louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02452827: The Correlation of Myodural Bridges to Biomechanical Parameters in Patients Suffering From Primary Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from Primary Chronic Neck Pain who have undergone MRI. Healthy volunteers who have undergone MRI of the cervical spine.

Brief summary: In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. In addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.


Eligibility criteria: Inclusion Criteria:

* Chronic Neck Pain

Exclusion Criteria:

* Have undergone cervical spine surgery
* Known cerebral vascular disease of the carotid or vertebral arteries
* Malignant disease of the cervical spine

Primary outcomes:
measure: Volume and Number of Muscle Fibers in Myodural Bridges
timeFrame: One hour
Secondary outcomes:
measure: Measurement of cervical range of motion
timeFrame: Two hours
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yaron River, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433027: A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: A Phase 2 Trial of Intratumoral EGFR Antisense DNA (BB-401) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) Who Have Failed All Available Standard Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Benitec Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 16
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: The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.


Eligibility criteria: Key Inclusion Criteria:

* Histologically or cytologically confirmed HNSCC
* Failed (or are ineligible/decline to receive) all available standard therapies
* Stable, treated brain metastases
* One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment
* Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy

Key Exclusion Criteria:

* Nasopharyngeal Carcinoma
* Concomitant anti-cancer therapy
* Unresolved toxicities from prior treatments
* Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation

Primary outcomes:
measure: Overall Response (OR) of the injected tumor
timeFrame: Up to 20 months (estimated length of the study)
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: End of Treatment Visit (Week 9) through to study end (up to 18 months)
measure: Progression Free Survival (PFS)
timeFrame: Up to 20 months (estimated length of study)
measure: Overall Survival (OS)
timeFrame: Up to 20 months (estimated length of study)
measure: Duration of Response (DoR)
timeFrame: 20 months (estimated length of study)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: The Chris O'Brien Lifehouse
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Calvary Central Districts Hospital
state: South Australia
city: Irkutsk
country: Russian Federation
facility: Irkutsk Oncology Center
city: Krasnodar
country: Russian Federation
facility: Clinical Oncology Dispensary #1
city: Leningrad Region
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg City Oncology Clinic
Study officials:
References:
Clinical trial NCT06439927: New Method to Close Nasal Septal Perforation
Official title: Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Perforated Septum
Keywords: nasal septal perforation
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria:

* Patients with known allergy to polycaprolactone.
* Pregnancy or lactation.

Primary outcomes:
measure: Mean Change in Post-operative healing of septal perforation
timeFrame: for a three months follow up period
Secondary outcomes:
measure: Postoperative complications
timeFrame: for a three months follow up period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Helwan University
Study officials:
affiliation: Helwan University
name: Mohamed H Sebaey, master degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213327: StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Official title: StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Keywords: mental health
assessment
health promotion
case management
health insurance
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Health and Medical Services
name: Helsana
name: Neomentum
name: Sanatorium Kilchberg AG
name: Design your life
First posted: 2017-07-11
Enrollment: 174
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are examined at two time points: baseline and 12 weeks after the Intervention.

The Intervention consists of health-promoting advices provided by the software algorithm. The effect of this intervention is evaluated 12 weeks after.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The validity and the sensitivity of different measures implemented in the web application StayOk are investigated. The measures are used primarily for the assessment and the early identification of psychosocial risks. Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.


Eligibility criteria: Inclusion Criteria:

* at 16 years of age
* mild to moderate psychological distress

Exclusion Criteria:

* serious cognitive impairment due to dementia or cerebrovascular insult
* Insufficient knowledge of one of the following languages: German, French, Italian or English

Primary outcomes:
measure: Psychological distress
timeFrame: 0 week (first assessment)
measure: Work-related sense of coherence
timeFrame: 0 weeks
measure: Perceived self-efficacy
timeFrame: 0 weeks
Secondary outcomes:
measure: Effectiveness of health-promoting advices
timeFrame: 12 weeks after the first assessment
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Helsana
Study officials:
affiliation: Zurich University of Applied Sciences
name: Agnes von Wyl, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
citation: Jenny GJ, Bauer GF, Vinje HF, Vogt K, Torp S. The Application of Salutogenesis to Work. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK435821/
citation: Damasio BF, Valentini F, Nunes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brahler E, Finck C, Zenger M. Is the General Self-Efficacy Scale a Reliable Measure to be used in Cross-Cultural Studies? Results from Brazil, Germany and Colombia. Span J Psychol. 2016 May 26;19:E29. doi: 10.1017/sjp.2016.30.
Clinical trial NCT01654627: Guided Bone Regeneration Using Synthetic Membrane
Official title: Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Jaw, Edentulous
Jaw, Edentulous, Partially
Keywords: Guided Tissue Regeneration
Dental Implants
Membrane, Synthetic
Lead sponsor: RegeneCure, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.


Eligibility criteria: Inclusion Criteria:

* Subject must have voluntarily signed the informed consent form before any study related action
* Age: 18 to 65 with missing teeth, seeking for implant therapy.
* Men/Women
* In good systemic health
* Present with no contra indication against oral surgical interventions
* Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
* The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
* Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
* Full mouth plaque score (FMPI) lower or equal than 25%
* Patients must be committed to the study

Exclusion Criteria:

* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonate intravenously
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled Diabetes
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
* Untreated inflammation
* Mucosal diseases or oral lesions
* History of local irradiation therapy
* Persistent intraoral infection
* Patients with bad oral hygiene or unmotivated for normal home care.

Primary outcomes:
measure: Bone volume
timeFrame: Change from Baseline in bone volume at 6 months
Secondary outcomes:
measure: Histomorphometry
timeFrame: 6 months
measure: Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant
timeFrame: six months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Department of Periodontology Hadassah and Hebrew University Medical Center
Study officials:
affiliation: Haddasah Medical Center, Jerusalem Israel
name: Lior Shapira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06079827: Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients
Official title: Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: MaxWell Clinic, PLC
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals diagnosed with Alzheimer's Disease or mild cognitive impairment who will be undergoing plasma exchange per the AMBAR Trial protocol

Brief summary: The study will determine if Therapeutic Plasma Exchange removes RNA biomarkers associated with Alzheimer's Disease and how quickly those biomarkers reappear after treatment.

Detailed description: Participants with a diagnosis of Alzheimer's or Mild Cognitive Impairment will undergo therapeutic plasma exchange as part of their treatment for the disease as per the AMBAR Trial protocol. Patients will undergo one non-invasive tests to assess their microvascular system and complete one online test to assess the degree of cognitive impairment. Patients will have their blood drawn pre-plasma exchange, immediately post plasma exchange and repeated assessments and blood draws at seven day intervals post plasma exchange ending on the twenty-eighth day after the plasma exchange.

Their blood will be analyzed by FBB Biomed to identify the presence of unique RNA biomarkers associated with Alzheimer's disease and determine how quickly they regenerate.

Eligibility criteria: Inclusion Criteria:

1. Subject is scheduled to undergo their first TPE Procedure for a diagnosis of Alzheimer's Disease or previous mental/cognitive impairment
2. Mentally capable of understanding and completing informed consent for the study.

Exclusion Criteria:

1. Subject is unable or failed to return/provide blood specimen on days seven (7), fourteen (14) , twenty-one (21), and twenty-eight (28) (plus or minus 1 day on follow up draws) post plasma exchange
2. Subject is unable to provide informed consent.

Primary outcomes:
measure: To ascertain if Therapeutic Plasma Exchange (TPE) reduces the presence of RNA biomarkers in a small sample of Alzheimer's patients.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: The MaxWell Clinic
state: Tennessee
Study officials:
References:
Clinical trial NCT00167427: Genotoxicity Assessment for Patients Undergoing Radiation Treatment
Official title: Genotoxicity Assessment for Patients Receiving Large Field Irradiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-09-14
Enrollment: 47
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: Patients that are scheduled to begin radiotherapy to the large-field chest region

Brief summary: The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

Detailed description: Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.

i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.

ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes.

iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.

iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.

Eligibility criteria: Inclusion Criteria:

* Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:

  * Daily radiation dose is between 1.8 and 5 Gy/day
  * Any single dimension of field size is ≥ 15 cm
  * Provision of written informed consent

or

* Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
* Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
* Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides

Primary outcomes:
measure: Measure the Change in MN-RET in the blood
timeFrame: Baseline and 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Yuhchyau Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094327: Proteinuria in Pre and Post Transplant
Official title: Evaluation of Recipients with and Without Proteinuria, Pre and Post Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proteinuria
Keywords: focal segmental glomerulosclerosis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 100
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population up to the age of 25 years old, with biopsy diagnosed of FSGS (focal segmental glomerulosclerosis).

Brief summary: Patients with focal segmental glomerulosclerosis (FSGS) who progress rapidly to end stage renal disease (ESRD) are at highest risk for development of recurrence of proteinuria following kidney transplantation. This study will look at serum specimens pre and post transplant, as well as kidney transplant specimens pre and post reperfusion to identify where the defects has occured that results in recurrence of proteinuria in a given kidney transplant.

Detailed description: This study will retrospectively review patient's medical records for protein in the urine, blood creatinine and kidney biopsy results. Also character of the fluid used to flush the kidney before transplant will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients
* Pediatric males and females up to the age of 25 years old.

Exclusion Criteria:

* Transplant recipients other than kidney

Primary outcomes:
measure: Explain mechanisms behind the development of proteinuria in patients immediately after receiving a kidney transplant
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine Transplant Clinic
state: Florida
Study officials:
affiliation: University of Miami
name: George Burke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06360627: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT
Official title: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Exposure
Lung Embolism
Lung Cancer
Pneumonia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT


Eligibility criteria: Inclusion Criteria:

* CT SCAN for pulmonary nodule detection/follow up
* CT SCAN for pneumonia detection/follow up

Exclusion Criteria:

* under 18
* BMI over 30

Primary outcomes:
measure: Dose Reduction by new scanner
timeFrame: through study completion, an average of 1 year
measure: stable Image Quality in reduced dose scans
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - Diagnostic Radiology
Study officials:
References:
Clinical trial NCT04127227: Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
Official title: Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NK/T Cell Lymphoma Nos
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)


Eligibility criteria: Inclusion Criteria:

* biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
* newly diagnosed stage III/IV patients;
* at least one evaluable lesion；
* ECOG PS 0-2;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* hemophagocytic syndrome or aggressive NK cell leukemia;
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

Primary outcomes:
measure: complete remission (CR) rate
timeFrame: 2years
measure: overall response rate (ORR)
timeFrame: 2years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2years
measure: progression survival (PFS)
timeFrame: 2years
measure: disease-free survival (DFS)
timeFrame: 2years
measure: bio-marker analysis
timeFrame: 2years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: