louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02699229: Non-linear Multimodal Microendoscopy for Lung Cancer Pathology
Official title: Non-linear Multimodal Microendoscopy for Lung Cancer Pathology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 0
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: Lung Cancer Patients

Brief summary: For this study the investigators are looking to do the following:

1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.
2. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue.

Detailed description: For this study the investigators are looking to do the following:

1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues. In particular, to investigate collagen content and ultrastructure with SHG (second harmonic generation) microscopy, to characterize cell and nuclear morphology and lipid vesicle content with THG (third harmonic generation) and CARS (coherent anti-Stokes Raman scattering) microscopy and to conduct spectroscopic and lifetime characterization of MPF (multiphoton fluorescence) signals in cancerous, benign, and normal tissues.
2. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue, from which to generate diagnostic algorithms, both to optimize the operating parameters of planned nonlinear endoscopic imaging and to serve as the basis for nonlinear optical histopathology.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Patients with confirmed or suspected lung cancer who require lobectomy as part of standard-of-care.

Exclusion Criteria:

* Patients deemed on clinical grounds not to be medically fit for a lobectomy
* Patients where there is a high clinical suspicion of lymphoma (to avoid mixing the data sets).
* Patients unable to give informed consent

Primary outcomes:
measure: Nonlinear optical microscopy for cancerous tissue detection in human lung lesions
timeFrame: Two years
Secondary outcomes:
measure: The first spectral/structural database for nonlinear optical micro-imaging of normal and abnormal lung tissue
timeFrame: Two Years
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Kazuhiro Yasufuku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302429: Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft
Official title: Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Abnormality
Keywords: Alveolar cleft -Platelet rich fibrin- calcium phosphate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.

Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
Primary purpose: TREATMENT

Brief summary: P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.

Detailed description: this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch

Eligibility criteria: Inclusion Criteria:

* Patients suffering from maxillary alveolar cleft
* Patients' age 8 years and older

Exclusion Criteria:

* Syndromic cases will be excluded
* Patients suffering from platelets disorders.

Primary outcomes:
measure: bone height
timeFrame: six months postoperative.
Secondary outcomes:
measure: bone volume
timeFrame: six months postoperative.
measure: operation duration
timeFrame: within 4 hours ( the actual number of hours will be determined intra-operative )
measure: hospital stay
timeFrame: within 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT02301429: Model 20105 Lead Study
Official title: Model 20105 Lead Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sick Sinus Node Syndrome
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2014-11-25
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 implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.


Eligibility criteria: Inclusion Criteria:

* Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
* Subject has signed and dated the study-specific informed consent form
* Subject is 18 years of age or older
* Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study

Exclusion Criteria:

* Subject is indicated for BiV pacemaker or ICD
* Subject is pacing dependent
* Subject has a previous Pacemaker System
* Subject has known coronary venous vasculature that is inadequate for lead placement
* Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
* Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Subject is not in sinus rhythm at implant
* Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
* Subject is contraindicated for \<1mg dexamethasone acetate
* Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Subject has a terminal illness and is not expected to survive more than 6 months
* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
* Subject meets exclusion criteria required by local law.
* Subject is unable to tolerate an urgent thoracotomy

Primary outcomes:
measure: All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Teaching Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf Hospital
city: Singapore
country: Singapore
facility: NUHCS, National University Hospital
city: Johannesburg
country: South Africa
facility: Milpark hospital
Study officials:
References:
Clinical trial NCT01557829: Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
Official title: Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Degeneration of Pfirrmann Grade III or Greater
Degenerative Spondylolisthesis
Isthmic Spondylolisthesis of Grade I or II
Keywords: spondylolisthesis
disc degeneration
lumbar interbody fusion
randomized controlled trial
ceramic interbody spacer
Lead sponsor: Amedica Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18-75 years
* Chronic low back pain unresponsive to at least six months of conservative care
* MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II

Exclusion Criteria:

* Osteoporosis
* Patients with prior failed fusion at the same level
* Degenerative scoliosis
* Degenerative spondylolisthesis greater than Grade II
* Pregnancy
* Psychiatric or mental disease
* Alcoholism (drinking more than 5 units per day)
* Active infection or prior infection at the surgical site
* Active cancer
* Insufficient language skills to complete questionnaires
* Participation in another study
* More than two symptomatic levels that need fusion

Primary outcomes:
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 12 months post-op
Secondary outcomes:
measure: Fusion status
timeFrame: 3 mo., 6 mo., 12 mo., 24 months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
References:
citation: Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57.
Clinical trial NCT00331929: Respiratory Health Study of Children in Kiryat Tivon
Official title: Respiratory Health Study of Children in Kiryat Tivon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Signs and Symptoms, Respiratory
Allergy
Keywords: Asthma
Allergy
Respiratory
Pollution
Children
Air pollution
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2006-05-31
Enrollment: 638
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

The health status will be evaluated using health questionnaires and spirometry.

Detailed description: Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.

Material and Methods: All the school children from K. Tivon (1800 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.

First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.

Second step: Spirometry checking of the children.

In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.

Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.

The prevalence of pulmonary disease will be evaluated according to the risk maps.

Eligibility criteria: Inclusion Criteria:

* All school children

Exclusion Criteria:

* Children that their parents did not signed the informed consent

Primary outcomes:
measure: The prevalence of respiratory symptoms in respect to air pollution
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kiryat Tivon
country: Israel
facility: Elementary School
Study officials:
affiliation: Carmel Medical Center
name: Haim Bibi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz J. Air pollution and children's health. Pediatrics. 2004 Apr;113(4 Suppl):1037-43.
Clinical trial NCT04787029: Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study
Official title: Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the purpose of this study is to investigate whether prophylactic medical compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could reduce the incidence and severity of lymphedema in the upper limbs that received axillary lymph node resection (sentinel lymph node biopsy or axillary lymph node dissection).


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent radical mastectomy and sentinel lymphctomy or axillary lymphectomy after diagnosis of unilateral breast cancer
2. Patients who are scheduled for adjuvant chemotherapy including Docetaxel after surgery
3. Patients aged 19 to 70
4. Patients who can understand the contents of this study and obtain consent

Exclusion Criteria:

1. Patients with a history of breast-related surgery prior to this breast cancer surgery
2. Patients with metastases to other organs
3. Patients who have undergone neoadjuvant chemotherapy or have previously received radiation therapy
4. Patients with systemic diseases that may not be able to conduct clinical research
5. Patients with skin diseases who cannot receive medical compression treatment

Primary outcomes:
measure: The cumulative incidence rate of lymphedema (%)
timeFrame: The cumulative incidence of lymphedema during the entire primary observation period
measure: Severity of lymphedema - percentage of excess limb volume (PCEV, ml)
timeFrame: Time of occurrence of lymphedema during the follow-up period
Secondary outcomes:
measure: ECW/TBW ratio (%) of whole body (body water analysis result)
timeFrame: Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Physical & Rehabilitation Medicine Samsung Medical Center
name: JIHYE HWANG, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01881529: A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Official title: A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limited Scleroderma
Diffuse Scleroderma
Keywords: limited scleroderma
diffuse scleroderma
Sclerosis
Progressive
Limited
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis

Brief summary: To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

Detailed description: Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Documented diagnosis of scleroderma
* Willing and able to provide written informed consent

Exclusion Criteria:

* Use of experimental therapies within 28 days prior to Screening.
* Aspirin use \> 81 mg daily within 1 week prior to Screening.
* Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

Primary outcomes:
measure: Summarized the number and percentage of subjects with elevated LOXL2 levels
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St Vincent's Centre for Applied Medical Research
state: New South Wales
Study officials:
affiliation: Gilead Sciences
name: Bittoo Kanwar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06191029: Translation and Validation of Cognitive Failure Questionniare in Urdu Among Elderly.
Official title: Translation and Validation of Cognitive Failure Questionniare in Urdu Among Elderly
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elderly Population
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the adult's having age above 60 years and able to read Urdu by themselves

Brief summary: study is based on translation of Cognitive Failure questionnaire in URDU and thrn to check its reliability an Validation in Elderly


Eligibility criteria: Inclusion Criteria:

* Both male and female patients Participants belonging to Urdu speaking class.

Age should above 60 years Participants should be capable to complete the questionnaire without any help. Participants with mild cognitive impairment.

Exclusion Criteria:

* Individual below 60 years. Participants not capable to complete the questionnaire without any help. Participant who can't understand urdu

Primary outcomes:
measure: Translation and validity of cognitive failure questionnaire in Urdu
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Aniqa
state: Punjab
Study officials:
affiliation: Riphah
name: Aniqa Khalid, MsNmpt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800329: Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery
Official title: Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Monitoring
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Snap40 Ltd.
First posted: 2019-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.

Detailed description: The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies.

Eligibility criteria: Target accrual: 100 patients

Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN

Inclusion Criteria:

* Patients undergoing isolated coronary artery bypass graft (CABG) surgery
* Must be undergoing the procedure at Mayo Clinic in Rochester, MN
* Must be greater than or equal to 40 years of age

Exclusion Criteria:

* Under 40 years of age
* Concomitant additional surgical procedure (e.g., CABG + valve replacement)
* Patients with implantable pacemakers/defibrillators
* Patients that find the device too uncomfortable to wear for 48 hours

Primary outcomes:
measure: Physician satisfaction in the use of remote monitoring technology.
timeFrame: 48 hours
Secondary outcomes:
measure: Patient satisfaction in the use of remote monitoring technology.
timeFrame: 48 hours
Other outcomes:
measure: Algorithms useful in prediction of readmission following cardiac surgery
timeFrame: 48 hours
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jordan D Miller
role: PRINCIPAL_INVESTIGATOR
References: