louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03652584: Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women
Official title: A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Physical Disability
Keywords: postmenopause
diet
Skeletal muscle mass
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Brazilian National Institute of Hormones and Women's Health
First posted: 2018-08-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite the importance of preventing muscle mass loss during senescence, only a few studies have investigated the relationship between diet and muscle mass in postmenopausal women. Therefore, the aim of this study is to investigate whether controlled protein consumption at the current Recommended Daily Allowance (RDA = 0.8 g/kg body weight) or twice the RDA (1.6 g/kg body weight) affects skeletal muscle mass, strength, and physical performance in postmenopausal women. In this parallel-group trial, participants were randomized for 6 months to low glycemic index diets with controlled protein consumption at the current RDA or twice the RDA, aimed to balance energy needs.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Without mobility aids, able to perform activities of daily living independently

Exclusion Criteria:

* Use of hormone therapy in the past 3 months
* Insulin therapy
* Previous diagnosis of heart disease
* Untreated thyroid diseases
* Conditions affecting neuromuscular function

Primary outcomes:
measure: Change in whole-body and appendicular lean mass
timeFrame: 6 months
Secondary outcomes:
measure: Change in isometric hand grip strength
timeFrame: 6 months
measure: Change in usual gait speed
timeFrame: 6 months
measure: Change in systolic blood pressure
timeFrame: 6 months
measure: Change in diastolic blood pressure
timeFrame: 6 months
measure: Change in fat mass
timeFrame: 6 months
measure: Change in resting metabolic rate
timeFrame: 6 months
measure: Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides
timeFrame: 6 months
measure: Change in glucose
timeFrame: 6 months
measure: Change in insulin
timeFrame: 6 months
measure: Change in high-sensitivity C-reactive protein
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Poli Mara Spritzer, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05503784: Study to Evaluate the Efficacy of Bite's Natural Deodorant
Official title: Study to Evaluate the Efficacy of Bite's Natural Deodorant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sweat
Underarm Odor
Keywords: sweat
underarm odor
perspiration
Lead sponsor: Kind Lab PBC.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-17
Enrollment: 38
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: OTHER

Brief summary: This is an open-label observational single-arm clinical trial to study the efficacy of a commercial deodorant and its effect on odor, clothing (stains), and quality of life. It is hypothesized that the deodorant marketed as Bite deodorant will mask bodily odor in participants, will not stain clothes, and improve the quality of life in trial participants.


Eligibility criteria: Inclusion Criteria:

* Agree to refrain from the use of any other deodorant or antiperspirant other than Bite for the study period
* Must be in good health (does not report any medical conditions asked in the screening questionnaire)
* Must be willing to comply with the requirements of the protocol
* Must be willing to add the deodorant to their daily routine
* Is willing and able to share feedback
* Shower daily, and put deodorant on the first thing in the morning (before sweating)
* If used deodorants previously must be a natural version

Exclusion Criteria:

* Unwilling to follow the routine of the protocol
* Currently participating in another research study
* Severe chronic conditions including oncological conditions, psychiatric disease, or other
* Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Presence of self-reported armpit sensitivity
* Known to have severe allergic reactions
* Have known allergies to the trial product ingredients
* Currently using an antiperspirant

Primary outcomes:
measure: Changes in underarm odor
timeFrame: 4 weeks
measure: Changes in clothing staining
timeFrame: 4 weeks
measure: Changes in reported quality of life
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05362084: Intravascular Injection Incidences During Lumbar Medial Branch Block
Official title: Comparison of Intravascular Injection Incidences Durig Lumbar Medial Branch Block Using Anteroposterior or Oblique Angle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravascular Injection
Keywords: intravascular injection
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block

Detailed description: In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection demonstrated technical easiness and reduced intravascular injection incidences. For the procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are possible. Usually, which approach method to use is determined according to the physician's preferences.

The final target for lumbar medial branch block is the junction betweeen superior articular process and transverse process. This target can be easily confirmed under the scotty dog appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty dog appearance more visible so that physician can identify bony landmark more easily for lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide more advantages in identifying bony landmark. However, it is uncertain whether this approach can provide technicaL easiness and reduce the intravascualr injection incidences.

Eligibility criteria: Inclusion Criteria:

* facet joint arthropathy

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality

Primary outcomes:
measure: incidence of intravasuclar injection
timeFrame: 1 minute after finishing lumbar medial branch block
Secondary outcomes:
measure: time required to complete lumbar medial branch block
timeFrame: 1 second after finishing lumbar medial branch block
measure: radiation amount to complete lumbar medial branch block
timeFrame: 1 second after finishing lumbar medial branch block
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
References:
Clinical trial NCT06677684: The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial
Official title: The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-Acquired Pneumonia
Vitamin a
Keywords: Community-acquired pneumonia
Vitamin A
Pediatrics
Hospitalization
Southern Iran
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This randomized clinical trial included 105 children with CAP who were admitted to Bandar Abbas Children's Hospital. Participants were randomly assigned to two groups: a control group receiving standard antibiotic therapy and an intervention group receiving standard antibiotics plus vitamin A (25,000 IU for 2 days).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial included 105 children with CAP who were admitted to Bandar Abbas Children's Hospital. Participants were randomly assigned to two groups: a control group receiving standard antibiotic therapy and an intervention group receiving standard antibiotics plus vitamin A (25,000 IU for 2 days). Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.

Detailed description: Children to present with CAP symptoms

Eligibility criteria: Inclusion Criteria:

* children to present with CAP symptoms, including fever, cough, pulmonary rales, respiratory distress (age-adjusted tachypnea: \>50 breaths per minute for infants under 1 year, \>40 for ages 1-5 years, and \>30 for those over 5 years), and radiographic findings indicative of pneumonia.

Exclusion Criteria:

* underlying immunodeficiency, chronic respiratory conditions, concurrent use of immunosuppressive medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours

Primary outcomes:
measure: duration of hospitalization
timeFrame: Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.
measure: Treatment duration daily Respiratory Index of Severity in Children (RISC) scores
timeFrame: From enrollment to the end of treatment and discharge of patients ( 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
References:
Clinical trial NCT05111184: Educational Impact of a Tablet Application on Nutrition in Maintenance Hemodialysis Patients
Official title: Educational Impact of a Tablet Application on Nutrition in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: Waid City Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigator examines of the impact of digital training on the sodium, potassium and phosphate content of various foods in dialysis patients. The training takes place visually as self-study in the form of a computer-based application.

The working hypothesis is that trained dialysis patients have consistently better plasma electrolyte values than untrained participants.


Eligibility criteria: Inclusion Criteria:

* Dialysis Patient

Exclusion Criteria:

* Pregnancy
* Not preparing own meals

Primary outcomes:
measure: Change of electrolyte levels
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04702984: Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Official title: Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Vision
Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

Detailed description: Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.

Eligibility criteria: Inclusion Criteria:

* Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
* Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any condition that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Front Surface Wettability, by Category
timeFrame: Dispense; Week 1 Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
city: Wichita Falls
country: United States
facility: Alcon Investigator 8028
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01333384: Study in Polish Acromegalic Patients Treated With Somatuline Autogel
Official title: A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland

Brief summary: The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.


Eligibility criteria: Inclusion Criteria:

* Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
* Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available

Exclusion Criteria:

* Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria

Primary outcomes:
measure: Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
timeFrame: 24 months
Secondary outcomes:
measure: Mean growth hormone (GH) levels
timeFrame: 24 months
measure: Proportion of patients with GH levels below 1.0 microgram/liter
timeFrame: 24 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02621684: Physical Activity Intervention in African American Men After Radical Prostatectomy
Official title: A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostatectomy
Prostate Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.


Eligibility criteria: Inclusion Criteria:

* Speaks English
* African American
* Radical prostatectomy for treatment of prostate cancer within the past 12 months
* Cleared by physician to safely participate in a physical exercise program

Exclusion Criteria:

* Does not speak English
* Non-African American
* Previously undergone radiation treatment to the pelvis
* Previously undergone major pelvic surgery
* Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter

Primary outcomes:
measure: Recruitment rate comparisons between physician referral and community advertisement
timeFrame: Completion of study (approximately 3.5 years)
measure: Attrition rate in each arm
timeFrame: Completion of study (approximately 3.5 years)
measure: Intervention effectiveness as measured by change in accelerometer measured physical activity
timeFrame: Completion of study (approximately 3.5 years)
measure: Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Completion of study (approximately 3.5 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Lin Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00671684: Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease
Official title: Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Constipation
Hirschsprung's Disease
Keywords: Hirschsprung's disease
Constipation
Endoscopy, digestive system
Diagnosis
Colonoscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients offered a rectal suction biopsy

Exclusion Criteria:

* any contraindication to general anesthesia or conscious sedation
* contraindication to endoscopy
* untreated or unmanageable coaguloapathy
* thrombocytopenia (\<50)
* inability to provide informed consent.

Primary outcomes:
measure: The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy.
timeFrame: April 2009
Secondary outcomes:
measure: Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain.
timeFrame: April 2009
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
Study officials:
affiliation: MGH
name: Field F Willingham, MD, MPH
role: STUDY_DIRECTOR
affiliation: MGH
name: Garrett C Zella, MD
role: STUDY_DIRECTOR
affiliation: MGH
name: Mari Mino-Kenudson, MD
role: STUDY_DIRECTOR
affiliation: MGH
name: Braden Kuo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MGH
name: William R Brugge, MD, FASGE
role: STUDY_DIRECTOR
affiliation: MGH
name: Leonel Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MGH
name: Clarissa Foy, NP
role: STUDY_DIRECTOR
References: