louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00673998: Isokinetic Testing Protocol in Elderly and Young Men
Official title: The Effects of Rest Interval on Quadriceps Torque During an Isokinetic Testing Protocol in Elderly and Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Isokinetic
Fatigue
Strength
Older
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 38
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue and recovery. To date, only one study has determined the effect of varied rest intervals (RI) between exercise sets in active younger and older women. They reported that active younger and older women require similar RI between sets to recovery full isokinetic knee extension peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery between younger and older men. Thus, the purpose of this study was to compare the effect of two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work (TW) between untrained younger and older men.

Detailed description: 18 young men (24.22 ± 2.58 yrs) and 20 older men (66.85 ± 4.02 yrs) performed 3 sets of 10 unilateral isokinetic knee extension repetitions at 60°/s. The rest intervals between sets were 1 and 2 minutes and were counterbalanced across 2 testing days, separated by a minimum of 48 hours. The work-to-rest ratio was 1:3 and 1:6. All subjects were not involved in exercise programs that included resistance exercises within the last 6 months. Statistical evaluation of the data was performed using a 2x 2 x 3 mixed factor repeated measures ANOVA \[age (younger and older) x rest interval (1 and 2 min) x set (1st, 2nd, and 3rd)\]. Statistical significance was set at p \< 0.05 for all comparisons.

Eligibility criteria: Inclusion Criteria:

* Less than 75 years
* Independent

Exclusion Criteria:

* History of cardiovascular disease
* Hypertension
* Orthopedic disease

Primary outcomes:
measure: Peak Torque
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: DF
Study officials:
affiliation: University of Brasilia
name: Martim Bottaro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761498: Is There a Microbiome Associated With Poor Growth in Preterm Infants?
Official title: Is There a Microbiome Associated With Poor Growth in Preterm Infants?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Growth Disorders
Growth Failure
Prematurity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born at less than 28 weeks gestation will be eligible from birth until discharge. Infants with major congenital anomalies which alter growth patterns will be excluded.

Brief summary: This study evaluates the relationship between growth and stool microbiota in premature infants.

Detailed description: Preterm infants often require increased caloric intake to maintain appropriate growth while in the neonatal intensive care unit (NICU). While some infants will have a clear source of need for greater calories, it is often not obvious why others require increased available calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut microbiota may play a role in infant and childhood growth. We hypothesize that differences in the microbial pattern in preterm infants is related to poor growth and need for increased caloric intake. This may ultimately represent a therapeutic target to improve the growth of preterm infants in the NICU. This study aims to describe the differences in microbiome which may vary with growth pattern.

Eligibility criteria: Inclusion Criteria:

All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.

Exclusion Criteria:

Infants \>27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.

Primary outcomes:
measure: quantitative rT-PCR of stool microbiome
timeFrame: 8-10 weeks depending on length of stay in NICU
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hopsital and Health System
state: Texas
Study officials:
References:
Clinical trial NCT01876498: Registry of Patient With M. Dupuytren and Validation of the Brief MHQ
Official title: Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren Contracture
Collagen Shrinkage
CRF
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with M.Dupuytren with Xiapex injection or surgery

Brief summary: The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.

Detailed description: examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients

Eligibility criteria: Inclusion Criteria:

* M.Dupuytren, over 18y, able to speak and understand german

Exclusion Criteria:

* recurrence, pregnancy, incapable of contracting

Primary outcomes:
measure: Brief Michigan Hand Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Joint mobility
timeFrame: 3 years
Other outcomes:
measure: Pain
timeFrame: 3 years
measure: Grip Strength
timeFrame: 3 years
measure: Quick DASH
timeFrame: 3 year
measure: Euroqol 5l5d
timeFrame: 3 years
measure: Michigan Hand Questionnaire
timeFrame: 3 years
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Daniel Herren, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT01403298: Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
Official title: Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescent
HIV
AIDS
Sexual risk
Family
Prevention
Juvenile Drug Court
Juvenile Justice
Drug Use
Marijuana
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to compare the effect of a family-based HIV prevention program to the effect of an adolescent-only health promotion program on adolescent HIV risk and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island Family Court.

Detailed description: Adolescents and parents admitted to our study receive either an adolescent-only health education program that focuses on general health risk behaviors related to HIV/AIDS, smoking, diet and exercise or one that focuses on family-based HIV/AIDS education through safe decision-making and control of one's emotions as well as parent-child interactions that are associated with dysregulated affect, subsequent parenting deficits and adolescent HIV risk behaviors.

Eligibility criteria: Inclusion Criteria:

* 13 to 18 years old;
* male and female;
* in Rhode Island Family Court - Intake and Juvenile Drug Court program;
* English speaking

Exclusion Criteria:

* HIV infection (by self-report);
* history of sex crimes,
* current pregnancy

Primary outcomes:
measure: adolescent HIV/STD risk
timeFrame: 3 months post intervention
measure: adolescent substance use
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Scores on measures of parent-child communication (general and sex-specific),parental monitoring and family emotional environment
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Marina Tolou-Shams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06258798: The Use of Artificial Intelligence in the Dental X-rays Analysis
Official title: Comparison of the Dental X-ray Analysis Performed by an Artificial Intelligence Algorithm and the Analysis Performed by Dentists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health
Dental Caries
Periapical Diseases
Tooth Loss
Lead sponsor: Hospital of the Ministry of Interior, Kielce, Poland
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 1025
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included in the study were admitted to the radiology department in Kielce, a city in southern Poland with around 200.000 inhabitants.

Brief summary: This cross-sectional study aims to perform a population-based assessment of the incidence of decay, dental fillings, root canal fillings, endodontic lesions, implants, implant and dental abutment crowns, pontic crowns, and missing teeth, taking into account the location.

Detailed description: This cross-sectional study aims to perform a population-based assessment of the incidence of decay, dental fillings, root canal fillings, endodontic lesions, implants, implant and dental abutment crowns, pontic crowns, and missing teeth, considering the location. Patients with indications for dental X-ray confirmed by a written referral and with permanent dentition will participate in the study. Then, the X-rays will be analyzed by the dentists and the AI-based software after the data has been anonymized. The results will be compared to determine the AI algorithm's sensitivity, specificity, and precision.

Eligibility criteria: Inclusion Criteria:

* Indications for dental X-ray confirmed by a written referral from the dentist or physician (both screening tests and tests performed for treatment purposes were allowed)
* Permanent dentition (after exfoliation is completed)

Exclusion Criteria:

* Patients with mixed dentition (exfoliation has not finished)

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 6 weeks
measure: Specificity
timeFrame: Up to 6 weeks
measure: Precision of the AI algorithm
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: Department of Maxillofacial Surgery
Study officials:
affiliation: Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
name: Maciej Sikora
role: STUDY_CHAIR
References:
Clinical trial NCT05504798: A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
Official title: Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spastic Diplegic Cerebral Palsy
Keywords: Diplegia, Neuromuscular electrical stimulation, Casting.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Combining the advantages of both Neuromuscular electrical stimulation and lower limb serial casting to a selected physical therapy program in children with spastic diplegic cerebral palsy to overcome the adverse effects during the period of casting and the long period of rehabilitative interventions, providing a new multimodal treatment approach.


Eligibility criteria: Inclusion Criteria:

* The children will have grade 2 or 3 on Modified Ashworth Scale.
* The children will have Level II, or III according to the Gross Motor Function Classification System.
* The children walk with equinus or jump gait patterns with spasticity of the hamstrings and hip flexors in addition to calf muscles spasticity.
* Children take their Antispastic drug use such as baclofen, diazepam or tizanidine.
* All children will be able to follow instructions.

Exclusion Criteria:

* children will be excluded from the study if they have any problems of the following:

  * Cognitive dysfunction.
  * Poor skin integrity.
  * History of or recent nonunion fracture.
  * Fixed contractures and deformities.
  * Previous surgery (tendon lengthening).
  * Received Botulinum toxin A injections in the last six months.
  * Impaired circulation.

Primary outcomes:
measure: Change of knee and ankle passive range of motion (ROM)
timeFrame: At the beginning and after six weeks of intervention
measure: Change of strength of knee extensors and ankle dorsiflexors muscles
timeFrame: At the beginning and after six weeks of intervention
measure: Change of tone of hamstring and gastrocnemius muscles
timeFrame: At the beginning and after six weeks of intervention
Secondary outcomes:
measure: Change in sagittal kinematics parameters of gait pattern
timeFrame: At the beginning and after six weeks of intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT02081898: Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids
Official title: Three-year Mild Calorie Restriction Partially Protects Against Age-related Increase in Sphingomyelin and Reduces Obesity-associated Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obese
Keywords: low calorie diet
BMI
sphingomyelin
L-leucine
L-phenylalanine
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in the extended plasma metabolites.

Detailed description: Overweight/obese subjects (25≤ BMI \<33 kg/m2) aged 40 to 59 years consumed a LCD (an approximate 100 kcal/day calorie deficit) or a weight-maintenance diet (control) in a randomized, controlled design with 3-year intervention period.

Eligibility criteria: Inclusion Criteria:

* 25 \<= BMI \< 33 kg/m2

Exclusion Criteria:

* type 2 diabetes
* cardiovascular disease
* psychiatric problems
* any medication use

Primary outcomes:
measure: anthropometry
timeFrame: 3-year follow-up
Secondary outcomes:
measure: biochemistry analysis
timeFrame: 3-year follow-up
Other outcomes:
measure: plasma metabolites
timeFrame: 3-year follow-up
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics
Study officials:
affiliation: Yonsei University
name: Minjoo Kim, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Lee SH, Lee JH. Global Metabolic Profiling of Plasma Shows that Three-Year Mild-Caloric Restriction Lessens an Age-Related Increase in Sphingomyelin and Reduces L-leucine and L-phenylalanine in Overweight and Obese Subjects. Aging Dis. 2016 Dec 1;7(6):721-733. doi: 10.14336/AD.2016.0330. eCollection 2016 Dec.
Clinical trial NCT04324398: Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Official title: Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Periapical Periodontitis
Keywords: Cryotherapy
Interleukins
Postoperative pain
Sodium hypochlorite
Lead sponsor: Suez Canal University
Sponsor class: OTHER
Collaborators: name: Nelly AbdElsalam
name: Dalia Fayyad
First posted: 2020-03-27
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study was to evaluate the effect of intra-canal cryotherapy on post-endodontic pain and interleukin-6 expression in teeth with symptomatic apical periodontitis using different irrigation protocols.


Eligibility criteria: Inclusion Criteria:

* Anterior or premolar single canal in single rooted teeth.
* Patients aged 20 to 50 years.

Exclusion Criteria:

* Patients under anti-inflammatory medication, immune-suppressive chemotherapy or any antibiotic medication for the last 2 months.
* Pregnant or lactating females.
* Teeth with endo-perio lesions.

Primary outcomes:
measure: PAIN
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Port Said
country: Egypt
facility: Ahmed
Study officials:
References:
Clinical trial NCT00004498: Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ornithine Transcarbamylase Deficiency Disease
Keywords: genetic diseases and dysmorphic syndromes
inborn errors of metabolism
ornithine transcarbamylase deficiency
rare disease
urea cycle disorder
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the safety, feasibility, and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency.

Detailed description: PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo a femoral arterial placement of a hepatic intraarterial catheter. Patients then receive adenoviral vector mediated gene transfer intravascularly over 30 minutes.

Cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined.

Patients are followed at 3, 5, 7, 8, 15, and 29 days, at 2 months, and then every 3 months thereafter.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of partial ornithine transcarbamylase deficiency Female heterozygote with abnormal allopurinol challenge or underlying defect in either N15 urea or N15 glutamine OR Male with childhood/adulthood onset OR Family history of 2 affected children
* Stable for at least 1 month prior to study
* Plasma ammonium levels less than 50 micromoles

--Prior/Concurrent Therapy--

* Concurrent alternate pathway therapy to control hyperammonemia allowed

--Patient Characteristics--

* Hepatic: No history of liver disease
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No high level of neutralizing antibodies to the adenovirus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Steven E. Raper
role: STUDY_CHAIR
References:
Clinical trial NCT01157598: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Official title: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Adenoma
Gastric Cancer
Keywords: gastric adenoma
early gastric cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.


Eligibility criteria: Inclusion Criteria:

* gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion

Exclusion Criteria:

* if they were under 18 years of age
* had an ASA classification of 4-5
* were pregnant
* had a history of stroke or an allergy to sedative drugs.

Primary outcomes:
measure: the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
timeFrame: within the one day after ESD
Secondary outcomes:
measure: the dose of midazolam and meperidine during ESD with BIS monitoring
timeFrame: within one hour after ESD
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05737498: Transcranial Direct Current Stimulation (tDCS) on Working Memory in College Going Students
Official title: Efficacy of Transcranial Direct Current Stimulation (tDCS) on Working Memory in College Going Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Working Memory Deficits
Keywords: working memory, immediate memory
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Working memory deficiencies, might make it difficult for students to recall instructions, complete complex activities, and grasp and follow directions solving a math problem or writing a sentence. The functions of working memory are critical for effective human activity. Transcranial direct current stimulation (tDCS) has grown in popularity and academic interest in recent years as a way to improve cognitive abilities. so there is need to determine the effect of tdcs on working memory in college going students.


Eligibility criteria: Inclusion Criteria:

1. College going students
2. Both male and female
3. Able to follow verbal commands

Exclusion Criteria:

1. Chronic skin problems.
2. Seizure and any neurological disorder
3. Any recent trauma or surgery
4. Any cardiovascular or pulmonary disease
5. Psychosomatic disorders

Primary outcomes:
measure: Trail making test
timeFrame: changes between baseline to 2 weeks
measure: Digit span test
timeFrame: changes between baseline to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: