louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04477564: Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism
Official title: Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Clonal Hematopoiesis of indeterminate potential
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women over 50 years old who have consulted at the Hematology laboratory of the Nîmes University Hospital for the occurrence or history of venous thromboembolism (Distal/proximal; Provoked/unprovoked) and who has accepted that their DNA was kept and used in the context of research on venous thromboembolism

Brief summary: The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism.

The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.


Eligibility criteria: Inclusion Criteria:

* Men and women over 50 years old who have consulted at the Hematology laboratory of the Nîmes University Hospital for the occurrence or history of venous thromboembolism
* Patient who has accepted that their DNA was kept and used in the context of research on venous thromboembolism (biobank (registration number DC-2008-290 and authorization number AC-2008-107))

Exclusion Criteria:

* Patients less than 50 years old
* Patient who has refused that their DNA was kept and used in the context of research on venous thromboembolism

Primary outcomes:
measure: DNMT3A mutations screening
timeFrame: For sequencing analysis: 2 months
Secondary outcomes:
measure: TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening
timeFrame: For sequencing analysis: 2 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
References:
Clinical trial NCT05771064: Promoting In-Home Activities at a Memory & Aging Clinic
Official title: Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: MCI
Mild Dementia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-16
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.


Eligibility criteria: Inclusion Criteria:

* Age 50+
* Fluent in English
* Diagnosed with MCI or mild dementia
* Physically inactive (\< 150 min/wk of planned PA)
* Able to sit in a chair independently for 15+ minutes

Exclusion Criteria:

* Have significant mental or physical disabilities that lead to inability to perform PA safely (e.g., major stroke)
* Severe uncompensated hearing or visual loss
* Having insufficient decisional capacity to consent to participate in research.
* Lack of safety awareness
* Unwilling to be assigned to Pro-Home MeC or control group
* Currently participating in PA intervention research

Primary outcomes:
measure: Program Feasibility
timeFrame: 3 months
measure: Program Acceptability
timeFrame: 3 months
measure: Feasibility of NIH Toolbox Cognition Battery
timeFrame: 3 months
Secondary outcomes:
measure: NIH Toolbox Cognition Battery scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Naoko Muramatsu
state: Illinois
Study officials:
References:
Clinical trial NCT00119964: The Healthy Lifestyle Study
Official title: Weight Management for a Defined Employee Population Using an Interactive eHealth Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
First posted: 2005-07-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if an internet-based intervention will be effective in improving the lifestyle and weight of an obese employee population.

The intervention will last 12 months, and includes a weight tracker, a food intake tracker, an activity tracker, a calorie balance tool, an electronic discussion board, and electronic greeting cards.

Detailed description: The study will compare two groups over time, one of which will utilize the electronic tools, and one of which will not. The samples will be drawn from the employees of a metro-Milwaukee hospital, and will consist of obese (Body Mass Index, or BMI, of 30 or greater) employees only.

The primary outcome will be change in weight over the study time period as measured by the BMI. Secondary outcome measures will include quality of life, blood pressure, tests of blood sugar, cholesterol, presence of depression, lifestyle wellness score, health care costs and productivity.

Eligibility criteria: Inclusion Criteria:

* Obesity as defined by a BMI of 30 or greater
* The ability to speak and understand english
* Health insurance coverage through First Health (Aurora's employee insurance plan)
* Not currently on another formal weight management program
* Not currently taking any weight loss medications
* Not currently disabled in such a way that participation would be precluded

Primary outcomes:
measure: change in body mass index
Secondary outcomes:
measure: quality of life
measure: blood pressure
measure: hemoglobin A1c
measure: total cholesterol
measure: HDL cholesterol
measure: HANDS depression score
measure: wellness score on Summex Health Risk Appraisal
measure: health care costs
measure: unscheduled paid time off
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Alison Lux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06015464: An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
Official title: An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Untreated Diffuse large B-cell lymphoma (DLBCL) patients

Brief summary: To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment; Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment. Standard treatment regimens include the R-CHOP regimen and the Pola-R-CHOP regimen.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years Diffuse large B-cell lymphoma (DLBCL) diagnosed by histopathology of the tumour, without any previous anti-tumour therapy or after ≤2 cycles of R-CHOP(like) or Pola-R-CHP therapy only
* Have a clear efficacy evaluation
* Patients eligible for Non-GCB or extra-nodal or dual expression or who, in the judgement of the investigator, would benefit from treatment with Orelabrutinib following genetic testing.
* Patients treated with at least 2 cycles of orelabrutinib in combination with an R-CHOP(like) or Pola-R-CHP regimen

Exclusion Criteria:

* Lymphoma involving the central nervous system or soft meningeal metastases
* Transforming lymphoma, i.e. from other types of lymphoma such as follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukaemia or small B-cell lymphoma
* Primary mediastinal large B-cell lymphoma
* Patients with poorly controlled cardiovascular disease, infectious disease, etc.

Primary outcomes:
measure: CR rate of EOT
timeFrame: at the end of Cycle 6-8 (each cycle is 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hematological Department, People's Hospital of Jiangsu Province
state: Jiangsu
Study officials:
References:
Clinical trial NCT05651464: Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Official title: Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter-Related Infections
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this prospective interventional study is to evaluate the impact of antibiotic prophylaxis on bloodstream infections after liberation of extracorporeal membrane oxygenation therapy. The main questions aims to answer are:

• does application of vancomycine prior to ECMO liberation have an impact of bloodstream infections?

Participants will get 1 dose of vancomycine I.V. (15-20 mg per kgKG) prior to liberation of ECMO.

Researchers will compare this interventional group to a group without antibiotic prophylaxis.


Eligibility criteria: Inclusion Criteria:

* adult patients older than 18 years
* ECMO-Therapy

Exclusion Criteria:

* patients younger than 18 years
* fever \>38,5°C
* pregnancy
* antibiotic treatment with Vancomycine, Linezolid, Daptomycin or Tygacil on the day of liberation
* prior adverse events after application of Vancomycine

Primary outcomes:
measure: Growth of pathogens in blood culture
timeFrame: taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
measure: Growth of pathogens in blood culture
timeFrame: taken directly before removal of extracorporeal membrane oxygenation therapy
Secondary outcomes:
measure: Growth of pathogens on cannula tip
timeFrame: on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO
measure: laboratory parameters
timeFrame: 6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
measure: laboratory parameters
timeFrame: 24 hours after liberation of extracorporeal membrane oxygenation therapy
measure: laboratory parameters
timeFrame: 48 hours after liberation of extracorporeal membrane oxygenation therapy
measure: laboratory parameters
timeFrame: 72 hours after liberation of extracorporeal membrane oxygenation therapy
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University Hospital of Saarland
state: Saarland
Study officials:
affiliation: Saarland University Medical Center
name: Philipp M Lepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154764: Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Official title: A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy male volunteers
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

Detailed description: * Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
* Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parameters. Concentrations below the lower limit of quantification, samplings which are not applicable, or missing data will be substituted by "\<LLOQ", "NA", or "MD" respectively. Pharmacokinetic analyses will be performed on CG100649 only.

Eligibility criteria: Inclusion Criteria:

1. Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
2. No significant chronic/congenital disease
3. Normal results for lab test
4. Ability of informed consent

Exclusion Criteria:

1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
3. History of known hypersensitivity to drugs including CG100649.
4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).

Primary outcomes:
measure: Cmax
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose
measure: AUClast
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Seoul Asan medical Center
name: Hyeong-Seok Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Youn Choi H, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of ketoconazole on the pharmacokinetic properties of CG100649, a novel NSAID: a randomized, open-label crossover study in healthy Korean male volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. doi: 10.1016/j.clinthera.2013.12.004.
Clinical trial NCT01939964: Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles
Official title: A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Wrinkles on Face and Neck Areas
Keywords: Wrinkles
Activation Mist
Lead sponsor: California Allergy and Asthma Medical Group, Inc.
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.

Detailed description: This study aims to study the effects of Activation Mist ( AM) on skin wrinkles. It contains a proprietary blend of minerals and nutritional supplements which is patented as "Liquidized Infrared Negative Ion Activation Energy". Active ingredients include sodium bicarbonate, potassium bicarbonate, sodium carbonate, strontium carbonate, gold nanoparticles, calcium, germanium, selenium , zinc, sugar and water. When applied to the skin , it has been shown to reduce the appearance of wrinkles by stimulation of skin fibroblasts to produce new collagen while removing aging dermis cells, facilitate the production of fibrillin proteins and protect the skin from ultraviolet rays.

Eligibility criteria: Inclusion Criteria:

1.Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician.

Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Subjects with skin conditions that are deemed by the investigator to interfere with the results of this study , including but not limited to: uncontrolled acne, rosacea, atopic dermatitis.
3. Subjects with clinically significant cardiovascular, neurological, renal, endocrine or hematological abnormalities uncontrolled on current therapy.
4. Subjects with history of skin malignancy
5. Subjects with signs of recent sunburn
6. Use of any of the following medications, within 1 week specified of visit 1

   1. Systemic steroids
   2. Topical steroids used on the face
   3. Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.

Primary outcomes:
measure: Silicone skin replica analysis
timeFrame: before and after 8 weeks of treatment
Secondary outcomes:
measure: Wrinkle Score
timeFrame: every week for 8 weeks
measure: Photographic evaluation
timeFrame: weekly for 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
Study officials:
References:
Clinical trial NCT05851664: Do we Intubate Faster With the Videolaryngoscope?
Official title: Do we Intubate Faster With the Videolaryngoscope?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngoscopy
General Anesthesia
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 100
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: The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Detailed description: Intubation on full stomach is at high risk of pulmonary suction. It must be quick, as this risk increases with the time needed to intubate. Videolaryngoscope (VL) is recommended in case of difficult airway. Yet, its interest in full stomach remains unclear, as the time needed to intubate with a VL is variable in literature. The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years-old;
* ASA status 1 to 3;
* General anesthesia and intubation.

Exclusion Criteria:

* Difficult intubations criteria.

Primary outcomes:
measure: Time needed to intubate
timeFrame: during the intubation
Secondary outcomes:
measure: Difficulty of the laryngoscopy
timeFrame: at the end of intubation
measure: Number of intubation attempts.
timeFrame: at the end of intubation
measure: Major desaturation
timeFrame: during intubation
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim hospital
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami MS Mebazaa, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591564: Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
Official title: Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Mood Dysregulation
Keywords: interpersonal psychotherapy
severe mood dysregulation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-05-04
Enrollment: 3
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).

The investigators hypothesize that retention rates will be \>80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.
* Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-2)
* Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
* Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.
* Children's Global Assessment Scale (CGAS) ≤ 60

Exclusion Criteria:

* Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
* Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
* Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
* Pregnant females.
* Primary caretaker does not speak English

Primary outcomes:
measure: Retention rate
timeFrame: 20 weeks
Secondary outcomes:
measure: Clinical Global Impressions Scale CGI-I (SMD)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Leslie Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: