louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01096550: Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Official title: Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Dependence
Keywords: opioid dependence
outpatient treatment
intensive outpatient treatment
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-03-31
Enrollment: 319
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: The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.

Detailed description: This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.

Eligibility criteria: Inclusion Criteria:

* heroin-dependent adults
* new admissions to buprenorphine outpatient treatment

Exclusion Criteria:

* pregnancy
* acute medical or psychiatric illness

Primary outcomes:
measure: Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
timeFrame: 6 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Shannon G Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184650: Nutrition and Neurological Development of Very Preterm Infants
Official title: Early Nutrition and Neurological Development of Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant
Infant Nutrition Disorders
Delayed Mental Development
Keywords: Premature infants
Nutritional status
Polyunsaturated fatty acids status
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 206
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.

Brief summary: The main goal of this study is to determine, in preterm infants born with a GA \< 32 weeks, the association between:

* the quantity of mother's milk and duration and breastfeeding
* the intake of polyunsaturated fatty acids and iron during hospitalizations

Detailed description: The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA \< 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.

In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA \< 32 weeks.

The secondary objective is :

- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.

Eligibility criteria: Inclusion Criteria:

* Premature infants previously included in EPINUTRI study
* Non opposition of the parents for the collection of clinical and nutritional data

Exclusion Criteria:

* Refusal of the parents to collect clinical and nutritional data

Primary outcomes:
measure: Neurological development
timeFrame: At 3 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Assistance Publique- Hôpitaux de Paris
Study officials:
affiliation: Hôpital Necker Assistance Publique-Hôpitaux de Paris
name: Alexandre Lapillonne, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05463250: Smartwatch and Physician Well-Being
Official title: Smartwatch and Physician Well-being: Are Wearables Part of the Solution?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Professional Burnout
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Physicians Foundation
name: Mayo Clinic
First posted: 2022-07-18
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The prevalence of burnout and other forms of distress among physicians is alarmingly high. This clinical trial is being conducted to learn more about if wearing a Smartwatch and having access to its data improves physicians' sense of well-being and if data measured from Smartwatches contain a 'signal' that predicts well-being

Detailed description: We will conduct a randomized controlled trail to evaluate if wearing a Smartwatch improves overall well-being among physicians, and if so, in which dimension of well-being (e.g., fatigue, stress, overall quality of life, burnout). Additionally, we will explore if data from Smartwatches can predict subsequent well-being among physicians.

Study Aims:

1. To determine if wearing a Smartwatch and having access to its physiological data (e.g., sleep, step count, activity, breathing reminders) improves well-being, and if so which well-being dimensions.
2. To determine whether continuous physiological measures (measured from Smartwatches) contain a 'signal' that predicts physician well-being, and if so in which dimensions.

Eligibility criteria: Inclusion Criteria:

* Physician

Exclusion Criteria:

* non physicians

Primary outcomes:
measure: Burnout
timeFrame: Up to 12 months
Secondary outcomes:
measure: Physician Well-Being Index
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Lotte Dyrbye
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Liselotte N Dyrbye, MD MHPE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518150: Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section
Official title: Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Detailed description: Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Eligibility criteria: Inclusion Criteria:

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* patient refuses to consent

Primary outcomes:
measure: mean Blood loss after placental separation
timeFrame: 30 minutes
Secondary outcomes:
measure: The number of participant needed for blood transfusion
timeFrame: 24 hours
measure: Number of Participants with postpartum hemorrhage
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT06802250: RINEW Randomized Controlled Trial 7-year Follow-up
Official title: Effects of a Multi-component Early Child Development Intervention in Middle- Childhood: a Follow-up Study of the RINEW Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Keywords: Child development
Water, Sanitation, and Hygiene
Nutrition
Intervention
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Purdue University
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2025-01-31
Enrollment: 620
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the impact of the RINEW multicomponent early child development intervention on child development and risk factors for poor child development in middle childhood. This study is a follow-up assessment of the children and primary caregivers enrolled in the RINEW cluster randomized controlled trial approximately 6 years following intervention completion.


Eligibility criteria: Inclusion Criteria: Child's primary caregiver was enrolled in the RINEW cluster randomized trial

Primary outcomes:
measure: Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)
timeFrame: 6 years after intervention completion
measure: Child Socioemotional Development
timeFrame: 6 years after intervention completion
measure: Self-regulation
timeFrame: 6 years after intervention completion
measure: Academic Achievement
timeFrame: 6 years after intervention completion
Secondary outcomes:
measure: Caregiver Mental Health
timeFrame: 6 years after intervention completion
measure: Home Environment
timeFrame: 6 years after intervention completion
measure: School Grade Level
timeFrame: 6 years after intervention completion
measure: Presence of Improved Latrine
timeFrame: 6 years after intervention completion
measure: Presence of Handwashing Station with Soap and Water
timeFrame: 6 years after intervention completion
measure: Knowledge of lead
timeFrame: 6 years after intervention completion
measure: Bone Lead Levels
timeFrame: 6 years after intervention completion
Other outcomes:
measure: Knowledge of 7 factors related to children's intelligence
timeFrame: 6 years after intervention completion
measure: Knowledge of ways to avoid harm from lead
timeFrame: 6 years after intervention completion
measure: Child screen time
timeFrame: 6 years after intervention completion
measure: Parental perceived intelligence
timeFrame: 6 years after intervention completion
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: University of California, Berkeley
name: Lia Fernald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02166450: Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers
Official title: Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Denture Stomatitis
Keywords: Denture stomatitis
Dentures
Denture wearers
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental clinic patients wearing dentures

Brief summary: The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.


Eligibility criteria: Inclusion Criteria:

* Patients with dental prostheses used for at least 6 months,
* Substantial portion of the oral mucosa covered by dental prosthesis.

Exclusion Criteria:

* acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment,
* antibiotics in less than 4 weeks before the enrolment,
* anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment,
* history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment,
* chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment,
* major medication changes less than 5 weeks before the enrolment or during study.

Primary outcomes:
measure: Change from baseline in blood pressure
timeFrame: Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
Secondary outcomes:
measure: Change from baseline in endothelial function
timeFrame: Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
measure: Changes in immune cell subset populations from baseline
timeFrame: Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Zbigniew Żak Voivodeship Dental Clinic
city: Krakow
country: Poland
facility: Jagiellonian University Dental Clinic
Study officials:
affiliation: Jagiellonian University
name: Tomasz Guzik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jagiellonian University
name: Marta Cześnikiewicz-Guzik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096250: Iron Absorption in Haiti
Official title: Iron Absorption From Wheat Flour in Haiti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
First posted: 2014-03-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.


Eligibility criteria: Mother-child pairs will be recruited!

Inclusion criteria for mothers :

* Women of reproductive age (18 to 45 years)
* Generally healthy
* Consenting to study participation

Exclusion criteria for mothers :

* Pregnancy or lactation
* Weight \>65 kg
* Chronic illnesses which may influence iron absorption
* Severe anemia (Hb\<10 g/dl)

Inclusion criteria for children:

* Age 4 years +/- 12 months
* Generally healthy

Exclusion criteria for children :

* Severe anemia (Hb\<10 g/dl)
* Weight for height \< -2 Z scores (wasting)
* Height of age \< -2 Z score (stunting)

Furthermore, the following exclusion criteria apply to both mothers and children :

* Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
* Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
* Allergies or intolerances relevant to the test meal (gluten)
* Blood donation or major blood losses during the 2 months prior to the study
* Illness during the 4 weeks prior to the study (will be judged by investigator)

Primary outcomes:
measure: Iron absorption
timeFrame: 14 days after test meal consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Port au Prince
country: Haiti
facility: Ministère de la Santé Publique et de la Population
Study officials:
affiliation: ETH Zurich (Switzerland)
name: Isabelle Aeberli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02275650: The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
Official title: The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: calcidiol
25(oh)d
nbUVB
cyp27A1
cyp27B1
vitamin D
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2014-10-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

Detailed description: The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

Eligibility criteria: Inclusion Criteria:

* age over 18
* Fitzpacker's skin type II-IV

Exclusion Criteria:

* age under 18
* diseases that inhibit vitamin D metabolism or absorption
* Fitzpacker's skin type I
* history of skin cancer
* vitamin D substitution 1 month before baseline or during study
* sun holidays 1 month before baseline or during study

Primary outcomes:
measure: 25(OH)D level
timeFrame: up to 30 weeks
Secondary outcomes:
measure: CYP27A1 and CYP27B1 enzyme expression levels
timeFrame: up to 14 weeks
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
state: Pirkanmaa
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Päijät Häme Central Hospital
name: Toni T Karppinen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Erna Snellman, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02286050: Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
Official title: Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.

Detailed description: All patients living with cystic fibrosis will be asked by questionnaire before (November 2014) and after (September 2016) the implementation of the program about their satisfaction with treatment, trust in the CF-Team, adherence, self-efficacy, treatment burden and quality of life.

Eligibility criteria: Inclusion Criteria:

* Cystic Fibrosis

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference between baseline patient satisfaction and month 22
timeFrame: month 22
Secondary outcomes:
measure: Difference between baseline adherence and month 22
timeFrame: month 22
measure: Difference between baseline self-efficacy and month 22
timeFrame: month 22
measure: Difference between baseline treatment burden and month 22
timeFrame: month 22
measure: Difference between baseline trust and month 22
timeFrame: month 22
measure: Difference between baseline information need and month 22
timeFrame: month 22
Other outcomes:
measure: Difference between baseline QoL and month 22
timeFrame: month 22
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References: