louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04915131: A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Official title: A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.

The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.

Detailed description: The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age ≥ 32 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand English or Spanish
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* Plurality higher than 1
* History of allergies to skin adhesives
* Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations
* Contraindication to the use of CTG

Primary outcomes:
measure: Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
timeFrame: 5 minutes
measure: Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Perinatal Services
state: Arizona
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
Study officials:
affiliation: Valley Perinatal Services
name: Avinash Patil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005431: Coronary Heart Disease Risk Factors in Blacks Vs Whites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To use data from the Epidemiologic Follow-up Study of the National Health and Nutrition Examination Survey (NHANES) to develop models to predict morbidity and mortality as a function of risk factors for coronary artery disease. Bivariate dependent survival distributions were examined.

Detailed description: The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: McGee D, Cooper R, Liao Y, Durazo-Arvizu R. Patterns of comorbidity and mortality risk in blacks and whites. Ann Epidemiol. 1996 Sep;6(5):381-5. doi: 10.1016/s1047-2797(96)00058-0.
Clinical trial NCT05054231: Immunological Profile for Patients Treated With CAR-T Cells
Official title: Immunological Profile for Patients Treated With CAR-T Cells
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematologic Neoplasms
Keywords: CAR-T cells
Immunological Profile
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Planned injection of CAR-T cells within the scope of marketing authorization
* Signed informed consent
* French social security affiliation

Exclusion Criteria:

* Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women.
* Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent
* Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons

Primary outcomes:
measure: Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
timeFrame: 1 year after T cells infusion
Secondary outcomes:
measure: CAR-T cells rate from infusion to one year after CAR-T cells infusion
timeFrame: From CAR-T cells infusion to one year
measure: Number of participants with a relapse
timeFrame: From CAR-T cells infusion to one year
measure: Number of participants with a cytokine release syndrome
timeFrame: From CAR-T cells infusion to one year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
References:
Clinical trial NCT01962831: Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter
Official title: Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy
Labor, Induced
Keywords: obesity
labor, induced
pregnancy
cervical ripening
dinoprostone
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.


Eligibility criteria: Inclusion Criteria:

* Obese (BMI \>30 before 20 weeks gestational age)
* Singleton pregnancy
* Vertex presentation
* Bishop Score \<6
* Intact membranes
* Gestational age 37+0 to 42+0
* Normal fetal heart tracing on admission for ripening

Exclusion Criteria:

* Induction of labour for intrauterine fetal demise
* Intrauterine growth restriction
* Suspected abruption at the start of induction
* Any contraindication for a vaginal delivery

Primary outcomes:
measure: Time(hours) from initiation of induction of labour to vaginal delivery
timeFrame: Will be assessed at the end of each vaginal delivery
Secondary outcomes:
measure: Number of vaginal deliveries within 24 hours in each group
timeFrame: 2 years
measure: Number of cesarean sections in each group
timeFrame: 2 years
measure: Number of operative vaginal deliveries in each group
timeFrame: 2 years
measure: Number of chorioamnionitis cases in each group
timeFrame: 2 years
measure: Number of patients that required oxytocin administration in each group
timeFrame: 2 years
measure: Number of patients that required an epidural in each group
timeFrame: 2 years
measure: Number of babies that required neonatal intensive care unit (NICU) admission in each group
timeFrame: 2 years
measure: Number of babies that had an arterial pH <7 in each group
timeFrame: 2 years
measure: Number of babies that had an APGAR score <7 at 5 minutes
timeFrame: 2 years
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Regina Qu'Appelle Health Region
state: Saskatchewan
Study officials:
affiliation: Saskatchewan Health Authority - Regina Area
name: Christine Lett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359631: Cephalic Vascular Recording Upon SPG Stimulation
Official title: Cephalic Vascular Recording Upon SPG Stimulation in CH Patients - Amendment to the Pathway CH-1 Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Cluster Headache
Keywords: Chronic Cluster Headache
Lead sponsor: Autonomic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: Hypothesis:

Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.

Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel diameter.

Detailed description: Efferent

Eligibility criteria: Inclusion Criteria:

•Subject is currently enrolled in Pathway CH-1 (CIP-001)

Exclusion Criteria:

•Subject is NOT currently enrolled in Pathway CH-1(CIP-001)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06329531: Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic
Official title: Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Occupational Therapy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer Participants

Brief summary: To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care.

Detailed description: Primary Aim

1. Explore the SOCS-OTS for use in the Physical Medicine and Rehabilitation (PM\&R) clinic by means of diagnostic testing including sensitivity and specificity.

Secondary Aims

1. Explore whether the SOCS-OTS identifies the likelihood that the presence or absence of OT referral is correctly predicted. To accomplish this, the likelihood ratios, and predictive values of the SOCS-OTS will be assessed.
2. Determine associations between the need for OT and demographic factors such as stage of cancer, cancer treatment etc.
3. Establish test-retest reliability of the SOCS-OTS.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years an older
2. Currently medically followed in the PMR clinic (with or without acute disease)
3. Must speak and read English. The AM-PAC is currently validated in adults only. Additionally, the assessment tools are in English without translation into other languages, therefore only clients who do speak and read English will be included. Pregnant participants are not excluded.

Exclusion Criteria:

1. Potential participants with confusion and cognitive impairments that might hinder their ability to sign an informed consent form or participate in the study.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ekta Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806831: Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Official title: Efficacy and Safety of Biocellulose Sheet From Coconut Juice Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Pigmentation
Skin Irritation
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Agricultural Research Development Agency (Public Organization)
First posted: 2013-03-07
Enrollment: 30
Sex: ALL
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: The laser areas treated with biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask", "Farhorm®") heal faster than vaseline ointment which is a standard treatment.

Detailed description: Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask","Farhorm®")was applied for 20 min on one side and the other side was treated with vaseline ointment. The redness, skin hydration and skin pigmentation were evaluated at that area before laser, immediately after laser and after applying the treatment. These parameters were compared between treatment (area treated with Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, "biocellulose mask", "Farhorm®") and control (vaseline ointment).

Eligibility criteria: Inclusion Criteria:

* Age 20-50 years old
* No skin problem such as inflammation, fresh wounds
* Not receive laser treatment during last 3 months
* No history of smoking or alcohol drinking
* No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate
* Willing to participate in this study and can comply with study protocol

Exclusion Criteria:

* Has history of hyperallergic reaction
* Has wound(s) on face during last 4 weeks
* Has history of eczema, psoriasis during last 6 months
* Has laser treatment during last month
* Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting
* Had major surgery during last 12 months
* Has history of cancer during last 12 months
* Pregnant or lactation

Primary outcomes:
measure: The skin pigmentation immediately after laser therapy and after using biocellulose mask
timeFrame: Change from immediately after laser treatment and 30 min after laser and treatment with mask
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References:
Clinical trial NCT05467631: Topical Phytoterpenes for Plantar Fasciitis
Official title: Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Heel pain
plantar
fasciitis
foot pain
Lead sponsor: Center for Biomedical Research, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test.

Detailed description: Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test. Primary outcome measure will be the difference in pain score between baseline score and pain score at 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration

Exclusion Criteria:

* Age under 18 years, any history of diabetes, history of foot surgery

Primary outcomes:
measure: Change in Pain Score Between Baseline and 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: Center for Biomedical Research,Inc.
state: Idaho
Study officials:
affiliation: Center for Biomedical Research, Inc.
name: Briant Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560131: Evaluation of Autonomic Cardiac Function in Patients With CRPS
Official title: Evaluation of Autonomic Cardiac Function in Patients With Complex Regional Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRPS (Complex Regional Pain Syndromes)
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2007-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: To evaluate the autonomic cardiac function in patients with complex regional pain syndrome

Detailed description: Tilt table testing in patients with complex regional pain syndrome: Effects on heart rate variability and baroreceptor sensitivity.

Primary outcome parameter: Autonomic cardiac function

Eligibility criteria: Inclusion Criteria:

* Age: 18 or older.
* Pain \> 3 months.
* Diagnosed with CPRS acc. to diagnostic research criteria (Harder et al., 2005).
* Inclusion of healthy subjects: age-, gender-, and BMI-matched.

Exclusion Criteria:

* Other significant disease affecting the parameters measured, including cardiovascular disease.
* Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.

Primary outcomes:
measure: Autonomic cardiac function
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center, Aarhus University Hospital
name: Troels S Jensen, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT03893331: AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
Official title: AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ablation of Arrhythmia's
Keywords: Arrhythmia's
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.

Brief summary: AcQMap Registry is an observational study

Detailed description: AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or older.
* Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
* Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
* Willing and able to give written informed consent.

Exclusion Criteria:

* In the opinion of the Investigator, any known contraindications to an ablation procedure.
* Current enrollment in any study protocol sponsored by Acutus Medical.
* Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

Primary outcomes:
measure: Procedural Ablation Outcomes
timeFrame: 12 hours
Secondary outcomes:
measure: Long-term Outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: I.C.P.S. Hôspital Privé Jacques Cartier
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cardiologie Elektrofysiologie
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital Northern General Hospital
Study officials:
affiliation: James Cook University Hospital
name: Simon James, MD
role: PRINCIPAL_INVESTIGATOR
References: