louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06151925: Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening
Official title: Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Onset and Length Abnormalities
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.

Detailed description: A new method for induction of labor to be studied

Eligibility criteria: Inclusion Criteria:

* Pregnant women with:

  * Age 18-45 years.
  * Live fetus with cephalic presentation.
  * Normal non-stress test with reassuring features (baseline heart rate 110-160 beats/min, baseline variability 5-25 beats/minute, and no decelerations) (National Institute for Health and Clinical Excellence 2017).
  * Gestational age of 37 weeks or more (Middleton et al. 2020).
  * Fetal weight less than 4 kilograms.
  * Bishop score less than 6 (Navve et al. 2017).
  * No labor pains.
  * No contraindications for vaginal delivery

Exclusion Criteria:

* o Presence of fetal distress.

  * Presence of thick meconium-stained amniotic fluid
  * Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.

Primary outcomes:
measure: o Bishop Score and cervical dilatation
timeFrame: 2 YEARS
Secondary outcomes:
measure: o Induction time to active phase of labor.
timeFrame: 2 YEARS
measure: o Induction time to delivery time.
timeFrame: 2 YEARS
Other outcomes:
measure: o Cesarean frequency rate
timeFrame: 2 YEARS
measure: o Intrapartum complications
timeFrame: 2 YEARS
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Faculty Of Medicine
Study officials:
affiliation: Lecturer of obstetrics and gynecology - Ain Shams University
name: Maya AbdelRazek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329625: Preventing Conduct Disorder in Child Welfare
Official title: PREVENTING CONDUCT DISORDER AMONG CHILDREN IN THE CHILD WELFARE SYSTEM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Disorder
Child Maltreatment
Keywords: Triple P
RCT
parent management training
Child welfare
child behavior problems
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months, and 18 months). Over 70% were retained from baseline to 18 months.


Eligibility criteria: Inclusion Criteria:

* Families with open child protective service case following allegation of child physical abuse or neglect
* parent of child between the age of 3 and 12
* Child remained in the home following investigation
* parent spoke English

Exclusion Criteria:

* parent's child could not have chronic medical condition or have a pervasive developmental delay

Primary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: 18 months
measure: PedsQL
timeFrame: 18 months
Secondary outcomes:
measure: Parenting Stress Inventory
timeFrame: 18 months
measure: Parent Anger Inventory
timeFrame: 18 months
measure: Parental Sense of Competence
timeFrame: 18 months
measure: Alabama Parenting Questionnaire
timeFrame: 18 months
measure: Depression Anxiety Stress Scales
timeFrame: 18 months
measure: AUDIT
timeFrame: 18 months
measure: The Drug Abuse Screening Test
timeFrame: 18 months
measure: HITS IPV Screening
timeFrame: 18 months
measure: PQL
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Patricia Kohl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831725: An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Therapy for Critical Illness
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized adult patients

Brief summary: 1. Demographics data;
2. Nutritional evaluation data;
3. All biochemical monitoring data during the study period;
4. All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene.
5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline.
6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling.
7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization


Eligibility criteria: Inclusion Criteria:

* age: 18-70
* patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation
* receive parenteral or enteral nutrition \> 3 days

Exclusion Criteria:

* has metabolic disorders: diabetes, thyroid disease
* Pregnant or breastfeeding
* The presence of drug or alcohol dependence
* The presence of tuberculosis, HIV infection and other acute infectious disease
* Serious liver, kidney, heart and other vital organ failure

Primary outcomes:
measure: complications after the operation
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00654225: Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)
Official title: A 6-Week, Randomized,Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidaemia
Keywords: Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Atorvastatin
Lipitor
South Asian
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 2340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Fasting low density lipoprotein \& triglyceride levels as defined by the protocol.
* Self described South Asian race
* Subjects with coronary heart disease or at high risk of coronary heart disease.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Primary outcomes:
measure: Low density lipoproteins cholesterol levels
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institute for Medical consultation, USA
name: Dr. Prashkrah Deedwania
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT01322230: Trial of Educational Outcomes of WISE-MD
Official title: Randomized Trial of Educational Outcomes of WISE-MD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Instructional Design
Online learning module
Surgical education
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Augusta University
name: University of Nebraska
name: University of Vermont
name: New York Medical College
name: State University of New York - Downstate Medical Center
name: Jefferson Medical College of Thomas Jefferson University
First posted: 2011-03-24
Enrollment: 1363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to compare the educational efficacy of instructional design enhancements in on-line learning modules in the context of clinical medical education.

Detailed description: This study involved medical students from seven US medical schools participating in a trial of two WISE-MD computer-based learning modules. Students were randomized to 1 of 4 study arms. The 4 content-equivalent conditions were: screen shots with voiceover and no interactivity; learner control of pacing through multi-media content; social networking features; and social networking features plus user interface enhancements.

Eligibility criteria: Inclusion Criteria:

* All third-year medical students at all of the 7 collaborating schools (N= 2308) rotating through the surgery clerkship from July 2009 and September 2011.

Exclusion Criteria:

* Students who do not consent to participate and who decide to withdraw from participation.

Primary outcomes:
measure: Immediate Post Knowledge Test
timeFrame: Week 2
measure: Mid-clerkship Knowledge Test
timeFrame: Week 4
measure: Mid-clerkship Clinical Reasoning Test
timeFrame: Week 4
measure: End-clerkship Clinical Reasoning Test
timeFrame: Week 8
Secondary outcomes:
measure: Students Baseline Characteristics
timeFrame: Immediately after consenting to participate - Day 1
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Philadelphia
country: United States
facility: Jefferson Medical College
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: NYU Langone Health
name: Adina Kalet, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalet AL, Coady SH, Hopkins MA, Hochberg MS, Riles TS. Preliminary evaluation of the Web Initiative for Surgical Education (WISE-MD). Am J Surg. 2007 Jul;194(1):89-93. doi: 10.1016/j.amjsurg.2006.12.035.
Clinical trial NCT00651430: Physical Functioning Following Total Hip Arthroplasty
Official title: Step Execution, Stability, Quality of Life, Fear of Falling and Their Association Following Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthrosis, Balance Control, Voluntary Movement Control
Keywords: Balance
Voluntary stepping
function
disability
fear of falls
Total Hip Arthroplasty
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 adults suffer from Hip OA prior THA

Brief summary: Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition step execution test and Late life function and disability questionnaires will be also examined.


Eligibility criteria: Inclusion Criteria:

* Able to stand safely for 30 seconds
* Able to walk independently
* Hip OA prior THA

Exclusion Criteria:

* Stroke or other neurological diseases
* Minimal score 24 or higher
* Blindness

Primary outcomes:
measure: SDF parameters
timeFrame: before, 3 month and 6 month after the THA
Secondary outcomes:
measure: Late Life Function and disability, Fall efficacy scale, step execution test
timeFrame: before 3 month and 6 month after
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Beer-Sheva
country: Israel
facility: SorokaUMC
Study officials:
affiliation: Soroka University Medical Center
name: Vadim Benkovich, MD
role: STUDY_DIRECTOR
affiliation: Ben-Gurion University of the Negev
name: Itshak Melzer, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989530: Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis
Official title: Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Randomized, Prospective, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Shock Wave Therapy
Keywords: Extracorporeal Shock Wave Therapy
ultrasonography
plantar fasiit
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis is the most common cause of heel pain in adults. It received FDA approval in 2000 for ESWT in the treatment of plantar fasciitis in adults whose pain did not resolve with conservative treatment.

ESWT energy levels are categorized as high, medium and low. It is not yet clear which energy level is most effective in the clinical recovery and pain relief of plantar fasciitis after ESWT treatment. Although there are studies in the literature evaluating the effect of different energy densities in the treatment of plantar fasciitis with ESWT, there are very few studies comparing different treatment doses of ESWT.

The aim of this study was to evaluate and compare the therapeutic effects of low, medium and high energy ESWT in patients with plantar fasciitis, and also to examine the correlation between plantar fascia thickness changes ultrasonographically and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

presence of heel pain, tenderness at the insertion site of the plantar fascia on the anteromedial aspect of the calcaneal tubercle elicited by palpation, and unresponsiveness to medical treatment.

Exclusion Criteria:

history of inflammatory rheumatic disease, trauma of the foot or foot surgery, local dermatological lesion or infection, impaired peripheral circulation, a neurological disorder such as radiculopathy and neuropathy, patients with sequelae of lower extremity fracture, a congenital or acquired deformity, malignancy, cardiac pacemaker, metal implant at the application site, pregnancy, anticoagulant use for coagulopathy

Primary outcomes:
measure: Foot Function index
timeFrame: 1 months
Secondary outcomes:
measure: Plantar fasia thickness
timeFrame: 1 months
Other outcomes:
measure: visual analogue scale
timeFrame: 1 months
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
References:
Clinical trial NCT01682330: The Long-term Effects of Training on Muscle Strength and Functionality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Training
Ageing
Muscle Strength
Functionality
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 65
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults (+65 years)

Brief summary: The purpose of the present study is to evaluate the long-term effects of 1 year of high-intensity fitness training and low-intensity whole-body vibration training on muscle strength and functionality. Therefore, muscle strength and functionality are measured after a 6-yr interval in older adults (65+).


Eligibility criteria: Inclusion Criteria:

* female (+65 years)
* participation in previous study "De effecten van oefenprogramma's op gezondheids- en fitheidsgerelateerde parameters in een groep van 60-plussers" \[The effects of exercise programs on health and fitness-related parameters in a group of people over 60\]
* able to perform a maximal strength test on a dynamometer

Exclusion Criteria:

- pathologies that prohibit a maximal strength test on a dynamometer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06595030: Investigating the Impact of Duration and Amount of Light on the Circadian System Response - Aim 3
Official title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25
* Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion Criteria:

* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
* Obstructing cataracts
* Severe macular degeneration
* Use of sleep medication
* Use of oral melatonin
* untreated moderate to severe sleep apnea
* Severe restless leg syndrome - Blindness

Primary outcomes:
measure: Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to Week 36
Secondary outcomes:
measure: Sleep efficiency using actigraphy
timeFrame: Up to Week 36
measure: Depression using the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Up to Week 36
measure: Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Up to Week 36
measure: Light measurements using the Daysimeter
timeFrame: Up to Week 36
measure: Cognitive status Using the Montreal Cognitive Assessment (MOCA)
timeFrame: Up to Week 36
Other outcomes:
Locations:
city: Menands
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: