louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04350541: Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD
Official title: Heart Failure Associated With Chronic Obstructive Lung Disease and Maximum Exercise Tolerance: Evaluation of the Distribution and Pulmonary Deposition of Radioaerosol, Peripheral and Coronary Endothelial Function, Brain Natriuretic Peptide
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.


Eligibility criteria: Inclusion Criteria:

* Sedentary individuals with Heart Failure of all etiologies;
* Diagnosed moderate and severe chronic obstructive pulmonary disease;
* Clinical stability;
* No change in the medication class within three months before the beginning of the research.

Exclusion Criteria:

* Unstable angina;
* Myocardial infarction;
* Previous cardiac surgery up to three months before the beginning of the study;
* Hemodynamic instability;
* Orthopedic and neurological diseases;
* Psychological and/or mental impairment.

Primary outcomes:
measure: Exercise tolerance
timeFrame: 24 weeks
measure: Peripheral endothelial function
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of life assessment: Short Form-36 questionnaire
timeFrame: 24 weeks
measure: Perception of clinical change
timeFrame: 24 weeks
measure: Distance covered in the six-minute walk test
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT03109041: Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Official title: Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreas Cancer
Cancer
Keywords: Whipple
brachytherapy
CivaSheet
CivaTech Oncology
radiation
intraoperative radiation
IORT
resectable pancreatic cancer
Pd-103
Lead sponsor: CivaTech Oncology
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.


Eligibility criteria: Inclusion Criteria:

* Subject signed informed consent
* Age \>/= 18 years
* Biopsy confirmed adenocarcinoma pancreatic cancer
* Patient capable of undergoing anesthesia
* Patient is a surgical candidate
* Patient selected to undergo pancreatic cancer resection
* Patient will have known or suspected close/positive surgical margin
* Confirmed diagnosis of resectable pancreatic adenocarcinoma
* Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle

Exclusion Criteria:

* Pregnant or breast feeding
* Patient has metastatic disease
* Patient has had prior radiation therapy to the region for separate cancer
* Patient has had prior chemotherapy
* Any other invasive cancer in the past 5 years, except basal cell skin
* Recurrent or previously resected tumors
* Alcoholism/Drug abuse

Primary outcomes:
measure: Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University, Brody School of Medicine
state: North Carolina
Study officials:
References:
Clinical trial NCT02260141: Treating Alzheimer's and Dementia With D-ribose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimers
Dementia
Lead sponsor: Practitioners Alliance Network
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study using ribose for alzheimers
Primary purpose: TREATMENT

Brief summary: To study the effectiveness of d-ribose in treating Alzheimer's and Dementia

Detailed description: Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm 3 X day for 8 weeks to monitor outcomes in a pilot study.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Alzheimer's and/or dementia with a Mini Mental Status Exam ( MMSE) score over 12 or being ambulatory and able to travel outside the home with assistance.
* Must have a caregiver living with them.

Exclusion Criteria:

* Overt and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.
* Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months.

Primary outcomes:
measure: ADAS-ADL
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kailua
country: United States
facility: PAN
state: Hawaii
Study officials:
References:
Clinical trial NCT00702741: Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
Official title: A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recovery Following Partial Medial Meniscectomy
Keywords: Knee
Meniscus
Meniscectomy
Mesenchymal Stem Cells
MSCs
Adult Human Stem Cells
Osiris
Chondrogen
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).

Detailed description: The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.

Eligibility criteria: Inclusion Criteria:

* Subject must have received an injection in Protocol No. 550
* Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
* Subject must provide written informed consent for entry into the extension study
* Subject must provide authorization for use and disclosure of protected health information for entry into the extension study

Primary outcomes:
measure: Comparison of treatment adverse event rates
timeFrame: Through 3 years
Secondary outcomes:
measure: Concomitant Medications
timeFrame: Through 3 years
measure: Visual Analog Scale
timeFrame: Through 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine
state: California
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
Study officials:
References:
Clinical trial NCT02479841: Health-promoting Competence, Coping and Quality of Life in Patients With COPD
Official title: Health-promoting Competence, Coping and Quality of Life in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Coping
Quality of Life
Lead sponsor: Helse Fonna
Sponsor class: OTHER
Collaborators: name: Helse Vest
name: University of Stavanger
First posted: 2015-06-24
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability, and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a major public health concern and has considerable impact on health and quality of life.

For this study an evidence based self-management program is developed, the purpose of the study is to see if this self-management program, in collaboration between specialized health services and municipality health services, improves patients with COPD health-promoting competence, coping and quality of life, and reduces health service costs.The study has a RCT design.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD, GOLD 2-4
* Speak and understand norwegian
* Adult

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Health promoting competence, HeiQ
timeFrame: Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program)
Secondary outcomes:
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Helse Fonna
Study officials:
affiliation: University of Stavanger, Norway
name: Signe B Bentsen, PhDProfessor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186641: High Dose Chemotherapy and Autologous Transplant for Breast Cancer
Official title: High Dose Chemotherapy and Peripheral Blood Progenitor Cell Rescue for Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graft vs Host Disease
Keywords: chronic Graft vs Host Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine survival outcomes for patients with chemosensitive brest cancer after treatment with high dose chemotherapy


Eligibility criteria: Inclusion Criteria:

* Stage II, III or IV breast cancer
* chemosensitive
* adequate organ function

Exclusion Criteria:

* prior transplant,
* life threatening disease
* brain metastases

Primary outcomes:
measure: Survival
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Ginna Laport, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04375241: Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
Official title: Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Mobile ECG device
Asymptomatic atrial fibrillation
Lead sponsor: Diagram B.V.
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 2168
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants of this study will be subjects who visit their general practicioner or cardiologist or who visit the DETECT AF team at an event.

Brief summary: Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.

The main objectives are:

* To examine the feasibility of screening subjects of ≥65 years old for AAF.
* To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

Detailed description: Study design:

Prospective validation study.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Is willing to give informed consent

Exclusion Criteria:

* Known medical history with Atrial Fibrillation
* Not mental competent

Primary outcomes:
measure: Sensitivity of the mobile ECG device
timeFrame: At screening
measure: Specificity of the mobile ECG device
timeFrame: At screening
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
Study officials:
References:
Clinical trial NCT05269641: Almond Supplementation on Mild to Moderate Acne
Official title: The Effect of Almond Supplementation on Mild to Moderate Acne
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: microbiome
nutrition
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Almond Board of California
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of almond supplementation on acne and on gut health.


Eligibility criteria: Inclusion Criteria:

* Subjects 15 years of age until 45 years of age.
* The presence of mild to moderate acne based on investigator global assessment.
* Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.

Exclusion Criteria:

* The presence of severe acne as noted by the investigator global assessment.
* Those with a nut allergy.
* Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
* Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
* Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
* Individuals who have been on an oral antibiotic for acne within the previous 1 month.
* Individuals who are pregnant or breastfeeding.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Oral supplementation that has nuts in it.
* Use of isotretinoin within the three months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Primary outcomes:
measure: Total lesion count
timeFrame: 20 weeks
Secondary outcomes:
measure: Inflammatory lesion count
timeFrame: 12 weeks
measure: Inflammatory lesion count
timeFrame: 20 weeks
measure: Non-inflammatory lesion count
timeFrame: 12 weeks
measure: Non-inflammatory lesion count
timeFrame: 20 weeks
measure: Investigator global assessment (IGA) of acne
timeFrame: 12 weeks
measure: Investigator global assessment (IGA) of acne
timeFrame: 20 weeks
measure: Quality of Life Survey
timeFrame: 12 weeks
measure: Quality of Life Survey
timeFrame: 20 weeks
measure: Sebum excretion
timeFrame: 12 weeks
measure: Sebum excretion
timeFrame: 20 weeks
measure: Gut microbiome assessment
timeFrame: 12 weeks
measure: Gut microbiome assessment
timeFrame: 20 weeks
measure: Skin microbiome diversity
timeFrame: 12 weeks
measure: Skin microbiome diversity
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References:
Clinical trial NCT03050541: Effects of MDMA on Emotional and Social Memories
Official title: The Effects of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on Encoding, Consolidation, and Retrieval of Emotional and Social Memories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MDMA
adult
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.

Detailed description: Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of positive, negative, social, and neutral memories. The study will use a between subjects design with three groups (N = 20 per group). Two of the groups will be randomly assigned to receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The third group will receive placebo only (PLC). All three groups will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and other capsules will contain placebo.

Participants will participate in two sessions: a viewing session during which they will view emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which there will be a surprise memory test with two components (verbally cued recollection and picture recognition). On all sessions subjects will also complete mood questionnaires.

Eligibility criteria: Inclusion Criteria:

* Normal healthy males and females, aged 18-40 years.

Exclusion Criteria:

1. any current medical condition requiring medication or abnormal electrocardiogram
2. current or past medical condition considered to be a contraindication for the study conditions
3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
4. less than high school education
5. lack of fluency in English
6. night shift work
7. pregnancy, lactation, or plans to become pregnant
8. use of hormonal contraception

Primary outcomes:
measure: Probability of Accurately Recalling Visual Stimuli
timeFrame: 90 minutes into Session 2
Secondary outcomes:
measure: Probability of Accurately Recognizing Visual Stimuli
timeFrame: 90 minutes into Session 2
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Harriet de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: David Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156141: High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Official title: High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal and Bulbar Muscular Atrophy
Healthy Subjects
Keywords: Kennedy's disease
Spinal and bulbar muscular atrophy
High Intensity Training
High Intensity Interval Training
HIT
HIIT
Training
Exercise
10-20-30
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Spinal and bulbar muscular atrophy or
* Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.

Exclusion Criteria:

* More than 1 hour of fitness weekly before inclusion
* Other disease possibly confounding the results
* Pregnancy or breastfeeding
* Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
* Physical and/or mental conditions preventing participating in the study protocol.

Primary outcomes:
measure: Incremental test
timeFrame: Baseline, week 6, week 11, week 18
Secondary outcomes:
measure: Functional test
timeFrame: Baseline, week 6, week 11, week 18.
measure: Self-rated muscle fatigue, muscle pain and activity level
timeFrame: Every day in week 1-11
measure: Serum concentrations of Creatine Kinase (CK)
timeFrame: Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.
measure: Activity level
timeFrame: Baseline, week 10 and week 18.
Other outcomes:
measure: Serum IGF-1
timeFrame: Baseline, week 11, week 18.
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit
Study officials:
References: