louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05607524: Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial
Official title: Effects of Grape King Bio Probiotic Capsules in Promoting Fat Excretion by Human Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2022-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.

Detailed description: This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. The subjects took two capsules of Grape King probiotics daily, a total of 1000 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Eligibility criteria: Inclusion Criteria:

* male or female participants
* aged 20-40 years old
* body mass index in 25-27 kg/m2
* body fat \> 25% for men and \> 30% for women

Exclusion Criteria:

* cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
* having systemic infections
* using probiotics.

Primary outcomes:
measure: Change from baseline fecel lipid weight at week 4
timeFrame: Week0, Week4
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Yu-Jou Chien, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Xin-Bei Lin, MS student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00624624: Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
Official title: Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Hypogonadism
Keywords: hypogonadotropic hypogonadism
bariatric surgery
serum androgen levels
bone density
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2008-02-27
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with planned bariatric surgery

Brief summary: The purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.


Eligibility criteria: Inclusion Criteria:

* Male
* Age 20-55 years
* Planned bariatric procedure
* Helicobacter pylori negative or adequate HP eradication

Exclusion Criteria:

* Liver and/or kidney dysfunction
* Psychiatric disease
* Medication influencing androgen profile and/or bone metabolism
* Weight \> 160 kg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: H de Boer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769324: Validation of Osmolarity System: Clinical Usability Study
Official title: Validation of Osmolarity System: Clinical Usability Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: I-MED Pharma
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dry Eye Disease

Brief summary: Confirmatory trial to validate usability of a new portable osmolarity testing device.

Detailed description: Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.

Eligibility criteria: Inclusion Criteria:

* Able to provide consent

Exclusion Criteria:

* Ocular pathology (other than Dry Eye)

Primary outcomes:
measure: Osmolarity Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: I-MED Pharma, Inc.
name: Ilan Hofmann, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00711724: Comparison of Self and Clinician Administered Rating Scales in Patients With ADHD
Official title: Comparison of Self and Clinician Administered Rating Scales in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Adolescent
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who are enrolled in the study Protocol 2003-P-001313: "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA."

Brief summary: The primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD
* Age 13-65\* \*Parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the MGH site)

Exclusion Criteria:

* Inability to reliably report ADHD symptoms at the discretion of the investigator

Primary outcomes:
measure: The ADHD-RS and ASRS v1.1 Symptom Checklist scales
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 7, or 8
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Paul Hammerness, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479724: A-line/CareTaker Comparison Study in ICU Patients
Official title: A-line/CareTaker Comparison Study in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: continuous, non-invasive
Lead sponsor: Empirical Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2015-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs)

Brief summary: Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients

Detailed description: The object of the work presented here was to validate a new approach to tracking blood pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond traditional pulse analysis by invoking a physical model that comprehensively links the components of the peripheral pressure pulse envelope with two reflection sites in the central arteries.

In these experiments, approved by the University of Virginia Institutional Review Board, the arterial blood pressures of patients (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs) were monitored using radial intra-arterial catheters, while the CareTaker system collected pulse line shapes at the lower phalange of the thumb of the ipsilateral hand.

Systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements and a Bland-Altman analysis was created. Results were within the limits established for the validation of automatic arterial pressure monitoring (AAMI/ANSI/ISO 81060-1:2013).

Eligibility criteria: Inclusion Criteria:

* male or female age 18 to 45
* presence of a radial arterial catheter
* informed consent by subject or surrogate
* available digital pulse

Exclusion Criteria:

* failure to meet all of the inclusion criteria

Primary outcomes:
measure: Performance comparison according to AAMI/ANSI/ISO 81060-1:2013
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Empirical Technologies Corporation
name: Martin C. Baruch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443924: Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: Bilateral ocular hypertension or early primary open angle glaucoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
* Have best corrected visual acuity in both eyes of at least +0.5 or better
* Have normal endothelial cell counts and morphology

Exclusion Criteria:

* Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
* Have a history of any type of intraocular surgery, except for cataract surgery
* Have had cataract surgery within three months

Primary outcomes:
measure: Safety and tolerability
timeFrame: 28 days
measure: Changes in intraocular pressure
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01797224: OTIS Cimzia Pregnancy Registry
Official title: Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn's Disease
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Psoriasis
Keywords: Autoimmune disease
certolizumab pegol
Cimzia
pregnancy
birth defect
birth outcome
TNF
Tumor necrosis factor
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Organization of Teratology Information Specialists
name: UCB Pharma
First posted: 2013-02-22
Enrollment: 925
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who reside in the United States or Canada.

Brief summary: The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Detailed description: The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Eligibility criteria: Inclusion Criteria:

* Currently pregnant

Primary outcomes:
measure: Major malformations
timeFrame: Duration of pregnancy and up to 1 year of life
Secondary outcomes:
measure: Minor malformations
timeFrame: At dysmorphological exam which will occur at one time point between birth and 5 years of age
measure: Pregnancy Outcome
timeFrame: Duration of pregnancy and up to 1 year of life
measure: Infant follow-up
timeFrame: Duration of pregnancy and up to 5 years of life
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Christina Chambers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04038424: The Effect of Art Therapy on Patients With Stroke
Official title: The Effect of Art Therapy on Cognitive Ability, Arm Activity and Mental Health Status in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ischemic Stroke and Hemorrhagic Stroke
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 60
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: Stroke can affect the physical, emotional and social aspects of the patient and their family members. It is the main cause of complex disability, with a high number of people living with its effects. Stroke can result in impairments in motor function, language, cognition, sensory processing, cognition, and emotional disturbances, which can affect the performance of functional activities and mental health status. Getting patients involved in art therapy (AT) class has shown to alleviate stress and promote a sense of wellbeing, which can aid their recovery and rehabilitation. The benefits of art therapy for people living with different health conditions worldwide have been reported, however, its effect on Egyptian patients with stroke has been neglected.

Detailed description: Art therapy refers to a group of techniques including painting, drawing and listening to music. The participants will receive the program on three steps (early step, middle step, and late step). These steps aim to train the participants on the AT from simple to complex and motivate them to engage in the AT program.Therefore, this study aims to investigate the effect of art therapy on cognitive ability, arm activity and mental health status of patients with stroke.

Eligibility criteria: Inclusion Criteria:

* able to sit upright, supported or unsupported,
* oriented to time and place by using the adapted Arabic Memory Screening Test,
* able to perform at least two of the following skills: drinking from a cup, eating with a spoon and taking money from a purse by the affected arm, and
* will stay in the stroke unit to at least 4 days (for receiving three sessions out of all sessions) before discharge,

Exclusion Criteria:

* diagnosis of transient ischemic attack or brain stem stroke;
* unconscious;
* unable to provide informed consent;
* hemodynamical unstable medical conditions, including fever;
* serious infectious diseases, for example, viral hepatitis or HIV; and/or
* severe dementia or uncontrolled psychiatric problems.

Primary outcomes:
measure: The Montreal Cognitive Assessment (MOCA)
timeFrame: 3 weeks
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 weeks
measure: The Arm Activity (ArmA) Measure
timeFrame: 3 weeks
Secondary outcomes:
measure: The Roger's Happy Sad face
timeFrame: pre and post each session/3 weeks
measure: Self-efficacy and satisfaction for Art
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Unit of stroke and cerebral vascular disease treatment
Study officials:
References:
Clinical trial NCT04863924: Accelerating Lung Cancer Diagnosis Through Liquid Biopsy
Official title: Accelerating Lung Cancer Diagnosis Through Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Lung Health Foundation
name: The Princess Margaret Cancer Foundation
First posted: 2021-04-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the UHN Lung Cancer Rapid Assessment \& Management Program (Lung RAMP) with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer.

Brief summary: This study will assess the utility of liquid biopsy to accelerate the time to treatment for patients with newly diagnosed advanced non-small cell lung cancer, compared to the conventional diagnostic pathway of molecular testing of tumour tissue after imaging and biopsy.


Eligibility criteria: Inclusion Criteria:

1. Lung RAMP Multidisciplinary Cancer Conference or study team confirms radiologic (clinical) evidence of advanced, unresectable lung cancer;
2. Measurable disease (presumed malignant) by RECIST 1.1;
3. Age ≥18 years;
4. Ability to provide written informed consent;
5. Diagnostic biopsy and molecular profiling ordered or planned. Patients remain eligible even if biopsy or tumour testing later fails or is deemed not feasible.

Exclusion Criteria:

1. Pregnancy;
2. Concurrent active malignancy except for localized non-melanomatous skin cancer or non-invasive cervical cancer. Any previous cancer (excluding NSCLC) must have been treated more than 2 years prior to study entry with no current evidence of active disease.

Primary outcomes:
measure: Time to treatment
timeFrame: Up to 18 Months
Secondary outcomes:
measure: Time to treatment - non-smoker subgroup
timeFrame: Up to 18 Months
measure: Turnaround time
timeFrame: Up to 18 Months
measure: Concordance between liquid and tissue
timeFrame: Up to 18 Months
measure: Costs of upfront use of liquid biopsy vs standard tissue profiling
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
Study officials:
References:
Clinical trial NCT00988624: A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Official title: A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Huntington Disease
Keywords: bioavailability pharmacokinetics Alzheimer's Disease Huntington Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with any history of a previous seizure (including childhood febrile seizures) or convulsion or significant head trauma.
* Subjects with hypersensitivity reactions to dimebon or other antihistamines.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Smokers who use greater than 5 cigarettes per day.
* Use of proton pump inhibitors, antacids, and H2-blockers are prohibited for the duration of the study.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception.

Primary outcomes:
measure: PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit).
timeFrame: Day 1-3 of Period 1, 2, 3, 4, or 5
Secondary outcomes:
measure: Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs)
timeFrame: Day 1-3 of Period 1, 2, 3, 4, or 5
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: