louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00960362: An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
Official title: A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Systemic Lupus Erythematosus (SLE)
Lead sponsor: Argos Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE
* Disease duration longer or equal to 6 months
* Stable, mild to moderate active SLE
* Receiving stable maintenance therapy

Exclusion Criteria:

* Significant lupus nephritis
* Active central nervous system (CNS) disease
* Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
* Active vasculitis requiring treatment
* Body weight over 120 kg
* History of cancer
* Infections
* viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
* tuberculosis (TB)
* Severe systemic microbial infections within the past 12 months prior to dosing
* Immunosuppressive and immune modulating therapy

Primary outcomes:
measure: Frequency of adverse events
timeFrame: From dosing at visit 2 until end of safety visits at visit 8.
Secondary outcomes:
measure: Pharmacokinetic - AUC (area under the curve)
timeFrame: From dosing at visit 2 until end of safety visits at visit 8.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Kansas City
country: United States
state: Kansas
city: Lake Success
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Argos Therapeutics
name: Fred Miesowicz, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00448162: The Chinese Mutation Hotspot of ENaC Causing Liddle's Syndrome and the Association of ENaC Variations and Hypertension
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hypertension
Keywords: hypertension, ENaC, Liddle's syndrome, variation
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2007-03-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were defined as being hypertensive if they had systolic and/or diastolic BP levels \>=140/90mm Hg on three occasions within 2 months and if they were without any antihypertensive treatment, and/or if they had been diagnosed as being hypertensive in the past and were currently receiving antihypertensive medications. The normotensive controls were defined as having systolic and/or diastolic BP levels \<130/85mm Hg and with no family history of hypertension. Patients were excluded when they had any known renal diseases or secondary hypertension.

Brief summary: The variations of ENaC have an impact on the degradation of epithelial sodium channels and sodium reabsorption, and thus are associated with hypertension and hypokalemia.

Liddle's syndrome is a rare monogenic form of autosomal-dominant hypertension caused by truncating or missense mutations in the C-termini of epithelial sodium channel β- or γ-subunit encoded by SCNN1B or SCNN1G. Our purpose is to determine the hotspot of mutation causing Chinese Liddle's syndrome.

The second purpose is to determine wether the polymorphisms of ENaC are associated with hypertension in Chinese. Some polymorphisms of ENaC associated with hypertension may be genetic risk factors for Chinese hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension and Liddle's syndrome
* Clinical diagnosis of normal controls with no cardiovascular disease

Exclusion Criteria:

* Hypertension caused by other single gene mutation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: FuWai Hospital
state: Beijing
Study officials:
affiliation: Key Laboratory for Clinical Cardiovascular Genetics, Ministry of Education, China & Sino-German Laboratory for Molecular Medicine,
name: Rutai Hui, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02031562: Geriatrics Balance and Low Back Pain Study
Official title: Geriatric Balance and Low Back Pain and Balance Assessment and Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distorted Balance
Low Back Pain
Keywords: Balance
Falls
Low back pain
Geriatric
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
Collaborators: name: St. Louis University
First posted: 2014-01-09
Enrollment: 169
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.

Detailed description: This study uses a randomized controlled research design and will enroll up to three hundred patients. Treatment will take place in outpatient facilities. It is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. The results of this study will help to further define effective treatment protocols.

Eligibility criteria: Inclusion Criteria:

* Between ages 60-85
* self reported balance problems
* With or with out low back pain.

Exclusion Criteria:

* History of recent fracture or surgery of lumbar spine, pelvis, hip or femur
* History of recent neoplasm (minor skin cancers are not excluded)
* Acute infectious disease
* Chronic low back pain persisting for \>8 weeks
* Severe disabling health problems so that patient is not ambulatory
* Non-mechanical low back pain
* Recent unstable peripheral vascular disease and or cardiac disease requiring recent hospitalization \< 6 months ago
* Patients with balance problems related to the following: Meniere's disease, vertigo, or vestibular disorders
* Recent history of self reported substance abuse
* Ongoing treatment for balance problems or low back pain by chiropractor, physical therapist, or orthopedic physician or other physician.
* Current use of medication from the following categories: antipsychotics, anxiolytics, and sedative/hypnotics

Primary outcomes:
measure: Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
timeFrame: Baseline, week 6 and week 12.
Secondary outcomes:
measure: Change in patient pain levels at baseline, 6 weeks and 12 weeks.
timeFrame: Baseline, week 6 and week 12.
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis E Enix, DC, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05027191: Effect of Desflurane Versus Sevoflurane With Recent Bio-markers on Renal and Hepatic Functions
Official title: Evaluating the Effect of Desflurane Versus Sevoflurane With Recent Biomarkers of Renal and Hepatic Function in Laparoscopic Cholecystectomy Patients: A Prospective Randomized Double Blinded Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-08-30
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After informed written consents have been taken, this study will be conducted on 70 patients scheduled for laparoscopic cholecystectomy. The patients will be randomly allocated into two groups (a desflurane (D) group and a sevoflurane (S) group) using a sealed envelope technique for each group.

Brief summary: Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Class: I\&II.
2. Elective laparoscopic cholecystectomy.
3. Age: 25-55 years.
4. Gender: Both male and female.
5. Body Mass Index (BMI): 18.5-24.9 km2-(Normal weight).

Exclusion Criteria:

1. Extremes of age.
2. Abnormal hepatic function by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values outside the normal range.
3. Abnormal renal function by blood urea nitrogen (BUN) and creatinine above the normal ranges.
4. Hypertension, unstable angina pectoris or myocardial infarction within the last six months.
5. Pregnancy and lactation.
6. Bronchial asthma.
7. Drug allergies.
8. Alcohol or drug addiction.
9. General anesthesia within the last three months.

Primary outcomes:
measure: Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: a change from baseline NGAL serum level at 6 hours
Secondary outcomes:
measure: Change in serum Arginase
timeFrame: Baseline, first hour, six hours, after 24 hours
measure: Change in serum Cystatin-c
timeFrame: Baseline, first hour, six hours, after 24 hours
measure: Change in urine Netrin-1
timeFrame: Baseline, first hour, six hours, after 24 hours
measure: Change in urine Kidney Injury Molecule
timeFrame: Baseline, first hour, six hours, after 24 hours
measure: Change in urine Interleukin-18
timeFrame: Baseline, first hour, six hours, after 24 hours
measure: Change in urine Alpha-Glutathione S-Transferase
timeFrame: Baseline, first hour, six hours, after 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Theodor Bilharz Rsearch Institute
name: Khalda G Radwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04916691: Ultrasound-guided Erector Spinae Plane Blocks
Official title: Erector Spinae Plane Block for Rib Fractures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rib Fractures
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or older.
* Patients with one or more acute traumatic rib fractures.

Exclusion Criteria:

* Inability to position appropriately.
* Unconscious or heavily sedated.
* Patients who are critically ill such that care should not be delayed for regional anesthesia.
* Patients under the age of 18 years old.
* Vulnerable populations including prison inmates and pregnant patients.
* Overlying skin infection, wound, or dressing/equipment (i.e., Chest tube).
* Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
* Known or documented allergy to ropivacaine or other amide local anesthetic.

Primary outcomes:
measure: Procedural success rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Daniel Stephens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06849791: A Study to Assess the Relative Bioavailability of Oral ABBV-932 in Healthy Adult Participants
Official title: Assessment of the Relative Bioavailability of ABBV-932 Formulations in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the relative bioavailability and effect of food on pharmacokinetics of ABBV-932 oral administration in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Time to Cmax (Tmax) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
timeFrame: Up to approximately 6 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 266649
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01199991: Comparison of Xtreme CT and DXA Bone Densitometry
Official title: Comparison of Xtreme CT and DXA Bone Densitometry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Density
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining bone density. However, most experts consider DXA an imperfect and intermediate technology. DXA is subject to artifact from arthritis and body composition, and also cannot account for geometric or material properties of bone which are also important components of bone strength.

Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new technology with dramatically improved spatial resolution. It is able to define bones' cortical and trabecular surfaces in a three-dimensional manner, and therefore provides information on bone microarchitecture as well as bone density. As such, it may provide new information about characteristics of bone strength.

The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and also to generate a normative database of healthy young adults. This cross-sectional study involves a single visit where both Xtreme CT and DXA measurements will be obtained for a single time-point. This normative database will allow us to generate clinically relevant comparisons between the two imaging technologies.


Eligibility criteria: Inclusion Criteria:

* Adults age 20-40 years

Exclusion Criteria:

* Pregnancy
* History of bone modifying diseases (hyperparathyroidism, Paget's, hyperthyroidism, renal failure, nephrolithiasis, liver disease, eating disorder)
* History of amenorrhea
* Use of chronic steroids for \>3 months

Primary outcomes:
measure: Xtreme CT
timeFrame: single measurement at baseline
measure: DXA
timeFrame: single measurement at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joel S Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04622891: Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection
Official title: Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Azithromycin
clarithromycin
COVID-19
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clarithomycin group Azithromycin group control group
Primary purpose: TREATMENT

Brief summary: The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough

Detailed description: The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.

All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.

The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.

Eligibility criteria: Inclusion Criteria:

* COVID-19 cases
* Oxygen saturation \> 93%
* Age \>18 years

Exclusion Criteria:

* Patients \<18 years,
* patients with Oxygen saturation \< 93%, patients with
* Diabetes mellitus or
* heart failure,
* patients on chemotherapy or immunosuppressive therapy

Primary outcomes:
measure: time to fever control
timeFrame: 15 days
Secondary outcomes:
measure: PCR conversion
timeFrame: 15 days
Other outcomes:
Locations:
city: Qena
country: Egypt
facility: south-Vally University faculty of medicine
Study officials:
affiliation: associate professor
name: Alaa Rashad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rashad A, Nafady A, Hassan MH, Mansour H, Taya U, Bazeed SES, Aref ZF, Sayed MAA, Nafady-Hego H, Abdelmaksoud AA. Therapeutic efficacy of macrolides in management of patients with mild COVID-19. Sci Rep. 2021 Aug 11;11(1):16361. doi: 10.1038/s41598-021-95900-z.
Clinical trial NCT05211791: TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection
Official title: Comparison Between Thoracic Epidural Anaesthesia, Erector Spinae Block and Paravertebral Block During Single-lung Ventilation for Lung Resection in Lateral Decubitus Position: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Pain, Acute
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 90
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: Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia.

Ultrasound-guided ESP block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. Thoracic epidural analgesia (TEA) is considered the gold standard analgesic technique for thoracic surgeries. But the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia

Detailed description: The aim of this study is to compare the effect of different blocks as TEA, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.

Eligibility criteria: Inclusion Criteria:

* aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III

Exclusion Criteria:

* Total pneumonectomy
* Hepatic or renal dysfunction.
* contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
* emergency cases

Primary outcomes:
measure: peri-operative analgesia
timeFrame: up to 48 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
affiliation: Lecturer of Anesthesia , ICU and pain management
name: Alaa A Elzohry
role: PRINCIPAL_INVESTIGATOR
References: