louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06712992: Electromyographic Response to TsDcs in CNSLBP
Official title: Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: German International University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* Individuals of both sexes.
* Age 18-60 years old.
* Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:
* Chronic low back pain, defined as pain lasting for more than 12 weeks.
* No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).
* No radicular symptoms(e.g. pain radiating down the leg).
* No significant neurological deficits or findings on physical examination(e.g. loss of reflexes or muscle strength).

Exclusion Criteria:

* Previous fractures and/or surgery in the vertebral spine.
* Neuropathic pain extending along the lower limb due to nerve root compression.
* History of spine trauma or fracture.
* Implanted pacemakers.
* Pregnancy.
* Malignancy.
* Systemic musculoskeletal diseases.
* Epilepsy.
* History of psychiatric disorders.
* Obesity

Primary outcomes:
measure: Changes in NPRS from baseline to four weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Sixth of October
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
city: sixth of October
country: Egypt
facility: Outpatient clinical of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
References:
Clinical trial NCT01958892: To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2013-10-09
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Amles who underwent transurethral prostate surgeryr between 2006 and 2010

Brief summary: The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate


Eligibility criteria: Inclusion Criteria:

* All who underwent TURP or TUERP

Exclusion Criteria:

* Those with prostate cancer, neurogenic bladder, previous urethral or prostate surgery

Primary outcomes:
measure: Maximum urinary flow rate
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: S'pore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT02144792: Development and Clinical Application of [11C]Verapamil-PET
Official title: Development and Clinical Application of [11C]Verapamil-PET, a Surrogate Marker on P-glycoprotein Expression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker that can quantify the expression of P-gp because of the difficulty in measuring substances in the neurologic system and the lack of clinical trials. Here, the investigators use a novel non-invasive \[11C\] -verapamil Brain PET and SPAM analytic method as a surrogate marker for quantifying the expression of p-glycoprotein.

Detailed description: A pilot study on healthy volunteers and a case-control study on patients with drug resistant epilepsy and drug sensitive epilepsy is performed. The investigators compare the whole brain SUV in each group (normal control, drug resistant epilepsy, drug sensitive epilepsy) and the asymmetry by the standardized uptake value(SUV) of ipsilateral areas and contralateral areas.

\[11C\] -verapamil PET will be used as a surrogate marker of P-gp expression in patients with epilepsy, and will be an important prognostic factor of individualized drug therapy. Also, it can be used as a biomarker in checking of the drug efficacy of novel medications. Furthermore, by localizing epileptogenic zones for patients, \[11C\] -verapamil PET could contribute in improving the prognosis of surgical treatment in drug resistant epilepsy.

Eligibility criteria: Inclusion Criteria:

* Healthy controls ( age range 20-45 years)
* Patient age (\> 15), diagnose as epilepsy

Exclusion Criteria:

* Subjects who take medicines that affect on the function of p-glycoproteins
* Pregnancy or subject who feed the breast milk
* Subjects who had severe renal disease or liver disease
* Subjects who need treated by immunosuppressant or take immunosuppressant

Primary outcomes:
measure: Measured Asymmetric index[(SUV in Right regions - SUV in Left regions)/(SUV in Right regions+ SUV in left regions)] in all three groups
timeFrame: first visit day
Secondary outcomes:
measure: Number of patients with side effect of cyclosporine and [11C]-verapamil PET
timeFrame: During and after the drug injection, During and after the PET Scan [first visit day]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Kun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00066092: Pegfilgrastim PBPC Mobilization Study
Official title: Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Hematology
Oncology
Keywords: PBPC transplant
Hodgkin's Disease
Non-Hodgkin's Lymphoma
NHL
mobilization
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2003-08-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.

Detailed description: This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting.

Eligibility criteria: * Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant

Primary outcomes:
measure: CD34+ collection during the collection phase
timeFrame: 10 days
Secondary outcomes:
measure: Time to ANC and platelet engraftment post-transplant
timeFrame: 100 days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00431392: Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions
Official title: Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Regional Blood Flow
Ocular Physiology
Keywords: Choroidal blood flow
NO-synthase
light/dark transition
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is evidence from a variety of animal studies that choroidal blood flow is under neural control. By contrast, only little information is available from human studies. Recent results indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. We have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism.

The present studies investigate this possibility by using pharmacological interventions. The pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor agonist (as a control substance for the blood pressure increasing nitric oxide synthase inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were chosen on the basis of previous animal experiments, as the systems, which are specifically influenced by these substances, are likely involved in neural control of choroidal blood flow.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: choroidal blood flow
measure: fundus pulsation amplitude
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252392: /Autism Spectrum Disorder(ASD)Hearing Abnormalities Study
Official title: Does Autism Spectrum Disorder(ASD)Show Any Degree of Hearing Abnormalities? :A Preliminary Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Keywords: hearing and communication abnormalities
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 3-12 years old attending phoniatric unit of assiut university from october 2017 t0 october 2020.

Brief summary: Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing.

Investigators are aiming to:

1. evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder.
2. compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.

Detailed description: Full audiological evaluation is carried out to all participants including:

* pure tone and speech audiometry.
* Tympanometry and acoustic reflex threshold evaluation.
* Threshold auditory brain stem response for threshold determination in non co operative children not respond to pure tone,speech audiometry.
* Auditory brain stem response for neuro-otologic diagnosis.
* Transient evoked otoacoustic emissions in children proved to have normal hearing to detect minimal cochlear affection .
* Transient evoked otoacoustic emissions with contralateral masking. Communication evaluation is carried out to all participants using arabic language test(kotby et al,1995).

Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum disorder.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)

Exclusion Criteria:

* children with otitis media with effusion.
* Associated neurological deficit .

Primary outcomes:
measure: Number of autistic participants suffering from hearing abnormalities.
timeFrame: 3 years from october 2017 to october 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07027592: The Relationship Between Training Dynamics and General Health Status in Veteran Football Players
Official title: The Relationship Between Training Dynamics and General Health Status With Injury Risk in Veteran Football Players
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Football
Injury
Veteran
Keywords: FIFA 11+
Veteran Football Players
Injury risk
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2025-06-18
Enrollment: 130
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veteran football players

Brief summary: The goal of this observational study is to learn how training habits and general health status are related to injury risk in veteran football players (men over 35 years old who play recreational football). The main questions it aims to answer are:

Do specific training patterns (such as frequency, intensity, and duration) increase or lower the risk of injury?

How does general health status (including factors like sleep, nutrition, and existing health conditions) affect injury risk?

Participants will:

Complete questionnaires about their training habits, lifestyle, and general health

Report any injuries they experience during the football season

Attend periodic health assessments


Eligibility criteria: Inclusion Criteria:

* Playing football as a veteran

Exclusion Criteria:

* Not participating in a regular training program

Primary outcomes:
measure: Injury Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT03260192: Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer
Official title: Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: circulating tumor DNA
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patient receiving NAC

Brief summary: Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Detailed description: Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.

Eligibility criteria: Inclusion Criteria:

* Female patients undergoing NAC
* Age: 18-70 yrs
* Any menopausal status
* Any hormal receptor status

Exclusion Criteria:

* Metastasis discovered during NAC
* Lost more than 2 blood samples during NAC and surgery

Primary outcomes:
measure: death of breast cancer
timeFrame: Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.
Secondary outcomes:
measure: tumor recurrence or distant metastasis
timeFrame: Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.
Other outcomes:
Locations:
city: Guandong
country: China
facility: Sunyat-sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: qiang Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04135092: Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Official title: Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-10-22
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Single Patient Expanded Access

Detailed description: Background:

Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.

Objective:

Under Individual Patient Expanded Access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer.

Eligibility:

* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.
* Must sign the informed consent document.
* Willing to sign Durable Power of Attorney Form.
* Must have all regulatory approvals prior to start of treatment.

Design:

* Please refer to NCI-SB protocol 18-C-0049, Amendment F.
* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility criteria: Inclusion Criteria:

* Measurable (per RECIST v1.1 criteria), metastatic prostate cancer.
* Refractory to approved standard systemic therapy.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Willing to sign a Durable Power of Attorney Form.
* Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
* Subject must be co-enrolled on protocol 03-C-0277.

Exclusion Criteria:

Not applicable.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03125889: Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
Official title: Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Image-guided
BPH
Aquablation
AQUABEAM
LUTS
Tissue resection
Robotics
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 11
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the AQUABEAM for treatment of LUTS resulting from BPH.

Detailed description: PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial.

Eligibility criteria: Inclusion Criteria:

* Male
* BPH symptoms

Exclusion Criteria:

* Serious concurrent medical conditions

Primary outcomes:
measure: Completion of the intended surgical procedure with adequate hemostasis
timeFrame: 7 days post-op
measure: Proportion of subjects who return to the OR for bleeding treatment or requires transfusion
timeFrame: 7 days post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
state: Gujarat
Study officials:
References: