louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02629445: HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
Official title: High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent.

Exclusion Criteria:

* Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing

Primary outcomes:
measure: Rapid pacing of the heart
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
References:
Clinical trial NCT06022445: Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT
Official title: Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stem Cell Transplant Complications
Keywords: septic shock
prognostic model
allogeneic hematopoietic stem cell transplant
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Navy General Hospital, Beijing
name: Second Hospital of Shanxi Medical University
name: The Second Hospital of Hebei Medical University
name: Shanghai Zhongshan Hospital
name: Shanxi Dayi Hospital
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Guangzhou University of Chinese Medicine
name: The First Affiliated Hospital of Zhengzhou University
name: Peking Union Medical College
name: First Affiliated Hospital of Harbin Medical University
First posted: 2023-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients diagnosed with septic shock after allo-HSCT. The clinical criteria of septic shock were sepsis as defined by suspected or documented infection and an acute increase of ≥ 2 SOFA points, together with vasopressor therapy (norepinephrine, dopamine, vasopressin, or any other vasopressor) needed to elevate mean arterial pressure ≥ 65 mmHg and lactate \>2 mmol/L (18 mg/dL) despite adequate fluid resuscitation.

Brief summary: Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study

Detailed description: A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.

The equation of the prediction model for 28-day mortality was as follows:

Probability(28-day mortality)=(exp⁡(Y))/(1+exp⁡(Y)) where Y=2.343+1.328\* Time of septic shock- 0.085\* Albumin + 0.016 \* Bilirubin-0.003\*PaO2/FiO2 +0.127\*Lactate- 0.011 \* Glomerular filtration rate

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* underwent allo-HSCT
* diagnosed with septic shock

Exclusion Criteria:

* experienced septic shock before enrollment
* relapsed or progressed after HSCT

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: up to 1 year
measure: 90-day mortality
timeFrame: 90 days
measure: Time on ventilator
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University Insititute of Hematology, Peking University People's Hospital
name: Xiaohui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554145: Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
Official title: Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Infections
Lead sponsor: GramEye
Sponsor class: INDUSTRY
Collaborators: name: Keio University
name: Kameda Medical Center
First posted: 2024-08-15
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specimens that have undergone urine culture and urine Gram staining for clinical purposes will be included.

Brief summary: The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.


Eligibility criteria: Inclusion Criteria:

* Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes

Exclusion Criteria:

* Samples for which suspension of use has been requested

Primary outcomes:
measure: Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
References:
Clinical trial NCT00267345: Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Chylothorax
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-20
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

Detailed description: Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

Eligibility criteria: Inclusion Criteria:

* Infants with congenital chylothorax requiring thorax drain

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Jacob Kuint, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04507945: Stablishment of Prevention and Treatment System for Intestinal Dysfunction
Official title: The Goal-direct Treatment of Chronic Bowel Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bowel Dysfunction
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.
Primary purpose: TREATMENT

Brief summary: Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy.


Eligibility criteria: Inclusion Criteria:

* The Patients with chronic bowel dysfunction

Exclusion Criteria:

* Past severe underlying diseases of the respiratory system and cardiovascular system,
* Allergy to treatment-related drugs,
* Pregnancy,
* Accept CID surgery.

Primary outcomes:
measure: nutrition index
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pironi L, Corcos O, Forbes A, Holst M, Joly F, Jonkers C, Klek S, Lal S, Blaser AR, Rollins KE, Sasdelli AS, Shaffer J, Van Gossum A, Wanten G, Zanfi C, Lobo DN; ESPEN Acute and Chronic Intestinal Failure Special Interest Groups. Intestinal failure in adults: Recommendations from the ESPEN expert groups. Clin Nutr. 2018 Dec;37(6 Pt A):1798-1809. doi: 10.1016/j.clnu.2018.07.036. Epub 2018 Aug 18.
citation: He D, Wang S, Hu H, Yin HY. [Advances in the research of protective effect of curcumin on intestinal mucosal barrier function]. Zhonghua Shao Shang Za Zhi. 2019 Feb 20;35(2):157-160. doi: 10.3760/cma.j.issn.1009-2587.2019.02.013. Chinese.
Clinical trial NCT06129045: Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80
Official title: Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Hygiene
Lead sponsor: Black Hills State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm study: No intervention, video only, video plus text messaging
Primary purpose: PREVENTION

Brief summary: This will be a study looking at trying to change older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.

Detailed description: Older adults ages 50-80 will be recruited and placed into one of three groups. Group One will watch a one-time educational video on sleep hygiene, Group Two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video, and Group Three will be a control group with no intervention. The participants in Groups One and Two will receive the education after two weeks of data tracking on a Fitbit device. They then will have four additional weeks of tracking. At the end of the study time of six weeks, all participants will return for follow-up testing. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep.

Eligibility criteria: Inclusion Criteria:

* own a smartphone with the capability of receiving text messages.

Exclusion Criteria:

* an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
* inability to wear the device on their wrist

Primary outcomes:
measure: Change scores of Ru-Sated Sleep Composite for overall sleep health using six health domains.
timeFrame: 6-weeks
measure: Change score of Pittsburgh Sleep Quality Index
timeFrame: 6-weeks
measure: Change score of Sleep Hygiene Index
timeFrame: 6-weeks
Secondary outcomes:
measure: Change Score on the Numeric Pain Rating Scale
timeFrame: 6-weeks
measure: Change on the Perceived Stress Scale
timeFrame: 6-weeks
measure: Change Scores for Participant's Body Mass Index
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Spearfish
country: United States
facility: Black Hills State University
state: South Dakota
Study officials:
affiliation: Black Hills State University
name: Ashley M Pfeiffer, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06757205: Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics
Official title: Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Personality
Life Style
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 115
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study involves the enrollment of 115 adolescents aged between 13-21 years treated at the psychiatric clinic.

Brief summary: Considering the growing importance of services psychiatric and psychological for adolescence and adulthood incidence of discomfort expressed in this age group, comes assessed the need to provide adequate and targeted services.

Reasons:

The study aims to evaluate the characteristics and trends of adolescents who access the service, in order to frame the type of discomfort expressed and the expectations with respect to access to the service and the resource base on which it can the therapeutic intervention must be thought out and organised. Furthermore, the study aims to identify the factors that influence the request for help and evaluate the quality of the assistance received, with the aim of improving it effectiveness.


Eligibility criteria: Inclusion criteria:

- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.

Exclusion criteria:

* Patients who do not give their consent are excluded from the study.
* Patients who do not speak fluent Italian or those who due to cognitive and/or thinking characteristics would not be able to understand or complete the questionnaire are also excluded.

Primary outcomes:
measure: Analyze the characteristics of adolescents who access the clinic, both with respect to the discomfort presented and the resources available to them
timeFrame: one year
Secondary outcomes:
measure: Relate these characteristics to the ways of relating within the family, through meetings that also involve their parents
timeFrame: one year
Other outcomes:
measure: Collect useful information to improve the effectiveness and variety of therapeutic paths to be offered to adolescents who consult the clinic and their parents.
timeFrame: one year
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
state: Roma
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Marianna Mazza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00320905: Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
Official title: Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Cardiac Rehabilitation
Cognitive functioning
Cardiovascular disease
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with cardiovascular disease

Brief summary: The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.

Detailed description: Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.

Eligibility criteria: Inclusion Criteria:

- 50 to 85 years of age, able to communicate in English, history of heart disease

Exclusion Criteria:

- history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Summa Health System
name: Richard A Josephson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01223105: Oocyte Cryopreservation by Slow Freezing and Vitrification
Official title: Longitudinal Evaluation of Vitrification of Human Oocytes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Women Diagnosed With Cancer
Egg Donors
Single Women
Failed Sperm Procurement in IVF
Keywords: slow freeze
cryopreservation
vitrification
oocyte preservation
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.

Detailed description: Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.

Eligibility criteria: Inclusion Criteria:

* Age between 21 and 50 years, at the time of informed consent.
* Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)

Exclusion Criteria:

* Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.

Primary outcomes:
measure: Oocytes survival after thaw
timeFrame: 1 month
Secondary outcomes:
measure: Fertilization
timeFrame: 1 month
measure: Implantation
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: RMA of NJ
name: Richard T Scott, MD, HCLD
role: STUDY_DIRECTOR
affiliation: RMA of NJ
name: Kathleen Ferry, BS
role: STUDY_CHAIR
References:
Clinical trial NCT05816005: Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies
Official title: Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pelvic maligniancies that will undergo to preoperative contrast enhanced MRI to precisely define the extent of local and/or distant disease before pelvic exenteration

Brief summary: The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Written Informed Consent
* All patients with recurrent gynecological cancer that are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and palliative intent
* Patients considered fit for srugery

Exclusion Criteria:

* Controindication to MRI (Claustrophobia, implanted ferromagnetic materials or foreign objects, Known intolerance or controindication to the MRI contrast agent, cardiac pacemaker)
* Individuals who are not able or willing to tolerate the required prologed stationary supine position during examination (approximately 40-60 minutes)
* Patient unable to give informed consent

Primary outcomes:
measure: Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI
timeFrame: Through study completion, an average of 2 yearS
Secondary outcomes:
measure: Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement
timeFrame: Through study completion, an average of 2 yearS
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Study officials:
References: