louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691426: Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study
Official title: Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Periodontal Diseases
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from the pool of patients consulting at Postgraduate teachingb clinics of the University Dental Hospital Sharjah

Brief summary: An association between periodontitis and endothelial dysfunction has been reported, suggesting that periodontitis presents an inflammatory burden to the cardiovascular system, that might lead to AVD. The study aims aim to assess whether non-surgical periodontal therapy enhances endothelial function in periodontitis patients using a non-invasive diagnostic device to assess endothelial function through PWA and the assessment of levels of salivary Endothelin-1, in a population of people in the UAE.


Eligibility criteria: Inclusion Criteria:

* Group 1: periodontally healthy subjects.
* Group 2: patients with periodontitis stage III or IV and grades A,B or C.

Exclusion Criteria:

* Medical conditions: Diabetes,pregnancy,obesity,renal disease,patients with cardiovascular diseases including hypertension,recent myocardial infarction or unstable angina (within 3 months),congestive heart failure,valvular heart disease
* Heavy smokers(\>10 cigarettes per day),
* Regular administration of drugs resulting in gingival hyperplasia,root planning in the past 6 months
* Regular administration of drugs resulting in gingival hyperplasia (such as cyclosporine and phenytoin)
* Recent antibiotic use (in the past 3 months)
* Non-surgical periodontal therapy in the past 6 monthsp

Primary outcomes:
measure: pulse wave amplitude
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University Dental Hospital Sharjah
Study officials:
affiliation: University of Sharjah
name: Zahi Badran
role: STUDY_DIRECTOR
References:
Clinical trial NCT06503926: Long Term Vestibular Impact of Covid-19 Vaccines Among Adolescence
Official title: Long Term Vestibular Impact of Covid-19 Vaccines Among Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Vaccination
Lead sponsor: Sinai University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 270
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Adolescence age range 10-17
* Vaccinated by any available SARS -COV-2 Vaccinations

Brief summary: Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence


Eligibility criteria: Inclusion Criteria:

* Adolescence age range 10-17
* received a dose or more of an approved COVID-19 vaccine at least one year before the study enrollment.

the ability to complete all assessment measures independently.

Exclusion Criteria:

1. vestibular or neurological disorders diagnosed before vaccination.
2. mixed COVID-19 vaccine types.
3. a history of traumatic brain injury.
4. current use of medications that affect balance.
5. documented COVID-19 infection within three months of assessment.
6. physical limitations that prevented them from completing balance testing.

Primary outcomes:
measure: Impact on Balance
timeFrame: Through study completion, an average of 1 day - 1 year after taking the vaccine
measure: Functional Disability
timeFrame: Through study completion, an average of 1 day - 1 year after taking the vaccine
Secondary outcomes:
measure: Emotional Disability
timeFrame: Through study completion, an average of 1 day - 1 year after taking the vaccine
measure: Physical Disability
timeFrame: Through study completion, an average of 1 day - 1 year after taking the vaccine
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Sinai University
Study officials:
References:
Clinical trial NCT03549026: Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy
Official title: Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy: Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 70
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: TREATMENT

Brief summary: Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine for patients undergoing lumbar discectomy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing lumbar discectomy

Exclusion Criteria:

* Patients on regular opioid therapy
* Uncontrolled hypertensive patients
* Patients with ischemic heart disease

Primary outcomes:
measure: the first 24 hour morphine consumption
timeFrame: the first postoperative 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
state: Assuit
Study officials:
References:
Clinical trial NCT01371526: Revival of Stem Cells in Addison's Study
Official title: Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenal Failure
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.


Eligibility criteria: Inclusion Criteria:

* Established autoimmune adrenal failure for \>1yr age 16 to 65

Exclusion Criteria:

* Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
* Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease
* Pregnancy, breast feeding or plan for pregnancy within 9 months
* Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.)
* Known hypersensitivity or allergy to Synacthen

Primary outcomes:
measure: Peak serum Cortisol following ACTH stimulation
timeFrame: Tested at 20 weeks
Secondary outcomes:
measure: Change in QoL
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University
state: Tyne and Wear
Study officials:
affiliation: Newcastle University
name: Simon H Pearce, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gan EH, MacArthur K, Mitchell AL, Hughes BA, Perros P, Ball SG, James RA, Quinton R, Chen S, Furmaniak J, Arlt W, Pearce SH. Residual adrenal function in autoimmune Addison's disease: improvement after tetracosactide (ACTH1-24) treatment. J Clin Endocrinol Metab. 2014 Jan;99(1):111-8. doi: 10.1210/jc.2013-2449. Epub 2013 Dec 20.
Clinical trial NCT01467726: Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Elderly
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.


Eligibility criteria: Inclusion Criteria:

• Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.

* Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study.
* Mild deviations from normal limits in PE, VS, ECG parameters, lab tests are acceptable if associated with the stable condition or are age-related

Exclusion Criteria:

* Has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or PK or PD of the investigational drug, or prevent compliance with the protocol

Primary outcomes:
measure: Tolerability of repeat dosing of velusetrag
timeFrame: 3 weeks
Secondary outcomes:
measure: Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite
timeFrame: Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose)
measure: Profile of urine PK of velusetrag and metabolite
timeFrame: Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose
measure: Pharmacodynamic effects of velusetrag
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Clinical Development
state: Florida
Study officials:
References:
Clinical trial NCT02013726: MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue
Official title: Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Gamma Medica, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary:

In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.

Secondary:

1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
2. In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
3. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.


Eligibility criteria: Inclusion Criteria:

* Women over 25 years of age with normal or increased risk of breast cancer.
* Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
* No contraindications to breast MBI or breast tomosynthesis.

Exclusion Criteria:

* Women under the age of 25.
* Women who are or may be pregnant.
* Women who are currently lactating or have discontinued breast feeding \< 2 months prior to the study.
* Male patients are excluded as subjects.
* Those unable or unwilling to provide informed consent.

Primary outcomes:
measure: Sensitivity/Cancer detection
timeFrame: 12 months
Secondary outcomes:
measure: Specificity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01404026: Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury
Official title: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burn Injury
Keywords: Transcranial Direct Current Stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The investigators hypothesize that the active tDCS group will show a significant pain/itch reduction when compared to sham stimulation.


Eligibility criteria: STUDY ELIGIBILITY CRITERIA:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study.

   - Subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries
4. Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study
5. No contraindications to tDCS:

   * metallic implants in the head
   * implanted brain medical devices
6. Subject is not pregnant at the time of enrollment
7. Neuropathic pain or itching (rated at least 4 on the VAS) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks.

Please note: If a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.

Primary outcomes:
measure: Effect of tDCS on pain/itch perception
timeFrame: Measured for approximately 2 weeks
Secondary outcomes:
measure: Effect of tDCS on motor cortex excitability
timeFrame: Measured for approximately 2 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital (SRH)
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05937126: Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia
Official title: Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia (RASP) - A Quality Improvement Theragnostic Stewardship Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Respiratory Tract Infections
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 1203
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: Lower respirator tract samples obtained from inpatient settings only (medical/surgical floors and intensive care units) at Mayo Clinic in Rochester, MN.

Brief summary: The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.


Eligibility criteria: Inclusion Criteria:

- Subjects who have the following samples collected and submitted for culture as part of routine clinical practice: Expectorated sputum, induced sputum, tracheal secretions, bronchoalveolar lavage.

Exclusion Criteria:

* Subjects who do not have MN Research Authorization on file
* Rejected sputum culture (i.e., due to low quality)
* Positive respiratory cultures within prior 7 days
* Deceased at time of sample randomization
* Any subject affected by Global Data protection Regulation (GDPR)
* Previous enrollment in the study.
* Outpatient status

Primary outcomes:
measure: Time until first modification of antibiotic therapy
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robin Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03918226: Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
Official title: Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis; Abdomen
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-04-17
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective interventional study was conducted in Services Instituton of Medical Sciences all patients who underwent emergency laparotomy from 2008-2018 due to abdominal tuberculosis. Data were analyzed using SPSS version 21


Eligibility criteria: Inclusion Criteria:

* Both sexes and age between years and 90 years
* Patients presenting with acute abdomen and who underwent exploratory laparotomy
* Patients who diagnosis confirmed on biopsy (caseating granulomas)

Exclusion Criteria:

* Peritoneal tuberculosis
* Other causes of acute abdomen (Typhoid perforation)
* Patients diagnosed with abdominal tuberculosis and on conservative management

Primary outcomes:
measure: Percentage of patients who develop complications after surgery
timeFrame: 9 months
measure: Percentage of patients who develop recurrence of abdominal tuberculosis (elevated ESR, CT scan findings of abdominal tuberculosis)
timeFrame: 1 year
measure: Mortality rate
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT03810326: Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Official title: Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Yuinvent Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional study to evaluate efficacy and safety of an active splint.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, above 40 years of age.
* Able to understand and sign informed consent
* Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
* Numbness and tingling in the median nerve distribution
* Nocturnal Numbness
* Weakness and/or atrophy of the thenar musculature
* Demonstrate positive Phalen's Test of the affected extremity
* Demonstrate positive Tinel's Test of the affected extremity
* Sensory impairment defined as a loss of 2-point discrimination
* Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome

Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome

* History of surgical carpal tunnel release
* Pregnancy
* Diabetes not controlled by medication
* Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
* Thoracic outlet syndrome
* Compromised skin integrity
* Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Primary outcomes:
measure: Reduction in pain score
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT00725426: Effect of Rifampin on Bosutinib When Both Are Given to Healthy People
Official title: A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Bosutinib When Administered Concomitantly to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.


Eligibility criteria: Inclusion Criteria:

* Healthy men age 18-50
* Healthy women of nonchildbearing potential, age 18-50

Primary outcomes:
measure: Pharmacokinetics (plasma concentrations)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Abbas R, Boni J, Sonnichsen D. Effect of rifampin on the pharmacokinetics of bosutinib, a dual Src/Abl tyrosine kinase inhibitor, when administered concomitantly to healthy subjects. Drug Metab Pers Ther. 2015 Mar;30(1):57-63. doi: 10.1515/dmdi-2014-0026.