louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02801318: Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium Symptoms
Keywords: Patient
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.


Eligibility criteria: Inclusion Criteria:

* Patients who had a cardiac surgery with extracorporeal circulation.
* Patients who were extubated at Day 0.
* Patients without any operation or anesthetic complication.
* Patients who speak French.
* Patients without TNC at Day 1.
* Patients who had completed the questionnaires before operation.

Exclusion Criteria:

* Age \< 18 years old.
* Delirium at Day 1.
* Central nervous system pathology or psychiatric pathology known and treated.
* Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep.
* Clinical condition alteration before polysomnography exam.
* Continue sedation required before Day 3 polysomnography exam.
* Agitation or clinical alteration that did not allow Day 3 polysomnography exam.

Primary outcomes:
measure: significant difference of REM sleep quantity in polysomnography at day 3
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05042518: Psychological Skill Training for Athletes
Official title: The Effectiveness of Psychological Skill Training on Quantitative Electroencephalogram (EEG) in Athletes Before the Competition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Conditions
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigator will determine the effectiveness of psychological skill training on quantitative EEG in athletes before the competition.

Detailed description: Psychological skills training is the mental training that can apply for increased athletes' performance to make athletes more confident. The objective of psychological skill training is to develop the potential of athletes to be able to show their abilities (Peak Performance), and to create satisfaction, self-esteem, for athletes. Additionally, the ability to concentrate and reduce anxiety could affect athletes' emotions and be ready to participate in the competition. Therefore, this study will apply psychological skills training for athletes. The effectiveness of psychological skill training will be measured by using quantitative EEG before and after training. The quantitative EEG assessments could demonstrate an anxiety level at different stages of the competition and it could reveal the changes caused by training. The intervention will begin 3 months before the competition. The quantitative EEG measurements are arranged 4-5 times following the previous study. The sequence of the measurement will be including a baseline: one month before the competition, two weeks before the competition, a week before the match, three days before the match (depend on the situation), three days after the match (post-training).

Eligibility criteria: Inclusion Criteria:

* Athletes male or female
* Age between 18-35

Exclusion Criteria:

* Having an acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months

Primary outcomes:
measure: ฺBrain wave
timeFrame: Through study completion, an average of 5 weeks
Secondary outcomes:
measure: Revised Competitive State Anxiety Inventory: CSAI - 2R
timeFrame: Through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Mahidol University
state: Nakhonprathom
Study officials:
affiliation: College of sports science and technology, Mahidol University, Thailand
name: Kittichai Tharawadeepimuk, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04493918: Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
Official title: Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Tuberculosis
Mesenchymal Stem Cell
Keywords: Mycobacterium tuberculosis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc

Detailed description: Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone.

In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area.

Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.

Eligibility criteria: Inclusion Criteria:

* Clinicoradiologically diagnoses Spinal Tuberculosis
* receives Anti TB drugs
* minimun destruction 1/3 vertebral body

Exclusion Criteria:

* patient under 15 years old
* reject to be included in the study

Primary outcomes:
measure: Vertebral bony fusion
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT00606918: Validation of a New Device to Measure Neuromuscular Disease Progression
Official title: Validation of a New Device to Measure Neuromuscular Disease Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders
Keywords: Strength testing
Disease progression
ALS
Healthy Adults
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with ALS

Brief summary: There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human subjects more efficiently. If we could more precisely measure whether an experimental drug slows the progression of ALS or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. This study will enable us to test the reliability and validity of ATLIS.


Eligibility criteria: Inclusion Criteria:

* All subjects must be at least 18 years old and able to provide informed consent
* All subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs.
* Subjects with a diagnosis of laboratory supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial, as determined by their referring neurologist at MGH.
* All subjects must be able to speak and understand English.

Exclusion Criteria:

* Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.

Primary outcomes:
measure: isometric strength measures
timeFrame: cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital - East
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Patricia L. Andres, MS, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06844318: Impact of IBD Activity on Frailty in Patients Over 60 Years
Official title: Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: IBD
Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 153
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.

Brief summary: The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.

The main questions it aims to answer are:

1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease?
2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.
* Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on PRO2 scales (UC: PRO \>4; CD: PRO2 \>14) and/or biological activity (fecal calprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).
* Signed informed consent for inclusion.

Exclusion Criteria:

* Lack or withdrawal of informed consent.
* Unclassified/indeterminate colitis.
* Change in medical treatment solely due to adverse events.
* Initiation of treatment only with salicylates and/or topical steroids for disease activity.
* Treatment intensification to manage disease activity.
* Patients with an ostomy.
* Comorbidities with a life expectancy of less than one year.

Primary outcomes:
measure: To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.
timeFrame: 12 months
measure: To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03416218: Prognosis--A Game-Based Intervention to Improve STEM Skills
Official title: Prognosis--A Game-Based Intervention to Improve STEM Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: STEM Skills
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants enrolled in the study will play Prognosis, a game-based intervention designed to improve STEM skills.
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate a game-based intervention (Prognosis) designed to improve science, technology, engineering, and mathematics (STEM) skills among high school-aged students.

Detailed description: The purpose of this study is to evaluate the usability, feasibility, and acceptability of a game-based intervention (Prognosis) designed to improve science, technology, engineering, and mathematics (STEM) skills among high school-aged students. The research questions are as follows:

H1: Students will find Prognosis usable, feasible, and acceptable and recommend continued development and testing of Prognosis.

H2: After playing Prognosis, students will be able to perform basic quantitative data skills such as calculating incidence and prevalence.

H3: After playing Prognosis, students will be able to observe patterns in data at the neighborhood and city level.

H4: After playing Prognosis, students will be able to construct explanations and models describing the organization of systems in the game and how they contribute to health outcomes.

H5: After playing Prognosis, students will be able to formulate and test hypotheses for how to best coordinate various city systems and leverage finite resources to reach their target health goal.

Eligibility criteria: Inclusion Criteria:

* Enrolled in study site high school
* 9th or 10th grade at time of study

Exclusion Criteria:

* Students not in 9th and 10th grade

Primary outcomes:
measure: Acceptability of the game-based intervention Prognosis as assessed by participants
timeFrame: immediately after completing the intervention
measure: Feasibility of the game-based intervention Prognosis
timeFrame: immediately after completing the intervention
measure: Usability of the game-based intervention Prognosis
timeFrame: immediately after completing the intervention
Secondary outcomes:
measure: Assessing participants' ability to solve quantitative epidemiological problems
timeFrame: immediately after completing the intervention
measure: Perceived self-efficacy to learn STEM concepts
timeFrame: immediately after completing the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Melissa Gilliam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320913: Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Official title: Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty, Postoperative Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in primary total hip arthroplasty. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare PENG and PMDI block with isolated PMDI block in patients undergoing total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness

Primary outcomes:
measure: Numeric rating scale pain score
timeFrame: at 24 hours postoperatively
Secondary outcomes:
measure: Pain score measured at 6 hours postoperatively and 48 hours postoperatively
timeFrame: Pain score measured at 6 hours postoperatively and 48 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of orthopaedic surgery, Yonsei University College of Medicine
name: Kwankyu Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473613: Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
Official title: Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Hyperstimulation
Keywords: Calcium infusion
Cabergoline
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 230
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: Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention

Detailed description: Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Eligibility criteria: Inclusion Criteria:

* women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin

Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes

-

Primary outcomes:
measure: Occurrence of ovarian hyperstimuation syndrome
timeFrame: 20 days from ovum pick up day
Secondary outcomes:
measure: Types of ovarian hyperstimuation syndrome and severity
timeFrame: 20 days from ovum pick up day
measure: Chemical pregnancy
timeFrame: 14 day from embryos transfer day
measure: Clinical pregnancy
timeFrame: 5 week from embryos transfer day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ashraf nassif Elmantwe
state: Elqalopia
Study officials:
affiliation: Benha University
name: Ashraf N Elmantwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531713: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
Official title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Depression
Keywords: hypothyroidism, quality og life, depression
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

Detailed description: double blind randomized cross-over study.

Eligibility criteria: Inclusion Criteria:

* Hypothyroidism, S-TSH\> 20 at diagnosis,Anti-TPO \>300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

* \<18 år
* \>75 år
* pregnant women
* Thyroid cancer
* T3 treatment
* Post-partum thyroiditis

Primary outcomes:
measure: Selv-rating scales: SF-36, SCL -90-R, BDI
timeFrame: 3 month treating
Secondary outcomes:
measure: BMI, bioimpedance
timeFrame: 3 month treament
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept of endocrinology , Herlev Hospital
Study officials:
affiliation: Herlev Trials
name: Birte Nygaard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823913: Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
Secondary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kim Y, Son M, Lee D, Roh H, Son H, Chae D, Bahng MY, Park K. Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study. Clin Ther. 2013 Jul;35(7):934-40. doi: 10.1016/j.clinthera.2013.05.021.