louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03303118: The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
Official title: The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Hypoxia
Keywords: Hypoxia
Brain
Cerebral vaso-reactivity
EEG
Concentration performance
Cerebral oxygenation
Cerebral blood-flow
Heart rate variability
Lead sponsor: Fliegerärztliches Institut
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Blind study.
Primary purpose: OTHER

Brief summary: The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.

Detailed description: The main goal of this project is to investigate how hypoxia affects cognitive functions. The KLT-R test asses the concentration level of a person. Subjects will do this test at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators' first hypothesis is that concentration level will be altered by hypoxia. The higher altitude the subjects are, the more the concentration would be altered. KLT-R performance would be impaired by hypoxia compare to sea level performance.

The primary endpoint of this project is to investigate how KLT-R performance is affected by the different hypoxic conditions. KLT-R test will be passed nine times in total during the test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH, 5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before each condition) and a post-test at the end of the protocol. To avoid influence of fatigue, all conditions will be randomized.

The second endpoint of this study is how the brain electrical activity is modulated by hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and 5500m HH).

Eligibility criteria: Inclusion Criteria:

* No history of flight sickness
* No relevant medical diseases
* Age 18 - 40 years
* Written consent acceptance

Exclusion Criteria:

* Known pathologies
* Relevant medical disorders
* Drug addiction
* Anemia or poor health
* People who have already had problems with elevation

Primary outcomes:
measure: Concentration performance
timeFrame: 4 minutes per test
Secondary outcomes:
measure: EEG micro-states
timeFrame: 5 minutes per record
Other outcomes:
measure: Cerebral vaso-reactivity
timeFrame: 8 Minutes per test
Locations:
city: Dübendorf
country: Switzerland
facility: Mathias Aebi
state: Zürich
Study officials:
References:
citation: Aebi MR, Bourdillon N, Kunz A, Bron D, Millet GP. Specific effect of hypobaria on cerebrovascular hypercapnic responses in hypoxia. Physiol Rep. 2020 Feb;8(4):e14372. doi: 10.14814/phy2.14372.
Clinical trial NCT03767413: The Effects of Mental Practice Combined With Proprioceptive Neuromuscular Facilitation on Muscle Strength of Upper Limb and Hand Grip
Official title: The Effects of Mental Practice Combined With Proprioceptive Neuromuscular Facilitation on Muscle Strength of Upper Limb and Hand Grip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Physical Activity
Neuromuscu
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2018-12-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two group of subjects: PNF group will receive only PNF training PNFMP group: will receive PNF training and mental pracice technique
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Influence of mental practice and proprioceptive neuromuscular facilitation on muscle strength of upper limb and hand grip will be measured in 30 to 50 healthy students with right dominant hand, Their age will be ranged from 18 to 26 years old. Subjects will randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or proprioceptive neuromuscular facilitation with mental practice (PNFMP) group.

Detailed description: PNF group: 15 - 25 individuals, these subjects will receive only PNF training. PNFMP: 15 individuals, these subjects will receive PNF training with MP. Training program will be conducted for every group for 5 weeks with 3 sessions x 30 min per week. Electromyography (EMG) device will be used to measure the electrical activity of muscles using surface electrodes. Hydraulic hand dynamometer will be used to measure hand grip strength.

Eligibility criteria: Inclusion Criteria:

1. The participant will be right-handed.
2. Previously untrained subjects.
3. Absence of a prior injury of the hand or arm

Exclusion Criteria:

1. History of a neurological disease.
2. History of musculoskeletal injury of upper limb.
3. Unstable medical condition

Primary outcomes:
measure: Shoulder joint strength
timeFrame: 6 minutes
measure: Elbow joint strength
timeFrame: 6 minutes
measure: Strength of hand grip
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Jazan University
state: Jazan
Study officials:
References:
Clinical trial NCT04625413: A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Official title: A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

Detailed description: Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Eligibility criteria: Inclusion Criteria for Patients:

* Age ≥60 years (conventional definition of older age in AML)
* Newly diagnosed AML
* Considering treatment
* Able to provide informed consent
* English-speaking

Inclusion Criteria for Caregivers:

* Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient.
* Able to provide informed consent
* English-speaking

Inclusion Criteria for Oncologists:

* A practicing oncologist
* At least one of their patients are recruited to the study
* English-speaking

Exclusion Criteria: None

Primary outcomes:
measure: Feasibility (Recruitment Rates)
timeFrame: Four weeks
measure: Usefulness
timeFrame: Four weeks
Secondary outcomes:
measure: Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)
timeFrame: Four weeks
measure: Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7
timeFrame: Four weeks
measure: Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15
timeFrame: Four Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370013: Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors
Official title: An Open Label, Multicenter Rollover Study for Continued Characterization of Safety and Tolerability of TT-00420 (Tinengotinib) Tablet Monotherapy in Adult Patients With Advanced Solid Tumors
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Advanced Solid Tumors
Cholangiocarcinoma
Lead sponsor: TransThera Sciences (Nanjing), Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors

Detailed description: This is a Rollover study. Only subjects who continue to receive clinical benefit from continuation of tinengotinib monotherapy and are tolerating tinengotinib at the time of enrollment are eligible to participate on this study. Subjects on this rollover study may continue to receive tinengotinib at the dose that they were previously receiving on the TransThera parent study and may continue for as long as the subject continues to benefit from treatment.

Eligibility criteria: Inclusion Criteria:

1. Subject is currently enrolled in a pre-defined TransThera-sponsored parent study and is receiving tinengotinib as a single agent.
2. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Exclusion Criteria:

1. Subject has been permanently discontinued from tinengotinib in the parent protocol for any reason other than enrollment in the Rollover study
2. Subject does not meet the criteria specified in the parent protocol for continued treatment on study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
Study officials:
References:
Clinical trial NCT01696513: Effect of Subcision and Suction on Acne Scars
Official title: Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Subcision and Suctioning With a Microdermabrasion Device on Rolling Acne Scars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acne Scars
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether the use of standard treatment in conjunction with suction will improve acne scars compared to a standard treatment alone.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Have bilateral rolling acne scars
* Are in good health
* Subject has the willingness and ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or lactation
* Unable to understand the protocol or give informed consent
* Has mental illness
* Recent Accutane use in the past 6 months
* Prone to hypertrophic and keloidal scarring

Primary outcomes:
measure: Change in acne scarring compared to baseline after treatments
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315613: Role of ST2 in Acute Pancreatitis
Official title: Study of ST2-IL-33 Pathway in Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Erasme University Hospital

Brief summary: Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are not well known. The IL-1 cytokine family is activated early during acute pancreatitis and secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to investigate ST2 pathway in human acute pancreatitis and in murine experimental models of acute pancreatitis.


Eligibility criteria: Inclusion Criteria:

* Time to take blood sample less than 24h after the onset of symptoms of AP
* Two of the following: typical pain, amylase and lipase concentrations more than 3x the upper normal limit, compatible modifications on imaging techniques

Exclusion Criteria:

* Chronic pancreatitis

Primary outcomes:
measure: Concentration of soluble ST2 in serum
timeFrame: Within 30 days after onset of acute pancreatitis
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: Romy Ouziel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188013: Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy
Official title: Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Retinopathy
Keywords: plasma
exosome
Diabetic Retinopathy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Plasma exosomal proteomics studies in patients with diabetic retinopathy should include healthy volunteers without diabetes mellitus and elderly cataract patients without diabetes mellitus; patients with systemic diseases such as cancer, immune disorders, infectious diseases, and hematological disorders, as well as patients suffering from cerebral infarcts, cardiac infarcts, and other cardiovascular diseases, are not eligible for enrollment.

Brief summary: Objective: Explore the biomarkers related to proliferative diabetic retinopathy by analyzing the protein expression profile changes of plasma exosomes in patients with difference phases of diabetic retinopathy, and investigate potential molecular mechanisms and therapeutic targets. Methods: Enrich exosomes from plasma by column extraction method. NTA, WB and TEM were used to characterize the obtained exosomes, and exosome proteinomics was performed by chromatography⁃mass spectrometry. Corhorts: The study was divided into four groups: a healthy control group, a diabetic without diabetic retinopathy group, a non-proliferative diabetic retinopathy group, and a proliferative diabetic retinopathy group, with 6 cases in each group.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without diabetes/ Senile cataract patients without diabetes；
* Patients with diabetes who are diagnosed without DR, NPDR, and PDR by mydriatic fundus photography (or FFA)；

Exclusion Criteria:

* Patients with systemic diseases such as cancer, immune diseases, infectious diseases, and blood diseases；
* Patients with cerebral infarction, myocardial infarction and other cardiovascular and cerebrovascular diseases

Primary outcomes:
measure: differential proteins of exosomes
timeFrame: December,2023-June,2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01089413: Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
Official title: A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with 1st line treatment with bevacizumab in Belgium

Brief summary: This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab \[Avastin\] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is \>300 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients =/\<18 years of age
* metastatic colorectal cancer
* patients for whom the physician has prescribed bevacizumab \[Avastin\] for the treatment of 1st line metastatic colorectal cancer
* patients, who have given written informed consent

Exclusion Criteria:

* hypersensitivity to recombinant human or humanised antibodies
* pregnancy or breast-feeding

Primary outcomes:
measure: Duration of Bevacizumab Treatment
timeFrame: Baseline up to end of treatment (up to approximately 3 years)
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to disease progression or death (up to approximately 3 years)
measure: Percentage of Participants With Best Overall Response
timeFrame: Baseline up to disease progression or death (up to approximately 3 years)
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline up to Cycle 51 (1 cycle = 21 days)
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Assebroek
country: Belgium
city: AYE
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Haine-saint-paul
country: Belgium
city: Hasselt
country: Belgium
city: Ieper
country: Belgium
city: Kortrijk
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Namur
country: Belgium
city: Roeselare
country: Belgium
city: Sint-Niklaas
country: Belgium
city: Tongeren
country: Belgium
city: Tournai
country: Belgium
city: Vilvoorde
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03247413: Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Official title: Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neuritis
Radiofrequency Ablation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
Primary purpose: PREVENTION

Brief summary: Chronic neck and back pain has become one of the leading causes of disability and loss of productivity. For many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe procedure with minimal risk of adverse events. However, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations


Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations
* age greater than 18 years old
* English speaking

Exclusion Criteria:

* patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints
* on anticoagulation
* have a pacemaker
* age less than 18 years old
* non-English speaking

Primary outcomes:
measure: Number of Lesions With Post-Ablation Neuritis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Akhil Chhatre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shustorovich A, AlFarra T, Arel AT, Singh JR, Roemmich RT, Chhatre A. Dexamethasone Effectively Reduces the Incidence of Post-neurotomy Neuropathic Pain: A Randomized Controlled Pilot Study. Pain Physician. 2021 Dec;24(8):517-524.