louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03173209: Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel
Official title: Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Child, Only
Keywords: school
Lead sponsor: Cleveland State University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of written reﬂections was used to explore the meaning and outcomes of the Calm Moments Cards program.
Primary purpose: PREVENTION

Brief summary: We explored the meaning and outcomes of a 4-month program designed to build capacity of school personnel in implementing evidence-based strategies for reducing stress and promoting mental well-being among students in school settings. A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of their written reactions was used to explore the meaning and outcomes of the Calm Moments Cards program.

Detailed description: In order to explore the effectiveness of the Calm Moments Cards program on school personnel's ability to recognize signs of stress and the implementation of embedded strategies to reduce stress and enhance emotional well-being, we conduct a mixed-methods research study using pretest-posttest surveys (assessing knowledge, beliefs, and actions) and qualitative analysis of written reflections about the meaning and use of the Calm Moments Cards. The focus of the intervention is on prevention of stress and anxiety based on situational stressors (e.g. taking a test, completing an assignment) so that students can focus on and succeed in doing their schoolwork. Occupational therapy practitioners oriented school personnel to the signs of stress and the use of the 17 Calm Moments Cards using a 1 hour inservice. This was followed by informal coaching to foster implementation.

Eligibility criteria: Inclusion Criteria:

* School personnel representing teachers, related service providers and para-educators working with elementary students in schools

Exclusion Criteria:

* School personnel who were informed of but declined to participate in the study

Primary outcomes:
measure: Change in knowledge, beliefs, and actions regarding recognizing and reducing stress in children
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland State University
name: Susan Bazyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01245309: Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure
Official title: Endometrial Injury Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization in Women With Previous IVF Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infertility
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 500
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scratching the linning of the womb before IVF cycle could increase the chances of having a baby after an IVF cycle.

Detailed description: All women with history of RIF (as defined by ESHRE) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. Women will be randomised to two arms; one undergoing endometrial sampling and control. Women in the experimental arm will be subjected to endometrial scrapping with Pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the IVF index cycle and after initiation of the GnRHa in the long agonist protocol. Women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Eligibility criteria: Inclusion Criteria:

WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

-

Exclusion Criteria:

* WOMEN\>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE

Primary outcomes:
measure: live birth rate per woman
timeFrame: 9 months
Secondary outcomes:
measure: ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT00004809: Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Familial Hypercholesterolemia
Keywords: familial hypercholesterolemia
inborn errors of metabolism
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 2000-02-25
Enrollment: 5
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.

Detailed description: PROTOCOL OUTLINE: Autologous hepatocytes are obtained from a partial hepatectomy and transduced with a recombinant retroviral vector containing the low-density lipoprotein receptor gene. The transduced hepatocytes are infused via the inferior mesenteric vein 3 days following surgery.

Traditional therapy is discontinued for 4 weeks prior to protocol therapy and may resume 6 weeks after the hepatocyte infusion.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Homozygous familial hypercholesterolemia, i.e.: Low-density lipoprotein (LDL) cholesterol greater than 500 mg/dL Autosomal dominant inheritance Early-onset tendon and tuberous xanthomas LDL receptor negative, i.e.: Receptor binding in cultured fibroblasts no more than 20% of normal OR Genotype with 2 previously described, disease-causing alleles Advanced coronary heart disease with relatively poor prognosis, i.e: Angina pectoris History of myocardial infarction Positive exercise tolerance test Atherosclerotic disease in proximal aorta or coronary arteries by ultrasound or angiogram None of the following: Unstable angina pectoris Left ventricular ejection fraction less than 30% Decompensated congestive heart failure Untreated ventricular tachycardia Moderate to severe aortic stenosis Other dyslipidemia Obstructive hepatobiliary disease

* Prior/Concurrent Therapy At least 2 weeks since the following: Drugs affecting cholesterol metabolism Plasma exchange LDL apheresis --Patient Characteristics-- Age: Any age Renal: No azotemia No significant proteinuria Other: No hypothyroidism No diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: James M. Wilson
role: STUDY_CHAIR
References:
Clinical trial NCT06688409: Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.
Official title: Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure measurement
blood pressure
blood pressure device validation
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.


Eligibility criteria: Inclusion Criteria:

* Adults aged \> 18 years scheduled to undergo an ABPM

Exclusion Criteria:

* Upper arm size outside of cuff range of selected devices (\<22 cm or \>42 cm)
* Night shift workers
* Permanent atrial fibrillation
* Known severe aortic stenosis
* Contraindication to measure BP on the non-dominant arm
* Ongoing pregnancy
* Inability or unwillingness to provide consent

Primary outcomes:
measure: Mean difference in systolic BP
timeFrame: At enrollment (time 0)
Secondary outcomes:
measure: Mean difference in diastolic BP
timeFrame: At enrollment (time 0)
measure: Mean difference in systolic BP from validated device
timeFrame: At enrollment (time 0)
measure: Mean difference in diastolic BP from validated device
timeFrame: At enrollment (time 0)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Sacré-Coeur de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT03814109: Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
Official title: Randomized, Double-blind, Triple-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Arterial Hypertension
Keywords: Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 years or more;
* Participants diagnosed with hypertension (mild to moderate), mild to moderate cardiovascular risk, not controlled by monotherapy and/ or lifestyle modification;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* BP ≥ 180/110 mmHg;
* Participants with BMI (body mass index) ≥ 40 Kg/m2;
* Previous diagnosis of secondary hypertension;
* History of taget organ damage;
* History of cardiovascular, hepatic and renal disease;
* History of gout, diabetes mellitus and hypokalemia;
* Current medical history of cancer;
* Current smoking;
* History of alcohol abuse or drug use;
* Pregnancy or risk of pregnancy and lactating patients;
* Known allergy or hypersensitivity to the medicines components used during the clinical trial;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.
timeFrame: 56 days
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 70 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06106256: Three-Axis Wearable Adaptive Vestibular Stimulator
Official title: 3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Motion Sickness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to improve current galvanic vestibular stimulation (GVS) technology to ease the motion sickness often associated with virtual reality (VR) simulation.

Detailed description: The Three-Axis Wearable Adaptive Vestibular Stimulator (3WAVeS) technology that combines galvanic vestibular stimulation (GVS) and Virtual Reality (VR) will not only increase VR-based simulation realism and presence, but will also mitigate the motion sickness often associated with VR simulation by re-coupling the vestibular and ocular inputs to the VR user. Additionally, due to GVS technology's ability to accurately provide continuous inputs to the vestibular system, 3WAVeS can intentionally simulate high-fidelity effects of spatial disorientation for training purposes.

Eligibility criteria: Inclusion Criteria:

* For our purposes, participants must be able to consent to participate themselves and be 21 to 55 years of age
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
* No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English.

Exclusion Criteria:

- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.

Primary outcomes:
measure: Pensacola Diagnostic Index-based motion sickness questionnaire
timeFrame: Immediately after each flight stimulation session, approximately 1 hour
measure: COG Sway velocity
timeFrame: Immediately after balance testing in each session, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gaurav Pradhan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078956: ABL90 Flex Plus Method Comparison Study_Adults
Official title: ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diagnostic Test
Keywords: Blood gas
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood in a Point of Care (POC) setting.

Detailed description: The main question it aims to answer is:

To quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).

Eligibility criteria: Inclusion Criteria:

* The subject must be 18 years or older.
* Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.
* The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick.
* Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.

Exclusion Criteria:

* Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
* Subject, who is pregnant or breastfeeding.
* Subject, who has an invalid written informed consent or has withdrawn consent.
* Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode
* Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference.
* Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).

Primary outcomes:
measure: Slope, R^2 and bias at medical decision points
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: Radiometer Medical ApS
name: Lisbet Bærentzen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05360056: Continuous Glucose Monitoring Following Hospital Discharge
Official title: Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-05-04
Enrollment: 100
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: In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Basal insulin use \>10 units per day
* Hemoglobin A1c \>8.0%
* Smartphone compatible with Clarity App
* Age ≥18 years

Exclusion Criteria:

* Type 1 DM
* Inability to consent
* Pregnancy
* Prisoners
* Discharge to skilled nursing facility

Primary outcomes:
measure: Percent change in TIR 70-180 mg/dl
timeFrame: 12 weeks
measure: The proportion of patients with % wear time >70% will be reported.
timeFrame: 12 weeks
measure: Change in DTSQc scores
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center - Outpatient Care East
state: Ohio
Study officials:
affiliation: OSU Medical Center
name: Kathleen Dungan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02884609: Tolerance and Efficiency of Paracetamol Subcutaneous Injection
Official title: Tolerance and Efficiency of Paracetamol bu Subcutaneous Releasing in Patients Hospitalized Into Palliative Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in palliative care service with an indication of Paracetamol by subcutaneous injection

Brief summary: The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of Paracetamol for patients in palliative care.

Detailed description: Subcutaneous administration is the most commonly used way for palliative care and geriatric service. A lot of drugs are recommended with subcutaneous administration, but their use is performed out of the Marketing Authorization, and fewer data exist about this practice in literature. Paracetamol is a grade 1 analgesic not currently recommended for subcutaneous injection, because of the lack of validated references. However this kind of administration is usually performed for Paracetamol in the French palliative care services related with its advantages for patients, as analgesic or antipyretic. The assumption of the study is that the use of paracetamol subcutaneously is possible with a good tolerance for hospitalized patients in palliative care service.

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* indication of paracetamol by subcutaneous injection, as an analgesic or an antipyretic

Exclusion Criteria:

* opposition to gather data patient
* subcutaneous administration of paracetamol during the last week before the inclusion of the patient

Primary outcomes:
measure: Occurrence of the severe or not adverse effects on the injection site
timeFrame: 8 days
Secondary outcomes:
measure: as antipyretic, a feedback of tympanic temperature below 38°C during the two hours after injection
timeFrame: 8 days
measure: as analgesic, the decrease of pain (decrease of 30 in the numerical scale score, or a Algo+ scale score lower than 2/5)
timeFrame: 8 days
Other outcomes:
Locations:
city: Metz Cedex 03
country: France
facility: CHR Metz-Thionville
city: Paris
country: France
facility: GH Diaconesses Croix Saint Simon
Study officials:
affiliation: CHR Metz-Thionville
name: Benoît LEHEUP, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leheup BF, Ducousso S, Picard S, Alluin R, Goetz C. Subcutaneous administration of paracetamol-Good local tolerability in palliative care patients: An observational study. Palliat Med. 2018 Jul;32(7):1216-1221. doi: 10.1177/0269216318772472. Epub 2018 May 8.