louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01803126: A Proposed Study of Atherosclerotic Plaques in Leg Arteries
Official title: A Proposed Study of Atherosclerotic Plaques in Leg Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Disease
Diabetes
Keywords: atherosclerosis
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject with vascular disease or diabetes.

Brief summary: Biofilm has been identified as the major bacterial phenotype contributing to atherosclerosis. It has become very important to evaluate atherosclerosis and the role of biofilm using advanced technologies. It is also important to understand wound biofilm at a genetic and a molecular level.

Detailed description: High throughput pyrosequencing is opening new doors in nucleic acid analysis. 454 Roche has developed sequencing instrumentation which has the ability to sequence not only genomic DNA (gDNA) but also derivatives of messenger RNA (mRNA) and 16s ribosomal DNA (rDNA). This technology has the potential to survey the nucleic acids involved within a mixed population of species, such as atherosclerotic biofilm. In addition to transcriptome science; proteome, metabolome, and other -omic sciences are advancing rapidly. Examining atherosclerotic plaque using transcriptome, proteome, metabolome, and other -omic approaches may provide valuable insight into the wound's microecology.

Eligibility criteria: Inclusion Criteria:

1. The subject with identifying leg or legs that were amputated for vascular disease and/or diabetes.
2. The subject must be 18 years of age or older.

Exclusion Criteria:

* The subject will be excluded if they have had a traumatic amputation which did not involve vascular disease and/or diabetes.

Primary outcomes:
measure: To study the role of biofilm in the hardening of the arteries. The study will evaluate the hardening of the arteries found in legs that have been amputated because of vascular disease and/or diabetes.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510626: Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Official title: Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Keywords: Multiple food allergies
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 35
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
* Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.

Exclusion Criteria:

* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
* Subjects with a total IgE at screening of \>2,000 kU/L
* Previous reaction to omalizumab
* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Primary outcomes:
measure: Number of adverse events in the treatment population
timeFrame: 2 years
Secondary outcomes:
measure: Number of subjects who reach 2g or more of food flour
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
citation: Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.
Clinical trial NCT01281826: Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
Official title: Use of Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compression Fracture of Thoracic Vertebral Body
Spinal Compression Fracture
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from Department of Orthopedics between january 2011 and december 2011.

Brief summary: The purpose of this study is to

1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference.
2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual noncalcium images, such as the morphologic signs, visual qualitative detection, and quantitative values.

Detailed description: Patients with multiple compression fractures and in those with chronic fracture, determining which vertebra to treat is frequently difficult. In such patients, the treatment location is commonly determined from findings at imaging, which includes magnetic resonance (MR) imaging, bone scintigraphy, and computed tomography (CT).

The bone marrow edema (BME) in acute/subacute VCFs is useful in determining the vertebra that is to be treated.

MR imaging provides information on anatomic vertebral collapse and the loss of normal T1 high signal intensity from the marrow space of vertebrae with acute fractures. Loss of normal T1 high signal intensity indicates the presence of BME, which is the important sign for the PVP treatment of VCFs.

Dual-energy (DE) CT has been used to create a virtual unenhanced scan by subtracting iodine from contrast agent-enhanced CT examinations.We expect that the same technique can be used to calculate a virtual noncalcium image from an unenhanced image, which makes bone marrow accessible for CT diagnosis.

Eligibility criteria: Inclusion Criteria:

* Compression fractures (thoracic and lumbar vertebrae)

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Any contraindications to MR imaging.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
affiliation: Department of Diagnostic Radiology Cheng Kung University Medicial Center
name: Chien-Kuo Wang
role: STUDY_CHAIR
References:
Clinical trial NCT02776826: World Bleeding Disorders Registry Pilot Study
Official title: World Bleeding Disorders Registry Pilot Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A and B
Lead sponsor: World Federation of Hemophilia
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 356
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hemophilia A or B, who are patients of participating Hemophilia Treatment Centres.

Brief summary: The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.

Detailed description: The pilot phase of the WBDR is an observational disease registry of patients with hemophilia. Forty hemophilia treatment centres (HTCs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in English, were invited to participate in the pilot phase. Participating HTCs will complete a Minimal Data Set (MDS) of data on approximately 10 patients each.

A series of performance indicators have been identified by the Steering committee and will be used to assess the feasibility of expanding the pilot phase to the WBDR. The performance indicators include: proportion of HTCs invited that are willing to participate; proportion of participating HTCs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.

Eligibility criteria: Inclusion Criteria:

* Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.
* Ability to provide data in English

Exclusion Criteria:

* none

Primary outcomes:
measure: Proportion of HTCs which agree to participate in the pilot phase of the WBDR
timeFrame: 6 months
measure: Proportion of participating HTCs who successfully obtain necessary regulatory approval
timeFrame: 6 months
measure: Proportion of patients who agree to participate in this pilot phase of the WBDR.
timeFrame: 6 months
measure: Proportion of enrolled patients on which data collection and database entry is successful.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01140126: Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
Official title: A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infection in Adults (Asymptomatic)
Keywords: HIV-1, CD4, antibody, immunotherapy
Lead sponsor: United Biomedical
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic, treatment-naive, HIV-1 seropositive
* CD4+ T cell count \>350 cells/cubic millimeter
* HIV-1 viral load \>5,000 copies/mL
* Other inclusion criteria apply

Exclusion Criteria:

* Active infection requiring immediate therapy (except HIV-1)
* Prior participation in any HIV vaccine trial
* Previous exposure to a monoclonal antibody
* Use of immunomodulating drugs or systemic chemotherapy
* Other exclusion criteria apply

Primary outcomes:
measure: To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
timeFrame: Screen, treatment & follow-up: 62 to 90 days
Secondary outcomes:
measure: To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.
timeFrame: Screen, treatment & follow-up: 62 to 90 days
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital (TVGH)
state: Beitou District
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital (KVGH)
state: Zuoying District
Study officials:
affiliation: Taipei Veterans General Hospital (TVGH), Taiwan
name: Wing Wai Wong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Veterans General Hospital (KVGH), Taiwan
name: Hung Chin Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367.
Clinical trial NCT05681026: Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States
Official title: Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To develop and measure the effects of a culturally sensitive yoga program for inpatients

Detailed description: Primary Objective:

1. To develop a culturally tailored yoga therapy (YT) program for HSCT patients. We will conduct semi-structured interviews with patients from each center to examine cultural norms, culturally sensitive language, and specific factors relevant to yoga and psychosocial support.

Secondary Objectives:

1. To optimize the HSCT YT program using an iterative process. Fifteen patients from each center (or until thematic saturation based on exit interviews) will participate in the yoga program two weeks prior to the transplant and throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination.
2. To examine the feasibility of adherence and follow-up completion. We will declare the intervention feasible if: (a) at least 50% of patients complete a minimum of 50% of the 12 YT sessions, and (b) at least 60% of participants complete follow-up measures at 2 months after transplant (± 7 days).

Eligibility criteria: Inclusion Criteria:

1. Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
2. Age 18 or older;
3. English, Hindi, or Swahili speaking;
4. Able to sign a written informed consent and be willing to follow protocol requirements.

Exclusion Criteria:

* Extreme mobility issues that preclude participating in the YT;
* Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;
* HCT comorbidity score of 3 or higher, excluding cancer diagnoses

Primary outcomes:
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05904626: Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Official title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Intestinal Malabsorption
Lead sponsor: Elgan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.


Eligibility criteria: Inclusion Criteria:

* Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
* Birth weight ≥ 450g
* Singleton or twin birth

Exclusion Criteria:

N/A

Primary outcomes:
measure: Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
timeFrame: Five days from birth until 42 days
measure: Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
timeFrame: Five days from birth until 42 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Elgan Pharma Ltd.
name: Miki Olshansky
role: STUDY_DIRECTOR
References:
Clinical trial NCT00889226: Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Official title: A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia With Type2DM
Keywords: pitavastatin
PWV
ESPRIT
Pitavastatin and Atorvastatin
Adiponectin
fasting insulin
hs-CRP
baPWV
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 161
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

Detailed description: To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Eligibility criteria: Inclusion Criteria:

* Age: 25yrs\~75yrs
* Fasting TG \<400mg/dL, LDL-C ≥130mg/dL
* 3months \> Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

* Type1 DM, Gestational diabetes
* Patient need to treat with Insulin
* Patient with operational treatment for severe diabetic complication
* Uncontrolled Hypothyroidism
* Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
* Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
* Renal disorder (Serum creatinine ≥ 2.0mg/dL)
* Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
* Creatinine Kinase \> 2.5 X UNL
* Gravida or lactation phase
* Administration of Atorvastatin, Rosuvastatin, Pitavastatin

Primary outcomes:
measure: Proportion of Patients Achieving LDL- C<100mg/dL
timeFrame: After 16wk drug administration
Secondary outcomes:
measure: The Change of LDL-C
timeFrame: After 16wk drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Endocrinology, Kangnam Saint Mary's Hospital
name: Ho Young Shon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06892626: Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm
Official title: Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stones, Kidney
Stones Ureter
Urolithiasis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 122
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: Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm


Eligibility criteria: Inclusion Criteria:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

Exclusion Criteria:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

Primary outcomes:
measure: stone free rate percentage defined as number of patients who have no stone residual
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hesham Torad
Study officials:
References: