louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04166396: Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
Official title: Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cystic Fibrosis
Keywords: resveratrol
nicotinamide riboside
exercise intolerance
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.

Detailed description: Exercise intolerance is a critical problem for people with cystic fibrosis (CF) able to predict hospitalization independent of lung function. Recent studies have suggested that certain supplements may help improving exercise intolerance.

Eligibility criteria: Inclusion Criteria:

CF

* Diagnosis of CF
* Men and women (\> 18 yrs. old)
* FEV1 percent predicted \> 40%
* Patients with or without CF related diabetes
* Resting oxygen saturation (room air) \>90%
* Traditional CF-antioxidant medications
* Ability to perform reliable/reproducible PFTs
* Clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status)
* Pancreatic sufficient and pancreatic insufficient patients

Exclusion Criteria:

CF

* Children 17 years old and younger
* FEV1\<40% predicted
* Resting O2 saturation \<90%
* Clinical diagnosis of heart disease
* Clinical diagnosis of PAH
* Febrile illness within 4 weeks of a study visit
* Antioxidant for pulmonary exacerbation within 4 weeks of a study visit
* Currently smoking, pregnant or nursing
* Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
* Patients with B. Cepacia

Primary outcomes:
measure: Change in Sirtuin1 (Sirt1)
timeFrame: Change from baseline to up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez Miguelez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006196: The Relationship Between Vitamin D, Fingernail Thickness and Bone Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: Vitamin D resistance
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-08
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: Vitamin D deficiency is common in the elderly and contributes to the increased incidence of falls, hip fracture and depression in this population. An unknown number of elderly have vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are no simple procedures or blood tests that identify vitamin D resistance, its prevalence and contribution to disability in the elderly is unknown. Our inability to screen for this condition precludes our ability to initiate and monitor treatment.

Previous studies indicate that fingernail thickness correlates with vitamin D status and may therefore provide a simple cost effective procedure to not only identify patients with vitamin D deficiency but also, those with vitamin D resistance. This procedure may also provide a way to monitor an individual's response to treatment.

This study is designed to demonstrate the association between fingernail thickness and vitamin D status.


Eligibility criteria: Inclusion Criteria:

* females 25-75 years of age with no known bone disorders

Exclusion Criteria:

* history of vertebral fractures or nonvertebral fractures without trauma
* prescription medications for prevention of osteoporosis (including vitamin D other than multivitamin and estrogen)
* history of malignancy other than basal cell or squamous cell cancer of the skin
* use of steroids or anticonvulsants in the 6 months prior to enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: 4488 Forest Park, Suite 201
state: Missouri
Study officials:
References:
Clinical trial NCT05899296: Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
Official title: Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Phobia
Dental Anxiety
Anesthesia, Local
Needle Phobia
Keywords: Dental anxiety
Pain perception
Anesthetic efficiency
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia:

1. Pain perception.
2. Pain related behaviors.
3. Dental anxiety
4. Anesthetic efficiency.
5. Patient acceptance and preference

Detailed description: The prevalent phobia of needles and the associated rise in dental anxiety when using the traditional needle method of LA infiltration, the development of needle-free alternatives for local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new gadget that promises less pain administration of local anesthetic without the use of a hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for intraligmentary injection without penetrating the periodontal ligament. This study was performed due to the lack of sufficient research on NumBee and since it meets a number of exceptional criteria, including being able to anesthetize just one tooth without having to do so for the entire alveolar dental nerve and having a needleless design that may be more appealing to children than the distressing appearance of traditional dental syringes.

Eligibility criteria: Inclusion Criteria:1. Patients with American Society of Anesthesiologists-1(ASA 1) health status (A completely healthy fit patient).

2. Not mentally retarded patient. 3. Cooperative patient, as determined by a behavioral rating of "positive" or "definitely positive" according to the Frankle behavior classification scale.

4. Without a history of dental visits.

-

Exclusion Criteria:

* 1. Mentally and medically compromised child. 2. Patient on medication that effect on the pain perception. 3. History of allergy to L.A.

Primary outcomes:
measure: pain perception
timeFrame: five months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
state: KHARkh
Study officials:
affiliation: University of Baghdad
name: Duaa K Naji
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04911296: Pill Swallow Study
Official title: Pill Swallow Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Not Determined
Lead sponsor: RANI Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP


Eligibility criteria: Inclusion Criteria:

1. Participant age is 21 - 75 years
2. Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
3. Participant currently taking injections to treat a chronic disorder
4. Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening

Exclusion Criteria:

1. Active case of COVID-19
2. History of Dysphagia
3. History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.)
4. Participant self-reports issues with swallowing pills.
5. History of drug or alcohol abuse or any other factor that, in the Investigator's opinion, may interfere with the participant's ability to cooperate and comply with the study procedures
6. History of allergic reaction to a component of the Mock-RP
7. History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks

Primary outcomes:
measure: Successful Swallowing of the Mock-RP
timeFrame: Immediately after swallowing
measure: Percent of Participants Who Would Chose a Pill Instead of Injection
timeFrame: Immediately after swallowing
measure: Mock-RP Swallowing Experience
timeFrame: Immediately after swallowing
measure: Mock-RP Swallowing Experience
timeFrame: Immediately after swallowing
measure: Mock-RP Swallowing Experience
timeFrame: Immediately after swallowing
measure: Adverse Events
timeFrame: Immediately after swallowing
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
References:
Clinical trial NCT05549596: CETIS-I (CEra Traction Improves Spine-I)
Official title: A Single-center, Open-label, Randomized, Parallel-group, Standard Therapy Controlled, Equivalence Clinical Trials to Evaluate the Efficacy and Safety of Structural Changes in the Spine to Determine the Traction Effect of an Investigational Device, Ceragem Master V6 (CGM MB-1701) Use in Patients With Lumber Disc Herniation & Degenerative Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Degenerative Spinal Stenosis
Spine Traction
Lead sponsor: Ceragem Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.

Detailed description: The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)

Eligibility criteria: Inclusion Criteria:

* Subject who has been diagnosed with intervertebral disc herniation or degenerative stenosis (a person who has been diagnosed in the past or has been diagnosed upon obtaining consent)
* Adult men and women over 19 years of age
* Body mass index (BMI) 18.5 over to less than 30

Exclusion Criteria:

* Subject with fibromyalgia, dystonia, and epilepsy
* Subject with sensory impairment
* Subject with physical irritation-induced skin lesions such as fever and compression (dermatosis, compression urticaria, choline urticaria, fever urticaria, etc.)

Primary outcomes:
measure: Anterior and posterior distance changes of L2-S1 intervertebral disc
timeFrame: Immediately after application
Secondary outcomes:
measure: Ratio of L2-S1 Anterior/posterior intervertebral distance
timeFrame: Immediately after application
measure: Changes in lower extremity radiation pain
timeFrame: Immediately after application
measure: Changes in the range of waist movement
timeFrame: Immediately after application
measure: Change in the angle evaluated by the SLR test
timeFrame: Immediately after application
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
Study officials:
affiliation: Presbyterian Medical Cente
name: Yong Soon Yoon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511796: Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
Official title: Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
upper limb rehabilitation function
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2012-01-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* at least 4 months post stroke
* present with UL spasticity (MAS \>1 in elbow and/or spasticity of the hand, wrist or shoulder)
* present with at lease a stage 3 of CMSA
* able to comply with the requirements of the protocol and UL therapy programme.

Exclusion Criteria:

* significant cognitive and speech impairments
* other upper limb impairments such as frozen shoulder
* another diagnosis which could contribute to upper limb spasticity .

Primary outcomes:
measure: Modified Ashworth
timeFrame: up tp 2013
Secondary outcomes:
measure: Goal attaiment Scale
timeFrame: up tp 2013
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabiliation institute
state: Ontario
Study officials:
References:
Clinical trial NCT05067296: Prevalance of Cesarean Section Niche in Patients With Abnormal Uterine Bleeding
Official title: Prevalance of Cesarean Section Niche in Patients With Abnormal Uterine Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Niche and Abnormal Uterine Bleeding
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prevalance of Cesarean section niche in patients with abnormal uterine bleeding

Brief summary: Prevalance of Cesarean section niche in patients with abnormal uterine bleeding


Eligibility criteria: Inclusion Criteria:

Age between 20-40 years old. Non pregnant women. Previous cesarean section (one or more). Presence of abnormal uterine bleeding

Exclusion Criteria:

Virgins Pregnant women. Patients with vaginal delivery. Patients with uterine bleeding with known cause.

Primary outcomes:
measure: Cesarean section niche in patients with abnormal uterine bleeding
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT06381258: Fetal Cardiac Function
Official title: Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers with Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 72
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A : patients with preeclampsia (either with FGR or normal growth) Group B : patients without preeclampsia (16 cases)

Brief summary: The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies.

Detailed description: Preeclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. Fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE .

Both syndromes share some pathophysiologic features, with a variable involvement of placental insufficiency and cause fetal cardiovascular remodeling and adaptations . Fetal adaptations as metabolic and cardiovascular programming occur in response to adverse intrauterine conditions as PE and FGR . Offspring from preeclamptic pregnancies showed cardiac structural and functional changes and greater blood pressure in childhood and adolescence .

Most of the studies on FGR included pregnancies complicated by PE and vice versa, which fails to adequately assess the independent effect of each condition on the fetal cardiac functions.

Eligibility criteria: Inclusion criteria:

* Pregnant women more than or equals 28 weeks
* Preeclampsia defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg
* Fetus with normal growth or with growth restriction

Exclusion criteria:

* congenital malformations
* intrauterine infection
* multiple pregnancies
* fetuses of mothers treated with a tocolytic agent
* fetuses with abnormal heart rates (tachycardia or bradycardia)

Primary outcomes:
measure: Cardiac systolic function
timeFrame: 4 months
Secondary outcomes:
measure: Cardiac diastolic function
timeFrame: 4 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
References:
Clinical trial NCT01385696: Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
Official title: Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Preference study: Genuair vs HandiHaler inhalers in COPD patients.


Eligibility criteria: Inclusion Criteria:

* Adult male or female patients aged ≥ 40 with stable COPD
* Naïve patients to the use of study inhalers
* Patients agreeing on participating and signing the Informed Consent Form

Exclusion Criteria:

* Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
* Patients unable to read product package instructions and answer patient reported questionnaires

Primary outcomes:
measure: Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
timeFrame: 14 days
Secondary outcomes:
measure: Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
timeFrame: 14 days
measure: Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
timeFrame: 14 days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Almirall investigative site 3
city: Koblenz
country: Germany
facility: Almirall investigative site 5
city: Enschede
country: Netherlands
facility: Almirall investigative site 1
city: Zutphen
country: Netherlands
facility: Almirall investigative site 2
Study officials:
affiliation: Almirall, S.A.
name: Jordi Estruch, Head of GMA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05358496: Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)
Official title: Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD- Non Alcoholic Fatty Liver Disease
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Italian caucasian patients over 18 years old with NAFLD diagnosis

Brief summary: The aim of the study is to define the relationship between neutrophils, platelets and the activity of T lymphocytes in patients with NAFLD (nonalcoholic fatty liver disease).

This study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by PMNs and circulating platelets to evaluate their role in disease progression.


Eligibility criteria: Inclusion Criteria:

* Patients over 18
* No alcoholic abuse
* Hepatic steatosis diagnosticated by abdominal ultrasound
* Negative hepatitis B and C tests
* No history of hepatic cirrhosis

Exclusion Criteria:

* Under 18
* History of alcoholic abuse
* Positive serology for hepatitis B or C
* History of hepatic cirrhosis

Primary outcomes:
measure: IL-8(interleukin 8)
timeFrame: 12 months
measure: Morphology of Circulating Platelets in healthy donors, NAFL, and NASH patients wondering how they may drive and modulate the activity of T cells in this disease
timeFrame: 12 months
measure: Platelets count in healthy donors, NAFL, and NASH patients
timeFrame: 12 months
measure: number of Neutrophilis
timeFrame: 12 months
measure: Morphology of Neutrophilis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Clara Balsano
state: Italy/L'Aquila
Study officials:
References: