louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03964311: Risk for Short-term Adverse Events in Older Emergency Department Users
Official title: Risk for Short-term Adverse Events in Older Emergency Department Users: '' Emergency Room Evaluation and Recommendation '' Cohort Study Database
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older People
Health Care
Evaluations
Health Impairment
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the association between risk levels (i.e.; low, moderate and high) of Emergency Room Tool (ER2) and length of stay in older Emergency Room Tool (ER) users admitted to the medical or surgery wards of the Jewish General Hospital.

Detailed description: The Emergency Room Tool (ER2) assessment can be used by Emergency Department nurses taking care of older Emergency Department (ED) users on stretcher, and that ER2 moderate and high risk levels is associated with long length of stay in Emergency Department and hospital as well as hospital admissions.

Eligibility criteria: Inclusion Criteria:

* Being 75 years and over
* An unplanned Emergency Department visit and to be on a stretcher.

Exclusion Criteria:

-Being 74 years and less

Primary outcomes:
measure: Short-term adverse events
timeFrame: In around 30 days
Secondary outcomes:
measure: Usability of assessment tool
timeFrame: 24 hours in Emergency
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Launay CP, Galery K, Vilcocq C, Afilalo M, Beauchet O. Risk for short-term undesirable outcomes in older emergency department users: Results of the ER2 observational cohort study. PLoS One. 2021 Aug 11;16(8):e0249882. doi: 10.1371/journal.pone.0249882. eCollection 2021.
Clinical trial NCT01040611: Effectiveness of Music Therapy
Official title: Effectiveness of Music Therapy on Anxiety, Depression and Physiological Responses for Inpatients of Tuberculosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: music therapy
Tuberculosis
anxiety
physiological response
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long period, admission to negative pressure isolation wards, and restrictions on visitors. During the in-patient admission, patients are vulnerable to social isolation and separation anxiety. If anxiety sustained, patients' quality of life would be affected. Thus, it is important to improve patients' experience of anxiety. Music has the effectiveness of relaxation, and is helpful to patients' anxious status and physiological responses. This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.

Detailed description: The experimental study was conducted on a medical center of North Taiwan. 66 patients with Tuberculosis were included in this study. Patients who fit the inclusion criteria were randomly assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days.

Eligibility criteria: Inclusion Criteria:

1. Patient with TB (including patient with drug resistent).
2. Age between 18\~65.
3. Conscious Patient without psychiatric/psychological disorders .
4. Patient without Visual, audio disorder.
5. Patient who is able to understand, speak Mandarin and/or Taiwanese, and is able to communicate with written or oral.

Exclusion Criteria:

1. Medical history of psychiatric/psychologic disorder, medication history of anti-anxiety or anti-depressant which might affect mental status.
2. Patient with Visual, audio disorder.
3. Patient who is not comply with 5 day music therapy.

Primary outcomes:
measure: Effectiveness of music therapy on anxiety, depression and physiological responses
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University -WanFang Hospital
Study officials:
References:
Clinical trial NCT03925311: Transcriptome Profiling and Endometrial Receptivity
Official title: Transcriptome Profiling and Immune/ Biochemical Markers of Peripheral Blood to Predict Endometrial Receptivity and Successful Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Keywords: Transcriptome
endometrial receptivity
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Prince of Wales Hospital.

Brief summary: The aim of this study is to correlate and identify the biochemical markers which may reflect WOI. Blood samples will be collected and endometrial biopsy will be performed at particular time points.

Detailed description: Endometrial receptivity in the midluteal phase of the menstrual cycle, known as the window of implantation (WOI), occurs only for a very short period of time. However, so far, there is no reliable clinical and biochemical indicators of WOI. Therefore, this study is to correlate and identify the biochemical markers which may reflect WOI.

participants will be asked to be:

1. performed endometrial biopsy
2. taken blood for a few time points (e.g. pre-conception and being pregnant) and to compare different kinds of biochemical markers.

Eligibility criteria: Inclusion Criteria:

Age 20-40 years.

Exclusion Criteria:

* Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
* Intrauterine adhesions.
* Adenomyosis.

Primary outcomes:
measure: The change of the transcriptome profiling in the peripheral blood
timeFrame: From the day of endometrial biopsy through study completion, an average of 2 months
measure: The change of the immune markers in the peripheral blood
timeFrame: From the day of endometrial biopsy through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Pui Wah Jacqueline Chung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161211: Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Official title: Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CBT Decoupling
CBT Anxiety Reduction
CBT Combined
Keywords: alcohol
anxiety
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
* inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
* alcohol use in the 30 days preceding the study
* ability to provide informed consent
* minimum of a sixth grade reading level (deemed necessary to complete study materials);
* willingness to provide contact information to confirm study follow-up appointments
* lives within proximity to the Twin Cities (e.g., within about an hour's drive) for the purpose attending follow-up visits

Exclusion Criteria:

* lifetime history of psychosis or mania by history
* cognitive or physical impairment that precludes study participation
* currently and seriously suicidal (i.e., plan and intent)

Primary outcomes:
measure: Number of Participants That Relapsed to Drinking at 4 Months
timeFrame: 4 month follow-up
measure: Number of Drinking Days in 4 Months Post Treatment
timeFrame: 4-months
measure: Number of Standard Drinks Per Drinking Day
timeFrame: 4 months
Secondary outcomes:
measure: Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months
timeFrame: 4 months
measure: Number of Participants Who Relapsed to Hazardous Drinking
timeFrame: 4 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Lodging Plus Program, Fairview Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Matt Kushner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931111: Cardiovascular Risk Factors, Maximal Oxygen Uptake and Sedentariness: an Observational Study
Official title: Correlation Between Cardiovascular Risk Factors, Sedentary Behaviors and Maximal Oxygen Uptake in an Elderly Norwegian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: physical activity
maximal oxygen uptake
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 874
Sex: ALL
Minimum age (years): 70
Maximum age (years): 77
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly, norwegian

Brief summary: This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.


Eligibility criteria: Inclusion Criteria:

* ability to walk at least 1km,
* born in 1938,1939,1940,1941 or 1942
* Sufficiently good health to be able to take part in the study, as determined by the researchers

Exclusion Criteria:

* Illness or disability that precludes exercise or hinders completion of the study
* Uncontrolled hypertension
* Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
* Active cancer
* Test results indicating that study participation is unsafe
* Inclusion in other studies conflicting with participation in this one

Primary outcomes:
measure: HDL blood correlation to maximal oxygen uptake
timeFrame: baseline
measure: LDL blood correlation to maximal oxygen uptake
timeFrame: baseline
measure: C-reactive protein (CRP) correlation to maximal oxygen uptake
timeFrame: baseline
Secondary outcomes:
measure: sedentariness correlation with maximal oxygen uptake
timeFrame: baseline
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: dorthe stensvold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zisko N, Nauman J, Sandbakk SB, Aspvik NP, Salvesen O, Carlsen T, Viken H, Ingebrigtsen JE, Wisloff U, Stensvold D. Absolute and relative accelerometer thresholds for determining the association between physical activity and metabolic syndrome in the older adults: The Generation-100 study. BMC Geriatr. 2017 May 16;17(1):109. doi: 10.1186/s12877-017-0497-1.
Clinical trial NCT01576211: Studying Genes Using Cord Blood and Placenta Samples From Relatively Healthy Newborns and Samples From Younger Patients With Wilms Tumor
Official title: Investigating the Frequency of Loss of Imprinting Across a Birth Cohort and the Link DNA Methylation Plays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: Wilms tumor and other childhood kidney tumors
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-12
Enrollment: 40
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered on Children's Oncology Group Wilms tumor protocols

Brief summary: RATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor tissue samples from patients with Wilms tumor.

Detailed description: OBJECTIVES:

* What is the frequency of loss of imprinting at birth (in the cord blood and placenta) in a relatively healthy birth cohort?
* Does deoxyribonucleic acid (DNA) methylation levels at imprinting genes have a direct association to the gene expression?

OUTLINE: Archived tumor tissue, cord blood, and placenta samples are analyzed for DNA methylation, single nucleotide polymorphism, and gene expression by polymerase chain reaction (PCR), pyrosequencing, and quantitative real-time PCR. Information regarding gender and age of the samples are also collected, if possible.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Wilms tumor tissue samples from Caucasians (fresh or frozen), or DNA and ribonucleic acid (RNA) samples already isolated from patients registered on Children's Oncology Group Wilms tumor protocols
* Normal/control blood samples from matched individuals
* Cord blood/ placenta samples from the Michels lab Epigenetic Birth Cohort

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of loss of imprinting at birth
measure: Association between methylation levels and gene expression
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: Karin Michels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04642911: Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy
Official title: Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabete Type 2
Mesenchymal Stem Cell
Lead sponsor: Ukraine Association of Biobank
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with diabetic 2 type who have treated with gene therapy in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study

Brief summary: This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion.

No investigation drug product will be administered in the study


Eligibility criteria: Inclusion Criteria:

* Treated with gene therapy of diabetes 2 type in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study
* Able to comply with study requirements
* Provision of written informed consent for this study by subjects or as applicable subject legal/parent guardian

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Overall survival of subject with diabetes 2 type with gene therapy drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study
timeFrame: 10 years post-drug product infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Kharkov
country: Ukraine
facility: Institute of Bio-Stem Cell Rehabilitation
Study officials:
References:
Clinical trial NCT03809728: IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Official title: IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

Detailed description: Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).

Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .

Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

Eligibility criteria: Inclusion Criteria:

* Age\>=18 years
* Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
* Patients \>=45 kg
* Affiliated member of the Social Security system

Exclusion Criteria:

* Patients with an undetermined colitis
* Patients with a non established diagnosis of CD
* Women of childbearing age without a method of contraception
* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
* Pregnant women, breastfeeding women

  -- Age \< 18 years
* Persons under legal protection
* Person who does not have the capacity to consent
* Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).

Primary outcomes:
measure: Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
timeFrame: 5 years
Secondary outcomes:
measure: Proportion of patients who underwent surgery
timeFrame: 5 years
measure: Post-operative morbidity rates in IBD
timeFrame: 5 years
measure: Surgical recurrent rate in Crohn's disease
timeFrame: 5 years
measure: Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
timeFrame: 5 years
measure: Proportion of patients developing a cancer
timeFrame: 5 years
measure: Readmission rates for acute severe colitis or ileitis
timeFrame: 5 years
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Adeline GERMAIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02413528: Pilot Study of a Mobile Asthma Adherence Intervention
Official title: Pilot Study of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Patient Compliance
Mobile Applications
Lead sponsor: CoheroHealth
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2015-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout the study in patients who receive a mobile app with reminders and asthma control as measured by the ACT \[asthma control test\].


Eligibility criteria: Inclusion Criteria:

* Age 11-19
* Asthma diagnosis
* Currently on a daily controller HFA (hydrofluoroalkane) medication for Asthma
* English-speaking
* Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

* Pregnant
* Foster Care
* Emancipated minor

Primary outcomes:
measure: Real-time medication adherence in patients receiving reminders and incentives compared to standard care.
timeFrame: 12 weeks
Secondary outcomes:
measure: Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test])
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew M Ting, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael M Parides, PhD
role: PRINCIPAL_INVESTIGATOR
References: