louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01245972: Pilot Study of PDL to Treat BCC and SCCIS
Official title: A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma in Situ
Keywords: pulsed dye laser
PDL
basal cell carcinoma
squamous cell carcinoma
BCC
SCC
594nM laser
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 23
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: This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.

Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.


Eligibility criteria: Inclusion Criteria:

* Patients requiring surgical excision (conventional or Mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size.
* Lesions in the Trunk, Extremities, and Scalp
* Presence of clinically identifiable residual tumor.
* Patients, males and females, aged 18-90 years.
* Willing to participate.
* Able to give informed consent.

Exclusion Criteria:

* Age younger than 18 years
* Location of lesion not in the Trunk, Extremities, and Scalp
* Fitzpatrick skin type V or VI.
* Prior history of known light sensitivity.
* Pregnancy
* Cognitive Impairment
* Prisoner

Primary outcomes:
measure: Tumor Clearance
timeFrame: 21 to 36 days after the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCSD Medical Center, Division of Dermatology
name: S. I. Brian Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02821572: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Official title: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Thrombocytopenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ITP Persons without autoimmune disease

Brief summary: Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings.

Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions.

Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous.

The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.


Eligibility criteria: Inclusion Criteria:

ITP group

* Patients who have provided written consent
* Patients over 18 years
* Patients with national health insurance
* Patients with ITP, defined as thrombocytopenia \< 100 G/L, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy.

Control Group

* Persons who have provided a written consent
* Persons over 18 years
* Persons with national health insurance
* Persons without autoimmune disease

Exclusion Criteria:

* Patients under guardianship
* Pregnancy

Primary outcomes:
measure: 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on monocytes will be compared between ITP patients at diagnosis and controls - physiological parameter
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on splenic macrophages will be compared between ITP patients and controls. - physiological parameter
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05695872: A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
Official title: The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zygomatic Fractures
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

Detailed description: The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:

Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.

Eligibility criteria: Inclusion Criteria:

* Patients with ZMC fractures requiring open reduction and internal fixation.
* Adult patients aged between 20 and 50 years with no gender predilection.

Exclusion Criteria:

* An existing laceration in the inferior and lateral periorbital site.
* Infection at the fracture line.
* Comminuted fracture with bone loss.
* Acute and chronic conjunctival diseases.

Primary outcomes:
measure: accessibility to the fracture site
timeFrame: intraoperative
measure: esthetic appearance and scarring
timeFrame: 6 weeks postoperative
measure: radiographic verification of adequacy of fracture reduction
timeFrame: immediate postoperative
Secondary outcomes:
measure: The duration for exposure of the fracture site
timeFrame: intraoperative
measure: postoperative pain
timeFrame: at 24 hours and 1 week
measure: sensory nerve function
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02604472: Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients
Official title: Stage-specified Concurrent Chemoradiotherapy With or Without Induction Chemotherapy for Locoregionally-advanced Nasopharyngeal Carcinoma - A Retrospective, Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Other Specified Site of Nasopharynx
Keywords: Nasopharyngeal carcinoma
induction chemotherapy
concurrent chemoradiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 12206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013

Brief summary: To investigate whether the additional induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for locoregionally advanced NPC.

Detailed description: Data of patients firstly diagnosed NPC from Jan 1st, 1998 to Jun 1st, 2013 were downloaded from Department of Medical Information, Sun Yat-Sen University Cancer Center. Patients were excluded if they had stage I or II disease, no complete medical records, received treatment previously, or without concurrent chemoradiotherapy. Follow-up data is updated on October 1st, 2015.The propensity score-matching (PSM) method was adopted to balance observed covariates between both groups. Propensity scores reflect the conditional probability that is intended to be uniform between patients received CCRT and IC+CCRT based on their baseline characteristics. Matching was performed based on nearest-neighbor matching, and comparing between CCRT and IC+CCRT patients were matched within their respective risk groups.

Eligibility criteria: Inclusion Criteria:

1. firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
2. with complete medical records;
3. received radical RT.

Exclusion Criteria:

1. distant metastasis patients at first diagnosis,
2. recurrent patients,
3. not finishing radiotherapy, missing medical data, death during RT, stage I or II disease,received treatment previously, or without concurrent chemoradiotherapy were excluded.

Primary outcomes:
measure: overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: disease-free survival
timeFrame: up to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Xiang Guo, MD, PhD
role: STUDY_CHAIR
References:
citation: Xia WX, Liang H, Lv X, Wang L, Ye YF, Ke LR, Xu LH, Guo X, Xiang YQ. Stage-specific concurrent chemoradiotherapy with or without induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a retrospective, population-based study. Cancer Manag Res. 2019 Nov 20;11:9813-9827. doi: 10.2147/CMAR.S179139. eCollection 2019.
Clinical trial NCT03183804: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
Official title: A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-DFU-201
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.

Brief summary: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.

Detailed description: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan medical center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Seung-Kyu Han, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Ki-Won Young, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Hyun-suk Suh, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Jin Woo Lee, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499004: A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Official title: A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: tofacitinib
CP-690
550
relative bioavailability
modified release
Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months

Primary outcomes:
measure: AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
timeFrame: 72 hours post dose
measure: AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration
timeFrame: 72 hours post dose
measure: Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)
timeFrame: 72 hours post dose
measure: Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration
timeFrame: 72 hours post dose
measure: t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma
timeFrame: 72 hours post dose
Secondary outcomes:
measure: Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation
timeFrame: 24 hours post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03998904: Muscle Preservation Hamstring Graft for ACL Reconstruction
Official title: Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graft Healing
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Muscle derived stem cell is a better source of stem cells than a tendon tissue
* Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft


Eligibility criteria: Inclusion Criteria:

* Primary ACL reconstruction using autogenous hamstring graft

Exclusion Criteria:

* Combined meniscal or ligament surgery
* Combined osteoarthritis (KL grade II or more)
* chondral injury more than grade 2
* Refuse to undergo MRI

Primary outcomes:
measure: SNQ value of MRI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References:
Clinical trial NCT04565704: Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Official title: Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastrointestinal Disease
Gastrointestinal Dysfunction
Keywords: OCT
Optical Coherence Tomography
Biopsy
GI disease
Endoscopy screening
Endoscopic Screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

Detailed description: The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology, Gastroenterology, and Pulmonology. They are looking to continue the advancement of these various technologies under development.

The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and/or endo-mucosal resection.The endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies.

The study will be optical imaging of the ex vivo GI specimens that are being collected. Specimens will be collected for research purposes only. Offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. This will require review of the medical record to link the findings of the imaging with the pertinent medical information. Samples will be de-identified and subjects will be assigned a unique number. The tissues will be placed in marked containers labeled "for research purposes only". The samples collected will be brought to the Tearney Research Laboratory for imaging and processing. The Optical imaging of the tissue samples will not affect the standard of care procedure.

Eligibility criteria: Inclusion Criteria:

• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

Exclusion Criteria:

• According to standard of care at MGH endoscopy department.

Primary outcomes:
measure: Device Feasibility based on image quality and presence of microscopic features
timeFrame: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, M.D, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426204: Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: Hepatitis C
Retreatment
Failures
Infergen
Interferon Alfacon-1
Lead sponsor: Closter Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Gastrointestinal Practices as well as hepatologyst practice. Academic Centers have been asked to participate.

Brief summary: This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor. The planned observation time is 48 weeks and 24 weeks of follow-up.

Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.


Eligibility criteria: Inclusion Criteria:

1. Willing to consent to data being collected
2. Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.

Primary outcomes:
measure: Incidence of SVR
timeFrame: 24 weeks post end of therapy
Secondary outcomes:
measure: Safety profile
timeFrame: Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24
Other outcomes:
Locations:
Study officials:
References: