louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06794164: Immediate Skin-To-Skin Care For Preterm Infants After Birth
Official title: Immediate Skin-To-Skin Care For Preterm Infants After Birth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Effect of Skin to Skin Care in Preterm Neonates
Skin to Skin Care
Keywords: skin to skin care
preterm neonates
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard procedure in our centre for preterm neonates is to enable skin-to-skin (SSC) contact within 24 hours after birth. As early SSC immediately after birth might provide numerous positive effects for mothers and their preterm neonates, the objective of this study is to evaluate the feasibility, the safety and the effect of skin-to-skin contact immediately after birth in preterm neonates born with gestational age between 26+0 and 32+0 weeks.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 26+0 and 32+0 weeks
* Written parental informed consent

Exclusion Criteria:

* No intention of full life support
* Severe congenital malformation

Primary outcomes:
measure: vital parameter: Heart rate
timeFrame: during the first 2 hours after birth
measure: vital parameter: Oxygen saturation
timeFrame: during the first 2 hours after birth
measure: vital parameter: blood pressure
timeFrame: during the first 2 hours after birth
measure: vital parameter: Temperature
timeFrame: during the first 2 hours after birth
Secondary outcomes:
measure: blood sugar
timeFrame: 1 hour after birth
measure: FiO2 (Fraction of inspired oxygen)
timeFrame: during first 2 hours after birth
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT05387564: Increasing Documentation and Disclosure of Sickle Cell Trait Status: an Implementation Science Approach
Official title: Increasing Documentation and Disclosure of Sickle Cell Trait Status: an Implementation Science Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Trait
Keywords: electronic health record
pediatric
newborn screen
implementation
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder. Because of its detection method, the NBS incidentally reveals hemoglobinopathy traits including sickle cell trait (SCT). In an effort to uphold the rights of the newborn to their medical data and preserve autonomy in medical decision making, pediatric and genetic society guidelines recommend disclosure and documentation of SCT results during infancy. Despite this guidance, a large guideline-to-practice gap exists: SCT status is grossly under-documented in the pediatric electronic health record and few adults report knowing their SCT status despite universal screening. We plan to evaluate the effect of a toolkit of SCT Documentation and Disclosure (SCT-DD) strategies on documentation and disclosure of SCT by pediatric primary care providers in a 2-arm randomized interrupted time series trial.


Eligibility criteria: Inclusion Criteria:

* Outpatient pediatric primary care providers within Nemours and their patients

Exclusion Criteria:

* none

Primary outcomes:
measure: Penetration
timeFrame: Every 1 month through study completion, on average 1 year
measure: Acceptability
timeFrame: Every 6 weeks through study completion, on average 1 year
measure: Self-efficacy
timeFrame: Every 6 weeks through study completion, on average 1 year
measure: Feasibility of using toolkit components
timeFrame: Every 6 weeks through study completion, on average 1 year
Secondary outcomes:
measure: Dispersion
timeFrame: Every 1 month through study completion, on average 1 year
measure: Knowledge
timeFrame: Every 1 months through study completion, on average 1 year
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delware
state: Delaware
Study officials:
affiliation: Nemours
name: Corinna Schultz, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180764: Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Official title: Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia
omega-3 acid ethyl esters
high-density lipoproteins
fish oil
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.

Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.

Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.


Eligibility criteria: Inclusion criteria:

* Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
* Age 35-75 years

Exclusion criteria:

* Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
* Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
* Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
* Excess ethanol consumption (regular intake \>4 drinks/d, or binges of \>8 drinks at once for men, half these levels for women)
* Poorly controlled diabetes mellitus (A1c \>9%)
* History of acute or chronic pancreatitis
* Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis
* History of significant unexplained or uncontrolled bleeding or bruising
* Poorly controlled blood pressure (\>140/90mmHg, with or without treatment)
* Poorly controlled thyroid disease (TSH outside of normal range)
* Hepatic disease (ALT \> 2.5x ULN, Dx of hepatitis or cirrhosis)
* Any contraindication or prior adverse reaction to Lovaza
* Active cancer (except basal cell or squamous cell skin cancer)
* Pregnancy, plan/desire to become pregnant, breast feeding
* Inability or unwillingness to provide informed consent

Primary outcomes:
measure: HDL Composition
timeFrame: 12 weeks
Secondary outcomes:
measure: HDL cholesterol composition by density subfraction
timeFrame: 12 weeks
measure: Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Eliot A Brinton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607490: A Randomized Clinical Trial for Women With Vulvodynia
Official title: Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Keywords: Vulvodynia
Vulvar pain
Dyspareunia
Sexual dysfunction
Vestibulitis
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2008-02-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

Detailed description: Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's\<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's\<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.

Eligibility criteria: Inclusion Criteria:

* Independently diagnosed with vulvodynia by two study physicians

Exclusion Criteria:

* Any conditions known to better account for the vulvar pain
* Psychotic illness
* Actively suicidal
* Substance dependent
* Life-threatening illness
* Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.

Primary outcomes:
measure: Pain Severity
timeFrame: Measured at 1-year follow-up
Secondary outcomes:
measure: Sexual Functioning
timeFrame: Measured at 1-year follow-up
measure: Emotional Functioning
timeFrame: Measured at 1-year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Robin M Masheb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352390: The Effect of a Coloring Prompt on Health Engagement
Official title: The Effect of a Coloring Prompt on Health Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In Need of a Pap Smear (Cervical Cancer Screening)
In Need of a Blood Pressure Check (Hypertension Screening)
In Need of a Cholesterol Test (Lipid Disorder Screening)
In Need of a Fasting Plasma Glucose Test (Diabetes)
Keywords: behavioral economics
nudge
artwork
Pap smear
Blood pressure check
Cholesterol test
Fasting plasma glucose test
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 8711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to determine whether prompting the recipient of a health reminder mailing to ask his or her 4-9 year-old child to color on the reminder could increase engagement with the targeted health behavior

Detailed description: The investigators will randomly assign some individuals with 4-9 year old children to receive colorful reminders to engage in a given health behavior. Others will receive identical reminders along with a prompt to share the reminder sheet with their child so it can be turned into a piece of art. The investigators are interested in whether the coloring prompt will lead the reminder to stay in the home for longer, be placed on the refrigerator, etc. and thus result in an increase in compliance with the recommended health behavior.

Eligibility criteria: Inclusion Criteria:

* Indications according to Spring 2011 CDC criteria for a Pap smear
* Indications according to Spring 2011 CDC criteria for a blood pressure check
* Indications according to Spring 2011 CDC criteria for a cholesterol test
* Indications according to Spring 2011 CDC criteria for a fasting plasma glucose test
* Employee at partner corporation that implemented the study

Primary outcomes:
measure: Number of Participants that schedule an appointment for receipt of a Pap smear.
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Number of Participants that schedule an appointment for receipt of a Blood pressure check
timeFrame: up to 52 weeks
measure: Number of Participants that schedule an appointment for receipt of a Cholesterol test
timeFrame: up to 52 weeks
measure: Number of Participants that schedule an appointment for receipt of a Fasting plasma glucose test
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02667990: Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
Official title: Maximal Plantar Pressure and Comfort Evaluation During Normal Every Day Use of an "Orthopedic" Stiletto, a Normal Stiletto and a Control Trainer Shoe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metatarsalgia
Keywords: metatarsalgia
pedobar
foot
stiletto
insoles
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.

Testing involves pedobar pressures and a validated comfort questionnaire.

Detailed description: 22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire.

x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal (IM) angles will be recorded.

Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus, hammertoes will be recorded.

Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel) and possible Emed system (Novel).

3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.

Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect.

16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.

Eligibility criteria: Inclusion Criteria:

* Foot healthy females used to wearing stilettos.

Exclusion Criteria:

* Shoe sized outside European 37-42.
* Sought doctor for foot or balance related issues

Primary outcomes:
measure: plantar foot pressure
timeFrame: 1 hrs
Secondary outcomes:
measure: comfort rating footwear
timeFrame: 1 month
Other outcomes:
measure: X ray angles of the foot
timeFrame: 1 hrs
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: jeannette penny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108390: Gluteus Medius Dry Needling and Ankle Instability
Official title: Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Instability of Joint
Trigger Point Pain, Myofascial
Keywords: ankle
dry needling
trigger point
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).

Detailed description: Inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. Exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

Initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb.

Once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.

Eligibility criteria: Inclusion Criteria:

* individuals with chronic ankle instability, 20 to 50 years old.

Exclusion Criteria:

* any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

Primary outcomes:
measure: Pain intensity
timeFrame: 1 day
measure: Pain pressure threshold
timeFrame: 1 day
Secondary outcomes:
measure: Range of motion
timeFrame: 1 day
measure: Balance
timeFrame: 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fiom clinic
Study officials:
References:
Clinical trial NCT02073890: Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage
Official title: Incidence and Outcomes of Traumatic Subarachnoid Haemorrhage Patients: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Subarachnoid Haemorrhage
Keywords: traumatic Subarachnoid Haemorrhage
Head Trauma
Computed Tomography
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: Center for Applied Research & Education
name: SMS Medical College and Hospital
First posted: 2014-02-27
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: traumatic subarachnoid haemorrhage

Brief summary: Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid haemorrhage refers to blood in subarachnoid space that lies between arachnoid and piameninges, covering brain. It is often associated with concurrent intracranial injury component. Individuals at higher risk for tSAH are those who are at higher risk for blunt head trauma. This includes adolescents, low-income individuals, men, and individuals with a history of substance abuse. The investigators present study aims to investigate prognostic factors associated with the neurological outcome among patients of post traumatic SAH.


Eligibility criteria: Inclusion Criteria:

* All patients of traumatic subarachnoid haemorrhage

Exclusion Criteria:

* Metabolic disorder
* Altered coagulation profile
* Cardiac disease
* Co- morbid illness

Primary outcomes:
measure: Level of consciousness measured by Glasgow coma scale
timeFrame: Change from baseline to one month
Secondary outcomes:
measure: appearance of subarachnoid hemorrhage on CT measured by Fisher Grading
timeFrame: Change from baseline to one month
Other outcomes:
Locations:
Study officials:
affiliation: Macmillan Research Group UK
name: Neha Sharma, PhD
role: STUDY_CHAIR
affiliation: SMS Medical College & Hospital, Jaipur
name: Virendra D Sinha, M Ch
role: STUDY_DIRECTOR
affiliation: SMS Medical College & Hospital, Jaipur
name: Manish Agrawal, M Ch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838990: TELEMS: Feasibility of Remote Patient Visits in MS
Official title: TELE MS RCT: A Randomized Controlled Trial to Evaluate Feasibility of Remote Patient Visits in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
remote visits
telemedicine
remote patient monitoring
remote monitoring
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trials randomizes patients with multiple sclerosis (MS, pwMS) to a remote visit (via phone or videochat) or a regular outpatient visit. Outcomes include satisfaction on the patients' and doctor's side.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of any type of MS
* own a phone/smartphone/computer
* informed consent

Exclusion Criteria:

* language barriers

Primary outcomes:
measure: TMPQ
timeFrame: 1 week after intervention
Secondary outcomes:
measure: PPSM
timeFrame: 1 week after intervention
Other outcomes:
measure: Ancillary Analyses
timeFrame: immediately after the intervention
measure: Empirical Questionnaire
timeFrame: 1 week after intervention
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Patrick Altmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altmann P, Leutmezer F, Ponleitner M, Ivkic D, Krajnc N, Rommer PS, Berger T, Bsteh G. Remote visits for people with multiple sclerosis during the COVID-19 pandemic in Austria: The TELE MS randomized controlled trial. Digit Health. 2022 Jul 11;8:20552076221112154. doi: 10.1177/20552076221112154. eCollection 2022 Jan-Dec.