louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05310123: AC-11 Supplement and Biological Aging
Official title: Investigation of AC-11® Supplementation in Reversing Epigenetic Markers of Biological Aging Including Those Related to Telomere Length
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aging
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: Optigenex, Inc
First posted: 2022-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, non-randomized
Primary purpose: PREVENTION

Brief summary: This is a prospective non-randomized clinical study of 24 patients to evaluate the effects of the AC-11®. The study will evaluate the effectiveness of the supplement's ability to reverse epigenetic markers of biological age. The duration of the study will be 6 months.


Eligibility criteria: Inclusion Criteria:

1. Men and women of any ethnicity.
2. Age Range 55 years and older
3. The patient must be able to comply with the treatment plan and laboratory tests

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. No immune system issues or immunodeficiency disease
3. No history of viral illness which could be reactivated by immune downregulation
4. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
5. Diagnosis of a transient ischemic attack in the 6 months prior to screening
6. Patients infected with hepatitis C or HIV
7. Patients with Body Mass Index (BMI) \> 40 kg/m2
8. Presence of active infection
9. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
10. Unable or unwilling to provide a required blood sample for testing
11. As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
12. If the patient has previously used AM/PM HealthSpan system supplements at any time before the start of the trial.

Primary outcomes:
measure: Methylation age clock testing
timeFrame: Change in epigenetic age from baseline to 6 months
measure: Telomere Test
timeFrame: Change in telomere length from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Thrive Medicine Clinic
state: Texas
Study officials:
affiliation: Thrive Medicine Clinic
name: Phillip Gallegos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guthrie OW, Xu H. Reduced Phosphorylation of Histone Variant H2Ax in the Organ Of Corti Is Associated With Otoprotection from Noise Injury. Otolaryngology 2013; 3:131.
Clinical trial NCT00439023: Glucose in Dialysis Water in Non-diabetics
Official title: Effect of Glucose in Dialysis Water on Blood Pressure and Vasoactive Hormones in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure, Chronic
Keywords: Chronic renal failure, dialysis, hemodialysis,
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes are

1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and
2. to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other

Detailed description: Measurement of hormones and blood pressure during dialysis treatment.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years,
2. Both men and women,
3. Dialysis treatment for at least three months

Exclusion Criteria:

1. Heart failure,
2. Chronic liver disease,
3. Diabetes mellitus,
4. Malignant disease,
5. Nephrotic syndrome,
6. Lack of compliance, 7 Unwillingness to participate

Primary outcomes:
measure: Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones
timeFrame: one week
Secondary outcomes:
measure: Relationship between changes in blood pressure and changes in hormones during treatment
timeFrame: one week
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Holstebro Hospital
Study officials:
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00403923: Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis
Official title: A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactose Intolerance
Ulcerative Colitis
Keywords: Lactose intolerance
Ulcerative colitis
Lactose
Threshold
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2006-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lactose intolerance

Brief summary: The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs.

There is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. The general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). However, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little as 0.02 grams (6).

Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose.

This study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions.


Eligibility criteria: Inclusion Criteria:

1. Confirmed lactose intolerance demonstrated with a lactose intolerance test.
2. Confirmed ulcerative colitis demonstrated with histological and radiological tests.
3. Adherence to a lactose free diet for at least four days before the start of the study.

Exclusion Criteria:

1. Failure to adhere to a lactose free diet.
2. Pregnancy.
3. Unwillingness to comply with study outline.

Primary outcomes:
measure: Symptoms of pain and diarrhoea
timeFrame: Over 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: Leicestershire
Study officials:
affiliation: University Hospitals, Leicester
name: John F Mayberry, DSc MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04023123: Anterior Corneal Striae in Hypotony
Official title: The Clinical Significance of Anterior Corneal Striae in Hypotony
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotony Ocular
Cornea Folds and Rupture of Bowman's Membrane Both Eyes
Maculopathy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 98
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: Subjects \>= 18 years of age with a history of glaucoma and glaucoma surgery

Brief summary: The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.


Eligibility criteria: Inclusion Criteria:

* Subjects \>= 18 years of age
* History of glaucoma
* History of glaucoma surgery
* Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation

Exclusion Criteria:

* Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis

Primary outcomes:
measure: Corneal hysteresis
timeFrame: Baseline
measure: Incidence of anterior corneal striae
timeFrame: Baseline
measure: Incidence of hypotony maculopathy
timeFrame: Baseline
Secondary outcomes:
measure: Axial length
timeFrame: Baseline
measure: Corneal thickness
timeFrame: Baseline
measure: Corneal curvature
timeFrame: Baseline
measure: Corneal resistance factor
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Leon Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409550: CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children
Official title: CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma
Keywords: Allergic Rhinitis
Asthma
Children
Control
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

Brief summary: This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

The study will be completed in two medical examination, within 3-6 weeks of each other.

CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient.

The main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.


Eligibility criteria: Inclusion Criteria:

* 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months
* 12 \< years old \> 6

Exclusion Criteria:

* Patients with asthma only or allergic rhinitis only, or younger or older than the targeted age group

Primary outcomes:
measure: CARATKids Italian language validation
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology, IBIM
Study officials:
References:
Clinical trial NCT05915650: Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty
Official title: Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study intends to carry out pain neuroscience education intervention for TKA patients to clarify the effect of this method on the degree of postoperative pain, the incidence of pain catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as to provide a basis for clinical nursing of such patients.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time;
2. The subjects included in this study were men or women aged 45-74 years;
3. Clear self-cognition, can browse the text by themselves or can answer questions correctly;
4. Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study;
5. Without serious physical diseases such as heart, liver or kidney;
6. No history of mental illness or drug dependence.

Exclusion Criteria:

1. Combined with severe trauma in other parts;
2. Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases;
3. Patients with knee tumor and severe knee deformity who could not complete the rehabilitation;
4. With neurological diseases that limit physical activity;
5. Participating in other investigators during the same period.

Primary outcomes:
measure: Visual analogue scale pain score, (VAS)
timeFrame: 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Yongmei Zhang
state: Guizhou
Study officials:
References:
Clinical trial NCT04009850: Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Official title: Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
First posted: 2019-07-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
Primary purpose: OTHER

Brief summary: This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Detailed description: The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker

Exclusion Criteria:

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol

Primary outcomes:
measure: Total Number of Cigarettes Smoked
timeFrame: Week 6
Secondary outcomes:
measure: E-cigarette Use
timeFrame: Week 6
measure: Tobacco Product Satisfaction
timeFrame: Week 6
measure: Motivation to Quit Smoking
timeFrame: Week 6
measure: Nicotine Dependence
timeFrame: Week 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Krysten Bold, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103050: A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine
Official title: A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic inflammation
Seasonal rhinitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
* positive skin prick test to ragweed allergen within twelve months of screening

Exclusion criteria:

* Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
* Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
* Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Total Nasal Symptom Score measured during allergen exposure
timeFrame: 14 Days
Secondary outcomes:
measure: Nasal airway patency assessed by acoustic rhinometry during allergen exposure
timeFrame: 14 days
measure: Nasal secretion weight during allergen exposure
timeFrame: 14 days
measure: Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure
timeFrame: 14 days
Other outcomes:
Locations:
city: Ontario
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05139550: Smartphone Rehabilitation App For Stroke Survivor
Official title: Smartphone Rehabilitation App For Stroke Survivor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
CVA
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of a smartphone app in which the tool will be developed and validation of the tool will be done for the rehabilitation of upper limb in stroke survivors. The study will be divided into two phases. The first phase will be the development of a smartphone app for upper limb function. The second phase of the study will be a pilot study where 10 stroke patients will be recruited and upper limb intervention will be applied through a smartphone app.


Eligibility criteria: Inclusion Criteria:

* Subacute and chronic stroke patient \> 3 months post stroke till 1 year.
* Modified Ashworth scale scoring ≤ 2
* An ability to understand the command
* First ever stroke
* Grade II, III on Functional mobility Scale
* Able to use and comprehend smart phone.

Exclusion Criteria:

* Vestibular disorders, paroxysmal vertigo
* Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome

Primary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: 4 weeks
measure: Nine-Hole Peg Test (9HPT)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD*
role: STUDY_CHAIR
References:
Clinical trial NCT04034550: Cohort of Hospitalized Patients Suspected of Leptospirosis
Official title: Cohort of Hospitalized Patients Suspected of Leptospirosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Leptospirosis
Keywords: leptospirosis
hospitalization
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2019-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.


Eligibility criteria: Inclusion Criteria:

* clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR
* onset of symptoms within 21 days
* participant benefits of health insurance

Exclusion Criteria:

* participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))

Primary outcomes:
measure: disease severity
timeFrame: 0 to 21 days after onset of symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Benoît
country: France
facility: Groupe Hospitalier Est Réunion (GHER)
state: Reunion
city: Saint Pierre
country: France
facility: CHU de La Réunion site Sud (GHSR)
state: Reunion
city: Saint-Denis
country: France
facility: CHU de La Réunion site Nord
state: Reunion
city: Saint-Paul
country: France
facility: Centre Hospitalier Ouest Réunion (CHOR)
state: Reunion
Study officials:
affiliation: CHU Reunion, INSERM, CNRS, IRD UMR PIMIT
name: Loïc RAFFRAY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: