louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00500825: Influence of Therapeutic Hypothermia on Resting Energy Expenditure
Official title: Influence of Therapeutic Hypothermia on Resting Energy Expenditure in Patients After Cardiopulmonary Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Resuscitation
Keywords: Cardiopulmonary resuscitation
Therapeutic hypothermia
resting energy expenditure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Vienna

Brief summary: The purpose of this study is the evaluation of the influence of therapeutic hypothermia on resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We hypothesized that hypothermia would reduce resting energy expenditure in these patients.

Detailed description: Therapeutic hypothermia improves neurologic outcome in patients after cardiopulmonary resuscitation (CPR) because of cardiac arrest. In the present study patients will be cooled to 33 degree Celsius after CPR for 24h. To avoid shivering patients will be analgosedated and medically paralysed. Analgosedation and relaxation have already shown to reduce oxygen consumption up to 20 % in critically ill patients.

In patients with brain injury, who were cooled to 33 degree Celsius using a cooling meadow REE could be significantly reduced. In critically ill patients with pyrexia cooling using a cooling meadow REE could be reduced. Oxygen consumption was reduced about 14,7% per degree Celsius.

So far no studies evaluating influence of therapeutic hypothermia on REE in patients after CPR have been published. Therefore we plan to measure REE in 25 cooled patients after CPR using indirect Calorimetry (Deltatrac II Metabolic Monitor, Datex Instrumentarium, Helsinki, Finland).

Eligibility criteria: Inclusion Criteria:

* St.p. CPR
* Indication for therapeutic hypothermia for 24h (33 degrees Celsius)

Exclusion Criteria:

* Contraindication for therapeutic hypothermia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna
name: Ulrike Holzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holzinger U, Brunner R, Losert H, Fuhrmann V, Herkner H, Madl C, Sterz F, Schneeweiss B. Resting energy expenditure and substrate oxidation rates correlate to temperature and outcome after cardiac arrest - a prospective observational cohort study. Crit Care. 2015 Mar 29;19(1):128. doi: 10.1186/s13054-015-0856-2.
Clinical trial NCT06588725: Brief Interventions to Improve Behavior Outcomes and Prevent Cavities
Official title: Brief Interventions to Improve Behavior Outcomes and Prevent Cavities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parenting
Cavity, Dental
Child Behavior
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 750
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.

Detailed description: The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities. Participants will be parents of children, ages 9 months to 3 years, presenting with their child for a well child visit. Parent/child dyads will be randomized into three different groups: Group 1 will be introduced to an online educational intervention to address childhood behavior problem, Group 2 will be introduced to a printed educational intervention to address childhood behavior problems, and Group 3 will be introduced to an educational intervention to prevent cavities. Study procedures will include 1) the educational intervention in the examination room before the clinic visit, 2) a brief survey immediately after the clinic visit and 3) a brief survey in 2-4 months sent via REDCap, and 4) follow up health and insurance records related to the study interventions.

Eligibility criteria: Inclusion Criteria:

* Parents of 9 month to 3 year old children.

Exclusion Criteria:

-

Primary outcomes:
measure: Child behavior problems
timeFrame: 3 years, or until the end of the study.
measure: Cavity-related outcomes
timeFrame: 3 years, or until the end of the study.
Secondary outcomes:
measure: Planned change to care for behavioral health
timeFrame: Same day as enrollment, for 3 years or until the end of the study.
measure: Planned change to prevent cavities
timeFrame: Same day as enrollment, for 3 years or until the end of the study.
measure: Report on helpfulness of interventions
timeFrame: 2-4 months after enrollment, for 3 years or until the end of the study.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Primary Care One Hundred Oaks
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Seth J Scholer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05329025: A Study of QL1706 Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer
Official title: A Study of the Safety and Efficacy of QL1706 in Combination With Chemotherapy in First-Line Treatment of Patients With Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 100
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: This study will evaluate the efficacy and safety of QL1706 when given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIB/C or IV non-squamous NSCLC Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy \>=3 months Adequate hematologic and organ function

Exclusion Criteria:

* History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Primary outcomes:
measure: Adverse events Adverse events Adverse events adverse events
timeFrame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator
timeFrame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
measure: Objective Response Rate (ORR) in the ITT population
timeFrame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
measure: Duration of response (DOR) in the ITT population
timeFrame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
measure: Overall Survival (OS) in the ITT population
timeFrame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05043025: Patient Positions for Locating the Cricothyroid Membrane
Official title: Comparison of Patient Positions for Locating the Cricothyroid Membrane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cricothyroid Membrane
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 138
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cricothyroidotomy is an emergency rescue technique to secure the airway in a 'Can't intubate, Can't Oxygenate' (CICO) situation. The cricothyroid membrane (CTM) is the target site of cricothyroidotomy, and accurate identification of the CTM is essential for successful cricothyroidotomy. In this study, the investigators compare patient positions (neck extension vs. modified ramped position) in terms of the success rate for identifying the CTM in obese patients.


Eligibility criteria: Inclusion Criteria:

* body mass index \>30 kg/m2

Exclusion Criteria:

* anatomical abnormalities or pathologies of the neck or larynx
* a history of neck surgery.

Primary outcomes:
measure: Success rate for the correct identification of the cricothyroid membrane
timeFrame: Immediately after identifying the cricothyroid membrane using a laryngeal handshake technique
Secondary outcomes:
measure: Duration for identifying the cricothyroid membrane
timeFrame: At 90 seconds after administering neuromuscular blockade
measure: Distances between the center of the actual and perceived cricothyroid membrane
timeFrame: Immediately after identifying the cricothyroid membrane using a laryngeal handshake technique
measure: Perceived difficulty during cricothyroid membrane identification
timeFrame: At 5 minutes after identifying the cricothyroid membrane using a laryngeal handshake technique
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04846725: Predictors of Attempted Inferior Vena Cava Filters Retrieval.
Official title: Predictors of Attempted Inferior Vena Cava Filters Retrieval.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolic Disease
Keywords: Inferior vena cava filter
inferior vena cava filter retrieval
inferior vena cava filter complications
deep vein thrombosis (DVT)
pulmonary embolism
venous thromboembolism event (VTE)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019 will be included.

Brief summary: The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.

All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.


Eligibility criteria: Inclusion Criteria:

* patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019.

Exclusion Criteria:

* None

Primary outcomes:
measure: Filter's retrieval rate (%)
timeFrame: Month: 2
Secondary outcomes:
measure: Predictive factors of attempted inferior vena cava filters retrieval
timeFrame: Month: 2
measure: Adverse event of vena cava filters
timeFrame: Month: 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain Grange, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03870425: Distribution of Nutrient Derived Amino Acids
Official title: Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Mass
Protein Intake
Diet Modification
Protein Synthesis
Protein Breakdown
Sarcopenia
Keywords: Dietary protein
Sarcopenia
Protein turnover
Muscle protein
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled
Primary purpose: PREVENTION

Brief summary: The project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Between 65-80 years of age

Exclusion Criteria:

* BMI above 30
* Smokers
* Vegetarians
* Diabetes or other metabolic diseases
* Medical treatment which affects protein turnover
* Gastro-intestinal diseases, reduced kidney or liver function, or chronic inflammation diseases
* Elevated blood-pressure or signs of atherosclerosis
* More than 5 hours of regular exercise each week

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 3 days
measure: Net protein balance
timeFrame: 10 hours
Secondary outcomes:
measure: D5-phenylalanine incorporation
timeFrame: 3 days
measure: Muscle protein synthesis
timeFrame: 10 hours
measure: Protein synthesis
timeFrame: 10 hours
measure: Protein breakdown
timeFrame: 10 hours
measure: Phenylalanine oxidation
timeFrame: 10 hours
measure: D5-phenylalanine appearance
timeFrame: 12 hours
measure: Signaling pathways in skeletal muscle
timeFrame: 10 hours
measure: Plasma insulin
timeFrame: 12 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
References:
Clinical trial NCT00125125: Fluvastatin in Adults With Dislipidemia With History of Muscle Problems
Official title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Dyslipidemia, adults, fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-29
Enrollment: 218
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 the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Eligibility criteria: Inclusion Criteria:

* Dyslipidemia
* History of Myalgia

Exclusion Criteria:

* Previous treatment with fluvastatin
* Age \< 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary outcomes:
measure: Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation
measure: Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks
measure: Number of patients who reach target LDL after 12 weeks
measure: Change from baseline in marker of inflammation after 12 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Stein EA, Ballantyne CM, Windler E, Sirnes PA, Sussekov A, Yigit Z, Seper C, Gimpelewicz CR. Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol. 2008 Feb 15;101(4):490-6. doi: 10.1016/j.amjcard.2007.09.099. Epub 2007 Dec 20.
Clinical trial NCT00414622: GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
Official title: A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer
Probable Alzheimer disease
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Detailed description: A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Eligibility criteria: Inclusion Criteria:

* probable Alzheimer

Exclusion Criteria:

* others

Primary outcomes:
measure: CDR
Secondary outcomes:
measure: ADAS-cog
Other outcomes:
Locations:
city: 280 South San Francisco
country: United States
facility: Clinical Dept.
state: California
Study officials:
affiliation: CoMentis
name: Henry Hsu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00466622: Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
Official title: Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
pregnancy
metformin
blood flow
Pulsatility index
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2007-04-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: FlowMet study is a "sub-study" of the PregMet study (registered in 2005).

The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13:

1. before and 3h after the first tablet intake of metformin/placebo
2. and 10-14 days after inclusion in the trial
3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.


Eligibility criteria: Inclusion Criteria:

* Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate.

Exclusion Criteria:

* Same as in the PregMet study

Primary outcomes:
measure: Pulsatility index of the uterine artery
timeFrame: up to delivery
Secondary outcomes:
measure: Blood flow in the umbilical artery and fetal cerebral artery
timeFrame: 24 weeks gestational
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eszter Vanky, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stridsklev S, Carlsen SM, Salvesen O, Clemens I, Vanky E. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial. J Clin Endocrinol Metab. 2014 Mar;99(3):972-7. doi: 10.1210/jc.2013-3227. Epub 2014 Jan 1.
citation: Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
Clinical trial NCT06685822: Expanding Autism Diagnostic Biomarkers to Kenya
Official title: Expanding Autism Diagnostic Biomarkers to Kenya
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2024-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

Detailed description: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. The investigators will recruit children from Moi Teaching and Referral Hospital (MTRH; Eldoret, Kenya) previously enrolled in the Health Equity Advancing through Learning Health Systems Research (HEAL-R) Autism at MTRH study (IREC/664/2023, approval number 0004633)

Eligibility criteria: Inclusion Criteria:

* Children enrolled in the HEAL-R Autism at MTRH study
* Children ages 14-72 months
* Caregivers of children must speak Kiswahili (local language) or English.

Exclusion Criteria:

* Children not enrolled in the HEAL-R Autism at MTRH study
* Children younger than 14 months or older than 72 months
* Caregivers of children do not speak Kiswahili (local language) or English.

Primary outcomes:
measure: Agreement between eye-tracking biomarker score and autism diagnosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
affiliation: Purdue University
name: Brandon Keehn, PhD
role: PRINCIPAL_INVESTIGATOR
References: