louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03545828: Multi-channel aEEG in Cardiac Arrest Patients With Targeted Temperature Management
Official title: Neurological Prognostication Using Multi-channel Amplitude-integrated Electroencephalographic Monitoring in Cardiac Arrest Patients With Targeted Temperature Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Arrest
Targeted Temperature Management
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TTM treated cardiac arrest patients

Brief summary: This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Relation of aEEG in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (ROSC) will be evaluated.

Detailed description: Normal trace was defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.

Eligibility criteria: Inclusion Criteria:

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion Criteria:

Cerebral origin cardiac arrest Known epilepsy

Primary outcomes:
measure: Time to normal trace in each aEEG channel
timeFrame: at day 180
Secondary outcomes:
measure: TTNT threshold for neurologic prognostication in each aEEG channel
timeFrame: at day 180
measure: Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)
timeFrame: at day 180
measure: Comparison of prognostic value between aEEG and various predictors
timeFrame: at day 180
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sang Hoon Oh
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627028: Thai Traditional Massage Increases Biochemical Marker of Bone Formation in Postmenopausal Women
Official title: Thai Traditional Massage Increases Biochemical Marker of Bone Formation in Postmenopausal Women: a Randomized Crossover Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Thai traditional massage
Bone formation
Bone resorption
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sampling

Brief summary: To investigate the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women

EXclusion Criteria:

* History of hyperthyroidism, thyrotoxicosis, diabetes, rheumatoid arthritis and cancer
* glucocorticoid or medication for osteoporosis
* Swelling joints

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
References:
citation: Saetung S, Chailurkit LO, Ongphiphadhanakul B. Thai traditional massage increases biochemical markers of bone formation in postmenopausal women: a randomized crossover trial. BMC Complement Altern Med. 2013 Mar 25;13:69. doi: 10.1186/1472-6882-13-69.
Clinical trial NCT06048328: Game Changers for Family Planning Peer Advocacy Program
Official title: Pilot of a Peer Advocacy Training Intervention to Reduce Unmet Need for Contraception in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Family Planning
Keywords: contraception
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2023-09-21
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel randomized controlled trial, with individual randomization to receive the intervention or wait-list control
Primary purpose: PREVENTION

Brief summary: This study will adapt the Game Changers peer advocacy training model for family planning context and pilot test the feasibility, acceptability and preliminary efficacy of the intervention to empower female contraception users to advocate for contraception use among women in their social networks who have unmet need for contraception.

Detailed description: The investigators will conduct a pilot RCT of Game Changers for Family Planning (GC-FP) with 40 female modern contraceptive (MC) users (index participants) at one rural public clinic, with 20 randomly assigned to receive the intervention (in 2 groups of 10) and 20 to the wait-list control; enrollment and randomization will be stratified by age and relationship status. Each index will recruit up to 3 social network members (alters) with unmet need for MC (max. total=120). Data will be collected at baseline and month 6 from all participants; primary outcome is alter MC use at month 6.

Eligibility criteria: Index participants:

Inclusion Criteria:

* MC user for past year

Social network member participant:

Inclusion Criteria:

* Not using MC, but reports trying to prevent pregnancy
* Know about the MC use of their referring index participant

Primary outcomes:
measure: Rate of use of modern contraceptives (social network participants)
timeFrame: 6 months
Secondary outcomes:
measure: Mean level of engagement in family planning advocacy (index participants)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: RAND
name: Glenn Wagner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688428: Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
Official title: A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcers
Upper GI Symptoms
Keywords: esomeprazole
upper gi symptoms
low dose Aspirin treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet


Eligibility criteria: Inclusion Criteria:

* Body mass index of 19-29kg/m2, inclusive
* Weight of 50-95kg, inclusive
* Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion Criteria:

* Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
* History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
* Condition which could modify the absorption of the investigational products, as judged by the Investigator

Primary outcomes:
measure: Samples for measurement of esomeprazole, ASA, and SA concentrations
timeFrame: Day 1 of each period
Secondary outcomes:
measure: Fasting blood samples for determination of clinical chemistry and hematology parameters
timeFrame: screening and follow up visit
measure: urine samples for urinalysis parameters
timeFrame: screening, Period 1, and follow-up visit
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Jörgen Naesdal, M.D.
role: STUDY_DIRECTOR
affiliation: Biokinetics Clinical Applications
name: Christopher Billings ., D.O
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03626428: Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study
Official title: Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Back Surgery Syndrome
Keywords: EEG
fMRI
correlation clinical data
effective connectivity
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Failed Back Surgery Syndrome, treated with spinal cord stimulation.

Brief summary: In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation.

In separate studies, fMRI and EEG recordings were made in resting state conditions on two time points. The fMRI assessments and EEG recordings were performed before the SCS implantation (baseline) and repeated around 3 months after the definitive SCS implantation. During both assessments, patients were asked to fill in a VAS diary for their leg and back pain (scores from 0 to 10).

The aim of the current retrospective study is to correlate the clinical data obtained from the VAS scores, with estimates of effective connectivity (obtained from fMRI and EEG). Effective connectivity will be calculated by using dynamic causal modeling (DCM) on the baseline data and the data obtained 3 months after SCS. The aim is to evaluate whether DCM data of EEG is equally/worse/better correlating with the clinical data as DCM data of fMRI.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old.
2. Diagnosis of FBSS with predominant leg pain (VAS) \> 5) and non-dominant back pain.
3. Cognitive and language functioning enabling coherent communication between the examiner and the subject;
4. Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
5. Stable neurologic function in the past 30 days
6. Subject is included in the previous studies and both EEG and fMRI data are available.

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
2. Subjects currently has an active infection

Primary outcomes:
measure: Correlation pain intensity scores with estimates of effective connectivity
timeFrame: The change between baseline and 3 months after the definitive implantation of the neurostimulator
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References:
Clinical trial NCT03072628: E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
Official title: The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: nicotine
sympathetic nerve activity
oxidative stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Detailed description: Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus

Primary outcomes:
measure: Flow Mediated dilatation (FMD)
timeFrame: 10 minutes after exposure
measure: Heart rate variability (HRV)
timeFrame: 10 minutes after exposure
Secondary outcomes:
measure: Paraoxonase (PON)
timeFrame: ~30 minutes after exposure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
References:
Clinical trial NCT03939728: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit
Official title: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric Lung Ultrasound
Pediatric Chest Radiography
Pediatric Lung Diagnosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in pediatric intensive care unit, under 18 years old, which has, during his stay, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.

Brief summary: In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.

However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.

On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.

We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.


Eligibility criteria: Inclusion criteria:

* Age under 18 years
* Patient in pediatric intensive care unit
* Patient registered with a social security scheme
* Agreement of the persons entitled to give parental authority over minor
* Patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.

Exclusion criteria:

- Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study

Primary outcomes:
measure: Kappa-measure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02908828: Calanus Oil Supplementation and Maximal Oxygen Uptake
Official title: Effect of Copepod Oil Supplementation (Calanus Finmarchicus) on Endurance and VO2max in Healthy Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Biological Products/therapeutic use
Copepoda
Dietary Supplements
Fish Oils
Fatty Acids, Omega-3
Oxygen Consumption
Calanus
Maximal oxygen uptake
Zooplankton
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: Calanus
First posted: 2016-09-21
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton species in the marine food web in the Norwegian Sea. Copepods constitute the largest renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now developed knowledge and technology for sustainable harvesting of this "new" resource. The purpose of this study is to investigate whether Calanus copepod oil supplementation has an equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in mice.


Eligibility criteria: Inclusion Criteria:

* in good health
* Body mass index (BMI) between 18,5 and 29,9

Exclusion Criteria:

* Medical condition limiting VO2max (COPD or asthma).
* diagnosed coronary artery disease
* Any other significant medical condition
* medication effecting exercise capacity (e.i. betablockers)
* Pregnancy
* Participation in other clinical trials
* Shellfish allergies
* Systolic blood pressure \> 170 mmHG, or diastolic BP \> 105 mmHG.
* contraindications for maximal exercise testing

Primary outcomes:
measure: maximal oxygen uptake (VO2max)
timeFrame: 6 months
Secondary outcomes:
measure: Body composition (InBody, Japan)
timeFrame: 6 months
measure: Self-reported physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Institutt for Medisinsk Biologi, UiT Norges arktiske universitet
city: Trondheim
country: Norway
facility: KG Jebsen-senter for Hjertetrening, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, phd prof
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Trine Karlsen, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110928: Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 227
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.

Brief summary: This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).


Eligibility criteria: Inclusion Criteria:

* Participation in the GHLIQUID-1517 trial
* Patients with SGA (small for gestational age) short stature that are still growing

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Diabetes Mellitus
* Patients with malignant tumor(s)
* Pregnant or likely to get pregnant

Primary outcomes:
measure: Number and type of suspected serious adverse drug reactions (SADRs) during the study period
timeFrame: evaluated binannually for 9 years
Secondary outcomes:
measure: Number of glucose intolerance events during the study period
timeFrame: evaluated biannually for 9 years
measure: Adult height
timeFrame: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Toshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59
Clinical trial NCT00805428: Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Lead sponsor: Clinical Hospital Center, Split
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with UC and control group

Brief summary: Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17


Eligibility criteria: Inclusion Criteria:

* endoscopic confirmed diagnosis

Exclusion Criteria:

* corticosteroid or immunosuppressive therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Klinički bolnički centar Split
Study officials:
References: