louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06900569: Ashwagandha Supplementation for Prevention of Muscle Damage
Official title: Ashwagandha Supplementation for Recovery From Muscle-damaging Exercise and Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Damage
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ashwagandha is an herbal supplement that has a wide range of benefits related to exercise when supplemented for about 8-12 weeks. This study aims to investigate whether short-term Ashwagandha supplementation can enhance muscle recovery following exercise by measuring muscle strength recovery, swelling, and soreness in the biceps.

Detailed description: The purpose of the study is to determine the effects of Ashwagandha supplementation on recovery from muscle-damaging exercise. Ten to twenty participants will be randomized to receive Ashwagandha supplementation (600 mg/d) or placebo for 10 days. On day 7, participants will perform a muscle damaging exercise session (six sets of concentric and emphasized eccentric repetitions with the biceps). Before and after exercise and at 24, 48, and 72 hours after exercise, isometric muscle strength, muscle swelling (ultrasound), and muscle soreness will be assessed. The investigators hypothesize the Ashwagandha will alleviate symptoms of muscle damage (swelling and soreness) and enhance strength recovery after a bout of muscle-damaging exercise.

Eligibility criteria: Inclusion Criteria: male or female, aged 18-35y

-

Exclusion Criteria:

Conditions that may be affected by exercise (determined by "yes" answers to the "Get Active Questionnaire") Pregnant Breastfeeding

Allergies to:

* Dicalcium Phosphate
* Cellulose
* Vegetable magnesium stearate
* Silica

Primary outcomes:
measure: Change in isometric biceps strength measured with a dynamometer (Nm)
timeFrame: 72 hours
Secondary outcomes:
measure: Change in muscle thickness measured with ultrasound (cm)
timeFrame: 72 hours
measure: Change in muscle soreness measured with a visual analog scale with scores ranging from 0 (no soreness) to 10 (maximal soreness)
timeFrame: 72 hours
measure: Change in sleep quality with the Pittsburgh Sleep Quality Index with scores ranging from 0 (no sleep problems) to 3 (lowest sleep quality)
timeFrame: 10 days
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT04119869: Smart Phone App Intervention In Young Adults With Cancer
Official title: Feasibility and Acceptability of a Smart Phone Application Intervention to Enhance Coping for Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Young Adults
Behavioral Intervention
Smartphone Application
Keywords: Cancer
Young Adults
Behavioral Intervention
Smartphone Application
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study aims to explore the feasibility and acceptability of a smartphone application intervention, called iaya, among young adults with cancer.

Detailed description: The iaya app was developed by clinicians from the Young Adult Program at the Dana-Farber Cancer Institute. The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.

The investigators are conducting this study to see if the iaya app, specifically developed for young adults with cancer, is practical, to determine patient satisfaction with the iaya app, and to test study procedures.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-39 years
* Able to speak/read English
* Have a smart phone
* Receiving cancer treatment
* Active cancer care from an oncologist at Dana-Farber Cancer Institute

Exclusion Criteria:

* Neurological/cognitive condition interfering with the ability to understand and adhere to study procedures
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Number of participants who log in at least 10 times and open at least 3 coping skills exercises
timeFrame: 12 weeks
measure: Mean score on app usability questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in coping scores on the Cancer Behavior Inventory Brief Form
timeFrame: 12 weeks
measure: Change in self-efficacy scores on the PROMIS Self-Efficacy for Managing Emotions Scale
timeFrame: 12 weeks
measure: Change in emotional support on the PROMIS Emotional Support Scale
timeFrame: 12 weeks
measure: Change in quality of life on the Functional Assessment of Cancer Therapy-General Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Hanneke Poort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02562469: ACTIVATE: A Computerized Training Program for Children With ADHD
Official title: ACTIVATE: A Computerized Training Program for Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).

Detailed description: In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be evaluated to determine its effectiveness in improving symptoms of attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly during treatment, and immediately post-treatment.

Eligibility criteria: Inclusion Criteria:

* Children ages 7-11 with a diagnosis of ADHD
* Parent and child must be fluent English speakers
* Family has access to desktop/laptop computer at home with internet access (in order to implement the ACTIVATE intervention component, which is an online-based computer program)

Exclusion Criteria:

* Developmental delay or psychosis that impacts the child's ability to function and engage in the computerized intervention
* If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home)
* If the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Intelligence Scale for Children - Fourth Edition

Primary outcomes:
measure: ADHD symptoms on the Disruptive Behavior Rating Scale
timeFrame: Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
Clinical trial NCT02396069: The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers
Official title: A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double blind, randomized, placebo control, multiple dose, dose escalation study

Detailed description: A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* 19\~55 years healthy male
* BMI measurement 20kg/m²\~27kg/m²
* 90 ≤ SBP\<140(mmHg) 60 ≤ DBP\<100(mmHg) 45 ≤ Pulse rate\<100(bpm)
* Signed the informed consent form to participate voluntarily and to comply with the trial requirements
* For a follow-up visit and during the study period, blood samples and availability

Exclusion Criteria:

* History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer)
* History of skin disease of graft affecting absorption of the drug
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 60 days of the screening test
* Donated blood within 60 days prior to screening test

Primary outcomes:
measure: AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)
timeFrame: 96 hours, 73 hours
Secondary outcomes:
measure: Cav,ss
timeFrame: 96 hours
measure: t1/2β
timeFrame: 96 hours
measure: Vd,ss
timeFrame: 96 hours
measure: CL
timeFrame: 96 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
affiliation: Asan Medical Center
name: Hyeong-Seok Lim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02258269: The Effect of Square Dance on Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* had wrist and/or MCP involvement
* aged 18 years diagnosed by rheumatology consultants with RA

Exclusion Criteria:

* severe psychological difficulties
* currently receiving mental health care
* any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
* previously attended an education programme
* had a Modified Health Assessment Questionnaire score above 2 (0-3)

Primary outcomes:
measure: Changes from baseline Arthritis Helplessness Index (AHI) at 24 weeks
timeFrame: At 0 week, 12 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References:
Clinical trial NCT06513169: Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia
Official title: Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia - a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Induction Hypotension
Keywords: hypotension
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if lower extremity elevation (LEE) will reduce the incidence of postinduction hypotension, to compare the utilization of vasoactive medications after induction in patients with LEE and patients without LEE and to determine if LEE will increase measured cardiac output


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA)3 or lower
* Patients requiring general anesthesia

Exclusion Criteria:

* Allergic reaction to drugs commonly used for general anesthesia including fentanyl, midazolam, propofol, ephedrine and phenylephrine
* Pregnant women
* Requiring rapid sequence induction
* Prisoners
* Patient refusal
* Emergency Surgery

Primary outcomes:
measure: Number of participants that demonstrate hypotension
timeFrame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Secondary outcomes:
measure: Number of participants that demonstrate Nadir blood pressure
timeFrame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
measure: Change in heart rate
timeFrame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
measure: Number of participants that need rescue vasoactive agents
timeFrame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
measure: Accumulated dose of rescue vasoactive agents
timeFrame: End of study (within 15 minutes of baseline)
measure: Change in non-invasive cardiac output
timeFrame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ranganathan Govindaraj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03802669: Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients
Official title: Molecular Assessment of Oral Mutans Streptococcus Isolated From Patients With Different Age and Caries Activity Via Selective Media and Protein Pattern.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: human saliva
mutans streptococcus
PCR
caries activity
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending out patient clinic of October University for Modern Sciences and Arts.

Brief summary: 90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique.


Eligibility criteria: Inclusion Criteria:

* healthy participant

Exclusion Criteria:

* participant received antimicrobial therapy in previous month.
* participant who taking xylitol chewing gum or undergo fluoride therapy.

Primary outcomes:
measure: oral mutans streptococcus screening
timeFrame: immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October University of Modern Sciences and Arts
Study officials:
affiliation: October University for Modern Sciences and Arts
name: Naglaa Ezzeldin, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816269: Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection
Official title: Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Dental scaling
Eradication
Reinfection
Helicobacter status
Lead sponsor: Goztepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible population with H.pylori infection and result of treatment based on presence of dental scaling.

Brief summary: Patients who had received H.pylori eradication treatment will be categorised as eradication and reinfection status and whether dental scaling has any influence on these results.

Detailed description: Patients over 18 years with no comorbidities especially liver, cardiac and haemorrhagic diathesis and giving informed consent will be categorised according to their status of dental scaling, eradication and reinfection rates of h.pylori.

Statistical examination will include the multiple regression and Chi-Square.

The result will emphasize the influence of dental scaling on eradication (Presence of Hp cure 1-6 months after treatment) and reinfection ( reappearance of Hp 12 months later than the treatment).

Eligibility criteria: Inclusion Criteria:

* Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.

Exclusion Criteria:

* Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.

Primary outcomes:
measure: The eradication and reinfection rates in dental scaled and non-scaled patients.
timeFrame: last 1 year
Secondary outcomes:
measure: Reinfection rate of patients treated for H.pylori
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: GoztepeTRH
city: Istanbul
country: Turkey
facility: GoztepeTRH
Study officials:
References:
Clinical trial NCT03772769: Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
Official title: Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Odontogenic Deep Space Neck Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eurofins
First posted: 2018-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the sensitivity and specificity of the Target Enriched Multiplex (TEM) polymerase chain reaction (PCR) platform for the rapid molecular diagnosis and treatment of odontogenic deep space neck infections.


Eligibility criteria: Inclusion Criteria:

* Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.

Exclusion Criteria:

* Patients with gross communication between the abscess and the oral cavity will be excluded.

Primary outcomes:
measure: Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
timeFrame: Baseline (at the time the sample was obtained from the patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Th University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jonathon Jundt, DDS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184269: A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Primary Hypercholesterolemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-28
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1017-1" and co-administration of "BR1017-1A" and "BR1017-1B" in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Primary outcomes:
measure: AUCτ
timeFrame: 0-72 hours after administration
measure: Cmax
timeFrame: 0-72 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Center, H PLUS Yangji Hospital
state: Gwanakgu
Study officials:
References: