louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005407: Statistical Analysis of Pediatric Task Force Data Base
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To define pediatric sex-specific blood pressure percentiles that were a function of both age and height. Also, to define the precise age at which blood pressure distributions for different racial groups diverged.

Detailed description: BACKGROUND:

Hypertension is a well-recognized risk factor for cardiovascular disease in adults. Furthermore, many studies have shown that there is tracking among longitudinal pediatric blood pressure determinations. An important unresolved goal in pediatric hypertension research is to define at what level of pediatric blood pressure is a child at increased risk for adult hypertension. When the grant was awarded in February 1991, there had been two NHLBI Task Forces in Blood Pressure Control in Children which had published reports in 1977 and 1987. One of the goals of each task force was to define appropriate percentiles for blood pressure in children. In the Second Task Force Report, results from nine large epidemiologic studies were combined into a data base with more than 70,000 readings from which blood pressure percentiles were derived as a function of age and sex. However, many research workers stated that height is more strongly related to blood pressure than age and have urged that Normative data for pediatric blood pressure be demarcated by height rather than age.

DESIGN NARRATIVE:

Blood pressure percentiles were constructed that were a function of age, sex, race, and height, thus providing a more comprehensive profile of pediatric blood pressure distributions than any previously published work.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06586307: Estimating Lymphocyte Counts from DNA Methylation
Official title: Assessment of DNA Methylation Signatures in Lymphocytes for Evaluating the Efficacy and Prognosis of Immunotherapy in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancers
Immunotherapy
DNA Methylation
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we prospectively enrolled 49 patients with advanced-stage CRC who received neoadjuvant immunotherapy as part of their treatment regimens at the Sixth Affiliated Hospital, Sun Yat-sen University from January 2022 to June 2024.

Brief summary: The goal of this observational study is to assess lymphocyte levels in colorectal cancer patients using DNA methylation levels in tissues or blood. The main questions it aims to answer are:

Can DNA methylation features calculate lymphocyte levels? Can the calculated lymphocyte levels assess the efficacy and prognosis of immunotherapy?


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with colorectal cancer by colonoscopy pathology and deemed eligible for immunotherapy after assessment.
2. Neoadjuvant immunotherapy regimen includes PD-1 or anti-PD-L1.
3. R0 resection is performed after neoadjuvant immunotherapy.
4. Complete immunotherapy efficacy assessment data and follow-up data are available.
5. The tissue bank stores the required whole blood and tissue samples for the experiment.

Exclusion Criteria:

1. Concurrent other malignancies.
2. Neoadjuvant immunotherapy not conducted according to the standard protocol.
3. Severe adverse chemotherapy reactions that lead to the discontinuation of immunotherapy midway.
4. Lack of complete neoadjuvant chemotherapy efficacy assessment data or follow-up data.
5. The tissue bank does not store the required whole blood or tissue samples for the experiment.
6. Patients with concurrent other immune system diseases.

Primary outcomes:
measure: Complete Response Rate
timeFrame: From the date of neoadjuvant therapy until the date when the surgical specimen pathology results are obtained, the duration of neoadjuvant therapy is approximately half a year, with a maximum of one year.
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06613607: Effects of Core Strengthening on Pelvic Tilt, Dynamic Balance and Agility in Lower Cross Syndrome: a Quasi-experimental Study
Official title: Effects of Core Strengthening on Pelvic Tilt, Dynamic Balance and Agility in Lower Cross Syndrome: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Cross Syndrome
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi Experimental Study
Primary purpose: TREATMENT

Brief summary: This study is a quasi experimental study and the purpose of this study is to determine the effects of core strengthening on pelvic tilt, dynamic balance and agilty in lower cross syndrome.

Detailed description: Participants will be recruited into the study using the criteria of lower crossed syndrome which is assessed using te following tests:

Prone hip extension test Trunk flexion strength test Tightness in erector spinae Modified Thomas test

Eligibility criteria: Inclusion Criteria:

* Age 19-35 years
* Both genders
* Positive modified Thomas test
* Positive prone hip extension strength test
* Positive trunk flexion strength test
* Tight erector spinae
* Asia pacific BMI normal (18.5-24.9 Kg/m2)
* Local intermittent lumbar pain
* moderate pain (NPRS 3-7)
* Painless movement and activity
* Pain only produced by sustained loading in relevant position, which is then relieved on moving from that pos

Exclusion criteria:

* Acute flare of LBP
* Centralization and peripheralization of pain
* Signs of stenosis(leg symptoms when walking that are eased upon flexion)
* Pain due to repetitive movements
* Paresthesia/Numbness
* Structual deformity(Kyphosis, spondylosis, spondylolisthesis,scoliosis and joint contractures)
* Curve reversal
* Pregnancy
* Post surgery
* Degenerative and inflammatory spine diseases

Primary outcomes:
measure: Lumber lordotic angle
timeFrame: 6 weeks
measure: Dynamic Balance
timeFrame: 6 weeks
measure: Agility
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT04618107: Wide Awake Surgery for Tendon Repair in Hand Trauma
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injury - Hand
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia.

Detailed description: All patients aged 15 or above with hand trauma resulting in tendon injuries were included.65 patients undergoing tendon repair in wide awake anaesthesia were grouped as approach arm and another 65 patients of general anaesthesia group were kept as control arm.Range of motion of corresponding tendons were measured at completion of sixth postoperative week using goniometer.Total active range of motion were calculated according to criteria given by Strickland method and American Society for Surgery ofthe Hand (ASSH).

Functional outcomes were compared among two groups.

Eligibility criteria: Inclusion Criteria:

1. Patients of either gender of age 15 years or above.
2. All of the patients with hand injuries with tendon repair required, operated within the hospital premises

Exclusion Criteria:

1. Patients allergic to agents of local anesthesia.
2. Patients with anxiety symptoms
3. Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.
4. Patients with associated nerve injuries.
5. Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.
6. Patients with massive contamination, crush injuries or infection which needs to be addressed and treated prior to definitive repair.

Primary outcomes:
measure: active range of motion
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Saba Kiran
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Saba Kiran, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Neill N, Abdall-Razak A, Norton E, Kumar A, Shah H, Khatkar H, Alsafi Z, Agha R. Use of Wide-Awake Local Anaesthetic No Tourniquet (WALANT) in upper limb and hand surgery: A systematic review protocol. Int J Surg Protoc. 2020 Mar 13;20:8-12. doi: 10.1016/j.isjp.2020.03.001. eCollection 2020.
citation: Fulchignoni C, Bonetti MA, Rovere G, Ziranu A, Maccauro G, Pataia E. Wide awake surgery for flexor tendon primary repair: A literature review. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8668. doi: 10.4081/or.2020.8668. eCollection 2020 Jun 29.
citation: Libberecht K, Lafaire C, Van Hee R. Evaluation and functional assessment of flexor tendon repair in the hand. Acta Chir Belg. 2006 Sep-Oct;106(5):560-5. doi: 10.1080/00015458.2006.11679952.
Clinical trial NCT05301907: Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials
Official title: Survey Among Healthcare Professionals and MS Patients/Caregivers in Selected European Countries to Evaluate the Knowledge Required for the Safe Use of Mayzent
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
NIS
survey
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod). And Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists in selected EU countries

Brief summary: Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

Detailed description: The survey- based study is conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

Eligibility criteria: Inclusion Criteria:

Physicians will be considered eligible for the survey if they meet the following screening criteria:

* Care for relapsing MS (RMS) patients
* Personally prescribed disease modifying therapies to MS patients, and;
* Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.

Nurses will be considered eligible for the survey if they:

* Provide supportive care for RMS patients
* Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.

Patient inclusion criteria include:

- Have been initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.
timeFrame: Throughout study completion, an average of 3 years
measure: Knowledge and understanding of the HCPs as per detailed in the educational information provided
timeFrame: Throughout study completion, an average of 3 years
measure: Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided
timeFrame: Throughout study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04017507: The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health
Official title: The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 2145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This meta-analysis includes healthy adult male and females.

Brief summary: The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.


Eligibility criteria: Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.

Primary outcomes:
measure: Number of Bleeding Sites
timeFrame: Up to 12 weeks
measure: Dental Plaque Scores
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Multiple P&G Investigation Clinical Sites
state: Ohio
Study officials:
References:
Clinical trial NCT05532007: Effects of Peanut Intake on Cognitive Functions
Official title: Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Inflammation
Keywords: Peanuts
cognition
inflammation
oxidative stress
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: The Peanut Institute
First posted: 2022-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a free living , randomized, controlled, parallel design study with 30 subjects, who will be randomized to either receive peanuts or abstain from them for 12 weeks.
Primary purpose: PREVENTION

Brief summary: The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.

Detailed description: The purpose of the study is to determine the effects of peanuts on cognitive performance and task-related brain activation on functional magnetic resonance imaging (fMRI) in older adults. The specific aim of the study is to explore the neuroprotective effects of a peanut-enriched diet (2-3 oz of peanuts to replace 20% of the total energy of the habitual diet) for 12 weeks compared to a peanut-excluded habitual diet in elderly men and women with increased risk for CVD and self-reported memory complaints. The study population is older adults 60-80 years in age.

Eligibility criteria: Inclusion Criteria:

* Non-demented elderly between 60-80 years of age
* Self-reported memory complaints
* Two cardiovascular risk factors
* Stable weight for at least 6 months prior to recruitment

Exclusion Criteria:

* Peanut allergy
* Smoker
* Endocrine, metabolic and neuropsychological disorders
* Ineligible to get an MRI
* Consuming more than 3 servings/week of nuts including peanuts

Primary outcomes:
measure: changes from baseline in Brian activation
timeFrame: baseline to 12 weeks
measure: changes from baseline serum markers of inflammation
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: changes from baseline in global cognitive composite score
timeFrame: baseline to 12 weeks
measure: Change in serum brain-derived neurotrophic factor (pg/mL)
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Sujatha Rajaram, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464407: High Protein Oral Nutritional Support With Special Nutrients in Patients With Type 2 Diabetes and Foot Ulcer
Official title: Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healing Ulcer
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus

Detailed description: The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes with newly diagnosed foot ulcer
* accept study participation

Exclusion Criteria:

* HbA1c \>90 mmol/L
* cognitive challenges, fx dementia
* history with known alcohol or drug abuse
* allergy to milk or soya
* home less
* critical ischemia, distal blood pressure \<0.30
* EGFR \< 30
* dialysis or planned dialysis or patients with terminal kidney insufficiency

Primary outcomes:
measure: foot ulcer area
timeFrame: 12 weeks
measure: Foot ulcer healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Compliance to intervention
timeFrame: 12 weeks
measure: Accept of intervention
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks and 6 months
measure: Adverse events
timeFrame: 12 weeks and 6 months
measure: Body weight
timeFrame: 12 weeks and 6 months
measure: Improvement in Quality of life
timeFrame: 12 weeks and 6 months
measure: Number of foot ulcers
timeFrame: 12 weeks and 6 months
measure: Depth foot ulcer
timeFrame: 12 weeks
measure: Classifying/scoring of food ulcer
timeFrame: 12 weeks and 6 months
measure: Time to complete healing of foot ulcer
timeFrame: 6 months
measure: Reduction in ulcer area
timeFrame: 6 months
measure: Number of new foot ulcers
timeFrame: 12 weeks and 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Randi Tobberup, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06812507: Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications
Official title: Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature
Placental Transfusion
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life


Eligibility criteria: * Inclusion Criteria:

  1. Premature neonates ≤ 32 weeks gestational age regardless birth weight
  2. will be admitted to neonatal intensive care unit in the first day of life of life

Exclusion criteria:

* Exclusion Criteria:

Patient with any of the following will be excluded:

1. Preterm babies \>32 weeks
2. Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
3. Evidence of head trauma causing major intracranial hemorrhage.

5. Concern for abruptions, placenta previa or retroplacental hematoma. 6. Cord accident, or avulsion at the time of delivery. 7. Refusal to perform the intervention by the obstetrician

Primary outcomes:
measure: Hemoglobin level
timeFrame: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Marwa Mohamed Farag
Study officials:
References:
Clinical trial NCT02084407: Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients
Official title: Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DM1
Keywords: DM1
Cardiopathy
Adult
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem cells in order to study the cardiac alterations induced by CTG expansions.


Eligibility criteria: Inclusion Criteria for DM1 patient with cardiomyopathy:

* aged 20-50
* DM1 confirmed by molecular analysis
* Confirmed cardiomyopathy (infrahissiens conduction disorders)
* able to sign the consent form
* affiliated to european social security.

Inclusion Criteria for DM1 patient without cardiomyopathy

* aged 20-50
* DM1 confirmed by molecular analysis
* No cardiomyopathy (no infrahissiens conduction disorders or other trouble linked to DM1)
* able to sign the consent form
* affiliated to european social security.

Inclusion Criteria for controls

* aged over 18
* brother, sister, father or mother of the DM1 patient
* No DM1 confirmed by molecular analysis (CTG repetition under 38)
* No cardiac disorders.
* able to sign the consent form
* affiliated to european social security.

Exclusion Criteria:

* no pragnant or nursing women
* patient unable to understand informed consent
* patient under juridic protection

Primary outcomes:
measure: Measure of DM1 alterations in human cardiomyocytes derived from induced pluripotent stem cells
timeFrame: At baseline
Secondary outcomes:
measure: Molecular changes in human DM1 cardiomyocytes expressing pathogenic CUGexp-RNA
timeFrame: At baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Institute of Myology
Study officials:
affiliation: Institute of Myology
name: Laurent Servais, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: