louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00806065: Study of ENMD-2076 in Patients With Multiple Myeloma
Official title: A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 13
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: Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

Detailed description: The study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of doses in patients with relapsed or refractory multiple myeloma.

Eligibility criteria: Major Inclusion Criteria:

1. Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
2. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
3. Age ≥18 years.
4. ECOG performance status 0-2.
5. Patients must have adequate organ and marrow function

Major Exclusion Criteria:

1. Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
2. Prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis).
3. Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
4. Have unstable angina pectoris or recent myocardial infarction (within 6 months.
5. Have uncontrolled hypertension or congestive heart failure.

Primary outcomes:
measure: Maximum tolerated dose of ENMD-2076
timeFrame: Within first 35 days
Secondary outcomes:
measure: Correlative studies of activity
timeFrame: throughout the study period
measure: Clinical Benefit
timeFrame: Each cycle of treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
References:
Clinical trial NCT06723665: The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients
Official title: The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
PET/CT
PSMA-1007
18F
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.

Detailed description: 1. Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
2. Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
3. Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
4. Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
5. Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.

Eligibility criteria: Inclusion Criteria:

Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.

Exclusion Criteria:

Patients who did not meet the requirements as assessed by the investigator.

Primary outcomes:
measure: 18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01396265: Drug Interaction Study With Rifampicin and Afatinib
Official title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I Trial in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers


Eligibility criteria: Inclusion criteria:

Healthy male volunteers

Exclusion criteria:

Any relevant deviations from healthy conditions

Primary outcomes:
measure: Area Under Curve From 0 to Infinity Hours (AUC0-∞)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Area Under Curve From 0 to tz (AUC0-tz)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Maximum Concentration (Cmax)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Secondary outcomes:
measure: Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Terminal Half-life of Afatinib in Plasma (t1/2)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Area Under Curve From 0 to 24 h (AUC0-24)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
measure: Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1200.152.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02042365: Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity
Official title: Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Enhanced recovery,
sleeve gastrectomy,
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
name: Ministry of Health, France
First posted: 2014-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: obese patients undergoing a sleeve gastrectomy

Brief summary: The primary purpose of the study is to test the feasibility of a protocol of enhanced recovery after surgery for reducing the total length of hospital stay in a large scale setting

Detailed description: This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac.

Eligibility criteria: Inclusion Criteria:

* Obese patients undergoing a sleeve gastrectomy Patients having signed the informed consent Patients over 18 year old ASA 1-3 Obesity with indication for surgery according the guidelines of the French High Authority for Health BMI \< 50 kg/m2 No contra-indication for general anesthésia

Exclusion Criteria:

contra-indication for general anesthésia Age under 18 years ASA 4 BMI \> 50 kg/m2 Patients having other serious comorbidities: cardiac, pulmonary, diabete, immunodepression, coagulopathy ou anticoagulant therapy Pregnancy Patients living alone

Primary outcomes:
measure: Duration of hospital stay
timeFrame: at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Karem SLIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181765: The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy
Official title: The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's Disease
infliximab
capsule endoscopy
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 1
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: This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining healing of lesions in the mucosa of subjects with Crohn's disease involving their small bowel.

Detailed description: Landmark trials in Crohn's disease demonstrated the efficacy of infliximab in inducing and maintaining clinical remission. Furthermore, the endoscopic sub-studies within these trials demonstrated the ability of infliximab to rapidly induce and maintain mucosal healing as evidenced by the complete absence of mucosal breaks in the colon and terminal ileum. Unfortunately, conventional colonoscopy does not allow intestinal exploration beyond a very restricted portion of the small bowel (at most 10-15 cm of the terminal ileum). A study that systematically examines the changes in the small bowel mucosa during Crohn's disease symptomatic improvement is clearly needed.

This study consists of 20 subjects and 30 weeks of follow up. All subjects will undergo wireless camera endoscopy at three (3) visits, namely: at Screening, at Week 10 and at Week 26. Infliximab is administered at (5) visits, namely: at Baseline (week 0), Week 2, Week 6, Week 14 and Week 22. In some subjects, an ileal-colonoscopy may be performed at Week 26.

Eligibility criteria: Inclusion Criteria:

* 18 years old
* Established diagnosis of Crohn's disease and evidence of small bowel involvement
* CDAI score between 220 and 450 inclusively
* Lewis score of at least 790 at Screening
* Colonoscopy within the last 6 months
* Successful excretion of the intact patency capsule Exclusion Criteria
* Contraindications to anti-TNF therapy (TB, cardiac impairment, etc.)
* Prior bowel resection
* Prior anti-TNF exposure

Primary outcomes:
measure: Endoscopic Improvement
timeFrame: Week 26
Secondary outcomes:
measure: Clinical improvement
timeFrame: Week 26
measure: Early endoscopic improvement
timeFrame: Week 10
measure: Clinical Improvement
timeFrame: Week 10
Other outcomes:
Locations:
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00237965: The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy
Official title: The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Skin Self Examination
Mole Mapping Diagram
Melanoma
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2005-10-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects above age 18 of any ethnicity will be enrolled in this study.

Exclusion Criteria:

* Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects.
* Since the study instructions are in English, Non-English speakers will be excluded.
* Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded.
* In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Veterans Affairs Medical Center Providence, RI
name: Martin A Weinstock, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00258765: Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.
Official title: A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: zoledronic acid
prostate cancer
high risk
PSA
docetaxel
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 1
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.


Eligibility criteria: Inclusion Criteria:

* Radical prostatectomy for prostate cancer within last 2 months.
* Post-operative Kattan nomogram predicts \>25% risk of PSA relapse by 5 years.
* 6-week post-operative serum PSA\<0.2ng/mL.
* Low levels of circulating prostate cancer cells in the blood, detected by PCR amplification of PSA mRNA 6 weeks post-prostatectomy.

Exclusion Criteria:

* Pre-operative serum PSA level \>20ng/ml.
* Clinical evidence of metastases by 6-week post-operative visit.
* Prior treatment with either ADT or bisphosphonate therapy.
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)

Other protocol defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa
timeFrame: 6 months after study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06310265: Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake
Official title: Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Earthquake
Crush Injury
Anesthesia
Keywords: pediatric
trauma
earthquake
anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After the earthquake on February 6, pediatric victims were transferred to our hospital and underwent surgery.

Brief summary: The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6.

Detailed description: In this study, The investigators planned to retrospectively investigate the anesthesia management of pediatric patients who were transferred to or admitted to the Ankara Bilkent City Hospital in the earthquake disaster of February 6. The anesthesia data on pediatric earthquake victims were insufficient in the literature.The investigators aimed to share our experiences to guide anesthesia management in future possible disasters.

Eligibility criteria: Inclusion Criteria:

* Child earthquake victims between the ages of 0-18
* Participants who had surgery and anesthesia between 9 February 2023 and 9 August 2023

Exclusion Criteria:

* The exclusion criterion is child earthquake victims patient who did not undergo anesthesia.

Primary outcomes:
measure: The anesthesia management under pediatric earthquake victims
timeFrame: 6 months (9 February 2023-9 August 2023)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Sengul Ozmert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04416165: Comparison of FDG and FAPI in Patients With Various Types of Cancer
Official title: Comparison of FDG and FAPI in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor, Solid
Positron-Emission Tomography
Metastasis
Keywords: Positron-Emission Tomography
Tumor, Solid
Diagnosis
Metastasis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Detailed description: Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: SUV
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: XiaMen
country: China
facility: First affiliated hospital of xiamen university
state: Fujian
Study officials:
References:
citation: Guo W, Pang Y, Yao L, Zhao L, Fan C, Ke J, Guo P, Hao B, Fu H, Xie C, Lin Q, Wu H, Sun L, Chen H. Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1604-1617. doi: 10.1007/s00259-020-05095-0. Epub 2020 Nov 11.