louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05430841: Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Official title: Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Pancreatic Cancer
Liver Cancer
Keywords: Diagnosis
Positron-Emission Tomography
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 100
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
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.

Detailed description: Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI 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 numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years or order);
* patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
* 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:

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

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 30 days
Secondary outcomes:
measure: SUV
timeFrame: 7 days
measure: Number of lesions
timeFrame: 7 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First affiliated hospital of xiamen university
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Long Sun, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01608841: The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
Official title: The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2012-05-31
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

Detailed description: The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Eligibility criteria: Inclusion Criteria:

* metastatic chemotherapy-naïve pancreatic cancer patients
* histologically confirmed
* adequate samples for analysis
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
* absolute neutrophil count (ANC) \>= 1,500/mm3
* platelet count \>= 100,000/mm3
* serum creatinine \<= 1.5 mg/dL
* aspartate aminotransferase (AST)
* alanine aminotransferase (ALT) \< 5 times the upper limit of normal

Exclusion Criteria:

* absence of any other malignancy or serious medical or psychological illness that would preclude informed consent

Primary outcomes:
measure: disease control rate
timeFrame: eight weeks
Secondary outcomes:
measure: response rate
timeFrame: eight weeks
measure: overall survival
timeFrame: one day
measure: progression-free survival
timeFrame: one day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Gastroenterology, Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chung-Pin Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yee Chao, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Wang JP, Wu CY, Yeh YC, Shyr YM, Wu YY, Kuo CY, Hung YP, Chen MH, Lee WP, Luo JC, Chao Y, Li CP. Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial. Oncotarget. 2015 Jul 20;6(20):18162-73. doi: 10.18632/oncotarget.4216.
Clinical trial NCT00676741: Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin
Official title: Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 3809
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: Diabetes type 2

Brief summary: The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.

Full acronym for this study: COMMIT - CLEAN SWITCH


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Patients treated with human soluble insulin, NPH insulin or premixed human insulin
* Patients willing to sign informed consent
* Selection of study participants at the discretion of the physician

Exclusion Criteria:

* Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients

Primary outcomes:
measure: Metabolic control measured as HbA1c
timeFrame: for the duration of the study
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%
timeFrame: after 12 weeks and 24 weeks
measure: Change in FPG (glucose variability)
timeFrame: after 12 weeks and 24 weeks
measure: Change in PPG (postprandial control)
timeFrame: after 12 weeks and 24 weeks
measure: Change in insulin dose and number of injections
timeFrame: after 12 weeks and 24 weeks
measure: Change in oral antidiabetic drug therapy
timeFrame: after 12 weeks and 24 weeks
measure: Change in body weight
timeFrame: after 12 weeks and 24 weeks
measure: Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
timeFrame: after 12 weeks and 24 weeks
measure: Number of adverse drug reactions (ADR)
timeFrame: after 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02197741: The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
Official title: The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain Syndrome
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with chronic pain syndrome

Brief summary: An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.

Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.

The following hypotheses were tested:

* The application of additional opiate boli results in significantly lower pain intensity.
* The application of additional opiate boli does not result in a higher rate of adverse Events.


Eligibility criteria: Inclusion Criteria:

* chronic pain syndrome
* intrathecal opiate pump
* signed informed consent

Exclusion Criteria:

* younger than 18 years
* other (than opiate) intrathecal drug administration
* discontent with intrathecal opiate therapy

Primary outcomes:
measure: change in pain intensity
timeFrame: day 0. day 14, day 28
Secondary outcomes:
measure: change in satisfaction with treatment outcome
timeFrame: day 0, day 14, day 28
measure: side effects
timeFrame: from day 0 to day 28
Other outcomes:
Locations:
Study officials:
affiliation: Center for Pain Medicine
name: Tim Reck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498219: Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity
Official title: Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Contrast Sensitivity
Keywords: Contrast Sensitivity
Iodinated contrast products
Allergic immunological mechanisms
Allergy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) treated in the allergology department in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to ICPs and having had at least one undiluted intradermal reaction to one or more ICPs.

Brief summary: Hypersensitivity to iodinated contrast products (ICP) affects 1 to 3% of injected patients. These reactions require an allergological assessment with skin tests in order to distinguish allergic immunological mechanisms from other non-specific mechanisms. Current recommendations recommend carrying out prick tests followed by intradermal reactions up to a 10th dilution. However, undiluted IDRs are carried out by several teams under certain conditions, without this having been validated. Experience tends to show that these IDRs are relevant in certain patients to make the diagnosis without risk.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject treated in the allergology department in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to ICPs and having had at least one undiluted intradermal reaction to one or more ICPs.
* Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Primary outcomes:
measure: Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test.
timeFrame: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pneumologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02803619: A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Leptomeningeal Metastasis
Keywords: Non-small cell lung cancer
leptomeningeal metastasis
EGFR sensitive mutations
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leptomeningeal metastasis (LM) in patients with non-small cell lung cancer (NSCLC)

Brief summary: Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.


Eligibility criteria: Inclusion Criteria:

1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
2. Non-small cell lung cancer patients.
3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
5. Expected survival time is greater than 1 month.

Exclusion Criteria:

Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Primary outcomes:
measure: Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Respiratory Medicine, Peking Union Medical College Hospita
state: Beijing
Study officials:
References:
citation: Xu Y, Hu M, Zhang M, Zhong W, Yin X, Sun Y, Chen M, Zhao J, Si X, Wang H, Zhang X, Zhang L, Li J, Guan H, Yang Z, Wang M. Prospective study revealed prognostic significance of responses in leptomeningeal metastasis and clinical value of cerebrospinal fluid-based liquid biopsy. Lung Cancer. 2018 Nov;125:142-149. doi: 10.1016/j.lungcan.2018.08.017. Epub 2018 Sep 17.
Clinical trial NCT00409019: Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
Official title: A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.


Eligibility criteria: Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
* Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Other inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C, hepatitis D or HIV
* Patient previously received nucleoside(tide) therapy other than adefovir
* Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Other exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06131619: The Role of DLOTCA-G in the Cognitive Function Evaluation of Parkinson's Patients
Official title: The Role of Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version (DLOTCA-G) in the Cognitive Function Evaluation of Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease
DLOTCA-G
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's dissease patients

Brief summary: The purpose of this study is to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in parkinson patients.

Detailed description: The purpose of this study to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in the early detection of cognitive impairment in parkinson patients aged 65 and over, with and without dementia.The investigators also aimed to compare the Mini Mental State Assessment Test with DLOTCA-G.

Eligibility criteria: Inclusıon Criteria

* Parkinson's patients aged 65 years and older with and without cognitive impairment (60 patients) and healthy control patients (30 patients)
* Hoehnn Yahr Staging between 1 and 2.5 in patients with Parkinson's diseas
* Confirmed by brain MRI from patients without vascular dementia who routinely attend the Parkinson's follow-up outpatient clinic
* At least primary school graduates
* In patients with Parkinson's dissease patients with cognitive impairment, MMSE below 20 in primary school education level; below 24 in secondary, high school and university education level
* In patients with Parkinson's disease without cognitive impairment, MMSE 20 and above in primary school education level; 24 and above in secondary, high school and university education level Exclusıon Criteria
* Preexisting cognitive impairment
* Psychiatric disorders such as psychotic disorders, mood disorders, alcohol or drug abuse
* Severe language dysfunction and/or bilateral limb motor dysfunction and inability to participate in clinical psychology tests, severe visual and/or auditory impairments
* Patients with significant cerebral atrophy or neurological vascular lesions
* The Geriatric Depression Scale was administered to all participants, and participants with a total score of 13 or more out of 30 points were excluded from the study.

Primary outcomes:
measure: Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
References:
Clinical trial NCT01216319: Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Official title: A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Reconstruction
Nipple Reconstruction
Keywords: Biodesign
Nipple Reconstruction
Breast Cancer
Mastectomy
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 50
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: Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.


Eligibility criteria: Inclusion Criteria:

* Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.
* Patient presents with a desire to obtain nipple reconstruction
* Patient is at least 18 years of age
* And other inclusion criteria

Exclusion Criteria:

* Patient is not medically fit enough for surgery under local anesthesia
* Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)
* Patient is pregnant, breastfeeding or planning further pregnancy during the study period
* Patient has physical allergies or cultural objections to the receipt of porcine products
* And other exclusion criteria

Primary outcomes:
measure: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Patient Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Lone Tree
country: United States
facility: Park Meadows Cosmetic Surgery
state: Colorado
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Sioux Falls
country: United States
facility: Sanford Clinic Plastic and Reconstructive Surgery
state: South Dakota
Study officials:
affiliation: Stanford University
name: Geoffrey Gurtner, MD
role: PRINCIPAL_INVESTIGATOR
References: