louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02738307: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Global Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Keywords: High Altitude
Attention
Cognitive Function
Acclimatization
Sleep
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-04-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on global cognitive function.

Detailed description: Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria: Inclusion Criteria:

* born, raised and currently living \<1300m
* No overnight stays at altitudes \>1500m 4 weeks before the study

Exclusion Criteria:

* previous altitude intolerance \<3000m
* pregnancy
* health impairment, which requires regular treatment

Primary outcomes:
measure: Change in global cognitive function assessed by neuropsychological test battery
timeFrame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Secondary outcomes:
measure: Change in cognitive subdomains (visual memory, executive function, working memory and planning, attention, semantic/verbal memory, decision-making and response control) assessed by neuropsychological test battery
timeFrame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
measure: Change in oxidative stress measured by venous blood sampling
timeFrame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Marc J Poulin, PhD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423407: Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)
Official title: Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: PET/CT
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at Washington University School of Medicine

Brief summary: The purpose of this research proposal is to establish a mechanism to develop tools that will allow the investigators to measure the impact of magnetic resonance (MR) acquisition correction sequences for attenuation correction on positron emission tomography (PET) quantitation accuracy.


Eligibility criteria: Inclusion Criteria:

* Participant must be ≥ 18 years of age
* Participant can be a male or a non-pregnant female.
* Successful completion of MRI screening form
* Participant must have undergone a PET/CT examination with injection of a standard dose of 18F-fluorodeoxyglucose (FDG) or other PET tracer with a half-life greater than one hour either for clinical or research purposes within 3 hrs of the proposed PET-MRI examination.
* Participant will be fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions

Exclusion Criteria:

* Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants)
* Women who are pregnant.
* Subjects who require sedation to participate will be excluded.
* Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary disease.

Primary outcomes:
measure: Measure the impact of MR acquisition correction sequences for attenuation correction on PET quantitation accuracy
timeFrame: At the time of the MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Richard Laforest, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668107: Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning
Official title: Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Premature, Diseases
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.

Detailed description: Randomized clinical trial, according to CONSORT standards, with newborn preterm gestational age \<34 weeks and birth weight \<1500 g, admitted to the intensive care unit. Newborns will be randomized. Those selected for the control group (CG) will be placed in the incubator following the service routine. Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. The evaluation of muscle activity will be carried out through surface electromyography. Evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.

Eligibility criteria: Inclusion Criteria:

* Preterm Infants with gestational age \<34 weeks
* Free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation
* Not in use of supplemental oxygen at the time of assessment

Exclusion Criteria:

* Apgar score of less than seven in the fifth minute
* Previous history of perintraventricular hemorrhage grade III and / or IV
* Congenital infection
* Congenital heart defects
* Neonatal Obstetric traumas
* Gastroesophageal Reflux Disease
* Genetic syndromes
* Congenital malformations
* Sepsis with meningitis
* Orthopedic and musculoskeletal alterations

Primary outcomes:
measure: Increase in Muscle activity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Professor Fernando Figueira
name: Isabel Eyre, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847807: The Organ Protection of Astragalus in Subjects With Metabolic Syndrome
Official title: The Cardiac and Kidney Protection of Astragalus in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Keywords: 5-10 gram astragalus per day
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In this study, prospective randomized, controlled, parallel designed ,different doses of Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time quantitative PCR and Western Blotting to detect the index of oxidative stress 、angiotensin-converting enzyme 2 mRNA expression and proteins.


Eligibility criteria: Inclusion Criteria:

1. age 18 years or older, meet the diagnostic criteria of MS
2. non-allergic with the astragalus
3. agree to conduct clinical trials and those who signed the informed consent

Exclusion Criteria:

1. patients with resistant hypertension
2. renal disease requiring dialysis
3. heart failure NYHA ⅢorⅣ;
4. complications of diabetes
5. arteritis
6. cancer
7. thyroid disease
8. unstable coronary heart disease
9. peripheral vascular disease
10. acute cerebral vascular disease11.pregnancy、 planned pregnancy
11. patients with anti-oxidants
12. acute infection
13. other organic dysfunction, such as the liver, respiratory system, blood system, and other rheumatic diseases.

Primary outcomes:
measure: index of cardiac function
timeFrame: one year
Secondary outcomes:
measure: blood pressure
timeFrame: one year
Other outcomes:
measure: kidney function
timeFrame: one year
measure: Central Blood Pressure
timeFrame: one year
measure: Ankle Brachial Index
timeFrame: one year
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
Study officials:
References:
Clinical trial NCT00002107: A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Official title: A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Interleukin-2
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed description: Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection by ELISA and Western blot.
* CD4 count \> 200 cells/mm3.

Required:

* FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Davies Med Ctr / c/o HIV Institute
state: California
Study officials:
References:
citation: Follansbee SE, Lacarrubba S, Fyfe G. Dose-ranging study of interleukin II (IL-2) in HIV-infected men on antiretroviral therapy (ARV). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 419)
Clinical trial NCT04178707: Anal Fistula and Microdialysis - What is Yet to Learn?
Official title: Intervention With Microdialysis Measurements in Anal Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: University Hospital, Umeå
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Microdialysis is used to investigate the inner enviorment of anal fistulas. The patient will be its own control with measurements at prior to intervention and after operative procedure.
Primary purpose: BASIC_SCIENCE

Brief summary: Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.

Detailed description: Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose.

The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* to be able to understand and accept the terms of study

Exclusion Criteria:

* age under 18
* dementia, language barrier

Primary outcomes:
measure: measurements of glucose in anal fistula using microdialysis
timeFrame: baseline measurement, 1 month follow up
Secondary outcomes:
measure: measurement of pyruvate in anal fistula using microdialysis
timeFrame: baseline measurement, 1 month follow up
Other outcomes:
measure: measurement of lactate in anal fistula using microdialysis
timeFrame: baseline measurement, 1 month follow up
Locations:
city: Umea
country: Sweden
facility: Umea University Hospital
state: Vasterbotten
Study officials:
affiliation: University Hospital, Umeå
name: Ulf Gunnarsson, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01170507: Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation
Official title: Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Vitamin D Deficiency
Keywords: vitamin D3, 25 OH vitamin D3 level
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.

The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.


Eligibility criteria: Inclusion Criteria:

* Adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
* Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.

Primary outcomes:
measure: Slope of 25 OH vitamin D3 level vs vitamin D3 dose
timeFrame: 5 months
Secondary outcomes:
measure: slope of vitamin D3 level vs vitamin D3 dose
timeFrame: 5 months
measure: incidence of hypercalcemia
timeFrame: 8 months
measure: incidence of hypercalciuria
timeFrame: 8 months
measure: slope of decline of 25 OH vitamin D3 level vs time
timeFrame: 3 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Muhammad M Hammami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05190107: Depression, Anxiety and Stress in High School
Official title: Prevalence of Depression, Anxiety and Stress in High School Students: A Survey Study in Western Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Stress
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2022-01-13
Enrollment: 3112
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents from 14 to 22 years old with an average age of 16 years are high school students.

Brief summary: Background: Social isolation secondary to the pandemic can predispose the population to mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety, depression, and stress in one questionnaire. In the last years, it has been observed effective in detecting these symptoms in teenagers.

Aims: Identify the prevalence of depression, anxiety, and stress in high school students during the COVID-19 pandemic This is an observational cross-sectional study.

For this study, the validated Spanish version of DASS-21 will be used. Qualitative variables will be evaluated through central tendencies, such as mean, standard deviation, and frequencies. The inferential analysis of categorical variables will be performed using the chi-squared test, analysis of variance (ANOVA), or Kruskal Wallis test as appropriate. For quantitative variables, Student's t-test or Mann Whitney U test will be performed depending on their distribution.


Eligibility criteria: Inclusion Criteria:

* Adolescents from 14 to 22 years old.
* That they voluntarily agree to participate, and consent.

Exclusion Criteria:

* Adolescents with depression, anxiety, and stress disorders previously detected
* Patients in psychiatric treatment for depression, anxiety, or stress.
* Participants who don´t consent to participate

Primary outcomes:
measure: Depression Score
timeFrame: Baseline
measure: Anxiety Score
timeFrame: Baseline
measure: Stress Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
References:
Clinical trial NCT04095507: Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes
Official title: Efficacy and Efficiency of Uterocervical Angle for Prediction of Labor Timing in Patients With Preterm Premature Rupture of the Membranes: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Labor
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: SCREENING

Brief summary: To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes


Eligibility criteria: Inclusion Criteria:

* no previous systemic illnesses
* Preterm Premature Rupture of the Membranes

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of loop electrosurgical excision procedure (LEEP) and cervical conization

Primary outcomes:
measure: prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes
timeFrame: 7 month]
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Traning and Research Hospital
Study officials:
References: