louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03160937: Neurodynamic Mobilization and Foam Rolling
Official title: Neurodynamic Mobilization and Foam Rolling in Delayed-onset Muscle Soreness in a Healthy Adult Population: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Muscle Damage
Movement Disorders
Nerve Pain
Keywords: pain
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single NM treatment session on Delayed Onset Muscle pain (DOMS) and to compare them with those of one foam roller (FR) session
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the acute effects of a single NM treatment session on DOMS and to compare them with those of one foam roller (FR) session. Following the damaging plyometric exercise bout, the participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group; treatments were administered 48-h post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise before treatment, and immediately post-treatment.

Detailed description: Currently, the foam-rolling massage is often used by athletes from many sports. However, there are a few studies on the effects of foam-rolling massage and they have conflicting results regarding the improvements in ROM and muscular performance. In contrast, neurodynamic mobilization (NM) is a manual therapy method used to assess and treat neuromuscular disorders. It includes gliding techniques and tensile techniques. Gliding techniques or "sliders" are intended to produce a sliding movement between neural structures and adjacent nonneural tissues. NM has been shown to reduce pain and soreness and improve ROM. However, no studies have investigated its effects after exercise-induced muscle soreness or DOMS.

Eligibility criteria: Inclusion Criteria:

* All subjects were moderately active (Category 2) as assessed by the International Physical Activity Questionnaire (IPAQ) questionnaire (Craig et al., 2003).
* None of the subjects had a recent history of intensive training, heavy eccentric resistance, or plyometric exercise, and all subjects were free from musculoskeletal disorders in the last year.
* All subjects were asked to refrain from unaccustomed exercise during the experimental period, and the subjects abstained from all medications and dietary supplements during the experimental period and between testing sessions.

Exclusion Criteria:

* Sedentary
* patients with pain

Primary outcomes:
measure: Pain
timeFrame: 1 minute after treatment
Secondary outcomes:
measure: Leg dynamometer measurements
timeFrame: 2 minutes after treatment
measure: Surface electromyography (sEMG)
timeFrame: 5 minutes after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitario La Salle
name: Daniel Muñoz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033837: Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT
Official title: Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT With 0.275-sec Gantry Rotation Speed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiac CT
Keywords: Coronary artery disease
Cardiac CT
Appropriate Use Criteria (AUC)
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 309
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients referred for coronary CT angiography at our hospital

Brief summary: The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.


Eligibility criteria: Inclusion Criteria:

* indicated for coronary CT assessment

Exclusion Criteria:

* aortic disease
* pulmonary embolism
* severe arrhythmia
* severe heart failure
* allergy for iodinated contrast agent

Primary outcomes:
measure: significant coronary stenosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University
Study officials:
References:
Clinical trial NCT03809637: A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Official title: Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. After the standard 1st line chemotherapy with doxorubicin, the only a few treatment option is available. Recently, pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated and moderately effective. Based on the background, investigators planned to conduct the phase II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue sarcomas.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
2. Measurable or evaluable disease (RECIST 1.1.)
3. Age ≥19 years
4. ECOG performance status of 0-2
5. Adequate laboratory findings

   * Absolute neutrophil count (ANC) ≥ 1500 /µL
   * Platelet count ≥ 75,000/ µL
   * Serum creatinine \< 1.5 x upper limit of normal (ULN)
   * AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal (ULN)
   * Total bilirubin \<1.5 x upper limit of normal (ULN)
6. more than 3 months of expected survival
7. Provision of written informed consent prior to any study procedure

Exclusion Criteria:

1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study'
2. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
3. Resectable lung metastases
4. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
5. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
6. Uncontrolled medical conditions

Primary outcomes:
measure: progression free rate
timeFrame: 12 weeks
Secondary outcomes:
measure: adverse event
timeFrame: every 3 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
citation: Kim JH, Kim SH, Jeon MK, Kim JE, Kim KH, Yun KH, Jeung HC, Rha SY, Ahn JH, Kim HS. Pemetrexed plus cisplatin in patients with previously treated advanced sarcoma: a multicenter, single-arm, phase II trial. ESMO Open. 2021 Oct;6(5):100249. doi: 10.1016/j.esmoop.2021.100249. Epub 2021 Sep 2.
Clinical trial NCT06765837: Comparison Between Low Level Laser Therapy and Active Oxygen Releasing Gel on Wound Healing Cleft Lip Patients
Official title: Effect of Low-Level Diode Laser Versus Active Oxygen Releasing Gel Application on Healing Outcome in Secondary Cleft Lip Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cleft Lip
Keywords: Low level laser
cleft lip
scars
active oxygen releasing
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-01-09
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups underwent secondary repair cleft lip surgeries the first group subjected to low level laser after surgery the second group applied active oxygen releasing topical gel the third was a control group
Primary purpose: TREATMENT

Brief summary: the study was performed on secondary cleft lip scars

Detailed description: the study aimed at comparing and Evaluation the effect of low-level diode laser and the effect of Active Oxygen releasing gel O3 (Blue-m gel) topical application on healing outcome in secondary cleft lip correction.

Eligibility criteria: Inclusion Criteria:

1. Age: can be done in any time after six months from the previous surgery if it severely disfiguring or in the preschool stage for children the time of surgery should be based on the severity of deformities
2. primary cleft lip repair was done
3. secondary lip repair with or without nose correction is indicated
4. the patient didn't undergo any surgeries procedures in the last 6 months

Exclusion Criteria:

1. previously subjected to secondary lip repair surgery.
2. syndromic cleft lip patient.
3. patient reporting abnormal reaction or scar healing in the previous surgery
4. smoking patients

Primary outcomes:
measure: Healing outcome of the wound is being measured by time
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hager Abdelmonem Abdelaziz
Study officials:
affiliation: lecturer of orthodontoics
name: Mohsena Ahmed
role: STUDY_DIRECTOR
References:
Clinical trial NCT02019615: tDCS in MCS: Repeated Stimulations
Official title: Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)
Keywords: disorders of consciousness
minimally conscious state
traumatic brain injury
stroke
transcranial direct current stimulation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Detailed description: Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-r total score at the end of the anodal session and that this improvement persists for a week.

Eligibility criteria: Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 3 months after the acute brain injury
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Primary outcomes:
measure: Change in the CRS-R total score
timeFrame: after each stimulation and one week later for anodal and sham sessions (total: 1 month)
Secondary outcomes:
measure: Influence of the time since insult
timeFrame: one month
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
Study officials:
References:
Clinical trial NCT01773915: New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
Official title: New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease, Late Onset
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with Alzheimer's disease

Brief summary: Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples have demonstrated to discriminate to some extend between AD and non-AD individuals based on the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose levels increase during the Braak Stages of AD that are accessible in other body fluids such as blood, urine or saliva. The detection of these proteins would allow performing simple tests in case its levels were confirmed to be associated with the AD pathology.

Detailed description: We do not desire to provide a more extensive description

Eligibility criteria: Inclusion Criteria:

- mild to moderate AD

Exclusion Criteria:

-

Primary outcomes:
measure: Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls.
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Bart De Strooper
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Francesc Guix
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzales PA, Pisitkun T, Hoffert JD, Tchapyjnikov D, Star RA, Kleta R, Wang NS, Knepper MA. Large-scale proteomics and phosphoproteomics of urinary exosomes. J Am Soc Nephrol. 2009 Feb;20(2):363-79. doi: 10.1681/ASN.2008040406. Epub 2008 Dec 3.
Clinical trial NCT03452215: Mobile Application and Pregnant Patient Knowledge
Official title: Impact of Mobile Application on Patient Knowledge of Pregnancy Topics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Mobile Application
Keywords: Pregnancy
Mobile Phone Application
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent (or 16-17 years of age with guardian present)
* Singleton gestation

Exclusion Criteria:

* Inadequate knowledge of English language
* Inability to read at or above 8th grade level
* Prior diagnosis of eating disorder

Primary outcomes:
measure: Pregnancy-specific topic/guideline questionnaire
timeFrame: Outcome assessed up to 23 weeks gestation
Secondary outcomes:
measure: Pregnancy-specific questionnaire
timeFrame: Outcome assessed up to 23 weeks gestation
measure: Gestational weight gain quantification
timeFrame: Outcome assessed through study completion, an average of 7 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
References:
Clinical trial NCT00688415: Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
Official title: A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lymphoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.


Eligibility criteria: Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility.

Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Histologically or cytologically confirmed solid tumors or lymphoma
* Locally advanced or metastatic disease
* Life expectancy of at least 16 weeks
* ECOG performance status of 0 or 1
* Acceptable physical exam and laboratory tests at study entry
* Willingness to use medically acceptable contraception
* A negative serum pregnancy test for women with reproductive potential

Exclusion Criteria:

* Anticancer therapy within 2 weeks
* Treatment with an investigational agent within 4 weeks
* Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
* Known brain metastases unless stable for at least 28 days
* Active autoimmune disease
* Insulin-dependent diabetes mellitus
* Clinically significant cardiac disease within 6 months
* Significant infection or fever within 1 week
* Pregnant or breast-feeding females
* Other conditions or circumstances that could interfere with the study

Primary outcomes:
measure: Safety and identification of dose-limiting toxicities
timeFrame: Study duration
measure: Pharmacokinetics
timeFrame: First dose of investigational drug
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: Study duration
measure: Identification of the MTD
timeFrame: First cycle of investigational drug
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
Study officials:
affiliation: Celgene
name: Amar Patel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01881815: Swab Sample Collection for the Detection of Bacterial Proteases
Official title: Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Wounds
Keywords: Chronic wounds with different etiologies
Diabetic foot ulcers
venous leg ulcers
pressure sores
acute wounds
Lead sponsor: Systagenix Wound Management
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (greater than 18 years old), presenting at participating clinical sites with wounds of different etiologies, who are willing to provide informed consent and who meet the inclusion / exclusion criteria, will be prospectively enrolled

Brief summary: The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.


Eligibility criteria: Inclusion Criteria:

* Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
* Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
* Subject is 18 years of age or older.
* Subject agrees to complete all aspects of the study and provides Informed Consent

Exclusion Criteria:

* Subject is less than 18 years of age.
* Target wound contains a malignancy
* Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
* Subject is confirmed to be positive for HIV or hepatitis.
* Subject is unable or unwilling to provide informed consent.
* Subjects deemed inappropriate for the study by the site's Principal Investigator.

Primary outcomes:
measure: The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques.
timeFrame: 3 days
Secondary outcomes:
measure: to determine the bacteria present in infected and non infected wounds by microbiological techniques
timeFrame: 3 days
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: St. John Wound Center
state: Oklahoma
Study officials:
affiliation: SerenaGroup, Inc.
name: Tom Serena, MD
role: PRINCIPAL_INVESTIGATOR
References: