louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963871: The Effect of Yoga in Chronic Low Back Pain
Official title: The Effect of Yoga in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: chronic low back pain
low back pain
yoga
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if yoga is an effective intervention in treating individuals with chronic low back pain (LBP).

Detailed description: Chronic LBP is a major public health problem associated with functional and psychological disability. Conservative interventions are often prescribed to people suffering from chronic LBP, but alternative interventions like yoga are not well researched. The regulator practice of yoga may improve pain, disability or quality of life in people with chronic LBP.

Study participation will last approximately 24 weeks. Yoga sessions will last 12 weeks for 2 one hour sessions per week

Eligibility criteria: Inclusion Criteria:

* a history of chronic LBP with degenerative joint or disc disease \> than 3 months (47-48)
* present with at least minimal pain (3 out on a 0 - 10 pain scale where 0 = no pain, 10 = maximum pain imaginable)
* disability (30% or more per Oswestry Disability Scale),
* score more than 24 on the Folstein Mini-Mental State Exam
* English comprehending individuals naïve to structured yoga practice

Exclusion Criteria:

* known current pregnancy
* claustrophobia
* glaucoma
* significant or chronic decline in immune function such as reported immune related diagnosis like pneumonia or systemic infection
* LBP resulting from something other than disc or joint disease
* spinal stenosis, spinal fusion or other orthopedic surgery in the past six months
* mental disease/psychosis such as dementia
* prior history of chronic neurological disorders (e.g. stroke, Parkinson's disease, multiple sclerosis)
* fibromyalgia
* radiculopathy
* standard MRI exclusion criteria
* inability to make regular time commitments
* no transportation means to the scheduled yoga sessions
* experience with regular practice of yoga within the past year.

Primary outcomes:
measure: self-perceived pain and disability
timeFrame: Change in questionnaire scores from baseline to week 24
Secondary outcomes:
measure: change in physical function
timeFrame: Change from baseline to week 24
measure: change in immunity
timeFrame: Change from baseline to week 24
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT00175071: Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Official title: Effect of Conventional and Reformulated Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Metabolic Syndrome X
Cardiovascular Diseases
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The current study is designed to assess the effect of a conventional cooking oil (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease risk factors.

Detailed description: It is known that in subjects with high cholesterol levels that substitution of hydrogenated fat (high in trans fat) with vegetable oil results in higher levels of total and LDL cholesterol ("bad" cholesterol). There has been tremendous interest within the food industry to identify cooking fats that have the physical properties necessary to make shelf stable products and have textural characteristics similar to existing products but that also favorably affects risk factors for coronary heart disease (CHD) such as LDL cholesterol levels and inflammatory markers. The current study is designed to assess the effect of a conventional cooking oil (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease risk factors.

Eligibility criteria: Inclusion Criteria:

* Gender: female
* Age: 50-85 years
* LDL-C concentrations \>120 mg/dL
* Menopausal status: postmenopausal

Exclusion Criteria:

* Use of medications known to affect lipid metabolism
* Untreated thyroid disease
* Diabetes mellitus
* Abnormal kidney function
* Abnormal liver function
* Smoking
* Alcohol consumption \> 2 drinks/day

Primary outcomes:
measure: Serum lipid, lipoprotein and apolipoprotein concentrations, measures of inflammation, cholesteryl ester transfer protein (CETP) and lecithin-cholesterol acetyltransferase (LCAT) activities, endogenous lipid synthesis rates, expression of genes associated
timeFrame: 5 weeks period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Alice H Lichtenstein, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vega-Lopez S, Matthan NR, Ausman LM, Ai M, Otokozawa S, Schaefer EJ, Lichtenstein AH. Substitution of vegetable oil for a partially-hydrogenated fat favorably alters cardiovascular disease risk factors in moderately hypercholesterolemic postmenopausal women. Atherosclerosis. 2009 Nov;207(1):208-12. doi: 10.1016/j.atherosclerosis.2009.03.039. Epub 2009 Apr 5.
Clinical trial NCT00672971: Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
Official title: An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Lice
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.


Eligibility criteria: Inclusion Criteria:

* 4 - 85 years of age
* active head lice infestation of at least ≥ 10 live lice
* short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)

Exclusion Criteria:

* had received or used an investigational new drug within the 30 days immediately preceding the study
* used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
* used topical medication of any kind on the hair for a period of 48 hours prior to the visit
* had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
* Female subjects that were pregnant or breast feeding

Primary outcomes:
measure: Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
timeFrame: 14 or 15 days after 1st treatment
Secondary outcomes:
measure: Any adverse events during or after application of the product
timeFrame: up to 7 or 8 d after product application
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Lice Source Services Inc
state: Florida
Study officials:
affiliation: Lice Source Services
name: Lidia Serrano, CRI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05750771: Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
Official title: Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.


Eligibility criteria: Inclusion Criteria:

* 1. older than 60 years of age.
* 2. meeting the indications for coronary intervention.
* 3. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm);
* 4. Target lesion vessel diameter \> 2.5 mm

Exclusion Criteria:

* 1. inability to provide written informed consent.
* 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
* 3. the subject is participating in another uncompleted clinical trial
* 4. life expectancy \<1 year.
* 5. non-in situ vascular lesions.
* 6. cardiogenic shock.
* 7. Patients with hemodynamic instability

Primary outcomes:
measure: LLL
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular Hospital
state: Henan
Study officials:
affiliation: Fuwai central China cardiovascular hospotial
name: Muwei Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02291471: Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Official title: An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatic Diseases
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers, able to give written informed consent for participation in the trial;
* Men or women 50% each , aged 18-45 years old;
* Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;

Exclusion Criteria:

* Acute or chronic infection, or history of active tuberculosis;
* History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
* Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
* Subjects with a history of mental problems;
* Pregnant and lactating women or women who plan to be pregnant in 3 months;
* Occurence of clinical significant abnormal laboratory examination value during the screening;
* Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols;
* Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;

Primary outcomes:
measure: Maximum Tolerance Dose
timeFrame: 3 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 3 weeks
measure: pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc）
timeFrame: Pre-dose，2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Phase I laboratory of Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
name: Wang wei
role: STUDY_DIRECTOR
affiliation: Peking University People's Hospital
name: Fang Yi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573971: Verbal Encouragement in Swimming
Official title: The Effect of Verbal Encouragement on Performance and Muscle Fatigue in Swimming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: verbal encouragement
performance
muscle fatigue
swimming
sEMG
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Verbal encouragement (VE) is used to enhance the performance in several sports, even though no studies have been conducted in swimmers and no effects have been reported in elite athletes by some Authors. Besides influencing motor performance, VE is also known to enhance the physical load, thus increasing the probability of developing fatigue. The aim of this research was to study VE in swimmers by evaluating both chronometric performance and muscle fatigue (using sEMG).


Eligibility criteria: Inclusion Criteria:

* at least 1 year of experience in training aimed at regional and international competitions
* a score ≥ 200 points on the personal best in the 200m freestyle, in accordance with the international point score (IPS) (http://www. swimnews.com/ipspoints)
* being healthy

Exclusion Criteria:

* having a disease

Primary outcomes:
measure: swimming velocity
timeFrame: up to 2min 30s
Secondary outcomes:
measure: Pectoralis Major muscle fatigue
timeFrame: up to 2min 30s
measure: Triceps Brachii muscle fatigue
timeFrame: up to 2min 30s
measure: Latissimus Dorsi muscle fatigue
timeFrame: up to 2min 30s
measure: Rectus Femoris muscle fatigue
timeFrame: up to 2min 30s
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Università degli Studi di Genova
state: GE
Study officials:
References:
Clinical trial NCT06688071: FAPI PET/CT in Various FAP-Related Disease Patients
Official title: FAPI PET/CT in Various FAP-Related Disease Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: FAP-related Disease
Tumor
Positron Emission Tomography
Metastasis
Keywords: PET/CT
FAP
FAPI
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-11-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.

Detailed description: Subjects with various FAP-related disease patients underwent 68Ga/18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-FAPI PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04325971: Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects
Official title: Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Grenoble Institut des Neurosciences
name: GIPSA-LAB
First posted: 2020-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of ocular movements and the corresponding brain activation during ecologic visual stimulation in the healthy population.

Detailed description: Cerebral activation following visual stimulation is explored using two neuroimaging techniques EEG and MRI while eye movements are recorded. Three experiments are performed: in MR scanner 1) functional localisation of specific areas: LOC, FFA, MT/V5, V1 and V2 and 2) a saccadic choice experiment; with EEG, replication of the experiments performed in the MR scanner and 3) an additional experiment of movement detection during the ocular saccades.

Thirty young volunteers (18-40 y old) are involved.

Eligibility criteria: Inclusion Criteria:

* Normal vision or corrected to normal
* Social security affiliation
* Signed consent to participate
* No pregnancy fo women

Exclusion Criteria:

* Audition and motor troubles
* Incapable to decide (Persons mentioned in L1121-5,6 et 8 of public health code)
* Neurological disorders
* Pathology affecting oculomotor control
* MRI incompatibility

Primary outcomes:
measure: Eye movement brain networks
timeFrame: 24 months
Secondary outcomes:
measure: OculoDB
timeFrame: 24 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Sara MEONI, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02635178: Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms
Official title: Randomized Control Trial Examining a Brief Anxiety Sensitivity Cognitive Concerns Intervention for Obsessive Compulsive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder and Symptoms
Keywords: Obsessive-compulsive disorder
OCD
Anxiety sensitivity
Cognitive Concerns
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 72
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: Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the population. Whereas several first-line treatments have been established (e.g., pharmacological and psychological), a substantial proportion of patients (40-60%) fail to experience symptom remission, underscoring the need for research in this area. One approach to increasing treatment efficacy is to target underlying risk factors or dysfunctions that may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., "It scares me when I am unable to keep my mind on a task"). There is recent evidence that AS cognitive concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains. However, questions remain as to whether reductions in AS cognitive concerns will lead to subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate the efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years of age or older
* Elevated levels of obsessive-compulsive symptoms as indicated by scoring one standard deviation above the non-clinical mean on any Dimensional Obsessive-Compulsive Scale dimension
* Elevated anxiety sensitivity cognitive concerns as indicated by scoring one standard deviation above the non-clinical mean

Exclusion Criteria:

* Evidence of a significant medical illness that would prevent the completion of interoceptive exposure (IE) exercises
* Non-English speakers
* Individuals currently receiving cognitive-behavioral therapy for anxiety and/or mood disorders or who are not stable on psychotropic medications (i.e., new medication or changes in dosage within the last three months)

Primary outcomes:
measure: Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: Month 1 Follow-Up
Secondary outcomes:
measure: Dimensional Obsessive Compulsive Scale (DOCS)
timeFrame: Month 1 Follow-Up
measure: Sheehan Disability Scale (SDS)
timeFrame: Month 1 Follow-Up
Other outcomes:
Locations:
Study officials:
affiliation: Florida State University
name: Amanda M Raines, M.S.
role: PRINCIPAL_INVESTIGATOR
References: