louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04049812: Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation
Official title: Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 50
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 aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.

Detailed description: Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Unilateral radicular pain for at least 3 months
* Severity of radicular pain with Visual Analog Score of at least 4/10
* Written informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body
* History of surgery or algological procedure of the lumbar region
* Physical therapy within the last year due to back pain
* Previous PEMF treatment
* Malignancy or suspicion
* Polyneuropathy (diabetic or other)
* Connective tissue disease
* Presence of inflammatory joint pain
* Fibromyalgia
* Presence of open surface wound
* Tuberculosis, mycosis, or viral disease
* Presence of pain in another region of the body with higher severity than radicular back pain
* Use of drugs other than paracetamol-derivative simple analgesics (Nonsteroidal Aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs
* Advanced mood disorder
* Radiographic evidence of Grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis

Primary outcomes:
measure: 10 cm Pain Visual Analogue Scale (VAS)
timeFrame: 3 weeks
measure: 10 cm Pain Visual Analogue Scale (VAS)
timeFrame: one month after treatment
Secondary outcomes:
measure: Disability; Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 3 weeks
measure: Disability; Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: One month after treatment
measure: Nottingham Health Profile (NHP)
timeFrame: 3 weeks
measure: Nottingham Health Profile (NHP)
timeFrame: One month after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00721812: A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
Official title: A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Diseases
Keywords: pharmacokinetics
Phase 1
first time in humans
IBD
safety
human volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers


Eligibility criteria: Inclusion criteria:

* Healthy as determined by a responsible physician
* Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.
* Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).
* QTcB or QTcF \< 450 msec
* Capable of giving written informed consent

Exclusion criteria:

* The subject has a positive pre-study drug/alcohol screen
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units
* Urinary cotinine levels indicative of active smoking or regular use of tobacco
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
* A positive test for HIV antibody
* The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product
* Exposure to more than four new chemical entities within 12 months
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days
* Subject is receiving hormone replacement therapy
* History of sensitivity to any of the study medications
* History of sensitivity to heparin or heparin-induced thrombocytopenia

Primary outcomes:
measure: • Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles
timeFrame: 72 hours and 14 days
Secondary outcomes:
measure: PK parameters per protocol
timeFrame: 72 hours and 14 days
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04204512: Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis
Official title: Comparison of 2 Probes Frequencies in the Diagnosis of Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Keywords: ultrasound,
giant cell arteritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with suspicion of giant cell arteritis

Brief summary: Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.

Detailed description: Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis

Eligibility criteria: Inclusion Criteria:

* sedimentation rate\> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis

Exclusion Criteria:

* previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate

Primary outcomes:
measure: halo sign of temporal arteritis
timeFrame: inclusion
measure: compression sign of of temporal arteritis
timeFrame: inclusion
Secondary outcomes:
measure: halo sign of carotid arteritis
timeFrame: inclusion
measure: halo sign of subclavian arteritis
timeFrame: inclusion
measure: halo sign of axillary arteritis
timeFrame: inclusion
measure: other structural abnormalities in unilateral B mode
timeFrame: inclusion
measure: other structural abnormalities in bilateral B mode
timeFrame: inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02335112: Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: irreversible electroporation
Unresectable Head and Neck Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Head and Neck Neoplasms.

Detailed description: By enrolling patients with unresectable Head and Neck Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Head and Neck Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Head and Neck Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: Voltage (A minimum and maximum range of voltage for safe and effective IRE)
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04253912: Topical 2% Povidone-Iodine Gel in Verruca Vulgaris
Official title: A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Warts
Lead sponsor: Veloce BioPharma LLC
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

* Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
* Male or female ≥ 8 years old.
* Subject has a clinical diagnosis of verruca vulgaris (common warts).
* Subject has up to 6 warts located on the trunk or extremities

Exclusion Criteria:

* Subject has clinically atypical warts on the trunk or extremities.
* Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
* Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.

Primary outcomes:
measure: Decrease in wart diameter (mm)
timeFrame: 12 weeks
Secondary outcomes:
measure: Resolution of wart
timeFrame: 12 weeks
measure: Application Site Reaction Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hunt Valley
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Maryland
city: Plymouth Meeting
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Pennsylvania
city: Sugarloaf
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Pennsylvania
city: Fort Mill
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: South Carolina
city: Arlington
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Virginia
city: Lynchburg
country: United States
facility: Veloce BioPharma Clinical Trial Site
state: Virginia
Study officials:
affiliation: Veloce BioPharma LLC
name: Samuel Barone, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06778512: LcProt: Proteomics Longitudinal Cohort Study on Lung Cancer
Official title: LcProt: Proteomics Longitudinal Cohort Study on Lung CancerProspective Longitudinal Cohort Study of Lung Cancer Based on Peripheral Blood and Tissue Proteomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung
Lung Cancer
Cancer
NSCLC
Keywords: Lung cancer
Proteomics
Protein
NSCLC
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung nodules confirmed by CT examination.

Brief summary: This study will utilize tissue and peripheral blood samples for proteomics analysis and establish a longitudinal proteomics cohort at multiple critical treatment time points to explore the research value of proteomics in the diagnosis and treatment of lung cancer. The study includes key time points such as screening, postoperative efficacy prediction, and efficacy prediction after medication.


Eligibility criteria: Inclusion Criteria:

1. Signing of the informed consent form;
2. Male or female, aged 18-75 years;
3. Patients with lung nodules confirmed by CT examination;
4. Good preoperative pulmonary function cooperation and complete reporting;
5. Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
6. The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

1. Poor preoperative pulmonary function cooperation or missing reports;
2. Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
3. The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
4. Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
5. Coexisting with other severe functional impairments;
6. Patients with obstructive lesions such as airway or esophageal stenosis;

(8) Medication use before pulmonary function testing that does not meet the cessation guidelines; (9) Pulmonary function report quality graded D-F.

Primary outcomes:
measure: Area Under the Curve
timeFrame: 3 years
Secondary outcomes:
measure: Differentially Expressed Proteins
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02751112: Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
Official title: Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemopathy
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.

In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.

Detailed description: The Hematopoietic Stem Cell (HSC) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias.

The acute Graft versus Host (aGvH) reaction is the most frequent complication, and could concern until 50% of recipients. It is mainly linked to immune characteristics of the donor which will act versus the graft recipient.

There is a huge need of a technology that could predict the risk of aGvH, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft.

The Predictor' kit allows to predict acute and severe forms of Graft versus Host disease before the graft of peripheral hematological stem cells, by the assesment of iNKT cells expansion.

Eligibility criteria: Main inclusion Criteria for Donors :

* Being a relative of the recipient patient, OR being registered on the National Registry of the volunteers for bone marrow donation
* Being candidate for a donation of Hematologic Stem Cells with a HLA compatibility 10/10

Main inclusion Criteria for Recipient :

* Being candidate for a donation of Hematologic Stem Cells with the following criteria:
* HLA compatibility 10/10 with the donor
* Suffering from malignant or non-malignant hemopathy in first remission
* Myeloablative or reducted intensity conditioning
* Classic scheme of immunosuppression decreasing

Main exclusion Criteria:

* Participation to a therapeutical protocol in the 30 last days

Primary outcomes:
measure: Assessment of the diagnosis test performance
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the reproductibility of the test
timeFrame: 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Hospitalier de Caen
city: Lille
country: France
facility: Hôpital de Huriez / CHRU de Lille
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
Study officials:
References:
Clinical trial NCT00750412: An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department
Official title: An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: TeenScreen
Mental Health
Adolescent Mental Health
Social Work
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2008-09-10
Enrollment: 112
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. It is anticipated that adolescents receiving the TeenScreen intervention will be more likely to attend a first session of outpatient mental health services within 60 days of the initial screening than those receiving the usual care.


Eligibility criteria: Inclusion Criteria:

* Patients between 11 and 17 years old
* Medically stable and presenting with a non-psychiatric complaint
* English speaking
* Parent/guardian present for consent
* Insurance coverage by Medicaid
* Hamilton County residents
* Not currently receiving mental health treatment

Exclusion Criteria:

* Less than 11 years or greater than 17 years old
* Parent/guardian not present at time of visit
* Medically unstable
* Non-English speaking
* Insurance other than Medicaid
* Presenting complaint is a mental health problem
* Currently receiving mental health treatment

Primary outcomes:
measure: Verified mental health service use through clinical administrative data
timeFrame: 60 days after the initial mental health screening
Secondary outcomes:
measure: Measurement of depressive symptoms and impairment of functioning utilizing the Center for Epidemiological Studies-Depressions Scale and Sheehan Disability Score
timeFrame: 60 days after the initial mental health screening
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Division of Emergency Medicine
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jacqueline Grupp-Phelan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grupp-Phelan J, McGuire L, Husky MM, Olfson M. A randomized controlled trial to engage in care of adolescent emergency department patients with mental health problems that increase suicide risk. Pediatr Emerg Care. 2012 Dec;28(12):1263-8. doi: 10.1097/PEC.0b013e3182767ac8.
Clinical trial NCT02040246: Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
Official title: Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 107
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well controlled.Among all kinds of antidiabetic medications, metformin is recommended as the first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide is still one of the most widely used antidiabetic medications in China. However, there were few studies comparing the effects of these two medications on glycaemic control in Chinese patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital

Exclusion Criteria:

* Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.

Primary outcomes:
measure: HbA1c change from baseline
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References: