louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01965613: A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Official title: A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.

Detailed description: XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥18
2. History of pyoderma gangrenosum with or without other systemic disease.

Exclusion Criteria:

1. Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
2. Treatment with corticosteroids or cyclosporine within the last 2 weeks.

Primary outcomes:
measure: Change in Physician's Wound Assessment & Patient's Global Assessment
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: XBiotech Investigative Site
state: Florida
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01409213: A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199)
Official title: Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-08-04
Enrollment: 1523
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes mellitus being treated in an office setting with metformin at the individual maximal tolerated dose (at least four weeks on stable dose) and had a resultant HbA1c \>6.5% were selected for this study. The first five eligible participants per site with type 2 diabetes mellitus and treatment with metformin were to be enrolled.

Brief summary: The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008


Eligibility criteria: Inclusion Criteria:

- Newly diagnosed with Type 2 diabetes in whom treatment with metformin in

the individual maximal tolerated dose (at least four weeks on stable dose) resulted in

HbA1c \>6.5%

- No contraindication or intolerability to metformin

Exclusion Criteria:

- Currently being administered a combination therapy for the treatment of their Type 2 diabetes

Primary outcomes:
measure: Change From Baseline for Mean Hemoglobin A1c (HbA1C)
timeFrame: Baseline and end of Observation (up to Month 6)
measure: Change From Baseline for Mean Fasting Blood Glucose (FBG)
timeFrame: Baseline and end of Observation (up to Month 6)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07014813: Mini-Open Subpectoral Biceps Tenodesis
Official title: Mini Open Subpectoral Press Fit Biceps Tenodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bicep Tendinitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Subpectoral tenodesis offers advantages, and this study assesses a novel press-fit bony plug technique for this approach, evaluating its safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Patients with Biceps tendon pathologies after failure of conservative measures: biceps tenosynovitis, recurrent subluxation, or SLAP lesions.
* Young and middle-aged individuals (20-60 years old).

Exclusion Criteria:

* Patients with avascular necrosis or arthritis.
* Extensive bone loss.
* Poor bone density.
* Active infection.

Primary outcomes:
measure: The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.
timeFrame: 42 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Kasr Al-Einy
Study officials:
References:
Clinical trial NCT04013113: Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
Official title: A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 250
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: The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .

In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with ACLF as per APASL criteria will be included.
2. Age : 18-65 yrs.

Exclusion Criteria:

1. Patient with ischemic heart disease
2. Patient with chronic obstructive disease.
3. Patient with hepato cellular carcinoma.
4. Patient with extra hepatic malignancy.
5. Patient with chronic renal insufficiency.

Primary outcomes:
measure: Transplant free survival in all the group
timeFrame: day 28
Secondary outcomes:
measure: Development of organ dysfunction in all the group
timeFrame: Day 7
measure: Development of organ dysfunction in all the group
timeFrame: Day 15
measure: Development of organ dysfunction in all the group
timeFrame: Day 28
measure: New onset of sepsis in ll the groups
timeFrame: Day 7
measure: New onset of sepsis in ll the groups
timeFrame: Day 15
measure: New onset of sepsis in ll the groups
timeFrame: Day 28
measure: Adverse Events in all the groups
timeFrame: Day 28
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT04507113: Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia
Official title: Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Keywords: Lumbar Radiculopathy
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Prognostic
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6 months.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Patient with Lumbar Radiculalgia (L4, L5 or S1)
* Pain VAS (Visual analog scale) \> 30/100
* Less than 3 months of evolution
* With a radiculalgia superior or equal to lumbalgia
* Disco radicular conflict, verified by MRI
* Able to receive information
* Affiliated to French social security

Exclusion Criteria:

* History of chronic lumbalgia and radiculalgia
* History of lumbar surgery
* Recent episode (less than 6 months) with the same radicular topography
* Bilateral radicular compression on MRI
* Patient requiring emergency surgery
* Evolutive disease interfering with pain assesment (neoplasia, inflammatory rheumatism, peripheral neuropathy, central neurological disease)
* MRI contraindication

Primary outcomes:
measure: Predictive performance of DTI imaging on the therapeutic evolution
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between DTI parameters and pain intensity
timeFrame: 6 months
measure: Correlation between DTI parameters evolution and neuropathic pain
timeFrame: 6 months
measure: Correlation between DTI parameters evolution and disability
timeFrame: 6 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Groupe Hospitalier de l'Institut Catholique de Lille
Study officials:
affiliation: Lille CU
name: Jean-François BUDZIK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05296213: Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents
Official title: Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enamel Caries
Keywords: Enamel remineralization
Randomized Clinical Trial
Experimental Tricalcium silicate
Sillver diamine flouride-potassium iodide
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents

Detailed description: Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions.

Fluoride was considered the "gold standard" remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion.

Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite.

In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.

Eligibility criteria: Inclusion Criteria:

* Patients with early enamel lesions (ICDAS score 1 and 2).
* Patients with normal occlusion .
* Patients must have a good oral hygiene
* patients free from any systemic diseases and don't receive any medication

Exclusion Criteria:

* smoker patients
* pregnant females
* patients with bad oral hygiene
* patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)

Primary outcomes:
measure: Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
timeFrame: 2-years after the first application of the remineralizing agents
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Kareem Hamdi
Study officials:
References:
Clinical trial NCT02728713: Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
Official title: Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Function
Keywords: Cranial manipulation
Visual function
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Osteopathic Heritage Foundations
First posted: 2016-04-05
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is a measurable change in visual function as a direct result of the application of osteopathic cranial manipulative medicine. The study will also attempt to determine whether any changes noted remain after withdrawal of the treatment.


Eligibility criteria: Inclusion Criteria:

* free of active ocular or systemic disease
* refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
* normal best-corrected visual acuity at 20/40 or better
* normal amplitude of accommodation
* willing to undergo osteopathic cranial manipulative medicine

Exclusion Criteria:

* pregnancy
* history of previous closed head trauma or brain injury
* prior cranial manipulative treatment/craniosacral therapy
* students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: Weekly for 16 weeks
measure: Accommodative System Testing
timeFrame: Weekly for 16 weeks
measure: Local Stereoacuity Testing
timeFrame: Weekly for 16 weeks
measure: Pupillary Size Testing
timeFrame: Weekly for 16 weeks
measure: Vergence System Testing
timeFrame: Weekly for 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Nova Southeastern University Davie Health Center
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Mark Sandhouse, D.O., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandhouse ME, Shechtman D, Fecho G, Timoshkin EM. Effect of Osteopathic Cranial Manipulative Medicine on Visual Function. J Am Osteopath Assoc. 2016 Nov 1;116(11):706-714. doi: 10.7556/jaoa.2016.141.
Clinical trial NCT04733313: Effect of Quadratus Lumborum Block in C/S
Official title: Comparison of Ultrasound Guided Quadratus Lumborum Block-2 and Quadratus Lumborum Block-3 for Postoperative Pain in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Cesarean Section Complications
Block
Patient Satisfaction
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-02
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: PREVENTION

Brief summary: to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.


Eligibility criteria: Inclusion Criteria:

* pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
* obtained patients informed consent

Exclusion Criteria:

* inability to comprehend
* bleeding diathesis
* allergy to the study agents
* localized infection
* block failure

Primary outcomes:
measure: Assesment of postoperative pain
timeFrame: during 24 hour after surgery
Secondary outcomes:
measure: need of analgesic
timeFrame: during 24 hour after surgery
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Healt Science University Bursa Training and Research Hospita
state: Yildirim
Study officials:
References:
Clinical trial NCT01380236: A Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Severe Asthma
Official title: A Phase II, Two-centre, Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Adult Subjects With Moderate to Severe Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2011-06-27
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: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe asthma.

Detailed description: The safety and tolerability of ASM8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum IL-1 and TNF-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring AEs

There are 5 study phases: screening (phase 1), run-in (phase 2), treatment A (phase 3) with Active or Placebo, treatment B(phase 4) with Active or Placebo and end of study (phase 5) that includes a wash out period and a final visit.

Eligibility criteria: Inclusion Criteria:

* Be diagnosed with asthma for 3 or more months Have moderate to severe asthma as defined by ATS criteria

Exclusion Criteria:

* No history of pulmonary or health problems for which the Investigator considers that participation in this protocol is a risk for the subject

Primary outcomes:
measure: Sputum total cells, differential and sputum levels of IL-1 and TNF alpha
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02732236: Marginal Zone Lymphoma Cohort in Korea
Official title: Hepatitis B Virus Reactivation in Patients With Marginal Zone B-cell Lymphoma After Rituximab Containing Treatment: Consortium for Improving Survival of Lymphoma (CISL) Marginal Zone Lymphoma Cohort Study (MARCO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, B-Cell, Marginal Zone
Keywords: marginal zone lymphoma
Cohort
Rituximab
HBV
Lead sponsor: Dong-A University Hospital
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL

Brief summary: Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study

Detailed description: Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7\~8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses.

Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)

Eligibility criteria: Inclusion Criteria:

* pathological confirmed marginal zone lymphoma
* No history of chemotherapy
* enable to routine staging w/u and sampling including HBV serology
* informed consent

Exclusion Criteria:

* mixed with other type lymphoma
* refuse informed consent
* co-existing cancer needed treatment
* prior organ transplantation
* accompany with immunodeficiency

Primary outcomes:
measure: Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Sung Yong Oh
Study officials:
affiliation: Consortium for improving survival of lymphoma office
name: Sung Yong Oh
role: PRINCIPAL_INVESTIGATOR
References: