louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06883474: Osteosclerotic Changes on CT Predict Survival in Prostate Cancer
Official title: Osteosclerotic Changes on Computed Tomography Predict Disease Progression and Poor Survival in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer (Adenocarcinoma)
Prostate Cancer Metastatic Disease
Keywords: Bone metastasis
computed tomography
osteosclerotic change
prostate cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 211
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate cancer patients with bone metastasis

Brief summary: The study specifically investigated PC patients with bone metastasis and conducted a comprehensive analysis of the correlation between OCs and patient survival outcomes.


Eligibility criteria: Inclusion Criteria:

* 1）Histopathological confirmation of prostate adenocarcinoma
* 2）Radiologically verified bone metastasis, assessed through bone scintigraphy and CT imaging from the initiation of systemic therapy until disease progression.

Exclusion Criteria:

* 1）Lacking of complete clinical profiles.

Primary outcomes:
measure: Radiographic progression-free survival
timeFrame: From enrollment to the end of treatment at 5 years
Secondary outcomes:
measure: overall survival
timeFrame: From enrollment to the end of treatment at 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03095365: Dry Needling and Pain Education in the Treatment of Chronic Neck Pain
Official title: Dry Needling and Pain Neuroscience Education in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neck
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 60
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: to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* Mechanical neck pain for at least 12 weeks
* 10% or higher on the Neck Disability Index questionnaire
* 20mm or higher on the Visual Analogue Scale (VAS) of neck pain
* Presence of at least one active myofascial trigger point

Exclusion Criteria:

* Neck pain associated with whiplash injuries
* Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
* Neck pain with cervical radiculopathy
* Neck pain associated with externalized cervical disc herniation
* Fibromyalgia syndrome
* Previous neck surgery
* Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches

Primary outcomes:
measure: Pain using Visual Analogue Scale
timeFrame: 3 months
Secondary outcomes:
measure: Medication intake
timeFrame: 3 months
measure: Disability using Neck Disability Index
timeFrame: 3 months
measure: Kinesiophobia using Tampa Scale of Kinesiophobia
timeFrame: 3 months
measure: Catastrophizing using Pain Catastrophizing Scale
timeFrame: 3 months
measure: Pain anxiety using Pain Anxiety Symptoms Scale
timeFrame: 3 months
measure: Beck Depression Inventory-II
timeFrame: 3 months
Other outcomes:
Locations:
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernandez-Carnero, PhD
role: STUDY_DIRECTOR
References:
citation: Valiente-Castrillo P, Martin-Pintado-Zugasti A, Calvo-Lobo C, Beltran-Alacreu H, Fernandez-Carnero J. Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial. Acupunct Med. 2021 Apr;39(2):91-105. doi: 10.1177/0964528420920300. Epub 2020 May 5.
Clinical trial NCT06043765: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Official title: TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Glioma
Keywords: repetitive transcranial magnetic stimulation (rTMS)
cognitive strategy training (CST)
cognitive impairment
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The TRUE-GRIT study will assess the feasibility of a study protocol investigating the efficacy of a combination therapy consisting of cognitive strategy training (CST) and repetitive transcranial magnetic stimulation (rTMS) to reduce cognitive impairment in adult glioma patients. This study is part of the GRIP-project, a project aimed at investigating interventions for improving quality of life in brain tumor patients.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Histological diagnosis of diffuse glioma (WHO grade 2,3, or 4)
* Subjective cognitive impairment, defined as CFQ-score ≥ 44
* Being able to give informed consent and undergo treatment and measurements based on researchers insight
* Stable disease, i.e. no oncological treatment for ≤ 2 months prior to inclusion; no radiological progression on the most recent MRI, not older than 6 months, and no clinical progression at inclusion
* Stable dosage (for at least 8 weeks) of anti-epileptic medication

Exclusion Criteria:

* Current pregnancy or have given birth less than three months ago
* Current other treatment for cognitive complaints
* Karnofsky performance score \<70
* A tumor located in the parietal cortex
* TMS exclusion: implanted medical devices (e.g. pacemaker, deep brain stimulator, cochlear implants, medical infusion device, etc.); metal in the body; sleep deprivation
* MRI exclusion: extreme claustrophobia or metallic objects in or on the body

Primary outcomes:
measure: Number of patients completing intervention and study protocol
timeFrame: Baseline versus directly post-intervention (max. 11 weeks after baseline)
Secondary outcomes:
measure: Tolerability and side effects of the combination therapy
timeFrame: Weekly during the intervention (7 weeks)
Other outcomes:
measure: Exploratory outcomes: neurocognitive functioning, pre- and post-treatment brain activity, connectivity and network topology.
timeFrame: Baseline versus directly post-intervention (max. 11 weeks after baseline)
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Centers, location VUmc
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Linda Douw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294865: Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
Official title: The Plasma Levels of suPAR in Late-onset Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Sepsis
Keywords: Sepsis
late-onset
suPAR
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants in Ankara University neonatal intensive care unit

Brief summary: The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.

Detailed description: Infection is a leading cause of neonatal morbidity and mortality worldwide. The clinical presentation of neonatal infection is subtle and nonspecific. Microbiologic cultures of clinical specimens, the gold standard for diagnosis, have low sensitivity and are not available in time to influence initial therapy. Therefore, reliable and rapid in vitro tests are needed for early diagnosis and management of infection in neonates. suPAR, secreted from the cells (neutrophils, lymphocytes, macrophages, endothelial cells) has recently been reported to be a potential biomarker for several infection diseases. The levels of suPAR have not been studied in newborn infants yet.

Eligibility criteria: Inclusion Criteria:

* Infants with late-onset neonatal sepsis

Exclusion Criteria:

* Infants without parents' consent

Primary outcomes:
measure: Levels of suPAR in late-onset neonatal sepsis
timeFrame: three weeks
Secondary outcomes:
measure: Level of plasma C-reactive protein
timeFrame: three weeks
measure: the white blood cell count
timeFrame: three weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Department of Pediatrics
Study officials:
affiliation: Ankara University
name: Saadet Arsan, Professor
role: STUDY_DIRECTOR
References:
citation: Okulu E, Arsan S, Akin IM, Ates C, Alan S, Kilic A, Atasay B. Serum Levels of Soluble Urokinase Plasminogen Activator Receptor in Infants with Late-onset Sepsis. J Clin Lab Anal. 2015 Sep;29(5):347-52. doi: 10.1002/jcla.21777. Epub 2014 Jul 10.
Clinical trial NCT01783665: The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Official title: The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In addition to the typical motor and sensory impairments, individuals with multiple sclerosis (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder. The research believes that aerobic exercise improve cognitive function and improve sleep quality.


Eligibility criteria: Inclusion Criteria:

* diagnosis of relapsing remitting or secondary progressive MS
* score 3-7 on the EDSS
* score \< 55 on the Symbol Digit Modalities Test
* score \> 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria:

* history of alcohol/drug abuse or nervous system disorder other than MS
* severe physical, neurological, or sensory impairments that would interfere significantly with testing
* developmental history of learning disability or attention-deficit/hyperactivity disorder
* relapse and/or corticosteroid use within four weeks of assessment
* unable to give consent
* uncorrected vision loss that would interfere significantly with testing
* score less than 24 on MMSE
* Acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
* Either unable to physically perform the exercise test using the recumbent stepper or demonstrate absolute indications for terminating exercise that follows the American College of Sports Medicine's (ACSM) guidelines
* Uncontrolled blood pressure with medication (BP \> 190/110mmHg)

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Change in Sleep Quality
timeFrame: Baseline to Month 3
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Catherine Siengsukon, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800865: A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
Official title: A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of participants already receiving cytotoxic therapy. Additional blood and urine samples will be collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing, respectively.


Eligibility criteria: Inclusion Criteria:

Participant has solid tumor that will be treated with one of the following treatments:

* Gemcitabine monotherapy
* Cisplatin monotherapy
* Carboplatin monotherapy
* Gemcitabine and cisplatin combination therapy
* Gemcitabine and erlotinib combination therapy
* Gemcitabine and carboplatin combination therapy
* Cisplatin and vinorelbine combination therapy
* Cisplatin and pemetrexed combination therapy
* Carboplatin and vinorelbine combination therapy
* Carboplatin and pemetrexed combination therapy

Exclusion Criteria:

* Participant has had recent cancer treatments including chemotherapy or radiation
* Participant has been in an investigational study within the last 30 days
* Participant has a history of drug or alcohol abuse
* Participant is Human Immunodeficiency Virus (HIV) positive or has a history of Hepatitis B or C

Primary outcomes:
measure: Level of Biomarkers
timeFrame: Baseline, 24, 32, and 48 hours post dose
measure: Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
timeFrame: 24, 32, and 48 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sun A, Lam R, Harman A, Pavlick A, Herman G, Dauffenbach L, Kerfoot C, Huang P, Cheng J, Demuth T, Iannone R. Induction of CDC2 phosphylation in skin biopsies from patients with solid tumors undergoing DNA-damaging chemotherapy. Global J Med Res. 2014;14(1-K):11-21
Clinical trial NCT02892565: Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)
Official title: Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System): Marker of Venous Thrombosis Risk in Systemic Lupus and Antiphospholipid Syndrome? Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Keywords: systemic lupus erythematosus
antiphospholipid syndrome
antiphospholipid antibodies
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).

Secondary purposes are:

1. To determine the frequency of hypercoagulable phenotype in study population;
2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.


Eligibility criteria: Inclusion Criteria:

Cases :

* Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
* Any weight and height
* Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment

Controls:

* Patients with SLE and/or APL without thrombosis (venous or arterial)
* Any weight and height
* Possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations)

Exclusion Criteria:

Cases and Controls :

* Pregnancy
* Refusal of consent
* Difficulty of follow-up (not sufficient motivation)

Primary outcomes:
measure: Thrombin potential measured with thrombinography
timeFrame: baseline
measure: Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05274165: Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
Official title: Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sound Relief Tinnitus & Hearing Center
First posted: 2022-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
Primary purpose: TREATMENT

Brief summary: Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.

After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

Detailed description: Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate hearing loss
* New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
* Must meet Lyric candidacy (see exclusion criteria)

Exclusion Criteria:

* middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
* radiation therapy to head or neck area
* participants who need regular MRI testing
* participants who regularly scuba dive or swim underwater

Primary outcomes:
measure: Trial to Success Rate
timeFrame: Day 30 of study
Secondary outcomes:
Other outcomes:
Locations:
city: Highlands Ranch
country: United States
facility: Sound Relief Hearing Center
state: Colorado
Study officials:
References:
Clinical trial NCT05626465: Biomarker-s of Abusive Head Trauma by Proteomics
Official title: Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abuse, Child
Protein Disorder, Blood
Keywords: abusive head trauma
proteomic
biomarker
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2022-11-23
Enrollment: 174
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant between 0 to 2 y.o

Brief summary: The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.


Eligibility criteria: Inclusion Criteria:

* Age : 0-2 y.o
* Medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty
* Blood test during medical care
* Accepted informed consent

Exclusion Criteria:

* Refused informed consent
* For control groups : medical history of child abuse
* For AHT group : rare metabolic disease (Menkes, etc..)

Primary outcomes:
measure: Highlight novel biomarker-s of AHT
timeFrame: Hospital admission to discharge (up to 3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ginhoux Thiphanie
state: Rhône
city: Geneva
country: Switzerland
facility: Wiskott Kim
Study officials:
affiliation: University Hospital, Geneva
name: Tony Fracasso, Prof.
role: STUDY_DIRECTOR
References: