louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06556992: Fitness Integrative Training for Pediatric Rheumatology Disorders
Official title: Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Systemic Lupus Erythematosus of Childhood
Joint Hypermobility
Juvenile Dermatomyositis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm behavioral intervention feasibility trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.


Eligibility criteria: Inclusion Criteria:

* Pediatric rheumatic diseases (PRD) or joint hypermobility (JH) diagnosed by a pediatric rheumatologist or pain physician.
* Initial diagnosis ≥ 3 months ago
* Ages 10-19 years, inclusive
* Ongoing symptoms of musculoskeletal pain and/or fatigue for at least 3 months
* Functional Disability Index (FDI) Score ≥ 13 indicating at least moderate disability.
* Child has written and spoken proficiency in English and parent has written and spoken proficiency in English or Spanish (will have a certified bilingual provider or interpreter available)

Exclusion Criteria:

* Untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) or documented developmental delay.
* Any other medical condition determined by their physician to be a contraindication for exercise.
* Childhood Myositis Assessment Scale (CMAS) ≤ 30

Primary outcomes:
measure: Feasibility of Enrollment
timeFrame: 2 years
measure: Session Attendance
timeFrame: 8 weeks
measure: Participant Retention at Post-Treatment
timeFrame: 8 weeks
measure: Treatment Fidelity
timeFrame: 2 years
measure: Participant Safety
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Susmita Kashikar-Zuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03215992: Optical Tomography in Prostate Cancer
Official title: Diffuse Optical Tomography in Prostate Cancer Detection and Risk Stratification A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Diffuse Optical Tomography
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is looking to see if a new device, diffuse optical tomography (DOT), can detect prostate cancer. The investigators will also see if DOT can tell the difference between high risk and low risk prostate cancers.

Detailed description: While some of these tools have helped to guide therapy in patients with prostate cancer, they are imperfect and as a result many men undergo unnecessary treatment for a disease that would not have caused their deaths. An improved method to risk stratify men with prostate cancer prior to definitive therapy may reduce the over-treatment rate, while maintaining or improving mortality.

Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. DOT analyzes the light being reflected and transmitted through tissue to generate three-dimensional images of chromophores and light scattering. As such, DOT serves as a functional imaging modality, measuring both tissue vascularity and architecture. The investigators believe that DOT will be able to detect prostate cancer in men suspected of the disease and will also be able to risk-stratify patients found to have prostate cancer to help guide treatment options. DOT may be able to directly measure two factors important in the prognosis of patients with prostate cancer: the Gleason score and microvessel density (MVD).

Eligibility criteria: Inclusion Criteria:

* Men 18 years of age or older scheduled for transrectal prostate biopsy or radical prostatectomy at Columbia University Medical Center
* Signing consent for study imaging procedure and analysis of prostate biopsy

Exclusion criteria:

* Patients failing to meet the inclusion criteria
* Contraindication for magnetic resonance imaging

Primary outcomes:
measure: Total number of subjects who are imaged using DOT and produce usable images
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Emerson Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197092: The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Official title: A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type II
Keywords: Diabetes
Lead sponsor: Center for Integrative Medicine, Germany
Sponsor class: OTHER
First posted: 2010-09-09
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: A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well as its risk factors.


Eligibility criteria: Inclusion Criteria:

* men and women between the ages of 18 and 60
* recently diagnosed Diabetes Type II (within the last 12 months)

Exclusion Criteria:

* no orally-taken medication up to present
* no insulin therapy
* no diseases resulting from diabetes like Nephropathy, Neuropathy, Angiopathy or Retinopathy
* fasting blood sugar values in the morning under 200mmol
* sufficient production of insulin

Primary outcomes:
measure: HbA1c Test (Glycated hemoglobin)
timeFrame: 4 month average
Secondary outcomes:
measure: Blood count
timeFrame: 4 month average
measure: Electrolytes
timeFrame: 4 month average
measure: Liver, pancreatic and kidney retention values
timeFrame: 4 month average
measure: Lipids: Cholesterol,Triglycerides
timeFrame: 4 month average
measure: Oxyd LDL (low-density lipoprotein cholesterol)
timeFrame: 4 month average
measure: Free lipids fasting
timeFrame: 4 month average
measure: Lipoprotein A
timeFrame: 4 month average
measure: Fibrinogen
timeFrame: 4 month average
measure: CRP (C Reactive protein)
timeFrame: 4 month average
measure: LDH-Isoenzymes (Lactate dehydrogenase)
timeFrame: 4 month average
measure: Homocysteins
timeFrame: 4 month average
measure: Nutrient IgGs Panels (BiomedicalScreen)
timeFrame: 4 month average
measure: Insulin, Adiponectin, Leptin
timeFrame: 4 month average
measure: Potassium, selene, magnesium, zinc in whole blood
timeFrame: 4 month average
measure: SHbG, full-testosterone (Androgen-Index)
timeFrame: 4 month average
measure: PlasminInhibitor I
timeFrame: 4 month average
measure: Vitamins B1,B2,B6,B 12, Vitamin D
timeFrame: 4 month average
Other outcomes:
Locations:
city: Speyer
country: Germany
facility: CFI Centrum für Integrative Medizin
Study officials:
name: Rainer Mutschler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06582992: DNA Methylation Trajectories in Aging
Official title: EPIGENETIC-SENSITIVE BIOMARKERS OF INFLAMMAGING FROM HEALTHY TO HEART FAILURE DISEASE
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Aging
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 150 subjects will be enrolled; n=50 healthy young, n=50 aged (≥65) without signs and symptoms of heart failure, and n=50 aged (≥65) with diagnosis of HFpEF will be enrolled at Trasfusion Medicine and Cardiology Departments of University of Campania Luigi Vanvitelli; Each group will be matched for sex (25 M and 25 F), smoker habits, and comorbidities. Demographic and clinical characteristics will be collected both from patients and healthy subjects at baseline. For HFpEF patients, echocardiographic parameters will be reported based on the echocardiogram acquired at the time of enrollment.

Brief summary: The goal of this observational study is to profile changes in DNA methylation of circulating CD4+ T and CD8+ T cells from healthy young to aged with diagnosis of HFpEF, a particular phenotype of HF which is highly prevalent in aging.

The main question it aims to answer is:

-Do DNA methylation biomarkers help us to understand the role of inflammation in HFpEF during aging?

Our goal is to provide a simple large-scale panel of epigenetic-sensitive biomarkers useful in aged patients with HF in the early natural history of the disease (HFpEF).


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged between 18 and 40 years
* Aged subjects (≥65) without signs and symptoms of heart failure
* Aged subjects (≥65) with diagnosis of heart failure with preserved ejection fraction (EF major than 50%)

Exclusion Criteria:

* Heart failure with reduced ejection fraction (EF minor than 40%)
* Heart failure with mildly reduced EF (HFmrEF) (EF 41-49%)
* History or diagnosis of cancer and inflammatory diseases

Primary outcomes:
measure: Number of differentially methylated positions and regions as assessed by RRBS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
state: No States Available
Study officials:
References:
Clinical trial NCT01256892: Insulin Dependent Gestational Diabetes Mellitus: Randomized Trial of Induction of Labour at 38 and 40 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-12-09
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the impact of induction of labour at 38 weeks with the induction of labour at 40 weeks in women with insulin dependent gestational diabetes mellitus on maternal and fetal outcome.


Eligibility criteria: Inclusion Criteria:

* pregnant women with insulin dependent gestational diabetes mellitus

Exclusion Criteria:

* chronic inflammatory disease,
* autoimmune disease,
* pre-existing diabetes mellitus,
* previous cesarean section,
* multiple pregnancies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05207592: Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study
Official title: Translation of Foot and Ankle Disability Index Into Local Urdu Language of Pakistan: A Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Fascitis
Keywords: Foot and Ankle Disability Index
Plantar Fascitis
Cultural adaptation
Validity
Urdu Version
Reliability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participant included in this study will be the patients of plantar fasciitis including both genders.

Brief summary: The purpose of this research is to translate Foot and Ankle Disability Index in Urdu and determine the validity and reliability in patients with plantar fasciitis and correlate IT with Quality of Life Short Form-36 and the Visual Analog Scale.

Detailed description: As per recommendation of the English Version of Foot and Ankle Disability Index will be translated and culturally adapted. Foot and Ankle Disability Index along with its correlation scales will be distributed in the seventy plantar fasciitis population that will be selected according to inclusion exclusion criteria and through convenience sampling technique. To check the inter and intra observer reliability of Foot and Ankle Disability Index, Short Form-36 to measure the quality of life and Visual Analog Scale to measure pain will be filled by participants.

Eligibility criteria: Inclusion Criteria:

* Inability to achieve 20 degrees of active dorsiflexion
* Heel pain
* Mid foot pain
* Heal swelling
* Mid foot swelling
* Achilles' tendon tightness diagnosed on the base of Windlass test

Exclusion Criteria:

* Recent foot injury
* Fracture
* Infections
* Surgical procedures
* Tendon injury
* Hypermobility
* Neuromuscular disorders
* Impaired sensation
* Open sores
* Skin disease
* Active deep vein thrombosis or thrombophlebitis
* Bruises
* Varicose veins
* Burn Scars

Primary outcomes:
measure: Foot and Ankle Disability Index
timeFrame: 1st day
measure: 36-Item Short Form Survey
timeFrame: 1st day
measure: Visual Analogue Scale
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT07005492: Factors Affecting Success and Survival Rates in Root Canal Retreatment
Official title: Factors Affecting Success and Survival Rates in Root Canal Retreatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Therapy
Root Canal Retreatment
Keywords: root canal retreatment
non-surgical root canal treatment
survival
success
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the effects of pre-treatment and procedural factors on survival and success rates in teeth that underwent non-surgical root canal retreatment at Trakya University, Faculty of Dentistry between 2015-2017.

Pre-treatment factors examined:

* Age
* Gender
* Presence and size of periapical lesion
* Quality of root canal obturation

Factors examined during treatment:

* Type of restoration
* Status of restoration at recall

The null hypothesis was that these factors have no effect on survival and success rate.

Detailed description: Patients with teeth that had undergone non-surgical recurrent root canal treatment at Trakya University, Faculty of Dentistry between 2015-2017 were invited for examination. Clinical and radiological examinations were performed on patients who agreed to participate in the study. No additional interventional procedures were performed. As a result of radiological and clinical examinations, whether the tooth was in the mouth, its clinical and radiological health, current clinical symptoms, etc. were determined.

Eligibility criteria: Inclusion Criterias:

* At least 18 years old at the time of treatment
* Systemically healthy (ASA 1-2)
* Acceptable obturation quality after treatment

Exclusion Criterias:

* Precense of seperated instrument before or after treatment
* Precense of perforation before or after treatment
* Apical surgery before of before or after treatment
* Immature root development
* Two adjacent teeth which required root canal treatment or treatment
* Pregnant women

Primary outcomes:
measure: Survival rate
timeFrame: 78.47 ± 10.48 months after treatment
measure: Success rate
timeFrame: 78.47 +10.48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University, Faculty of Dentistry
state: Merkez
Study officials:
affiliation: Trakya University, Faculty of Dentistry, Department of Endodontics
name: Burhan Can Çanakçş, Associate professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03191292: Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection
Official title: Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Infection
Keywords: probabilistic antibiotherapy
prosthetic joint infection
treatment failure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with prosthetic joint infection and treated with probabilistic antibiotherapy after a first surgery

Brief summary: The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.


Eligibility criteria: Inclusion Criteria:

* patient with prosthetic joint infection and treated with probabilistic antibiotherapy, between 2010 and 2015, at the Croix-Rousse Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: identification of bacteria involved in patients with prosthetic joint infection
timeFrame: 3 weeks after the surgery
measure: collection of probabilistic antibiotic treatment in patients with prosthetic joint infection
timeFrame: the day of surgery
Secondary outcomes:
measure: adverse events
timeFrame: up to 24 months after antibiotic therapy disruption
measure: Treatment failure
timeFrame: up to 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan Ferry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342092: Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté
Official title: Rebond d'adiposité précoce Chez l'Enfant de 4 Ans et Risque de Surpoids Chez l'Enfant de 11 Ans : troisième Temps d'Une Cohorte Franc-comtoise.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 868
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children initially enrolled in two successive surveys of build evolution and overweight determinants among a children cohort (both surveys representing the first time of the cohort), conducted in 2008.

Brief summary: This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.


Eligibility criteria: Inclusion Criteria:

* Boys and girls born between 1st July 2003 and 30th June 2004
* Attending school in Haute-Saône
* Enrolled in the 2008 cohort survey

Exclusion Criteria:

* Children whose parents refused to take part in this cohort study.

Primary outcomes:
measure: Body mass index of 11 years old pre-adolescents
timeFrame: month 22
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Stéphanie Pasteur, MD
role: PRINCIPAL_INVESTIGATOR
References: