louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05102188: Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2
Official title: Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions -2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: African American
Sleep
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African Americans residing in Greater Baton Rouge area will be invited to participate in the study.

Brief summary: The purpose of the HD-SLEEP2 study is to help researchers understand sleep in African Americans. The investigators also want to know what factors may affect sleep.

Detailed description: African Americans who self-report poor sleep (n=80) will be invited to complete questionnaire based self-assessment of known factors and comorbidities contributing to alterations in sleep such as demographic characteristics, anthropometrics, depression, insomnia, and food habits in conjunction with objective and subjective measures of sleep via 7-day accelerometry (sleep duration), overnight oximetry (sleep apnea), and sleep questionnaires.

Eligibility criteria: Inclusion Criteria:

* Self-identified African American
* Age range: \>18 years (inclusive)
* Sex: Both males and females will be allowed to participate in the study
* Self-perceived poor sleep

Exclusion Criteria:

* Unable to provide written informed consent
* Unable to understand English

Primary outcomes:
measure: Habitual sleep duration
timeFrame: 7 days
measure: Oxygen desaturation index
timeFrame: 1 day
measure: Sleep Quality
timeFrame: 1 day
measure: Daytime Sleepiness
timeFrame: 1 day
measure: Sleep behaviors
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Recruiting core Pennington
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Prachi Singh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036788: Comparison of Two Tests in the Assessment of the Accuracy of Esophageal Pressure Variations Measurement During Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Pressure Measurement
Keywords: Esophageal pressure, Mechanical ventilation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU after surgery treated with mechanical ventilation

Brief summary: Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is fundamental to assess mechanical characteristics of the respiratory system during mechanical ventilation. The correct positioning of the catheter (usually at the medium third of the esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the correct positioning of the catheter is verified with an occlusion test (If the patient is breathing spontaneously) or with thoraco-abdominal compressions (if the patient is sedated and paralyzed). Aim of this study is to compare the accuracy of these two methods at different PEEP and esophageal catheter positions.


Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation for clinical purposes

Exclusion Criteria:

* Hemodynamic instability
* Esophageal diseases
* Refusal of the patient

Primary outcomes:
measure: Correct esophageal catheter balloon position
timeFrame: 10 minutes after the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Study officials:
References:
citation: McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
citation: Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.
citation: Hedenstierna G. Esophageal pressure: benefit and limitations. Minerva Anestesiol. 2012 Aug;78(8):959-66. Epub 2012 Jun 14.
citation: Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
citation: Higgs BD, Behrakis PK, Bevan DR, Milic-Emili J. Measurement of pleural pressure with esophageal balloon in anesthetized humans. Anesthesiology. 1983 Oct;59(4):340-3. doi: 10.1097/00000542-198310000-00012.
Clinical trial NCT02620488: A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
Official title: A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Pain Perception
Autonomic Nervous System
Sickle Cell Disease
Hypnosis
Guided Imagery
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2015-12-03
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will assess the effects of a brief laboratory-based guided imagery procedure on responses to pain in patients with sickle cell disease (SCD) and healthy controls.


Eligibility criteria: Inclusion Criteria:

1. Healthy control or with a diagnosis of sickle cell disease
2. Age 13 or older
3. African-American
4. Subject is able to provide informed signed consent
5. Subject is able to follow instructions

Exclusion Criteria:

1. Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity
2. Neurologic disorders affecting sensation
3. Skin abnormality/abrasion over sites of stimulus
4. Under 13 years of age
5. Unable to follow instructions

Primary outcomes:
measure: Change in heart rate variability (HRV) before, during, and after hypnosis
timeFrame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
measure: Change in galvanic skin response (GSR) before, during, and after hypnosis
timeFrame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
measure: Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis
timeFrame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
measure: Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis
timeFrame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Secondary outcomes:
measure: Change in pain threshold temperature
timeFrame: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
measure: Change in pain tolerance temperature
timeFrame: 9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
measure: Change in heat pulse pain ratings
timeFrame: 5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: UCLA Pediatric Pain and Palliative Care Program
name: Lonnie K Zeltzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02548988: Selective Neuromuscular Electrical Stimulation on VMO
Official title: Immediate Effect of Selective Neuromuscular Electrical Stimulation of Vastus Medialis Obliquus in Women With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Electric Stimulation
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is analyze the immediate effect of selective neuromuscular electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain syndrome.


Eligibility criteria: Inclusion Criteria:

* For Healthy group:
* with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months
* non-corrected neurological, vestibular, visual and/or hearing impairment
* For Patellofemoral pain syndrome group:
* clinical diagnosis of patellofemoral pain syndrome
* absence of other disorders in the knee
* refer pain at leafs two of the following activities: when remain seated for a long period, squat, kneel and go up or down stairs.

Exclusion Criteria:

* Individuals experiencing pain during collection procedures
* do not perform exercises as instructed by the researches

Primary outcomes:
measure: Electromyographic activity (root mean square - RMS) of vastus medialis obliquus
timeFrame: Change from baseline in Electromyographic activity at 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande do Norte
Study officials:
References:
Clinical trial NCT04947488: Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital
Official title: Evaluation of the Effects of Treatment With Bioarginin C on Physical Exhaustion , Systemic Inflammatory State and Endothelial Function in Adult Subjects Belonging to the Post-Covid Day Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Inflammation
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive difficulties.

On the duration and resolution of this syndrome, now recognized as a highly debilitating condition, there are still no great answers: for this reason it is always important to emphasize that contracting Covid, even in a not serious form, still means exposing oneself to long-term risks that are still not well codified by the scientific community. Guidelines and more tools are expected to best assist these patients.


Eligibility criteria: Inclusion Criteria:

subjects with proven positivity to the molecular test for Sars-cov2 with demonstration of microbiological healing patients discharged from FPG or other hospital structures; or only contact in PS; or home management age: range 20-60 years Fatigue operationalized as an affirmative answer to item "7" (CES-D)

Exclusion Criteria:

Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)

Primary outcomes:
measure: 6 minute walking test to evaluate Fatigue
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Barbara Maglione
Study officials:
References:
Clinical trial NCT05995288: Homeopathic Treatment of Children Suffering From PFAPA
Official title: Homeopathic Treatment of Children Suffering From PFAPA: a Retrospective Case Series.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodic Fever Syndrome
Keywords: PFAPA
periodic fever
homeopathy
Naranjo criteria
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children were suffering from PFAPA for at least 6 months.

Brief summary: Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired autoinflammatory disorder, which recurs in association with at least one sign of aphthous stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective case report is to gain an impression of the course of disease during individualized homeopathic treatment in children suffering from PFAPA.

Detailed description: In this retrospective study, the investigators collected the history and symptoms of 13 consecutive PFAPA patients. The investigators also described the individually chosen homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical outcome of case reports was assessed using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points are taken as the threshold for the possible correlation between homeopathic therapy and improvement of symptoms or cure in chronic cases

Eligibility criteria: Inclusion Criteria:

Children suffering from fever with at least one of the symptooms of PFAPA besides fever

Exclusion Criteria:

Parents not willing to sign informed consent.

Primary outcomes:
measure: Periodic fever flares
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Michael Frass
Study officials:
affiliation: Sigmund Freud Private University
name: Peter Panhofer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00123188: Ultrasound and Endometrial Hyperplasia
Official title: Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometrial Hyperplasia
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Research on Women and Health
First posted: 2005-07-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.

Detailed description: The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort. Endometrial carcinoma is an understudied cancer. This study will provide benefit regardless of its outcome, because it will be the first prospectively designed screening trial in an asymptomatic population.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension

Exclusion Criteria:

* Women who have had a hysterectomy

Primary outcomes:
measure: Endometrial Hyperplasia
timeFrame: End of study
Secondary outcomes:
measure: Endometrial Cancer
timeFrame: End of study
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800488: Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months
Official title: Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Bacterial Infection
Keywords: Fever
Infant
Procalcitonin
Serious Bacterial Infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 2209
Sex: ALL
Minimum age (years): 7
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children 7 days older to 3 month older with fever

Brief summary: The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Evaluation of the area under the ROC for Procalcitonin concentration.

Detailed description: Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

Eligibility criteria: Inclusion Criteria:

* Infant older than 7 days old and less than 3 months old.
* Fever (defined by a rectal temperature greater than or equal to 38°C)
* Emergency consultation

Exclusion Criteria:

* Infants with a previously identified immunodeficiency or chronic disease,
* Antibiotic treatment within the previous 48 hours

Primary outcomes:
measure: Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections
timeFrame: At the day of emergency consultation for fever
Secondary outcomes:
measure: Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin
timeFrame: At the day of emergency consultation for fever
measure: Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin
timeFrame: At the day of emergency consultation for fever
measure: Diagnostic value (sensibility and specificity) of CRP versus procalcitonin
timeFrame: At the day of emergency consultation for fever
Other outcomes:
Locations:
city: Clamart
country: France
facility: Pediatric Emergency Depatment - Hôpital Antoine Béclère
state: Hauts-de-Seine
Study officials:
affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
name: Vincent GAJDOS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00774488: Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Insulin Sensitivity
Keywords: Euglycemic-hyperinsulinemic clamp
fat biopsies
microarray analysis
quantitative real time PCR
overnutrition
low grade-inflammation
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2008-10-17
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.


Eligibility criteria: Inclusion Criteria:

* BMI \> 28
* Healthy subjects
* Normal glucose tolerance

Exclusion Criteria:

* Diabetes,IFG, IGT
* Chronical-inflammatory diseases
* Hb \< 12g/dl
* Elevation in liver enzymes or creatinin concentrations
* Great weight changes within last 12 months
* Any cancer diagnosis in last 10 years

Primary outcomes:
measure: Changes in gene expression of subcutaneous adipose tissue with microarray analysis
timeFrame: 3 years
Secondary outcomes:
measure: Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Tuvia N, Pivovarova-Ramich O, Murahovschi V, Luck S, Grudziecki A, Ost AC, Kruse M, Nikiforova VJ, Osterhoff M, Gottmann P, Gogebakan O, Sticht C, Gretz N, Schupp M, Schurmann A, Rudovich N, Pfeiffer AFH, Kramer A. Insulin Directly Regulates the Circadian Clock in Adipose Tissue. Diabetes. 2021 Sep;70(9):1985-1999. doi: 10.2337/db20-0910. Epub 2021 Jul 5.
citation: Gogebakan O, Osterhoff MA, Schuler R, Pivovarova O, Kruse M, Seltmann AC, Mosig AS, Rudovich N, Nauck M, Pfeiffer AF. GIP increases adipose tissue expression and blood levels of MCP-1 in humans and links high energy diets to inflammation: a randomised trial. Diabetologia. 2015 Aug;58(8):1759-68. doi: 10.1007/s00125-015-3618-4. Epub 2015 May 21.
citation: Rudovich N, Pivovarova O, Gogebakan O, Sparwasser A, Doehner W, Anker SD, Arafat AM, Bergmann A, Nauck MA, Pfeiffer AF. Effect of exogenous intravenous administrations of GLP-1 and/or GIP on circulating pro-atrial natriuretic peptide in subjects with different stages of glucose tolerance. Diabetes Care. 2015 Jan;38(1):e7-8. doi: 10.2337/dc14-1452. No abstract available.