louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05120635: Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
Official title: Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fear
GAD
Emotional Memory
PTSD
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: VA Greater Los Angeles Healthcare System
name: NeuroPace
First posted: 2021-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.

The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images.


Eligibility criteria: Inclusion Criteria:

* 12 years of age or older
* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Willing to provide informed consent and participate in the study Ability to read and write English fluently

Exclusion Criteria:

* Unwilling to provide informed consent
* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Pregnant women
* Participants with active psychosis
* Participants with suicidal ideation
* Participants with substance abuse issues

Primary outcomes:
measure: Physiological change - eye-blinks
timeFrame: during the intervention/behavioral tasks with and without stimulation
measure: Physiological change - heart rate variability
timeFrame: during the intervention/behavioral tasks with and without stimulation
measure: Physiological change - skin conductance
timeFrame: during the intervention/behavioral tasks with and without stimulation
measure: Neurophysiological activity
timeFrame: during the intervention/behavioral tasks with and without stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
References:
Clinical trial NCT00768235: Yoga Program in Respiratory Function
Official title: Influence of Yoga Program in Respiratory Function of Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Elderly
Keywords: Sedentary elderly women that had medical assignment
Lead sponsor: Catholic University of Brasília
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 36
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tested the hypothesis that yoga practice can improve respiratory function in the elderly.

Detailed description: Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Sedentary women

Exclusion Criteria:

* Physical impairment

Primary outcomes:
measure: Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
timeFrame: pre-intervention and post-intervention
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
timeFrame: pre-intervention and post-intervention
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Catholic university of brasilia
state: Distrito Federal
Study officials:
affiliation: catholic University of Brasilia
name: Lidia MA Bezerra, Ms.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchman AS, Boyle PA, Wilson RS, Leurgans S, Shah RC, Bennett DA. Respiratory muscle strength predicts decline in mobility in older persons. Neuroepidemiology. 2008;31(3):174-80. doi: 10.1159/000154930. Epub 2008 Sep 11.
Clinical trial NCT04594135: Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Official title: Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T-cell Acute Lymphoblastic Leukemia
T-cell Non-Hodgkin Lymphoma
Keywords: anti-CD5 CAR
T cell leukemia/lymphoma
T-ALL
Lead sponsor: iCell Gene Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iCAR Bio Therapeutics Ltd.
name: Peking University Shenzhen Hospital
First posted: 2020-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.

Detailed description: Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the research
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Any drug used for GVHD must be stopped \>1 week

Primary outcomes:
measure: Number of adverse events after anti-CD5 CAR T cells cell infusion
timeFrame: 2 years particularly the first 28 days after infusion
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: up to 6 months
measure: Disease Free Survival (DFS)
timeFrame: up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: Peking University Shenzhen Hospital, China
name: Hongyu Zhang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037635: A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Official title: A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
End Stage Renal Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.


Eligibility criteria: * Patients must be receiving hemodialysis; \* Have elevated parathyroid hormone levels; \* Not be pregnant or nursing; and \* Not have had a heart attack in the last 3 months.

Primary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.
timeFrame: efficacy assessment phase (last 14 weeks of treatment)
Secondary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase
timeFrame: efficacy assessment phase (last 14 weeks of treatment)
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase
timeFrame: efficacy assessment phase (last 14 weeks of treatment)
measure: To evaluate the safety of AMG 073 compared with placebo.
timeFrame: entire study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Martin KJ, Juppner H, Sherrard DJ, Goodman WG, Kaplan MR, Nassar G, Campbell P, Curzi M, Charytan C, McCary LC, Guo MD, Turner SA, Bushinsky DA. First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl. Kidney Int. 2005 Sep;68(3):1236-43. doi: 10.1111/j.1523-1755.2005.00517.x.
Clinical trial NCT01520935: Influenza Burden Assessment in the United Kingdom, 1996-2008
Official title: Burden of Influenza in the United Kingdom, 1996-2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Office of National Statistics
Burden of Disease
Influenza
Hospital Episode Statistics
General Practitioners Research Database
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Sage Analytica
First posted: 2012-01-30
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People of any age in the United Kingdom who were registered with an acceptable flag in the GPRD, or with a potentially influenza-related event in the HES database or the ONS mortality data.

Brief summary: The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.

Detailed description: This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.

Eligibility criteria: Inclusion Criteria:

• Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza
timeFrame: From 1996 to 2008 (up to 13 years)
measure: Relative impact of influenza on high versus low risk populations
timeFrame: From 1996 to 2008 (up yo 13 years)
measure: Relative impact of influenza during match versus mismatched seasons
timeFrame: From 1996 to 2008 (up to 13 years)
measure: Relative impact of influenza on vaccinated versus unvaccinated populations
timeFrame: From 1996 to 2008 (up to 13 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Matias G, Taylor RJ, Haguinet F, Schuck-Paim C, Lustig RL, Fleming DM. Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom. BMC Public Health. 2016 Jun 8;16:481. doi: 10.1186/s12889-016-3128-4.
citation: Fleming DM, Taylor RJ, Haguinet F, Schuck-Paim C, Logie J, Webb DJ, Lustig RL, Matias G. Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 2016 Feb;144(3):537-47. doi: 10.1017/S0950268815001119. Epub 2015 Jul 13.
Clinical trial NCT01028235: Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Official title: Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphagia
Keywords: Eosinophilic Esophagitis
Lead sponsor: San Antonio Uniformed Services Health Education Consortium
Sponsor class: FED
First posted: 2009-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia

Brief summary: The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* complaint of dysphagia

Exclusion Criteria:

* pregnancy
* age \<18
* on inhaled steroids within the last 30 days
* on systemic steroids in the last 30 days
* known diagnosis of Eosinophilic Esophagitis
* obvious obstructive etiology found at endoscopy
* increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: San Antonio Uniformed Services Health Education Consortium
name: Jonathan M Ricker, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00415935: PRINTO (the Paediatric Rheumatology International Trials Organisation)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-12-25
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: A comparison of outcome in children with JIA who are in remission on MTX, when MTX is then stopped for either 6 or 12 months


Eligibility criteria: Inclusion Criteria:

* Any child with JIA who has gone into remission using methotrexate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Rheumatology ICH
Study officials:
affiliation: Institute Of Child Health and Great Ormond Street Hospital
name: Lucy Wedderburn, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991535: Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
Official title: Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuromuscular Disorders
Chest Wall Disorders
Obesity Hypoventilation Syndrome (OHS)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

Detailed description: Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).

Eligibility criteria: Inclusion Criteria:

* Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
* Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
* Clinically stable (within the previous month).
* Patients without previous NonInvasive Mechanical Ventilation treatment.

Exclusion Criteria:

* Clinical exacerbation.
* Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio \< 70% or Sleep Apnea-Hypopnea Syndrome

Primary outcomes:
measure: Transcutaneous carbon dioxide measurement
timeFrame: One hour
Secondary outcomes:
measure: Inspiratory-time/total-respiratory-cycle value
timeFrame: One hour
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
name: Pedro A Anton Albisu, Medical Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
name: Patricia Peñacoba Toribio, Physician
role: STUDY_CHAIR
affiliation: Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
name: Macarena Segura, Physiotherapist
role: STUDY_CHAIR
References:
Clinical trial NCT03069235: Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program
Official title: Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/Aids
Breast Feeding
Keywords: HIV
Breast Feeding
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: MU-JHU CARE
First posted: 2017-03-03
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited setting.

Detailed description: This is a single center, operational research study with two components. A formative component and randomized intervention trial. The study aims are to inform, promote and evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited settings.

The primary objective of the qualitative formative research which includes Focus Group Discussions (FGD) and Key Informant Interviews (KII) is to explore factors affecting decisions on EBF and continued breastfeeding among HIV infected women.

The primary objective for the Intervention phase is to compare either of two intervention strategies against the standard arm using Ministry of Health (MOH) messages aimed at promoting EBF for 6 month.

Eligibility criteria: Inclusion Criteria:

* HIV-positive pregnant women in their late second or third trimester
* On antiretroviral therapy (ARVs) for PMTCT or meets MOH guidelines for ARV therapy
* Intention to breast feed
* Willingness to deliver at Mulago Hospital
* Living within Kampala and planning to stay within Kampala district for months after delivery
* Willingness to participate during post partum period
* Willingness to be home visited
* Willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on EBF

Exclusion Criteria:

* none

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MU-JHU CARE
name: Joyce Matovu, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992835: Resolution of Allergic Inflammation
Official title: Resolution of Allergic Inflammation: Identification and Kinetics of Specific Lipid Mediators During Nasal Allergen Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grass Pollen Allergic Rhinitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.


Eligibility criteria: Eligibility criteria:

Inclusion Criteria

* Allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing
* Grass pollen sensitization determined by a positive skin prick test and / or presence of specific IgEs to a grass pollen allergen extract

Exclusion Criteria:

* Smoker
* Specific immunotherapy with grass allergens or other respiratory allergen for inclusion.
* Current exhibition to another clinically relevant respiratory allergen

Primary outcomes:
measure: Clinical nasal score and measurement of mediators in biological fluids
timeFrame: Measurement of mediators in biological fluids during 72 h after nasal allergen challenge
measure: Clinical nasal score and measurement of mediators in biological fluids.
timeFrame: Measurement and indentification of specific lipid mediators during nasal allergen challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires
Study officials:
affiliation: Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
name: Cindy Barnig
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qi S, Barnig C, Charles AL, Poirot A, Meyer A, Clere-Jehl R, de Blay F, Geny B. Effect of nasal allergen challenge in allergic rhinitis on mitochondrial function of peripheral blood mononuclear cells. Ann Allergy Asthma Immunol. 2017 Mar;118(3):367-369. doi: 10.1016/j.anai.2016.11.026. Epub 2017 Jan 7. No abstract available.