louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04842903: Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease
Official title: Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Anxiety
Sleep
Keywords: Chronic obstructive pulmonary disease
Therapeutic touch
Sleep quality
Anxiety
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose is to determine the effect of therapeutic touch on the sleep quality and anxiety of individuals with chronic obstructive pulmonary disease.

Material and methods: This study was conducted between March 2018 and March 2019 as a randomized controlled experimental study conducted with pre-test post-test model. In addition to the routine nursing care, therapeutic touch (TT) and study scales were applied to the experimental group for a total of three sessions, once a day and 10 minutes each, for three consecutive days and only study scales were applied to the control group. The data was collected using Personal Information Form, Richard-Campbell Sleep Questionnaire and State Anxiety Inventory.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Literate
* Oriented, open to communication and cooperation
* Those who are hospitalized in the clinic for at least four days
* Patients who volunteered to participate in the study were included.

Exclusion Criteria:

* Have any diagnosed psychiatric disorder
* Using antidepressants, antihistamines, benzodiazepines, hypnotic and narcotic drugs
* Persons using any other complementary and alternative treatment method during the therapeutic touch application were not included in the study.

Primary outcomes:
measure: Richard-Campbell Sleep Questionnaire
timeFrame: 3 days
Secondary outcomes:
measure: State Anxiety Inventory
timeFrame: 3 days
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal Univercity
Study officials:
affiliation: Bolu Abant Izzet Baysal University Faculty of Health Science
name: Birgül CERİT, PhD
role: STUDY_DIRECTOR
References:
citation: Caliskan MA, Cerit B. Effect of therapeutic touch on sleep quality and anxiety in individuals with chronic obstructive pulmonary disease: A randomized controlled trial. Complement Ther Clin Pract. 2021 Nov;45:101481. doi: 10.1016/j.ctcp.2021.101481. Epub 2021 Sep 8.
Clinical trial NCT02573103: Air Pollution and Cardiovascular Disease
Official title: Air Pollution and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will maintain enrollment criteria of the in-progress study being healthy adults without CV disease or risk factors

Brief summary: To determine the effects of ambient airpollution exposures on cardiovascular responses among healthy adults without cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* without CV disease or risk factors (e.g., hypertension, diabetes, or treated hyperlipidemia). Subjects are non-smokers in non-smoking household.

Exclusion Criteria:

* Screening visit BP\>140/90 mm Hg, fasting glucose \>126 mg/dL, or positive urine pregnancy test (females). Subjects cannot be taking any medications or over-the-counter drugs that affect CV function.

Primary outcomes:
measure: Dyslipidemia
timeFrame: One year
Secondary outcomes:
measure: System oxidative stress
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University School of Public Health
name: Wei Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721643: Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)
Official title: Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oxidative Stress
Keywords: Angelica keiskei
absorption kinetics
quercetin
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (\>60 yr, n=5)
* subjects with metabolic syndrome (\>60 yr, n=5)
* Subjects who has

  * high fasting plasma glucose (\>5.6 mmol/L),
  * central obesity (waist-hip ratio, \>0.9 for men, \>0.85 for women)
  * either high blood pressure (\>130/85 mmHg) or high triacylglycerol (\>1.7 mmol/L) will be selected to have metabolic syndrome.
* normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function
* no history of smoking or alcoholism.

Exclusion Criteria:

* consume \>7 alcoholic drinks/wk
* taking cholesterol medication or hormone replacement

Primary outcomes:
measure: Plasma quercetin
timeFrame: 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min
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: Kyung-Jin Yeum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595543: Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pseudophakic Cystoid Macular Edema
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-01-16
Enrollment: 166
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: To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
* Males and females 18 years and older
* Able to provide written informed consent

Exclusion Criteria:

* Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
* Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
* History of Uveitis
* Ipsilateral intraocular surgery prior to cataract surgery
* CME greater than one year duration

Primary outcomes:
measure: Acute Pseudophakic Cystoid Macular Edema
timeFrame: 5 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 5 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Soll Eye Associates
state: Pennsylvania
Study officials:
affiliation: Soll Eye Associates
name: David Rho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351543: Effect of Microbial Exposure on Health, Particularly Immune System
Official title: ADELE: Autoimmune Defense and Living Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Disorders
Keywords: vaccine response
immune system activity
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2017-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.

Detailed description: The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.

Eligibility criteria: Inclusion Criteria:

* Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.

Primary outcomes:
measure: difference in blood serum's cytokine levels
timeFrame: 1-3 months
measure: difference in blood serum IgE levels
timeFrame: 1-3months
measure: Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
timeFrame: 1-3 months
Secondary outcomes:
measure: difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community
timeFrame: 1-3 months
measure: difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community
timeFrame: 1-3 months
measure: Number of participants with treatment-related adverse events as assessed by a questionnaire described below
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Helsinki University
state: Häme
Study officials:
affiliation: University of Helsinki
name: Aki Sinkkonen, Ph D Docent
role: STUDY_CHAIR
References:
Clinical trial NCT02818543: Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis
Official title: An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Lycera Corp.
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy.
* Male or female age 18 to 75
* May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy

Exclusion Criteria:

* Current anti-tumor necrosis factor use
* Current immunosuppressant use (Note: this does not include corticosteroid use)
* Subjects with only distal active disease (i.e. proctitis)
* Clinically significant active infection
* Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required
* History of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ
* Clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin)
* History of colon resection
* Any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: up to 48 hours
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: up to 48 hours
measure: Percentage of estimated Area Under the Curve (0-inf)
timeFrame: up to 48 hours
Secondary outcomes:
measure: Treatment emergent adverse events (TEAEs)
timeFrame: 7 days post-dose
measure: Clinical laboratory data
timeFrame: 7 days post-dose
measure: Vital signs
timeFrame: 7 days post-dose
measure: 12-Lead Electrocardiogram (ECG)
timeFrame: 7 days post-dose
Other outcomes:
Locations:
city: Balatonfured
country: Hungary
facility: DRC Ltd.
city: Budapest
country: Hungary
facility: PRA Magyarorszag Kft
Study officials:
References:
Clinical trial NCT01020643: Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia
Official title: Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conscious Sedation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.


Eligibility criteria: Inclusion Criteria:

* patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria:

* contraindication to spinal anesthesia
* allergies to any study drug

Primary outcomes:
measure: Controller performance
timeFrame: 1 year
Secondary outcomes:
measure: fluid management
timeFrame: end of surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC - Montreal General Hospital
state: Quebec
Study officials:
affiliation: MUHC - MGH
name: Thomas Hemmerling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330143: Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
Official title: A Phase II Multi-center, Randomized, Blind, Placebo-controlled Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1-infection
HIV Infections
PD-L1 Gene Mutation
Keywords: ASC22
HIV
PD-L1
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 19
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: This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤ 60 years old at screening.
* Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
* Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
* CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
* Weight ≥ 50 kg at screening.

Exclusion Criteria:

* Known allergy to the drug or excipients used in this trial.
* HIV-associated opportunistic infections in the past 5 years.
* Co-sensors of HBV, HCV, syphilis, etc.
* With bleeding disorders or on anticoagulant therapy.

Primary outcomes:
measure: CD4/CD8 ratio changes compared with baseline
timeFrame: Week 4\Week 8\Week 12
Secondary outcomes:
measure: HIV-DNA copy changes compared with baselnie
timeFrame: Week 12
measure: CD4+ count changes compared with baseline
timeFrame: Week 12
measure: CD8+ count changes compared with baseline
timeFrame: Week 12
measure: HLA-DR number changes compared with baseline
timeFrame: Week 12
measure: CD38 count changes compared with baseline
timeFrame: Week 12
measure: IL-2 concentration changes compared with baseline
timeFrame: Week 4\Week 8\Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of the General Hospital of the Peoples Liberation Army
state: Beijing
Study officials:
References:
Clinical trial NCT01993043: 39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
Official title: Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ROP Threshold
Keywords: ROP
Bevacizumab
Laser
Development
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature infants

Brief summary: Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular endothelium growth factor (VEGF) is an important component of this disease. The goal of treatment is to reduce the production of VEGF in the immature retina and to eliminate the abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is important for the development of neurons and vessels in the systemic organs in premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm effects on ocular and systemic systems, especially neurological development. In this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to compare the short and long-term vision and neurodevelopmental outcomes of infants treated with IVB compared to laser ROP.

Detailed description: This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. Descriptive statistics from a two sample t-test or Fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. We predefined a statistical significance level p=0.05.

Eligibility criteria: Inclusion Criteria:

Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I ROP .

Exclusion Criteria:

1. Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
2. Lack of signed consent by the parent or legal guardian.

Primary outcomes:
measure: Vision
timeFrame: 5 years
Secondary outcomes:
measure: The changes of neurodevelopment outcome from birth to 5 years of age
timeFrame: 1 to 5 years old
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lubbock
country: United States
facility: TTUHSC
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Lingkun Kong, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331343: Effectiveness Study of the Guardian RT in Type 1 Diabetics
Official title: The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes
Glycemic Control
Continuous Glucose Monitoring
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 156
Sex: ALL
Minimum age (years): 8
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.

Detailed description: The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes for at least 12 months
* HbA1c must be 8.1% or above at study entry
* Intensive Insulin Therapy 3 months prior to study entry

Exclusion Criteria:

* Impaired hearing or vision (must see screens and hear alarms)
* Unable to comply with protocol
* Chronic debilitating or psychiatric disturbances

Primary outcomes:
measure: Difference in Change in A1c (%) between continuous use of CGM and control
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in change in A1c (%) between biweekly use of CGM and control
timeFrame: 12 weeks
measure: Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Corbeil-Essonnes Cedex
country: France
facility: Hospital Sud Francilien
city: Paris
country: France
facility: CH Robert Debre
city: Berlin
country: Germany
facility: Klinik fur Allgemeine Charite
city: Petah Tikva
country: Israel
facility: Schneider Children Centre
city: Milano
country: Italy
facility: U.O. Medicina Generale
city: Ljubljana
country: Slovenia
facility: University Children's Hospital
city: Huddinge
country: Sweden
facility: Huddinge University Hospital
city: Dorset
country: United Kingdom
facility: Royal Bournemouth Hospital
Study officials:
References: