louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00070980: Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Official title: Massage to Enhance Well-Being in HIV-Positive Dominican Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
AIDS
Keywords: Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-10-13
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

Detailed description: The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic.

Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.

Eligibility criteria: Inclusion Criteria:

* HIV infection
* Parent/caregiver signature on consent form

Exclusion criteria:

* Unknown HIV status
* Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry
* Massage therapy within 30 days prior to study entry
* Unable to have massage (e.g., extensive skin lesions)
* Symptoms of child abuse
* Child born drug-addicted

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: CENISMI/Robert Reid Cabral Children's Hospital
Study officials:
affiliation: University of Miami
name: Gail Shor-Posner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03814980: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Official title: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Emphysema
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: In this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third leading cause of death in the United States and no cure exists. Shortness of breath is the most common disabling symptom. Pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with COPD. It requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain PLB. Additionally, syncing breathing and heart rate variation offers patients additional benefits. The proposed project explores the use of biofeedback to guide COPD patients in a breathing practice and to provide data for health coaching to monitor and support the practice.


Eligibility criteria: Patients eligible for Pulmonary Rehabilitation will be recruited for this study.

Primary outcomes:
measure: Test the feasibility of a mindful breathing application for COPD patients
timeFrame: About 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04344080: Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Official title: Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: critically ill
intensive care medicine
CytoSorb
hemoadsorption
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.


Eligibility criteria: Inclusion Criteria:

* confirmed COVID-19 disease
* refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
* IL6 ≥ 500 ng/l
* Indication for CRRT or ECMO

Exclusion Criteria:

* Liver cirrhosis Child Pugh C
* "do not resuscitate"-order
* expected survival due to comorbidities \< 14 days
* pregnancy or breastfeeding
* participation in another interventional trial

Primary outcomes:
measure: Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Change in organ dysfunction
timeFrame: 10 days
measure: Lactate clearance
timeFrame: 10 days
measure: Renal replacement therapy
timeFrame: 10 days
measure: Extracorporeal Membrane Oxygenation
timeFrame: 10 days
measure: ICU length of stay
timeFrame: 90 days
measure: Time on mechanical ventilation
timeFrame: 10 days
measure: Cumulative catecholamine dose
timeFrame: 10 days
measure: Overall and ICU mortality
timeFrame: 90 days
measure: Change of plasma Interleukin-6 (IL6) level
timeFrame: 10 days
measure: Change of plasma Interleukin-10 (IL10) level
timeFrame: 10 days
measure: Change of plasma Procalcitonin (PCT) level
timeFrame: 10 days
measure: Change of HLA-DR level
timeFrame: 10 days
measure: Change of TNF alpha level after ex-vivo stimulation
timeFrame: 10 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
name: Stefan Kluge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983280: The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients
Official title: The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients: A Prospective Cross Over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn
Keywords: polysomnography
sleep
healing touch
pediatric burn
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

Detailed description: This study examines the impact of Healing Touch on the quality and quantity of sleep in pediatric burn survivors. Polysomnography recordings are obtained in order to assess nocturnal sleep in conjunction with Healing Touch; which is done on 1 of 2 nights during Polysomnography. Soft background music is played on both nights.

Healing Touch is performed by one of 2 Healing Touch Certified Practitioners.

Eligibility criteria: Inclusion Criteria:

1. All pediatric patients (from 5 to 21 years of age) admitted for treatment (following an acute burn injury) to Shriners Hospitals for Children - Cincinnati Burns Hospital will be screened.
2. Include electrical, flame, scald and chemical burns.
3. Signed informed consent

Exclusion Criteria:

1. Patients admitted for treatment unrelated to a burn injury.
2. Patients admitted for less than 2 nights.
3. Patients with face and head grafting if they interfere with the lead placements
4. Neurological disorder

Primary outcomes:
measure: Quality of sleep
timeFrame: It takes 1 month for the PSG results to be completed
Secondary outcomes:
measure: Quantity of sleep
timeFrame: It takes 1 month for the polysomnography results to be completed.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
Study officials:
References:
Clinical trial NCT04965480: Detecting Delayed Discharge in Acute Geriatric Unit Using Natural Language Processing
Official title: Detecting Delayed Discharge in Acute Geriatric Unit Using Natural Language Processing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Language
Geriatric
Older
Electronic Health Record
Keywords: Natural Language Process
appropriate stay
acute geriatric unit
older
Electronic Health Record.
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 300
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \>75 years, hospitalized in AGU in Amiens University Hopsital

Brief summary: Delayed discharge in geriatric units is a health and economic issue. There is no algorithm to automatically measure the appropriateness of admissions or hospital days. 30% of the days of hospitalization in acute geriatric units (AGU) are not appropriate. Waiting for a transfer to a follow-up care and rehabilitation unit (SSR) is the main risk factor for inappropriate days. The purpose of this project is to develop an algorithm using natural language processing to predict the appropriateness of an admission to UGA, or a day at UGA.


Eligibility criteria: Inclusion Criteria:

* age : \>75 years
* patient hospitalized in an AGU

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Concordance between Appropriateness Evaluation Protocol algorithm prediction result and real admission in AGU
timeFrame: 15 days
measure: Concordance between Appropriateness Evaluation Protocol algorithm prediction result and real admission for one day in AGU
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT04159480: Facilitating Assessment of At-Risk Sailors Using Technology
Official title: Facilitating Assessment of At-Risk Sailors Using Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
name: Military Suicide Research Consortium
First posted: 2019-11-12
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized clinical trial with individuals being allocated to experimental (Cogito Companion) or Active Control arms. Those in the latter will receive information regarding widely available mobile self-help apps via a custom mobile app built in MyCAP. This same platform will be used to collect data regarding symptoms. Randomization will be stratified by gender, force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms differ based on smartphone platforms. Participants will be willing Naval personnel being redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform future implementation..


Eligibility criteria: Inclusion Criteria.

* Member of the Navel Surface or Aviation Forces;
* Age: 18-55 years at the time of enrollment;
* Ability to provide verbal and electronic informed consents;
* Ownership of smartphone;
* Willingness to use smartphone and personal data plan to participate.

Exclusion Criteria.

* Having redeployed (returning to the Continental United States) more than twelve months (approximately) prior to consent.
* Having an iPhone (until later in 2019 when the Cogito Corporation plans to release the iOS version of the Cogito Companion app).

Primary outcomes:
measure: Percentage of Cogito Participants Reported Being Satisfied
timeFrame: From Baseline to Follow-Up, Approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: VA/University of Colorado
name: Lisa Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01188980: Early Increase in Blood Supply in Patients With Barrett's Esophagus
Official title: Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Brief summary: The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older,
* informed written consent,
* patient scheduled for previously planned upper endoscopy

Exclusion Criteria:

* liver disease;
* gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy;
* severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder);
* known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.);
* known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.

Primary outcomes:
measure: determine if early increase blood supply (EIBS)can predict presence of Dysplasia
timeFrame: 10 minutes during standard upper endoscopy
Secondary outcomes:
measure: determine if EIBS can predict presence of BE in patients undergoing upper endoscopy
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
References:
Clinical trial NCT05728580: PCI in Beijing Friendship Hospital
Official title: Risk Factor for Percutaneous Coronary Intervention in the Beijing Friendship Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Percutaneous Coronary Intervention
Keywords: coronary heart disease
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 10000
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 with PCI accorrding to Inclusion and exclusion criteria.

Brief summary: The goal of this study is to discover the potential risk factors related percutaneous coronary intervention. It aims to stratify the risk of PCI patients and discover the prognostic value of these risk fators.

Detailed description: Coronary heart disease is the main cause of death worldwide. Ischemic heart disease is the most common cause of death. Percutaneous coronary intervention (PCI) is a very effective treatment for coronary heart disease, which can alleviate myocardial ischemia and reduce the mortality of patients with acute myocardial infarction. It is an important measure to treat coronary heart disease at present. However, the study found that the incidence of major adverse cardiac and cerebrovascular event (MACCE) after PCI was more than 10%, which could reach 20-30% in elderly patients. Therefore, the purpose of this study is to investigate the risk factors related to PCI and to intervene or change the treatment strategy as early as possible. Risk stratification was performed in these patients for improving the quality of life of patients, reducing medical costs, and improving the life expectancy of patients. Patients with PCI in Beijing friendship hospital are enrolled.The primary outcome is MACCE and all-cause mortality.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years at the time of admission to the hospital
* PCI patients with coronary heart disease: according to the criteria interpreted in the 2011 American Guidelines for Percutaneous Coronary Intervention. The successful diagnostic criteria of PCI: residual stenosis of the treated vessel\<10% (preferably 0%), and the forward flow is TIMI grade 3, there is no dissection that affects the flow, no important side branch occlusion, no visible thrombus and peripheral embolism.

Exclusion Criteria:

* Patients who failed in PCI treatment;
* Current known inability to follow instructions or comply with follow-up procedures.

Primary outcomes:
measure: MACCE
timeFrame: These data is collected during follow-up for 5 years after discharge
measure: All-cause mortality
timeFrame: These data is collected during follow-up for 5 years after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Hongwei Li, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00622180: The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands
Official title: The Efficacy of Hand-Foot Narrow-Band Ultraviolet B (UVB) Versus Focal 308-nm Treatment in Inducing Repigmentation of Vitiligo After Minigrafting on the Dorsal Hands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Light treatment for vitiligo
Excilite
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin minigraft transplants to the backs of the hands in patients with light brown to black skin. Subject will undergo treatment for 13 weeks.

Detailed description: Prospective investigator-blinded study involving 13 adult male and female subjects with vitiligo on the backs of both hands. Punch minigrafting will be performed on both hands taking skin from the thighs and/or buttocks. Light treatments will be administered starting at week one after grafting. One hand will receive narrow-band ultraviolet B light and the other will receive focal 308-nm light treatments. Light treatments will be administered 3 times per week for 12 weeks. A long term follow-up visit will be completed at week 25. The investigator will evaluate the subjects at week 4, 7, 13 and 25 in addition to screening and baseline evaluations/procedures.

Eligibility criteria: Inclusion Criteria:

* male and female subjects 18 years of age or older
* skin type III-VI
* vitiligo on both dorsal hands
* history of stable vitiligo ( no new lesions and no more than 10% enlargement of existing lesions) for six months with an absence of Kebner phenomenon (new lesions appearing after trauma to the skin)
* refractory to topical steroids and immunomodulators

Exclusion Criteria:

* pregnant and/or breast-feeding females
* history of skin cancer
* history of taking photosensitizing medications
* history of recent phototherapy (light therapy) or topical medications within one month prior to enrollment
* history of organ transplantation
* history of failed vitiligo skin transplantation
* history of segmental vitiligo
* history of 12 or more continuous light treatments

Primary outcomes:
measure: Percent Repigmentation of Target Lesion
timeFrame: 25 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas - Department of Dermatology
name: Amit Pandya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403480: Rates of Positive Basal Cell Carcinomas (BCCs) in Re-excisions
Official title: Rates of Positive BCCs in Re-excisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Keywords: Basal Cell Carcinoma
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that underwent an incomplete BCC excision during the years 2008-2010.

Brief summary: Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is primarily surgical with the goal of excising the growth in its entirety. When pathology results show that this has not been achieved, a re-excision is routinely performed. This study examines retrospectively the percentage of re-excisions of BCC that actually proved to be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus and Zvulun Community Medical Center during the years 2008-10.


Eligibility criteria: Inclusion Criteria:

All patients that underwent an incomplete BCC excision during the years 2008-2010.

Exclusion Criteria:

Patients that underwent an incomplete BCC excision and were subsequently referred to undergo a MOHS procedure.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: