louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02369991: Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique
Official title: Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique: a Cross-sectional Study of Long-term Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reconstructive Surgical Procedure
Keywords: latissimus dorsi flap
bone transport
bone reconstruction
tibia
tibial fracture
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport

Brief summary: This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.

Detailed description: A retrospective review of hospital records was conducted to chart the clinical and operational characteristics of patient. Patients current condition is assessed by applying two function-related (Disabilities of the Arm, Hand and Shoulder, DASH; Lower Extremity Functional Scale, LEFS) and a health-related quality of life (the 15-dimensions, 15D) questionnaires. The patients received the questionnaires by mail. A written informed consent was obtained from the participants. The obtained data was computerized and analyzed.

Eligibility criteria: Inclusion Criteria:

* Age over 15 years.
* Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.

Exclusion Criteria:

* Deceased.
* Patients under 15 years of age.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 10-25 years
measure: The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.
timeFrame: 10-25 years
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 10-25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.
name: Erkki J. Tukiainen, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01957891: Hypoxia at Multiple Wavelengths of Light
Official title: Effect of Induced Hypoxia at Multiple Wavelengths
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia in Healthy Individuals
Keywords: Hypoxia
Multiple wavelengths
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light.

Detailed description: No additional information is required.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 35 years of age
* Is American Society Anesthesiologist status 1
* Has a BMI between 18 and 30

Exclusion Criteria:

* Currently taking any medications other than birth control pills
* Has participate in an investigational drug study within one month prior to the start of the study
* Fails the Allen's Test to confirm patency of the colateral artery
* Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination
* Has a positive urine continine or drug test
* Has an reported allergy to Lidocaine
* Has anemia or other hemoglobinopathy
* Has a room air saturation less than 95% by pulse oximetry
* Has an abnormal EKG
* Has an abnormal pulmonary function test via spirometry
* Is intolerant to a breathing mask apparatus
* Has a COHb greater than 3%, or MetHb greater than 2%
* Has another condition, which in the opinion of the principle investigator would not be suitable for participation in the study
* Is unwilling or unable to provide informed consent or comply with the study procedures

Primary outcomes:
measure: Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: HPPL Duke Univeristy
state: North Carolina
Study officials:
affiliation: Duke University
name: David MacLeod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04392791: Does Balnotherapy Influence the Qualitiy of Life in SLE
Official title: Balnotherapy in SLE, the First Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SLE
Lead sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Sponsor class: OTHER
Collaborators: name: University of Debrecen
name: Szeged University
First posted: 2020-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effects of balneotherapy on the quality of life and on work productivity of SLE patients.

Detailed description: SLE patients in remission/low disease activity of three immunology centers were included in this randomized, controlled, follow-up study. In addition to the standard of care (SOC) sixteen out of the thirty SLE patients received balneotherapy (15 times, for 30 minutes) and fourteen patients received the SOC only. Prevalidated survey instruments including LupusQol, SF36, and WPAI questionnaires were recorded.

Eligibility criteria: Inclusion Criteria:

* diagnosis of SLE according to SLICC/ACR, 2012 criteria;
* remission or low disease activity, evaluated with SLEDAI-2K

Exclusion Criteria:

* explorable psychiatric disease
* general contraindications to balneotherapy

Primary outcomes:
measure: Lupus Quality of Life (LupusQoL)
timeFrame: 10 weeks
measure: WPAI-Lupus is a disease specific questionnaire developed to measure work capacity and daily activity
timeFrame: 10 weeks
measure: The Short Form Health Survey (SF-36)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Polyclinic of Hospitaller Brothers of St. John of God
Study officials:
name: Tamás Bender, MD, PhD. DSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756191: Antifungal Drugs in Pulmonary Mucormycosis
Official title: Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pulmonary Mucormycosis
Keywords: Pulmonary Mucormycosis
Amphotericin B liposome
isavuconazole
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis


Eligibility criteria: Inclusion Criteria

* Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
* Individuals with Probable or proved PM, as indicated by clinical and radiological findings.

Exclusion Criteria:

* Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days.
* Patients who have documented allergies to azoles or amphotericin B regimens
* Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN).
* Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis.
* Patients who have experienced a myocardial infarction or cerebral infarction.
* Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment.
* Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.

Primary outcomes:
measure: 4-week favourable response rate
timeFrame: 4 week
Secondary outcomes:
measure: 12-week mortality
timeFrame: 12 week
measure: 24-week mortality
timeFrame: 24 week
measure: Frequency of adverse events
timeFrame: 4 week
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00548691: Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Official title: A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard Medical Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure


Eligibility criteria: Inclusion Criteria:

* Male or Female 18 to 85 years of age
* NDD-CKD Patients
* TSAT \</= 25%
* Hgb \</= 11.5
* Ferritin \</= 300
* HD-CKD Patients
* TSAT \</= 30%
* Hgb \</= 12
* Ferritin \</= 500

Exclusion Criteria:

* Previous participation in a FCM trial
* Known Hypersensitivity to FCM
* History of anemia other that anemia due to chronic renal failure
* Current history of GI bleeding
* Received IV Iron within the last 30 Days
* Anticipated need for surgery
* Malignancy history
* AST or ALT greater than normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually active females who are not willing to use an effective form of birth control

Primary outcomes:
measure: Incidence of Treatment-emergent Serious Adverse Events (SAE's)
timeFrame: from Day 0 through 30 days after the last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02195791: Neuroprotection of Pioglitazone in Acute Ischemic Stroke
Official title: Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease inflammation. It has been proven to be an effective neuroprotective agent in animal model of ischemic stroke. In this study, the investigators will conduct a phase II clinical trial (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control group (placebo). The investigators expect to prove the neuroprotective efficacy of Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with good neurological outcome in patients with Pioglitazone treatment from the investigators clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke onset within 48 hours
2. Age≧20 years
3. Stroke severity with at least one point for limb weakness in National Institutes of Health Stroke Scale (NIHSS).
4. The patients with no known history of diabetes with admission serum glucose ≧130 mg/dl.

Exclusion Criteria:

1. The patients who have history of urinary bladder cancer or hematuira.
2. The patients who have history of congestive heart failure or myocardial infarction.
3. The patients who have known history of using pioglitazone before the onset of stroke.
4. The patients who have mRS≧3 before stroke onset.

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: Day 90 after stroke
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: Day 90 after stroke
measure: Barthel's Index
timeFrame: Day 90 after stroke
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical Universtiy- Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Nai-Fang Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00003291: Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
Official title: Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: untreated childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 200
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE

Brief summary: RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
* Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.

OUTLINE: Patients are stratified by risk (standard vs high).

Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Patients are followed for at least 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed acute lymphoblastic leukemia (ALL)
* Meets criteria for 1 of the following:

  * Standard risk, as defined by the following:

    * 1 to 10 years old at diagnosis
    * WBC less than 50,000/mm\^3
  * High risk, as defined by the following:

    * Less than 1 year old or over 10 years old at diagnosis
    * WBC greater than 50,000/mm\^3
* Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
Study officials:
affiliation: Telethon Institute for Child Health Research
name: Ursula R. Kees, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03699891: Evaluation of the Fortilink IBF System With TETRAfuse Technology
Official title: Evaluation of the Fortilink IBF System With TETRAfuse Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical and Lumbar Fusion
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient must have had an attempted implant of the Fortilink IBF System

Brief summary: This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.

Detailed description: This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.

The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.

Eligibility criteria: Inclusion Criteria:

* Patient must have had an attempted implant of the Fortilink IBF System

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Safety outcomes associated with use of the Fortlink System
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Los Angeles Orthopedic Institute
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Spine
state: Colorado
city: Boca Raton
country: United States
facility: Florida Back Institute
state: Florida
city: Delray Beach
country: United States
facility: Spine Institute of South Florida
state: Florida
city: Bethesda
country: United States
facility: OrthoBethesda
state: Maryland
Study officials:
References:
Clinical trial NCT00002094: Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Official title: Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Virus Replication
Acquired Immunodeficiency Syndrome
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Enrollment on protocol RV-43 (AZT resistance study).
* Development of a primary RV-43 study endpoint-opportunistic infection.
* HIV isolate with an AZT IC50 \> 50 times that of the sensitive type strain.
* Able to swallow tablets without difficulty.
* Normal QTc interval on EKG.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
* Severe uncontrollable diarrhea or vomiting or known malabsorption.
* Symptomatic hyperlipidemia.

Concurrent Medication:

Excluded:

* Other experimental drugs.
* AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).

Patients with the following prior conditions are excluded:

History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.

Prior Medication:

Excluded:

* Experimental drugs within 4 weeks prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Natl Naval Med Ctr
state: Maryland
Study officials:
References:
Clinical trial NCT00435994: Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Official title: Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Respiratory Syncytial Virus Infections
Keywords: Infant
Respiratory Syncytial Virus
Bronchiolitis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2007-02-16
Enrollment: 59
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.

Detailed description: We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.

Eligibility criteria: Inclusion Criteria:

* Group 1 Infants between 2 and 24 months that are healthy
* Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing

Exclusion Criteria:

* Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \< 37 weeks, and cannot be in the ICU.

Primary outcomes:
measure: Lung Function
timeFrame: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
measure: Endothelial Growth Factor (VEGF)
timeFrame: During nasal wash
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert S. Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References: