louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03051581: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
Official title: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, T-Cell, Peripheral
Keywords: Lymphoma, T-Cell, Peripheral
Positron-Emission Tomography
Prognosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2017-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of PTCL can predict disease progression

Detailed description: In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in PTCL.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed PTCL
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.

Primary outcomes:
measure: 3 year progression-free survival
timeFrame: up to 3 years after initial diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01215981: Influenza Vaccine Post Allogeneic Transplant
Official title: MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Hematologic Malignancy
Keywords: influenza vaccine
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study Design:

This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.


Eligibility criteria: Inclusion Criteria:

* Patient Population

  * HSCT recipients who are greater than 60 days post transplant.
  * Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
  * Show neutrophil recovery, platelet count \> 50,000/mm3 (may be transfused), no known disease relapse
  * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
  * No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
* Controls:

  * Age 18 to 50 years
  * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
  * No flu vaccine in previous 4 months

Primary outcomes:
measure: Number of Subjects With T-Cell Based Immune Response to Vaccine
timeFrame: 8 Weeks After Vaccination
Secondary outcomes:
measure: Number of Subjects With H3 Based Immune Response to Vaccine
timeFrame: 8 Weeks After Vaccination
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Michael Verneris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390181: The Effect of Losartan in Bicuspid Aortic Valve Patients
Official title: The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bicuspid Aortic Valve
Thoracic Aortic Aneurysm
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aims of this study are to:

* Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements \>40mm.
* Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
* In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate


Eligibility criteria: Inclusion Criteria:

* Adults \>age 18 years and \< 65 years old
* Able to give informed consent
* Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva \>4.0cm
* No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
* Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.

Exclusion Criteria:

* Unable to safely take losartan due to one or more of the following:

  * Hypersensitivity to losartan or other angiotensin receptor blockers
  * Pregnancy
  * Nursing mothers
  * History of angioedema
  * Hypotension - chronically volume depleted patients
  * Hepatic or renal impairment (Cr\>1.5mg/dL)
  * Hyperkalemia (K+\>4.8)
  * Renal artery stenosis
  * Severe congestive heart failure (class III-IV)
  * Currently taking potassium supplements or salt substitutes containing potassium
  * Currently taking lithium
* Prior surgical intervention to aorta or aortic valve
* Unable or unwilling to give informed consent and follow up with study activities
* Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
* Females of child bearing who are unwilling to practice adequate birth control throughout the study.

Primary outcomes:
measure: Inflammatory Markers Levels
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anna Booher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05392881: Interstitial Lung Disease Research Unit Biobank
Official title: University of Kansas Medical Center Interstitial Lung Disease Research Unit (ILDRU) Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Sarcoidosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Hypersensitivity Pneumonitis
Keywords: Interstitial Lung Disease
Sarcoidosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Hypersensitivity Pneumonitis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 1000
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: Patients with ILD, RLD and subjects at risk for ILD

Brief summary: Establish a interstitial lung disease (ILD) registry and biorepository to lead towards a further understanding of the disease.

Detailed description: The University of Kansas ILD and Rare Lung Disease clinic sees hundreds of new patients per year. The investigators would like to leverage this resource to develop an Interstitial Lung Disease Research Unit (ILDRU) repository and database to help develop new methods for early diagnosis, uncover underlying genetic and environmental risk factors, as well as potential treatment targets in the broad range of interstitial lung diseases and rare lung diseases (RLD).

Eligibility criteria: Inclusion Criteria:

1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
2. The participant is being followed for the presence of autoimmune disease, ILD or other rare lung diseases at TUKHS.
3. The participant is ≥ 18 years of age.
4. The participant has signed an approved consent for this study (living patients only)

Primary outcomes:
measure: Collect clinically obtained data for patients with ILD, RLD and risk for ILD/RLD to support research.
timeFrame: Enrollment to Year 10
measure: Establish a collection of biological samples from patients with ILD, RLD and subjects at risk for ILD.
timeFrame: Enrollment to Year 10
measure: Correlate biological samples with individual longitudinal clinical data.
timeFrame: Enrollment to Year 10
measure: Provide biological samples to researchers performing studies in ILD and RLD.
timeFrame: Enrollment to Year 10
measure: Collect historical data and imaging from deceased patients with ILD.
timeFrame: Enrollment to Year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Chase Hall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661281: Function Following Thumb MP Fusion and IP Fusion
Official title: Function Following Thumb MP Fusion and IP Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to determine function following simulated thumb metacarpophalangeal (MP) and thumb interphalangeal (IP) joint fusion. The investigators want to determine the functional limitation created by MP and IP joint fusion. 20-30 volunteers will be fitted for custom molded orthoplast splints immobilizing either the MP or IP joint. The volunteers will then be taken through multiple tests including lateral pinch strength, tip pinch, grip strength, grooved pegboard test time, and Jebson Taylor test. Each patient will be tested without a splint, with their MP joint immobilized and with their IP joint immobilized. The results of this study can be used for patient education before surgery in order to help them make informed decisions as well as manage expectations. It can also serve as a decision aid in pinch restoration in the context of ulnar nerve palsy.


Eligibility criteria: Inclusion Criteria:

* Patient is a healthy volunteer
* Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

* Any subject who does not want to voluntarily participate.

Primary outcomes:
measure: Jebsen Taylor hand function test
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eitan Melamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02808481: FOLLOW HEART TRANSPLANT FOR ACHIEVING THE HEART PRIMITIVE RELATED SCLERODERMA SYSTEMIC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
cardiac disease
Heart transplantation
primitive cardiac damage
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvemen

Brief summary: Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients sclérodemiques.

Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.

we see patient data analysis with systemic sclerosis who used cardiac transplantation to understand the primitive cardiac damage associated with systemic sclerosis


Eligibility criteria: Inclusion criteria:

* Adult patients meet the criteria for classification of systemic sclerosis
* Adverse primitive heart that required a heart transplant
* Patients who have given their verbal agreement to use their data for research purposes.

Exclusion criteria:

* Localized Scleroderma or sclerodermiform syndrome
* Heart disease secondary to pulmonary or renal impairment
* Refusal to participate in the study

Primary outcomes:
measure: Analysis of data from patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvement
timeFrame: 1month post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00192881: Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
Official title: Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Balloon angioplasty
Restenosis
Stents
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
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: The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Stable, or unstable angina and/or objective signs of myocardial ischaemia
* Informed consent
* Optimal result (\< 35% residual stenosis and \< type C dissection) after balloon angioplasty
* Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
* Complex lesions to be included should have at least one of the following characteristics:

  * ostial in location (\< 5 mm from ostium)
  * total occlusions with a length ≥ 15 mm
  * bifurcational (side branch \> 1.75 mm in diameter)
  * angulated (\> 45° within lesion)

Exclusion criteria:

Patients:

* Other severe disease with an expected survival \< 1 year
* Other significant cardiac disease
* Known allergy against paclitaxel, clopidogrel (or ticlopidine),
* Myocardial infarction within 3 days of the index procedure
* Linguistic difficulties needing an interpreter
* Renal insufficiency (p-creatinine \> 200 micromol/l)
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study

Lesions:

* Unprotected left main disease
* Restenosis
* Lesions containing visible thrombus
* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
* Diffuse coronary disease distal to the treated lesion
* Heavily calcification
* Lesion located in saphenous vein graft

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Cardiac Cath Lab
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Kelbaek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508181: Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients
Official title: Intra Ocular Pressure After I-gel and Supreme Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intra Ocular Pressure
Keywords: intra ocular pressure
I-gel
LMA Supreme
strabismus surgery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 57
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

Detailed description: We already know that tracheal intubation increased intraocular pressure. We tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the I-gel and LMA Supreme supraglottic airway devices. We enrolled the pediatric patients who are undergoing to strabismus surgery.

Eligibility criteria: Inclusion Criteria:

* pediatrics \> 2 years
* pediatrics \< 7 years
* undergoing strabismus surgery

Exclusion Criteria:

* pediatrics \< 2 years
* pediatrics \> 7 years
* neuromuscular blockage using

Primary outcomes:
measure: intra ocular pressure
timeFrame: 15 minutes
Secondary outcomes:
measure: vomiting
timeFrame: 2 hour
measure: bradicardia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
References:
Clinical trial NCT02049281: A Study of Vintafolide (MK-8109) in Participants With Advanced Solid Tumor (MK-8109-011)
Official title: A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 3
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: This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier
* Primary central nervous system (CNS) tumor
* Active CNS metastases and/or carcinomatous meningitis
* Known hypersensitivity to the components of the study therapy or its analogs
* Recent history of abdominal surgery or peritonitis
* Bowel occlusion or sub occlusion
* Prior abdominal or pelvis radiation therapy or radiation therapy to \> 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast / sternum, head, or neck
* Requires anti-folate therapy
* Symptomatic ascites or pleural effusion
* Prior stem cell or bone marrow transplant

Primary outcomes:
measure: Number of Participants Experiencing Dose-limiting Toxicities
timeFrame: Up to 28 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Vintafolide
timeFrame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
measure: Area Under the Plasma Concentration-time Curve (AUC) for Vintafolide
timeFrame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
measure: Plasma Concentration of desacetylvinblastine hydrazide (DAVLBH)
timeFrame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03708081: Comparative Evaluation of Different File Systems in Postoperative Pain
Official title: Comparative Evaluation of Different File Systems in Postoperative Pain: Randomize Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulpitis
Periapical Periodontitis
Necrotic Pulp
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred to dental clinic for endodontic treatment

Brief summary: Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion.

The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

Detailed description: Sixty patients having root canal treatment indication and a single root canal were included in the study. The patients were randomly assigned into 2 groups according to root canal instrumentation technique used. In group 1; ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) instruments with rotational motion, in group 2 TF Adaptive (SybronEndo, Orange, CA) instruments with adaptive motion were used for root canal treatments. Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. All the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. Data were analyzed using the Mann Whitney-U, Friedman and Wilcoxon tests.

Eligibility criteria: Inclusion Criteria:

* having root canal treatment indication
* single root canal

Exclusion Criteria:

* previously treated tooth

Primary outcomes:
measure: Post operative pain
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Bülent Ecevit University, Faculty of Dentistry
Study officials:
References: