
* Sepsis
* Poor echogenicity

Primary outcomes:
measure: Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)
timeFrame: Day 0
Secondary outcomes:
measure: The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Emmanuel LORNE, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05545358: Neural Bases of Phantom Pain After Amputation
Official title: Experimental Study of the Neural Bases of Phantom Pain After Amputation and Their Modification by Proprioceptive Training: MRI Study of the Brain and Spinal Cord
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Phantom Pain
Keywords: fMRI
spinal fMRI
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of :

* patients who have been amputated for more than 2 years and have chronic phantom pain;
* patients who have been amputated for more than 2 years and do not have chronic phantom pain;
* healthy participants with no neurological history. The patients will be recruited from the cohort of amputee patients followed by the Physical Medicine and Rehabilitation departments of the Hôpital d'Instruction des Armées Laveran, the Hôpital d'Instruction des Armées Desgenettes and the CHU de Saint-Etienne.

Brief summary: The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years old
* For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain
* For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain
* For the "healthy participants" group: healthy participants with no neurological history

Exclusion Criteria:

* Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)
* Progressive psychiatric or neurological pathology
* On psychotropic medication
* Pregnant or nursing woman
* Inadequate level of French language

Primary outcomes:
measure: Change in brain activity, measured through fMRI, following proprioceptive training
timeFrame: Up to 3 months
measure: Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04791358: Decision Impact Trial of KidneyIntelX
Official title: A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Kidney Disease
Lead sponsor: Renalytix AI, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Brief summary: The current trial is designed to evaluate how the results of KidneyIntelX test impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.


Eligibility criteria: Inclusion Criteria:

* 23 years of age or older.
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-60 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients who are currently on Enbrel.

Primary outcomes:
measure: Blood pressure
timeFrame: 12 Months
measure: HbA1c
timeFrame: 12 Months
measure: ACEi/ARB
timeFrame: 12 Months
measure: SGLT2/ GLP1
timeFrame: 12 Months
measure: Urine albumin to creatinine ratio
timeFrame: 12 Months
measure: Referrals
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Slingerlands
country: United States
facility: Delmar Family Medicine
state: New York
Study officials:
References:
Clinical trial NCT05445258: Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon
Official title: Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II
Lead sponsor: InnoRa GmbH
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 3
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: This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II
* Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening
* Target vessels with a sufficient "runoff" to the foot with at least one vessel
* Rutherford classification 1-4 if physical and medicinal therapies have not been successful

Exclusion Criteria:

* Aneurysms at the site of inflation
* Application directly in the area of large vessel wall injuries with heavy bleeding
* Rutherford classification 5 and 6

Primary outcomes:
measure: Safety and tolerance
timeFrame: up to 30 days after intervention
Secondary outcomes:
measure: Procedural success
timeFrame: till the end of the procedure
measure: Handling of the InnoCath AB® hyper-compliant balloon catheter
timeFrame: throughout the entirety of the procedure
measure: Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter
timeFrame: throughout the entirety of the procedure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus
city: Berlin
country: Germany
facility: Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus
Study officials:
affiliation: Martin-Luther-Krankenhaus
name: Michael Werk, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191658: Can Neck Circumference Measurements Less Than 43cm or Greater Than 43cm Predict Difficulty of Tracheal Intubation?
Official title: Can Neck Circumference Measurements Less Than 43cm or Greater Than 43cm Predict Difficulty of Tracheal Intubation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Circumference, Difficulty of Tracheal Intubation
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients who require tracheal intubation for general anesthesia and surgery

Brief summary: The circumference of a person's neck is a useful predictor of difficulty of insertion of a breathing tube.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-4
* Receiving general endotracheal anesthesia for surgery

Exclusion Criteria:

* Limited range of motion of the neck or jaw
* Cervical spine injuries
* Upper airway pathology
* Previous facial trauma, or goiter
* Patients receiving regional anesthesia or anesthesia other than general, endotracheal anesthesia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
References: