linjc16/ctgov huggingface dataset:
Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)

Study Overview
=================
Brief Summary
-----------------
Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Social and work obligation can, therefore, suppress sleep time. Sleep deprived individuals may be facing anxiety and depression symptoms. The aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application Onar. Onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/ HADS) will be used to quantify and detect the presence of anxiety and depression in the study population.

Official Title
-----------------
Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)

Conditions
-----------------
Sleep Deprivation, Sleep Hygiene, Sleepiness, Sleep Driving, Depression, Anxiety, Anxiety Disorders, Depressive Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acceptance of terms of use of the application must be done prior to participation in the study. Male and female adults aged ≥18 years old and ≤60 years old. Subjects using the application on a daily basis for at least 1 week prior to participation. Exclusion Criteria: History of alcohol or other substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the existence of depression and anxiety symptoms in the study population. | Comparison of HADS score with population standardized mean value. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of depression and anxiety symptoms with Total sleep time (TST). | Total sleep time (TST). | 2 weeks | 
| Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO). | Wake after sleep onset time (WASO). | 2 weeks | 
| Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL). | Sleep Onset Latency (SOL). | 2 weeks | 
| Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS). | Epworth Sleepiness Scale (ESS). | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smartphone, wearables, app, sleep, anxiety, depression
Patient Perspectives in Mantle Cell Lymphoma Clinical Research

Study Overview
=================
Brief Summary
-----------------
Clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. These trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their broad utilization. This particular study stands out as it centers on the firsthand experiences of individuals battling mantle cell lymphoma who are actively engaged in a clinical trial featuring medicinal interventions. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this patient group.

Official Title
-----------------
Exploring Patient Engagement Patterns and Participation Trends in Mantle Cell Lymphoma Clinical Trials

Conditions
-----------------
Mantle Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of mantle cell lymphoma No serious medical or psychiatric illness likely to interfere with participation in this clinical study. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Concurrent participation in another therapeutic clinical trial. Subject has an uncontrolled infection Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who decide to enroll in a mantle cell lymphoma clinical study |  | 3 months | 
| Rate of patients who remain in a mantle cell lymphoma clinical study to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mantle cell lymphoma
Asymmetric Movement of the Diaphragm

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the movement of the right hemidiaphragm when lifting a load with the left and right hand.

Detailed Description
-----------------
Hemidiaphragm movement will be assessed by m-mode ultrasonography in a standing position. The study will include 30-40 healthy adult volunteers. The examination will consist of two tidal inspirations and expirations, two inspirations and expirations during lifting the kettlebell with the left hand and two inspirations and expirations during lifting the kettlebell with the right hand. The weight of the kettlebell will correspond to about 10% of the participant's body weight.

Official Title
-----------------
The Effect of Asymmetric Postural Loading on the Movement of the Right Hemidiaphragm

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Able to comply with the study protocol, in the investigator's judgment Aged 18-40 years, inclusive Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination Waist-to-height ratio < 0,59 Exclusion Criteria: Low back pain (acute or chronic) Previous abdominal or spine surgery Acute or chronic respiratory or musculoskeletal disorder Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemidiaphragm movement | Distance of the diaphragm from the ultrasound transducer in millimeters during tidal breathing, and when lifting a load with the left and right hand. | 7 months |
Liquid Biopsy Collection Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a liquid biopsy approach for detection of circulating tumor cells (CTC) that could be used in place of the more invasive and potentially risky methods of tissue biopsy. The aims of the project are: (a) determine whether the Chaperonin-Containing TCP-1 (CCT) chaperonin can used to identify rare cancer cells in blood, and (b) establish whether the cancer cells detected using the CCT chaperonin for identification have invasive or metastatic potential.

Official Title
-----------------
Collection of Human Blood for Development of Liquid Biopsy Assay

Conditions
-----------------
CCT, Chaperonin-Containing TCP-1, Circulating Tumor Cells, CTC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age greater than or equal to 18 and less than or equal to 80 years. Exclusion Criteria: Adults unable to give informed consent Individuals who are not yet adults (infants, children, teenagers; under the age of 18) Individuals who weigh less than 110 lbs (as standard clinically advised to not give blood) Pregnant women (due to hormonal changes in blood) Prisoners Persons reporting a current microbial (bacterial, viral, or fungal) infections Persons reporting that they are current taking antibiotic medications Persons with body temperatures above 99oF (indicating a fever)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the CCT chaperonin can provide information on the metastatic potential of CTC. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
Security Efficacy COVID-19 Vaccination

Study Overview
=================
Brief Summary
-----------------
Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.

Detailed Description
-----------------
Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.

Official Title
-----------------
Studio Sierologico in Volontari Vaccinati Contro COVID-19

Conditions
-----------------
Autoimmune State, SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare workers undergoing SARS-CoV-2 vaccination Exclusion Criteria: Pregnancy Full blown autoimmune diseases Active vaccinations within 3 months before enrolment (excluding the influenza vaccine) Previous vaccination severe side effects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autoantibodies<br>Detection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG | Diagnostic Test: Blood sampling<br>* Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autoantibody Levels | ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG | Before vaccination and 1, 6 and 12 months after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Vaccine
Chronic Pain After Cardiothoracic Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

Detailed Description
-----------------
This is a prospective cohort study of all patients undergo cardiothoracic elective surgery in Cipto Mangunkusumo Hospital using general anesthesia. Patients with emergency surgery, history of psychologic and neurologic disease which cannot reliably state their pain score, cannot communicate well, and disagree to follow the research will be exempted. The pain score will be recorded one week after surgery during walk-in consultation, followed by 3 months and 6 months after surgery via telecommunication.

Official Title
-----------------
Chronic Pain After Cardiothoracic Surgery

Conditions
-----------------
Chronic Pain, Thoracic, Chronic Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergo elective sternotomy and/or thoracotomy using general anesthesia Patients agree to follow the study Exclusion Criteria: Patients undergo emergency sternotomy or thoracotomy Patients with pyschological and neurological disorder, that it is not reliable to determine the pain intensity Patients who cannot communicate Patients disagree to follow the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Pain score to assess pain intensity | 1 week after surgery | 
| Visual Analog Scale | Pain score to assess postoperative pain intensity | 3 months after surgery | 
| Visual Analog Scale | Pain score to assess postoperative pain intensity | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, thoracotomy, sternotomy, cardiothoracic surgery
Prenatal Nutrient Status Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to gather data on nutritional status from approximately 250 pregnant women who are currently taking a prenatal vitamin in order to better understand if the prenatal vitamins that most people use are providing enough nourishment during pregnancy. Participants will be asked to: complete an online survey schedule a blood draw for the Study Multivitamin Blood Test complete the blood draw visit complete a final survey at study end

Official Title
-----------------
Baseline Nutritional Status During Pregnancy

Conditions
-----------------
Pregnancy Related, Nutrient Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Speaks, reads, and understands English Lives in the United States Lives within a ZIP code from the metropolitan areas where mobile phlebotomists will be available for blood draws Assigned female sex at birth Currently within weeks 24-34 of pregnancy Currently taking a daily prenatal vitamin Exclusion Criteria: Birth sex other than female Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of sample deficient in each nutrient in pregnant women | Stratified by the type of prenatal vitamin they are taking at baseline (standard or Needed Prenatal Multivitamin). | Baseline |
Anxiety and Depression Among Gendarmes Posted to French Guiana

Study Overview
=================
Brief Summary
-----------------
This is a mixed-method, single-center study involving two concurrent phases: a quantitative phase with an anonymous self-administered questionnaires, and a qualitative phase with individual contextual interviews and a focus group. The hypothesis underlying this study is that isolated postings are a risk factor for anxiety-depressive disorders. The aim of this study is to provide new information to help propose targeted prevention and health promotion measures.

Official Title
-----------------
Anxiety and Depression Among Gendarmes Posted to French Guiana (TAD-GENDGF)

Conditions
-----------------
Anxiety Depression Disorder

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gendarme in active position Age over 18 Assignment in French Guiana for more than 6 months at the time of the study Not opting for study participation Exclusion Criteria: Previously diagnosed psychiatric condition People with a reading/writing disability in the French language Major incapacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|Anonymous self-administered questionnaire|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anxiety-depressive disorders according to posting site. | Comparison of the prevalence of anxiety-depressive disorders among gendarmes posted to French Guiana according to their posting site. | Through study completion (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with the presence of an anxiety-depressive disorder | Evaluate factors associated with the presence of an anxiety-depressive disorder, both overall and by type of disorder | Through study completion (6 months) |
METabolism After Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
This prospective observational study evaluates changes in resting basal metabolic rate in 51 adult patients undergoing elective major orthopedic surgery (hip, knee, or spine surgery).

Official Title
-----------------
Study of Energy Metabolism Modifications in Patients Undergoing Orthopedic Surgery

Conditions
-----------------
Orthopedic Disorder, Metabolism and Nutrition Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥55 Male and female gender Major elective orthopedic surgery (hip, knee, spinal) Signature of the informed consent Exclusion Criteria: Inability to follow the study protocol Neuropsychiatric disease, developmental disorders

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in basal energy expenditure | Changes in the basal metabolic rate (kcal) evaluated before and after major orthopedic surgery | Day before surgery and first day after surgery |
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Official Title
-----------------
Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

Conditions
-----------------
OSA

Intervention / Treatment
-----------------
* Drug: AD109
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age at the time of informed consent. PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15 PROMIS-Fatigue: raw score ≥17 PAP intolerance or current PAP refusal. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive. Exclusion Criteria: Narcolepsy, restless leg syndrome, REM sleep behavior disorder Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD109<br>AD109 | Drug: AD109<br>* Oral administration at bedtime<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral administration at bedtime<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AD109 on airway obstruction in mild to sever OSA | Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea