louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00782561: Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
Official title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Focal Segmental Glomerulosclerosis
Keywords: steroid resistant focal segmental glomerulosclerosis
FSGS
adolescent focal segmental glomerulosclerosis
focal segmental glomerulosclerosis
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).


Eligibility criteria: Inclusion Criteria:

1. Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
2. Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
3. Age less than or equal to 2 years old at onset of proteinuria
4. First morning urine protein/creatinine ratio (U p/c) \>1 gm/gm
5. Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2

Exclusion Criteria:

1. Non-FSGS renal disease other than benign cyst; or secondary FSGS
2. History of organ transplantation
3. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
4. History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
5. Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal
7. Hematocrit \< 30%

Primary outcomes:
measure: Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
timeFrame: 32 weeks
Secondary outcomes:
measure: Standard plasma and urinary PK parameters
timeFrame: 32 weeks
measure: Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Hyde Park
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
Study officials:
References:
Clinical trial NCT05381961: Observational Study of BIS in Hemodialysis Patients
Official title: Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Failure, Chronic
Renal Failure Chronic
Hemodialysis
Lead sponsor: ImpediMed Limited
Sponsor class: INDUSTRY
Collaborators: name: California Institute of Renal Research
name: Frenova Renal Research
First posted: 2022-05-19
Enrollment: 70
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: Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.

Brief summary: This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

Detailed description: This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

1. Age \>=18 years of age;
2. End-stage renal disease with a GFR \<15 mL/min/1.73m\^2 and dialysis dependent requiring 3-times weekly dialysis;
3. Able and willing to remove shoes and stand on SOZO for BIS measurements;
4. Able to provide written informed consent and authorization to use and disclose health information.

Exclusion Criteria:

1. Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
2. Has a clinical condition that would not allow them to complete the study;
3. Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
4. Is lactating;
5. Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
6. Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);
7. Patient determined by the attending physician unlikely to be compliant with study procedures.

Primary outcomes:
measure: BIS correlation with amount of fluid dialyzed
timeFrame: 12 hemodialysis sessions (over 4 to 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Balboa Research - Kearny Mesa
state: California
city: San Diego
country: United States
facility: Balboa Research - Rancho Bernardo
state: California
Study officials:
affiliation: Balboa Research
name: Mark Boiskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687061: Chronic Hepatitis B and C Recall Northern Holland
Official title: Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Hepatitis C
Keywords: Recall study
Lost to follow-up
Lead sponsor: Stichting MDL Holland-Noord
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2016-02-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The groups will be selected from registries of the Public Health Service (PHS) and medical microbiology laboratories. All positive anti-HCV and HBsAg will be checked and if patients with positive HBsAg or HCV are not known in specialised/hospital care, they will be included in our database.

Brief summary: The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Subsequently the investigators will compare the registered cases with the list of known cHB and cHC patients in hospital care. Patients lost to follow up will be informed and approached via either the Public Health Service (PHS) or their primary care physician. Identified patients will be invited for re-evaluation at the regional hepatitis centre (The North Western Hospital, formerly Medical Centre Alkmaar) to assess the current status of their chronic disease. Evaluation will be performed in accordance with (inter-)national guidelines, no extra interventions will be performed.

After completion of re-evaluation, a final report will be made and send to both patient and primary care physician with recommendations for further follow-up.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic hepatitis B (two positive HBsAg measurements with an interval of 6 months)
* Diagnosis of chronic hepatitis C (two positive anti-HCV with an interval of 6 months)

Exclusion Criteria:

* Already known in specialized care for chronic HBV or chronic HCV
* Cured from chronic HBV or chronic HCV

Primary outcomes:
measure: Liver-related morbidity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stichting MDL Holland-Noord
name: Michael Klemt-Kropp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247961: Early Treatment With Dexamethasone in Mild Acute Pancreatitis
Official title: Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Patients With Acute Pancreatitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot trial will evaluate the following in patients with acute pancreatitis:

1. Safety profile of early treatment with intravenous dexamethasone
2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
3. Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes


Eligibility criteria: Inclusion Criteria:

* Age\>=18 years
* Diagnosis of acute pancreatitis confirmed by at least 2 of the following:

  1. Typical epigastric abdominal pain
  2. Elevation amylase/lipase \>3 times upper limit normal and/or
  3. Confirmatory findings on cross-sectional imaging
* Enrollment within 8 hours of presentation

Exclusion Criteria:

* Class II or greater NYHA heart failure
* Oxygen dependent COPD
* Chronic kidney disease\>stage 2
* Cirrhosis
* Existing necrosis on abdominal CT
* Organ dysfunction prior to enrollment
* Sepsis
* Acute respiratory distress syndrome
* Malignancy not in remission for at least 5 years
* Active drug use
* Known allergy to dexamethasone
* Altered mental status
* Insulin-requiring diabetes
* Abdominal surgery within 60 days

Primary outcomes:
measure: Systemic Inflammation (measured by c-reactive protein level)
timeFrame: 48 hours
Secondary outcomes:
measure: Safety parameters
timeFrame: 72 hours post-randomization
measure: Composite clinical outcome
timeFrame: Up to 14 days from hospital admission
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Center for Pancreatic Disease, Brigham and Women's Hospital
name: Bechien U Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082583: The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
Official title: A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: High Altitude Polycythemia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.


Eligibility criteria: Inclusion Criteria:

* Patients with high-altitude polycythemia aging 18 to 65 years.

Exclusion Criteria:

* Allergic to Tibetan medicine ingredients;
* Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.

Primary outcomes:
measure: The incidence of effective treatment
timeFrame: Baseline and 1 month after treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00315783: Comparison of Data Obtained by Echocardiography and Magnetic Resonance Imaging in Hypertrophic Cardiomyopathy
Official title: Comparison of Data Obtained by Echocardiography and Magnetic Resonance Imaging in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Keywords: hypertrophic cardiomyopathy
echocardiography
magnetic resonance imaging
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: Compare data (structural and functional) obtained by transthoracic rest echocardiography and magnetic resonance imaging (with gadolinium) in 30 patients with hypertrophic cardiomyopathy

Detailed description: All data from consecutive patients with HCM explored by 2D-echo or MRI in our institution will be analyzed blindly by a senior echocardiographist and a senior radiologist to highlights the respective interest of each of these examinations for the detection of structural or functional abnormalities in HCM.

Eligibility criteria: Inclusion Criteria:

* Hypertrophic cardiomyopathy
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Pacemaker
* IACD
* Allergy to gadolinium
* Secondary hypertrophy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
Study officials:
affiliation: Hopital Européen Georges Pompidou, Paris-FR
name: Albert A HAGEGE, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06938061: Utilizing 3D Imaging for Burn Wound Assessment
Official title: Integrating 3D Imaging Technology for Precise Burn Wound Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burn
2nd Degree Burn of the Skin
3rd Degree Burn of the Skin
1st Degree Burn of the Skin
Keywords: 3D Imaging
AI
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting outpatient to the Regions Hospital burn clinic after a burn

Brief summary: The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:

1. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
2. An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.

Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.


Eligibility criteria: Inclusion Criteria:

* Adults sustaining burns
* Outpatients
* No prior surgery on the wounds
* No known infection of the wounds

Exclusion Criteria:

* Burns to the face or sensitive areas (genitals)
* Burns located on or near identifying landmarks such as tattoos or birthmarks
* Non-English speaking patients
* Patients unable to sign their name
* Burn occurred greater than 7 days prior to clinic visit
* Age greater than 90 (Patient age is sent externally to IKO, to ensure no PHI is sent, patients with an age \>90 will not be enrolled)

Primary outcomes:
measure: Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Concordance between clinician burn depth determination (1st, 2nd, 3rd degree burn) and AI determination of burn depth based on DermaMonitor images
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital Burn Clinic
state: Minnesota
Study officials:
References:
citation: Irwin LR, Reid CA, McLean NR. Burns in children: do casualty officers get it right? Injury. 1993 Mar;24(3):187-8. doi: 10.1016/0020-1383(93)90291-d.
citation: Ho HL, Halim AS, Sulaiman WAW, Fatimah MJ. Estimation of Total Body Surface Area Burned: A Comparison Between Burn Unit and Referring Facilities. Ann Burns Fire Disasters. 2023 Mar 31;36(1):19-28. eCollection 2023 Mar.
Clinical trial NCT05474261: Valsalva Maneuver in Thyroidectomy
Official title: Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent total thyroidectomy

Brief summary: Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.

Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.

The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.


Eligibility criteria: Inclusion Criteria:

* thyroid diseases

Exclusion Criteria:

* lymph node dissection
* minimally invasive approaches
* high anesthesiological risk

Primary outcomes:
measure: Volume of cervical drainage after total thyroidectomy
timeFrame: 24 hours
measure: Number of reinterventions
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Policlinico Di Foggia
Study officials:
References:
Clinical trial NCT02803983: Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture
Official title: An Multicenter Prospective Observational Study to Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (Delbet Type II and III)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fractures
Lead sponsor: The Fuzhou No 2 Hospital
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric femoral neck fracture(Delbet type II and Delbet type III)

Brief summary: The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).

Detailed description: The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.

Eligibility criteria: Inclusion Criteria:

* Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.

Exclusion Criteria:

* Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.

Primary outcomes:
measure: Radiographic union
timeFrame: Through study completion, an average of 0.5 year.
Secondary outcomes:
measure: The Ratliff classification standard score
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: The complication
timeFrame: Through study completion, an average of 1 year.
Locations:
Study officials:
References:
citation: RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.
citation: Joeris A, Audige L, Ziebarth K, Slongo T. The Locking Compression Paediatric Hip Plate: technical guide and critical analysis. Int Orthop. 2012 Nov;36(11):2299-306. doi: 10.1007/s00264-012-1643-1. Epub 2012 Aug 26.
Clinical trial NCT02029183: Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke
Official title: Screening and Treatment of in Sleep Apnea Hypopnea Syndrome（SAHS)Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Sleep Apnea Syndrome
Keywords: stroke, SAHS, BiPAP
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment with noninvasive ventilation for patients with acute ischemic stroke should improve the functional prognosis（measuring with 90d modified Rankin score）.

Detailed description: In acute state of ischemic stroke，if patients with sleep apnea hypopnea syndrome may need additional respiratory management such bi-level positive airway pressure.We supposed the patients with stroke can take benefit of functional recovery form bi-level positive airway pressure. We choose the patients who suffered ischemic stroke in 48 hours ，then evaluate the respiratory status. Stroke patients who were diagnosed as sleep apnea hypopnea syndrome will accept additional treatment with bi-level positive airway pressure for 7 night（per night 6 hours）.Then the modified Rankin scale score and NIHSS will be recorded at 30 days and 90 days after stroke.

Eligibility criteria: Inclusion Criteria:

* ischeic stroke onset within 48 hours , NIHSS:4-15

Exclusion Criteria:

* mRs\>2 before onset of enrollment severe hepatic renal insufficiency cancer in reached an advanced stage

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days after symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, P
role: STUDY_CHAIR
References: