louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06250387: Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies
Official title: Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endobronchial Mass
Keywords: Patients with mediastinal lymphadenopathies.
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mediastinal lymph nodes enlargement with short axis diameter \>15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age
* Mediastinal and/or hilar lymphadenopathies \> 20 mm on an injected chest CT scan
* Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
* Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max \> 3)
* No contraindication for general anesthesia
* French-speaking Patient
* -Signed informed consent

Exclusion Criteria:

* Patient not covered by the French social security system
* Patient with legal protection
* Pregnant or breastfeeding patient (if applicable)
* Patient under guardianship or curatorship
* Patient deprived of liberty

Primary outcomes:
measure: To evaluate the feasibility of EBUS TBCB 1.1 mm probe.
timeFrame: 6 Months
Secondary outcomes:
measure: To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
timeFrame: 7 Months
measure: To estimate the specificity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
timeFrame: 7 Months
measure: To estimate the procedure time.
timeFrame: Day 0
measure: To assess the post-procedure complications rate.
timeFrame: 1 Month
Other outcomes:
Locations:
Study officials:
References:
citation: Ernst A, Anantham D, Eberhardt R, Krasnik M, Herth FJ. Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy. J Thorac Oncol. 2008 Jun;3(6):577-82. doi: 10.1097/JTO.0b013e3181753b5e.
citation: Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.
Clinical trial NCT00535587: Testing Mestinon and Exercise in Fibromyalgia
Official title: Maximizing Exercise Effectiveness in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Exercise
Mestinon
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-09-26
Enrollment: 178
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.

Detailed description: Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

Eligibility criteria: Inclusion Criteria:

* Have Fibromyalgia

Exclusion Criteria:

* Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.

Primary outcomes:
measure: Levels of Growth Hormone Post Exercise
timeFrame: 6 months
Secondary outcomes:
measure: Improvement of Fibromyalgia Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Edit Serfozo, MPH
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University
name: Kim Dupree Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05756387: Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
Official title: Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Respiratory Failure
Non-invasive Ventilation
Keywords: Monitoring
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Löwenstein BV
name: Vivisol
name: Sencure BV
First posted: 2023-03-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients with chronic hypercapnic respiratory failure needing chronic NIV will be included

Brief summary: The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.

For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

Detailed description: Can be provided on request as the registry rules are no in Dutch

Eligibility criteria: Inclusion Criteria:

* COPD patients indicated for chronic home NIV

Exclusion Criteria:

* not able to read the written information and/or sign the informed consent form
* no possibility to perfrom measurements at home

Primary outcomes:
measure: Gas exchange
timeFrame: baseline
measure: Gas exchange
timeFrame: 2 months
measure: Gas exchange
timeFrame: 4 months
measure: Gas exchange
timeFrame: 6 months
measure: Patient comfort
timeFrame: baseline
measure: Patient comfort
timeFrame: 2 months
measure: Patient comfort
timeFrame: 4 months
measure: Patient comfort
timeFrame: 6 months
measure: AECOPD
timeFrame: 2 months, 4 months, 6 months
measure: AECOPD
timeFrame: 2 months
measure: AECOPD
timeFrame: 4 months
measure: Hospitalisations for AECOPD
timeFrame: 6 months
measure: Sleep quality
timeFrame: 2 months
measure: Sleep quality
timeFrame: 4 months
measure: Sleep quality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: University Medical Center Groningen
name: Marieke L Duiverman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04977687: Machine Learning Predict Renal Replacement Therapy After Cardiac Surgery
Official title: Using Machine Learning to Predict Acute Kidney Injury Requiring Renal Replacement Therapy After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Machine Learning
Acute Kidney Injury
Renal Replacement Therapy
Prediction Models
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 2108
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: age over 18 years who underwent cardiac surgery

Brief summary: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The researcher here developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes. The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.


Eligibility criteria: Inclusion Criteria:

* age over 18 years who underwent cardiac surgery

Exclusion Criteria:

* data miss greater than 10%

Primary outcomes:
measure: patients required renal replacement therapy
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01619787: Price Changes and Hypothetical Food Purchases in Adult Grocery Shoppers
Official title: Experimental Analysis of Price Changes and Food Purchases in Obese and Lean Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Taxes and Subsides on Food Purchases in Mothers
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Lean and overweight Low and high socioeconimic status primary grocery shopper

Brief summary: The goal of the proposed study is to apply experimental economics in an online grocery store shopping model to examine the effects of pricing on hypothetical food purchases

Detailed description: Participants will be lean and overweight primary grocery shoppers aged 18 years and older. Participants will be considered lean if their body mass index (BMI = kg/m2) is less than 29.9, overweight if their BMI is greater than or equal to 30.12 To meet eligibility for the study, participants must be the guardian of a child at least 2 years or older, do the primary grocery shopping for the family, they must also report being weekly household grocery shoppers, and purchase the majority of their household's groceries once a week.

Eligibility criteria: Inclusion Criteria:

18 or older primary shopper in the household, at least one child over 2 years of age

Exclusion Criteria:

eating disorders, not liking study foods

Primary outcomes:
measure: Change in Energy Purchased as a Result of Taxes.
timeFrame: Study Completion
measure: Change in Energy Purchased as a Result of Subsidies
timeFrame: Study Completion
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Leonard H Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein LH, Paluch RA, Carr KA, Temple JL, Bickel WK, MacKillop J. Reinforcing value and hypothetical behavioral economic demand for food and their relation to BMI. Eat Behav. 2018 Apr;29:120-127. doi: 10.1016/j.eatbeh.2018.03.008. Epub 2018 Apr 3.
citation: Epstein LH, Finkelstein E, Raynor H, Nederkoorn C, Fletcher KD, Jankowiak N, Paluch RA. Experimental analysis of the effect of taxes and subsides on calories purchased in an on-line supermarket. Appetite. 2015 Dec;95:245-51. doi: 10.1016/j.appet.2015.06.020. Epub 2015 Jul 3.
citation: Epstein LH, Jankowiak N, Fletcher KD, Carr KA, Nederkoorn C, Raynor HA, Finkelstein E. Women who are motivated to eat and discount the future are more obese. Obesity (Silver Spring). 2014 Jun;22(6):1394-9. doi: 10.1002/oby.20661. Epub 2013 Dec 6.
Clinical trial NCT03158987: Regional Differences in Human Immunodeficiency Virus (HIV) Testing
Official title: Regional Differences in Human Immunodeficiency Virus (HIV) Testing Procedures in Eastern German Federal States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
CD4+ T Lymphocytopenia
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: University of Magdeburg
name: University of Leipzig
name: University of Rostock
name: Technische Universität Dresden
name: MUC Research GmbH
First posted: 2017-05-18
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have displayed for the first time a serological proof of HIV infection

Brief summary: This retrospective observational study aims at the examination of regional differences in the procedure of referral for serological HIV testing between eastern (new) and western (old) German federal states.

Detailed description: Increasing incidence of HIV infections urges early recognition and timely introduction of therapy. Regional differences in referral approach and patient behavior are presumably associated with considerable delays in infection recognition and therapy onset. Comparison of records of new cases which were diagnosed in 2014 in several eastern federal states and a major western German city is expected to disclose whether the regionally preferred type of the primary care institution affects the time point of first diagnosis and the elapsed time since the emergence of the infection, as assessed by Cluster of Differentiation 4 positive (CD4+) lymphocyte counts and manifestation of clinical symptoms of immune deficiency.

Eligibility criteria: Inclusion Criteria:

* first-time HIV seropositivity

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Type of HIV-verifying medical institution
timeFrame: 1 day
Secondary outcomes:
measure: CD4+ lymphocyte counts
timeFrame: 1 day
measure: Symptoms of AIDS-related diseases
timeFrame: 1 day
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
Study officials:
affiliation: University Hospital Jena
name: Benjamin Schleenvoigt, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01099787: Pediatric Alliance for International Neurogastrointestinal Functional Research
Official title: Pediatric Alliance for International Neurogastrointestinal Functional Research Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 348
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 4 through 16 years of age (up to the day of the 17th birthday) will be recruited from the Nationwide Children's Hospital Gastrointestinal Department that are presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months.

Brief summary: To explore the predictive value of alarm signs ("red flags") for a diagnosis of functional gastrointestinal disorders (FGID) in children.

To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients.

To document the benefit of various treatment regimens currently employed in managing FGID.

To assess the short- and long-term impact of various FGID regimens.

To allow physicians to gain a better understanding of the epidemiology of FGID.

Hypothesis:

There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS.

Symptoms of children with FAP/IBS change overtime regardless of the treatments used.


Eligibility criteria: Inclusion Criteria:

* Males and females ages 4 through 16 years of age (up to the day of the 17th birthday)
* Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry.

Exclusion Criteria:

* Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled.
* Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Hospital
state: Connecticut
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital
Study officials:
affiliation: Nationwide Children's Hospital
name: Carlo Di Lorenzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06718387: Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence
Official title: Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ptsd
Sexual Violence
Therapeutic Alliance
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2024-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.

Detailed description: In 2022, CRP Sud NA set up a psycho-education group for victims of sexual violence (PE-VVS). Two groups were held, involving 10 patients:

* Average age = 35 (29-50)
* Average PCL5 before PE-VSS = 53 (31 - 63)
* Type of SV experienced

  * In childhood or adolescence outside family environment
  * Incest
  * Rape in adulthood outside intimate relationship
  * Rape by intimate partner A special feature of this therapeutic group is the involvment of the CRP's patient-partner. He took part in both design and facilitation of the sessions, along with the two CRP co-therapists (IDE / psychologist).

Eligibility criteria: Inclusion Criteria:

* At the suggestion of CRP therapists,
* Patient treated at the CRP having been exposed to sexual violence

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluation of impact on quality of life (QoL) concerning participation in this psychoeducation program
timeFrame: 6 months after the end of program
measure: Evaluation of impact on self-esteem of participation in this psychoeducation program
timeFrame: 6 months after the end of program
measure: Evaluation of Impact on mental well-being of participation in this psychoeducation program
timeFrame: 6 months after the end of program
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles PERRENS
Study officials:
affiliation: Charles Perrens
name: Chantal BERGEY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Millon EM, Shors TJ. Taking neurogenesis out of the lab and into the world with MAP Train My Brain. Behav Brain Res. 2019 Dec 30;376:112154. doi: 10.1016/j.bbr.2019.112154. Epub 2019 Aug 14.
citation: Shors TJ, Millon EM. Sexual trauma and the female brain. Front Neuroendocrinol. 2016 Apr;41:87-98. doi: 10.1016/j.yfrne.2016.04.001. Epub 2016 Apr 13.
citation: Shors TJ, Olson RL, Bates ME, Selby EA, Alderman BL. Mental and Physical (MAP) Training: a neurogenesis-inspired intervention that enhances health in humans. Neurobiol Learn Mem. 2014 Nov;115:3-9. doi: 10.1016/j.nlm.2014.08.012. Epub 2014 Sep 9.
Clinical trial NCT00004787: Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shwachman Syndrome
Fanconi's Anemia
Dyskeratosis Congenita
Thrombocytopenia
Keywords: Fanconi's anemia
Shwachman syndrome
aplastic anemia
dermatologic disorders
dyskeratosis congenita
hematologic disorders
rare disease
thrombocytopenia
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: James Whitcomb Riley Hospital for Children
First posted: 2000-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in patients with inherited bone marrow failure syndromes.

II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF.

III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before and after G-CSF using flow cytometry and immunohistochemistry.

Detailed description: PROTOCOL OUTLINE: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously every day for 8 weeks; nonresponders receive an increased dose for an additional 8 weeks. Patients who respond at week 8 or 16 are then tapered to a lower maintenance dose of G-CSF administered every other day through week 40. The dose is adjusted to maintain an absolute neutrophil count above 1500.

Patients are removed from study for failure to achieve a complete response by week 16, unacceptable nonhematologic toxicity, the identification of a clonal karyotype in marrow, or the onset of leukemia.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Inherited bone marrow failure syndrome, including:

* Fanconi's anemia
* Dyskeratosis congenita
* Shwachman syndrome
* Amegakaryocytic thrombocytopenia
* Decreased megakaryocytes in infancy
* No thrombocytopenia with absent radius syndrome (TAR)
* No trisomy 13 or 18
* No clonal bone marrow karyotype

--Prior/Concurrent Therapy--

* At least 4 weeks since growth factors
* Concurrent therapy allowed if not altered for 30 days prior to entry through week 8
* No concurrent investigational drugs

--Patient Characteristics--

* Hematopoietic: ANC \<1000
* No leukemia
* Other: No medical or psychiatric contraindication to protocol participation
* No pregnant or nursing women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: James Whitcomb Riley Hospital for Children
name: David A. Williams
role: STUDY_CHAIR
References:
citation: Rackoff WR, Orazi A, Robinson CA, Cooper RJ, Alter BP, Freedman MH, Harris RE, Williams DA. Prolonged administration of granulocyte colony-stimulating factor (filgrastim) to patients with Fanconi anemia: a pilot study. Blood. 1996 Sep 1;88(5):1588-93.