louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03561324: Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
Official title: Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Radiation Monitoring Devices, Inc.
First posted: 2018-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18- to 90-years old.
* Positive for PET positive disease in the neck.

Exclusion Criteria:

* Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care)
* Nursing or lactating women

Primary outcomes:
measure: Detection of PET positive disease
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: 501-686-5140
name: Deanne L King, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02026024: Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
Official title: Clinical and Genetic Variations Study of Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Poorly Controlled Type 2 Diabetic Patients

Brief summary: Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.

Detailed description: Background:

Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects.

Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.

Eligibility criteria: Inclusion Criteria:

* i) Age \> 20 years old ii)DM (diabetes mellitus) diagnosed \> 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor

Exclusion Criteria:

* Type 1 Diabetes Mellitus

Primary outcomes:
measure: mean amplitude of glycaemic excursions (MAGE)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: CHIA-HUNG LIN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770024: Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging
Official title: Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subjects Undergoing Diagnostic Imaging Tests
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing diagnostic imaging tests

Brief summary: The purpose of the study is to validate a radiological quality control (QC) system on the performance of diagnostic imaging. Patient images, previously anonymized by each radiologic diagnostic structures (SDR), will be sent to the QC service, which will blindly submit the images for evaluation external peer review by experts in the field. Through the blinded approach, the information obtained from the QC will allow the SDR to know its own performance analytics, but not those of other SDRs using the service, and to a centralized system to have an anonymized estimate of the quality of performance delivered. Finally, the analyzed data will provide not only a mere count, but will allow to reduce and prevent errors in the appropriateness, execution, reporting and diagnostic content of the examinations


Eligibility criteria: Inclusion Criteria:

* Diagnostic examinations related to imaging modalities (RX, CT, MR, PET, SPECT...), agreed with SDRs, of body districts on which diagnostic images are available in DICOM format, medical history data and clinical question, report

Exclusion Criteria:

* Incompleteness of data for the purpose of the review process

Primary outcomes:
measure: Definition and implementation of diagnostic image quality control procedures for the purpose of purposes of monitoring the accuracy and appropriateness of the service provided by SDRs
timeFrame: 1-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Synlab SDN
Study officials:
References:
Clinical trial NCT02494934: Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia
Official title: A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Vestibulitis
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

Detailed description: Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

Eligibility criteria: Inclusion Criteria:

* fluent in English
* vulvar pain with attempted vaginal penetration for at least 6 months
* pain limited to vulvar vestibule during cotton swab test

Exclusion Criteria:

* other serious medical, psychiatric, or other pain conditions
* generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally)
* current pregnancy, breastfeeding, or being less than 6 months postpartum
* unwillingness to abstain from other treatments for their PVD pain during the course of the study

Primary outcomes:
measure: change from baseline in pain with sexual intercourse at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Caroline Pukall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03077334: Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer
Official title: Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer-Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary Referral Hospital

Brief summary: The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying hidden metastasis, and assessment of treatment responses in clinical oncology. Although there are important studies suggesting potential associations between PET-based parameters and oncologic outcomes, the calculation and official documentation of individual PET-based parameters might not be routine in clinical practice because these processes usually require time- and labor-consuming processes for the radiologists. In this study, the investigators prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in pancreatic cancer and compare oncologic outcomes between the types.


Eligibility criteria: Inclusion Criteria:

* Candidate for radical pancreatectomy due to pancreatic cancer without neoadjuvant treatment
* Age between 20 years old and 80 years old
* General performance status greater than 70
* Results of peroperative PET-CT available

Exclusion Criteria:

* Unresectable, locally advance and metastatic pancreatic cancer
* Patients not wanting operation
* ASA score of greater than 3
* History of chronic alcoholism ot drug abuse
* Lack of patient compliance
* Patients not agreeing to enroll in the study.
* Patients unable to understand and sign the study agreement.
* History of neoadjuvant treatment

Primary outcomes:
measure: Clinical PET type assessed by surgeons from preoperatively preformed PET imaging
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Number of patients with recurrence of cancer or mortality from cancer following operation
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00282334: A Comparison of Telemedical and Conventional Antihypertensive Treatment
Official title: A Comparison of Telemedical and Conventional Antihypertensive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Telemedicine
Blood pressure
Quality of life
Cost-effectiveness
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-01-26
Enrollment: 236
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office.

We want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.


Eligibility criteria: Inclusion Criteria:

* age 20 - 80 years
* office blood pressure \> 150/95 mmHg or systolic blood pressure \>150 mmHg and diastolic blood pressure \< 90 mmHg

Exclusion Criteria:

* not able to perform home blood pressure measurements
* low compliance
* abuse of alcohol/ medicine
* unwillingness to participate

Primary outcomes:
measure: Difference in Number of Patients Who Reached Target Blood Pressure
timeFrame: 6 months
measure: Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Dept. of Medical Research, Holstebro Hospital
Study officials:
affiliation: Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark
name: Line B Madsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
citation: Madsen LB, Christiansen T, Kirkegaard P, Pedersen EB. Economic evaluation of home blood pressure telemonitoring: a randomized controlled trial. Blood Press. 2011 Apr;20(2):117-25. doi: 10.3109/08037051.2010.532306. Epub 2010 Nov 24.
Clinical trial NCT01538134: Antiphospholipid Antibodies and Fetal Growth Restriction
Official title: Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Restriction
Antiphospholipid Syndrome
Keywords: Antibodies, anticardiolipin
Antibodies, B2 Glycoprotein I
Lupus Anticoagulant
Fetal Growth Restriction
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients admitted for fetal growth restriction (cases) and normal patients in labor at term (controls).

Brief summary: The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 24-34 weeks.
* Ultrasonographic evidence of fetal growth restriction

  * Abdominal circumference \< 3rd percentile.
  * Doppler with increase of placental resistance.

Exclusion Criteria:

* Known antiphospholipid syndrome.
* Known presence of antiphospholipid antibodies.
* Patients with systemic lupus erythematosus.

Primary outcomes:
measure: Lupus anticoagulant
timeFrame: 8 months
measure: Anticardiolipin antibodies
timeFrame: 10 months
measure: B2 Glycoprotein I
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152334: Efficacy of Botox in Patients With Idiopathic Clubfoot
Official title: Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Clubfoot (Talipes Equinovarus)
Keywords: Efficacy study
assessment of patient outcomes following treatment
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of Botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.

Detailed description: All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.

Eligibility criteria: Inclusion Criteria:

1. Children presenting with idiopathic clubfoot/feet at BC Children's Hospital
2. Children ranging in age from 1 day to 2 years old at initial treatment Children who have had previous intervention for their clubfoot (methods including surgery, Ponseti method, Kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention

Primary outcomes:
measure: The rate of successful clubfoot correction from a single Botox injection. This coincides with entrance into Boots and Bars. This was measured 8 weeks following injection.
timeFrame: 8 weeks
Secondary outcomes:
measure: Secondary outcomes of the study as outlined in protocol (include time of measurement)
timeFrame: See protocol
measure: Secondary Outcomes: Patient outcomes collected at every patient visit including:
timeFrame: See protocol
measure: 1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)
timeFrame: See protocol
measure: 2. Heel Bisector Scores (collected at every visit)
timeFrame: See protocol
measure: 3. Pedobarographs (every 6 months from 18 months to 5 years)
timeFrame: See protocol
measure: Gait Analysis (every 2 years from 5 years of age until skeletal maturity)
timeFrame: See protocol
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital, Department of Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Christine Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05854134: Effectiveness of CC VS Aerobic Exercise for Strengthening and Improving QOL in Post Stroke Patients
Official title: Effectiveness of Closed Chain Versus Aerobic Exercise for Strengthening and Improving Quality of Life in Post Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effects of closed chain versus aerobic exercise for strengthening and improving quality of life in post stroke patients


Eligibility criteria: Inclusion Criteria:

* Hemiplegic post stroke patients (either left or right side)
* Patients of both gender
* Age range in between 40 to 60
* Patient with cognitive functioning

Exclusion Criteria:

* History of any cardiac problem
* Recurrent stroke
* Any kind of disability or amputated limb
* Neurological conditions like Parkinsonism, epilepsy and
* spinal cord injury.
* Any kind of fracture or dislocation history.

Primary outcomes:
measure: Barthel Index Scale
timeFrame: 6 Months
measure: The Oxford Scale
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00602134: Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
Official title: A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
* Must voluntarily consent.

Exclusion Criteria:

* Must not have a known history of thiopurine methyltransferase deficiency or family history.
* Must not have a history of elevated uric acid or gout.
* Must not be currently using allopurinol.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, two period, 3 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Mark J Allison, MD
role: PRINCIPAL_INVESTIGATOR
References: