louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05010083: The University of Michigan OWL (Online Wellness and Lifestyle) Study
Official title: The University of Michigan OWL (Online Wellness and Lifestyle) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Keywords: nutrition
Diet, Ketogenic
Diet, Carbohydrate-Restricted
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Nutrition Science Initiative
First posted: 2021-08-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.

Detailed description: Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease Control, American Heart Association, and the National Institutes of Health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the disconnect between recommendations and research, higher quality, long term, large trials are needed. In preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30 young adults followed over 4 months.

Eligibility criteria: Inclusion Criteria:

* Age 18-25
* Obese (BMI ≥ 30)
* Sufficient control over diet
* Access to internet and texting
* Living in the United States
* Willing and able to follow intervention and complete measurements

Exclusion Criteria:

* Non-English speaking
* Pregnant, breastfeeding, or planning to be in the next 6 months
* Vegan or vegetarian
* Currently enrolled in weight loss program
* Taking medications known to cause weight loss or gain
* Taking glucose-lowering medications other than metformin
* Type 1 diabetes
* Cancer
* Heart failure
* Kidney failure
* History of eating disorders
* Untreated psychiatric disorder
* History of or planned weight loss surgery
* Consumption of greater than 30 alcoholic beverages per week

Primary outcomes:
measure: Change in percent bodyweight
timeFrame: 4 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05240183: Viral Dynamics of Omicron in Children
Official title: Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection, COVID-19
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 107
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children less than 19 years of age with acute SARS-CoV-2 infection

Brief summary: SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.

Detailed description: The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children \< 19 years with acute infection to inform public health practice.

Specific Aims:

1. Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
2. Assess the impact of various host factors on viral dynamics, including age (\<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses)
3. Estimate the time point at which children are less likely to be infectious
4. Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)

Eligibility criteria: To be included in the study, the participant must be:

1. Less than 19 years of age
2. Have a positive molecular or rapid antigen test in the previous 48 hours
3. If symptomatic, onset of any COVID-19 symptom within last 72 hours.
4. If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear)
5. Able to collect daily samples

Primary outcomes:
measure: SARS-CoV-2 Viral Load
timeFrame: 10 days
Secondary outcomes:
measure: Rapid antigen test sensitivity
timeFrame: 10 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT01529983: Fractional Laser vs. Ultrasound for Periorbital Wrinkles
Official title: A Comparison of 1550-nm Fractional Photothermolysis Versus Intense Focused Ultrasound for Treatment of Periorbital Wrinkles: A Pilot, Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Wrinkles
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of intense focused ultrasound and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.

Detailed description: This is a prospective randomized comparison study comparing the efficacy of micro-focused ultrasound versus fractionated carbon dioxide laser for treatment of periorbital wrinkles. Subjects who meet inclusion and exclusion criteria will be enrolled in the study. The treated sites are both lower eyelids and lateral orbits. Each side will be randomized to receive 1550nm-fractionated laser treatment on one side and the contralateral side will receive micro-focused ultrasound treatment every 6-8 weeks for a total of 2 treatments.

Eligibility criteria: Inclusion Criteria:

1. Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
2. Subjects with Fitzpatrick skin type I-III.
3. Subjects who are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator.

Exclusion Criteria:

1. Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
2. Subjects who were received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
3. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with periorbital treatment with energy devices.
4. Subjects who are allergic to lidocaine or prilocaine.
5. Subjects who have a history of abnormal scarring in the treatment area.
6. Subject who have ectropion or or other eyelid disfigurement.
7. Subjects who have history of isotretinoin use in the preceding year
8. Pregnant or lactating individuals

Primary outcomes:
measure: Global Improvement Scale
timeFrame: 3 months
measure: Quantitative eyelid laxity scale
timeFrame: 3 months
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 10 years
measure: Adverse events
timeFrame: 10 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05978583: Impact of Physical and Occupational Therapy in New BMT Patients
Official title: Assessing the Impact of Physical and Occupational Therapy for Patients Admitted for Bone Marrow Transplant on Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Marrow Transplantation
Bone Marrow Disease
Keywords: exercise
physical therapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are admitted for bone marrow transplantation (BMT) at the study site.

Brief summary: This is a single-site, non-randomized, observational study designed to evaluate the impact of adding physical and occupational therapy consultation upon inpatient admission for a bone marrow transplantation (BMT). The purpose of this study is to investigate whether consultation with physical and occupational therapists as part of the general admission order set for patients scheduled for bone marrow transplant will result in reduced complications, morbidity, length of inpatient stay, 30-day readmission, and 90-day mortality. Baseline data collection will be used to determine eligibility. This study will be partially retrospective (pre-implementation of physical and occupational therapy consultation order) and partially prospective.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at the time of admission for bone marrow transplantation (BMT)
2. Received BMT

Exclusion Criteria:

1. No history of inpatient admission for BMT

Primary outcomes:
measure: 30-day readmission
timeFrame: Up to 30 days after bone marrow transplantation
Secondary outcomes:
measure: The feasibility
timeFrame: 1 day (the date of bone marrow transplantation)
measure: Acute care length of stay
timeFrame: Up to 90 days after bone marrow transplantation
measure: Mortality rates
timeFrame: Up to 90 days after bone marrow transplantation
measure: Complication types and rates
timeFrame: Up to 90 days after bone marrow transplantation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Sasha Stephen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206283: A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.
Official title: Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Subarachnoid Hemorrhage
Keywords: traumatic brain injury
subarachnoid hemorrhage
secondary brain ischemia
microdialysis
modified Lund concept
cerebral perfusion pressure
intracranial pressure
Lead sponsor: University of Sarajevo
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We present a randomised controlled study to compare the two management strategies.

The hypotheses of the study were:

* SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology.
* ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI.

Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups. Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good outcome (Glasgow Outcome Scale score 4 and 5).


Eligibility criteria: Inclusion Criteria:

* patients with subarachnoid haemorrhage who had anterior circulation aneurysm rupture only
* multiple anterior aneurysm rupture
* severe traumatic brain injury with isolated head injury and intradural focal lesions only

Exclusion Criteria:

* Glasgow Outcome Score of 3 with or without brainstem reflexes
* Significant co-morbidities
* posterior circulation aneurysm
* multisystem injuries
* diffuse axonal injuries

Primary outcomes:
measure: Mortality rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Department of Neurosurgery, Clinical Centre University of Sarajevo
Study officials:
affiliation: Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina
name: Kemal Dizdarevic, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202083: The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
Official title: The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Keywords: Oxytocin
Cook Balloon
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Currently, the study about intervention on the induced abortion at trimester is so little. So, the investigators want to compare the safety and effectiveness of different induced labor.

Detailed description: In this study , the investigators want to compare the safety and effectiveness of different induced labor. The safety and effectiveness such as the success rate of induced labor and the gestation outcome,etc.

Eligibility criteria: Inclusion Criteria:

* Gestation age ≥37week
* Single fetus
* No serious complications

Exclusion Criteria:

* Gestation age \<37week
* Multiple fetus
* With serious complications

Primary outcomes:
measure: The success rate of induced labor
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second Hospital
state: Sichuan
Study officials:
affiliation: West China second Hospital
name: li zhang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00015483: Hematotoxic Effects of Particulate Exposure
Official title: Hematotoxic Effects of Benzene and Doxorubicin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Hematotoxicity
Benzene
Bone Marrow
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Hematotoxicity is caused by a number of agents such as a benzene by-product called hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted using normal human donors, of mechanisms involved in hematotoxicity and of the protective response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor exposure protects these cells from a subsequent exposure to hematotoxic agents. The alteration of gene expression in these cells caused by tumor necrosis factor is being studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in protection of human hematopoietic progenitor cells will be studied.


Eligibility criteria: * healthy
* nonsmoking
* no history of hematologic disorder
* not pregnant
* no medications which suppress hematopoiesis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00379483: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
Official title: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transfusional Iron Overload
Keywords: Transfusional iron overload
Deferasirox
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.


Eligibility criteria: Inclusion Criteria:

* Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion Criteria:

* Pregnant or breast feeding patients
* Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Primary outcomes:
measure: Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
timeFrame: at 3, 4, 5 years
Secondary outcomes:
measure: Change in liver iron content measured by SQUID, at 3, 4, and 5 years
timeFrame: at 3, 4, 5 years
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Milan
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00361283: Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Official title: Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: American College of Clinical Pharmacy
First posted: 2006-08-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

Detailed description: All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Eligibility criteria: Inclusion Criteria:

* 18+ years old
* Normocholesterolemic

Exclusion Criteria:

* Cardiovascular disease or risk equivalents
* Malignancy
* Active alcohol abuse
* Contraindications to statins
* Interacting drugs
* Chronic anti-inflammatory drugs

Primary outcomes:
measure: Mean Change in Level: Week 16-baseline in Ena-78
timeFrame: 16 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida College of Pharmacy
name: Reginald Frye, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310283: Caries Management by Risk Assessment in Children
Official title: Caries Management by Risk Assessment in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
children
mutans streptococci
lactobacilli
cariogenic bacteria
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.


Eligibility criteria: Inclusion Criteria:

1. Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be:
2. Patients of record at the Tenderloin community and UCSF pediatric dental clinics
3. 5-9 years old

3. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures

Exclusion Criteria:

Persons with:

1. Prolonged antibiotic use in the past three months.
2. Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics

Primary outcomes:
measure: new decayed surfaces
timeFrame: 1 year
Secondary outcomes:
measure: cariogenic bacteria levels
timeFrame: 6 month and 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
state: California
city: San Francisco
country: United States
facility: The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ling Zhan, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: