louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00863577: Pharmacokinetic Study of Two Oral Bemiparin Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Rovi Pharmaceuticals Laboratories
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers: male or female subjects aged between 18 and 45 years
2. Body weight: 65-80 Kg
3. Not meaningful abnormalities in physical examination and in clinical history
4. Without evidence of significant organic or psychiatric illness
5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
8. Not give blood in the last 4 weeks.
9. Healthy male volunteers who have not received heparin in the past
10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
11. contraceptive methods double barrel or sterile surgery

Exclusion Criteria:

1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
2. Important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day
3. Allergy, idiosyncrasy or hypersensitivity to medicines
4. Healthy volunteers who are receiving another medication in the past 15 days
5. Positive serology of hepatitis B, C or HIV
6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
7. Mayor Surgery in the last 6 months
8. Smoking \> 10 cigarettes / day
9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
10. Healthy volunteers with a familiar history evident hemorrhagic episodes
11. positive fecatest and comburtest
12. positive pregnant test
13. Bemiparin contraindication

Primary outcomes:
measure: The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity
timeFrame: pre-medication, +1 h , +2 h, +3h, +4 h , +5h, +6 h, +8 h, +10h, +12h, +18 h, +24 h,+25h, +26h, +27h, +28h, +29h, +30h, +32h, +34h, +36h, +42h, +48 h, +60 h and +72 h
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT03901677: Tai Chi Exercise on Balance and Awereeness
Official title: Effects of Tai Chi Exercise on Balance and Body Awareness of Younger Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Young Adult
Keywords: exercise
Awareness
posture
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of Tai chi exercises on balance and body awareness in younger adults. Forty-two healthy subjects between the ages of 18-25 who do not have any restriction to exercise participate in our study. After recording the sociodemographic characteristics of the subjects, static and dynamic balance and body awareness will be evaluated. Kinesthetic Ability Trainer will be used to assess static and dynamic balance and body awareness will be evulated with Body Awareness Questionnaire. All assessments will be done before and 12 weeks after the tai chi exercise. Tai-chi training will be performed as a group exercise. Duration for tai chi exercise will be 60 minutes for 2 days per week totally 12 weeks.

Detailed description: Tai-chi training was performed as a group exercise. Duration for tai chi exercise was 60 minutes for 2 days per week for 12 weeks. Each session includes 10 min warm-up and cool-down and 40 min Tai Chi exercises. During exercises, attention was paid to correct positioning of the upper and lower extremity joints, and mentally concentration was achieved. Slow and controlled movements were carried out by a specialized physiotherapist

Eligibility criteria: Inclusion Criteria:

1. Subjects between the ages of 18-25,
2. Subjects who had lack of disease.

Exclusion Criteria:

1. Subjects with neurological symptoms,
2. Subjects with orthopedic problems,
3. Subjects with heart failure,
4. Subjects with respiratory distress.

Primary outcomes:
measure: Body Awareness Questionnaire
timeFrame: 12 week
Secondary outcomes:
measure: Balance Test
timeFrame: 12 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University
name: ayca tigli, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05733377: Non-invasive Imaging Technique for the Study of Lordosis in Pregnant Women and Its Relationship to Birth Outcome
Official title: Validation of a Non-invasive Image Technique for Studying Pregnant Women´s Lordosis. Relation Between Lordosis and Childbirth Outcome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Outcome
Biomechanics
Back Disorder
Diagnostic Imaging
Biomedical Technology
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Fuenlabrada
First posted: 2023-02-17
Enrollment: 122
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women are being monitored by the Fuenlabrada Hospital.

Brief summary: The study consists of collecting measurement data of the rachis in pregnant women and the subsequent outcome of her delivery.

This will make it possible to validate a non-invasive imaging technique through software that can be used to study this anatomical curve proposing a new measurement method for the angle of lordosis.

Finally, with the research data, the investigators will try to find a correlation between these variables (angle of lordosis and delivery outcome.


Eligibility criteria: Inclusion Criteria:

* pregnant women between 20 and 40 years old with a low-risk pregnancy

Exclusion Criteria:

* Pregnant women under 20 years and over 40 years of age or with a significant lumbar pathology or with a very high-risk pregnancy or with IMC \>35

Primary outcomes:
measure: Lordosis angle using an app
timeFrame: 2025
Secondary outcomes:
measure: Lordosis angle by means of arrow test
timeFrame: 2025
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
References:
Clinical trial NCT02860377: Maternal Voice on Anesthetic Emergence Period
Official title: Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: emergence agitation
emergence time
pediatric
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive an operation under general anesthesia

Exclusion Criteria:

* ASA PS III or IV
* with developmental delay or neurological diseases associated with symptoms of agitation
* refusal of consent
* with developmental delay
* with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)

Primary outcomes:
measure: Emergence time
timeFrame: During 1 hour after operation
measure: Incidence of emergence delirium (ED)
timeFrame: During 30 minutes after PACU admission
Secondary outcomes:
measure: peak PAED scale
timeFrame: During 30 minutes after PACU admission
measure: peak Watcha scale
timeFrame: During 30 minutes after PACU admission
measure: eye opening or purposeful movement time
timeFrame: During 1 hour after operation
measure: BIS over 60
timeFrame: During 1 hour after operation
Other outcomes:
measure: peak FLACC score
timeFrame: During 30 minutes after PACU admission
measure: The amount of analgesic/anesthetic consumption at PACU/ward
timeFrame: During 1 hour at PACU
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Eugene Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02236377: Dismantling Exposure, Relaxation, and Rescripting Therapy
Official title: Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frequent Trauma-related Nightmares
Keywords: ERRT
Nightmares
Sleep
Trauma
PTSD
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this case series dismantling study is to extend previous findings regarding the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose effect and mechanism of change.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis \& Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, \& Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, \& Favorite, 2011).

Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to conduct a set of case series in order to examine the possible mechanisms: psycho-education, dose response for exposure, and no exposure components of the treatment. Each part of the treatment is theorized to contribute to the improved treatment outcome and it is hypothesized that participants will benefit no matter what group they are in. All participants will receive 5 to 6 treatment sessions, conducted once per week for about 90 minutes, of a modified version of ERRT.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at the time of the intake,
* experienced a traumatic event, as defined by the Diagnostic and Statistical Manual (DSM-5),
* have approximately one nightmare each week for the past month
* be able to read and speak English.

Exclusion Criteria:

* age of 17 or younger
* acute or apparent psychosis
* unmedicated bipolar disorder
* intellectual disability
* active suicidality,
* recent parasuicidal behaviors
* untreated substance use disorder in past 6 months

Primary outcomes:
measure: Nightmare Frequency Past Week
timeFrame: up to 6 months followup
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Joanne L. Davis
state: Oklahoma
Study officials:
affiliation: University of Tulsa
name: Joanne L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.
Clinical trial NCT05786677: Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
Official title: Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Depression
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.

Detailed description: This study will investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.

Eligibility criteria: Inclusion Criteria:

1. Fibromyalgia patients will be included if they meet the diagnosis of FM according to the American College Rheumatology (ACR), diagnosed with depression and referred by a physician.
2. Patients diagnosed with mild and moderate forms of major depression.
3. Their ages range from 20- 60 years old.
4. Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.

Exclusion Criteria:

1. severe spinal injuries
2. severe musculoskeletal abnormalities
3. inflammatory rheumatic diseases
4. respiratory or cardiac pathologies
5. Any vestibular, visual or neurological dysfunction affecting balance.
6. History of suicidal attempts
7. Severe depression
8. Suffering from severe somatic or psychiatric disorders.

Primary outcomes:
measure: Assessing the change in severity of respondents' depression
timeFrame: at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physica therapy cairo university
Study officials:
affiliation: Cairo University
name: Mahitab Momen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316977: Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
Official title: Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Reproducibility of Results
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients, diagnosed with RA, referred for regular controls in the rheumatology clinic at Copenhagen University Hospital, Bispebjerg and Frederiksberg, will be screened via the database, DANBIO, for in- and exclusion criteria.

Brief summary: The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis.

The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home.

Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with RA ≥ 12 months
* DAS28-CRP \< 5,1
* Age between 18 and 85 years
* Computer and Internet connection at home

Exclusion Criteria:

* Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening
* Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening
* Blood samples (ALAT) outside the reference limit -/+ 100 % at screening
* Dementia or other linguistic/cognitive/physical deficiency that prevents participation
* Vision impairment that prevents the use of the devices and computer

Primary outcomes:
measure: ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness
timeFrame: Day 1,3,56 and 58
Secondary outcomes:
measure: Standford Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Day 1 and 56
measure: PainDetect Questionnaire (PDQ)
timeFrame: Day 1
Other outcomes:
measure: Disease Activity Score 28 (DAS28)
timeFrame: Day 1,3,56 and 58
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Study officials:
affiliation: The Parker Research Institute
name: Henning Bliddal, DMSci
role: STUDY_DIRECTOR
References:
Clinical trial NCT04422977: Serological Study of the Exposure of Personnel to COVID-19
Official title: Serological Study of the Exposure of Personnel to Sars-cov-2 in an Urban Hospital Two Months After Managing an Influx of COVID Patients 19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV2
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 957
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. The seroconversion test will be with a questionnaire to determine:

* whether the subject has shown signs of infection in the last 3 recent months
* if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or scanner) outside of the activity or within the professional activity (patient or colleague)
* Working conditions during the period
* The level of knowledge and respect of the barrier measures practices.
* Respect for distance during meals professional. Overall seroprevalence and stratified seroprevalence by care and administrative areas will be determined.


Eligibility criteria: Inclusion Criteria:

* Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave (male or female).

  * Free and informed consent
  * Social security affiliation

Exclusion Criteria:

* Subject refusal
* Subject on leave during the entire period

Primary outcomes:
measure: Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff with a seroconversion test for SARS-Cov-2
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier St Joseph St Luc
Study officials:
References:
citation: Vivier E, Pariset C, Rio S, Armand S, Doroszewski F, Richard D, Chardon M, Romero G, Metral P, Pecquet M, Didelot A. Specific exposure of ICU staff to SARS-CoV-2 seropositivity: a wide seroprevalence study in a French city-center hospital. Ann Intensive Care. 2021 May 13;11(1):75. doi: 10.1186/s13613-021-00868-8.
Clinical trial NCT01599377: Tofacitinib Bioequivalence Study Comparing Tablets And Capsules
Official title: Phase 1, Open-Label, Randomized, Single-Dose, Cross-Over, Bioequivalence Study Comparing Tablets (5 And 10 Mg) And Capsules (5 And 10 Mg) Of Tofacitinib Under Fasted Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Primary outcomes:
measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )
timeFrame: 24 hours
measure: Maximum plasma concentration (Cmax)
timeFrame: 24 hours
Secondary outcomes:
measure: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: 24 hours
measure: Time for Cmax (Tmax)
timeFrame: 24 hours
measure: Terminal elimination half-life (t½)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: