louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02381808: Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China
Official title: Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2015-03-06
Enrollment: 150
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: NSCLC (SageI-IV)

Brief summary: To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Detailed description: This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years,both male and female
* Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV)
* ECOG 0-2
* Patients with enough paraffin tissue specimens or fresh tissue for detection
* Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing
* Subjects who provide detailed clinical and follow-up information

Exclusion Criteria:

* Patients with other tumors
* Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc)
* Pregnant women shall be excluded

Primary outcomes:
measure: Potential predictive biomarker to resistant to afatinib
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital & Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guang general hospital,Guangzhou, Guangdong, China, 510080
name: China China
role: STUDY_CHAIR
References:
Clinical trial NCT04912908: Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
Official title: Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: Ganymed Robotics
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The surgeons involved in the study will propose to all patients corresponding to the eligibility criteria to participate to the study during pre-surgery appointment.

Brief summary: Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.

Detailed description: During knee replacement surgery, per-operative images of the patient's knee will be taken. These images will then be compared with the pre-operative CT-scan of the patient using the novel navigation algorithm. The algorithm will be validated based on its ability to correctly compare both modalities (pre-operative and per-operative images).

Eligibility criteria: Inclusion Criteria:

* Adults patients who signed the ICF of the study
* Patients suffering from knee osteoarthritis requiring a total knee replacement surgery

Exclusion Criteria:

* Patient under the age 18
* Patient unable to consent to the study or refusing to participate
* Patient with history of knee replacement on the knee that will be operated again
* Patient unable to realize a pre-operative CT-scan
* Patient not covered by French Health insurance or equivalent.

Primary outcomes:
measure: Validation of navigation algorithm
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital prive Jean Mermoz-Ramsay Santé
Study officials:
References:
Clinical trial NCT00877708: Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol
Official title: Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E Coli Infections
Keywords: E. Coli
isolates
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with E. coli infections at UPMC

Brief summary: The purpose of this study is to review patients with E. coli infections at UPMC from September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes and determine their clinical outcomes.

The specific aims of this study are to:

1. Review whether cephalosporin-resistant E. coli infections are hospital-acquired, healthcare-associated or community-associated.
2. Determine the clinical outcome of the patients according to the antibiotics given.

Detailed description: De-identified data will be obtained by the honest broker for the requested time period. In addtion, the honest broker will work with the microbiology laboratory to collect the isolates associated with the de-identified data. All data and samples will be de-identified. De-identified data will be given to the nurse coordinator to complete the case report forms and enter the data into the password protected database and the de-identified isolates will be stored and analyzed on the 8th floor Scaife in Dr. Yohie Doi's laboratory.

Eligibility criteria: Inclusion Criteria:

* patients with E. coli infections at UPMC

Exclusion Criteria:

* not meeting entry criteria

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yohei Doi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805608: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Official title: Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Bladder Neoplasms
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer

Detailed description: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.

Eligibility criteria: Inclusion Criteria:

* Biopsy-verified urinary bladder cancer
* The participants must be capable of understanding and giving full informed written consent age above 18 years

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Age above 85 years old
* Weight above 140 kg
* Treatment with neoadjuvant chemotherapy
* Known allergy towards 68Ga-NOTA-AE105
* Other malignant disease within last 5 years, except for non-melanoma

Primary outcomes:
measure: uPAR PET/CT: regional lymph node metastases
timeFrame: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
measure: FDG PET/MRI: regional lymph node metastases
timeFrame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Secondary outcomes:
measure: uPAR PET/CT: Number of lymph node metastases
timeFrame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
measure: FDG PET/MRI: Number of lymph node metastases
timeFrame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
measure: uPAR PET/CT: sensitivity for detection of distant metastases
timeFrame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
measure: FDG PET/MRI: sensitivity for detection of distant metastases
timeFrame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Dorthe Skovgaard, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287208: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Official title: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity
Accelerometer
Steps
Medical residents
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-02-01
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are:

1. To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback).
2. To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
3. To determine if activity level is associated with change in weight during the residency year.
4. To determine if the average hours of sleep per week is associated with changes in weight and with activity level.


Eligibility criteria: Inclusion Criteria:

* Massachusetts General Hospital medicine resident

Exclusion Criteria:

* none

Primary outcomes:
measure: Steps Per Day
timeFrame: 12 weeks
Secondary outcomes:
measure: Distance Per Day
timeFrame: 12 weeks
measure: Calories Burned Per Day
timeFrame: 12 weeks
measure: Weight
timeFrame: 6 months
measure: Hours of Sleep Per Night
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne N Thorndike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorndike AN, Mills S, Sonnenberg L, Palakshappa D, Gao T, Pau CT, Regan S. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial. PLoS One. 2014 Jun 20;9(6):e100251. doi: 10.1371/journal.pone.0100251. eCollection 2014.
Clinical trial NCT06621108: Focus Group Study on the Feeling Tone Mindfulness Course
Official title: Focus Group Study on the Feeling Tone Mindfulness Course
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mindfulness
Self-Compassion
Depression
Anxiety
Stress
Well-being
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study are adult individuals who have previously completed the four-week feeling tone mindfulness intervention course.

Brief summary: This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course by gathering qualitative feedback from course participants in a focus group format.

Detailed description: This is a follow-up study of the four-week feeling tone mindfulness course study, exploring the acceptability, feasibility, and effectiveness of the four-week feeling tone mindfulness course by gathering qualitative feedback from course participants in an online (e.g., Zoom), focus group format. A trained moderator will use a semi-structured interview guide with a set of questions to facilitate focus group discussions. Each focus group session will last for about two hours. With the consent from focus group participants, each focus group will be audio-recorded. After participants have completed the focus group, they are eligible to receive HKD100, as a token of thanks to their support and participation to this focus group study.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or above
* Speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the focus group session without the need for translation support
* Have means to access online teleconferencing meeting software (e.g., Zoom), online surveys (to give their informed consent and to schedule a focus group session), online materials, and Short Message Service (SMS) or WhatsApp messenger.
* Participants who have completed the four-week feeling tone mindfulness course

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Acceptability and feasibility of the four-week feeling tone mindfulness course, based on an unpublished focus group interview guide at the Department of Psychology, The University of Hong Kong
timeFrame: 4 weeks
measure: Effectiveness of the four-week feeling tone mindfulness course, based on an unpublished focus group interview guide at the Department of Psychology, The University of Hong Kong
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychology, The University of Hong Kong
Study officials:
affiliation: Department of Psychology, The University of Hong Kong
name: Hoi Chun Lok, MSocSc(CP)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860508: A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
Official title: Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: Progression free Survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 94
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PFS


Eligibility criteria: Inclusion Criteria:

.≥65 years or PS 2

* Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
* Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
* Presence of at least one index lesion measurable by CT scan or MRI

  * leucocyte ≥ 3.5×109/L
  * neutrophil ≥ 1.5×109/L
  * platelet ≥ 80×109/L
  * Hemoglobin ≥ 9g/L
  * ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
* BUN≤ 1.5×ULN
* Signed written informed consent

Exclusion Criteria:

* squamous carcinoma or small cell lung cancer
* Patients were allergic to pemetrexed
* Patients received chemotherapy before
* Uncontrolled acute infection

  .Uncontrolled pleural effusion
* Severe symptomatic heart disease
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

  * Mental disorientation of disorder
  * Glucocorticoids taboo

Primary outcomes:
measure: PFS
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
citation: Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.
Clinical trial NCT03152708: CAN008 Biomarker CD95 Ligand and CpG2 Methylation in Chinese Patients With Glioblastoma
Official title: The Exploratory Study on CAN008 Biomarker CD95 Ligand and Its Promoter (CpG2) Methylation in Chinese Patients With Glioblastoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Lead sponsor: CANbridge Life Sciences Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese GBM patients

Brief summary: This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices are necessary for all the CD95 and CpG2 test in the central lab by the methods of immunisation and DNA methylation.


Eligibility criteria: Inclusion Criteria:

* Chinese nationality
* No limits on Gender and age
* First diagnosed GBM
* Brain tumor tissue cytological diagnosis of glioblastoma (GBM, pleomorphic glioblastoma, WHO level IV)

Exclusion Criteria:

* Other types of glioma by histological diagnosis
* Tumor tissue not eligible for the central laboratory testing standard
* No enough tumor tissue for the central laboratory test

Primary outcomes:
measure: CD95 Ligand Positive Rate
timeFrame: 0 day
Secondary outcomes:
measure: CpG2 Positive Rate
timeFrame: 0 day
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Jinsong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348408: Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy.
Official title: Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 62
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 study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.

Detailed description: This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment.

Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.

Eligibility criteria: Inclusion Criteria:

* cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment

Exclusion Criteria: patients with:

* Foot ulcers and / or amputation.
* Peripheral vascular disease.
* Uncontrolled diabetes
* Vertebral pathologies.
* Connective tissue diseases.
* Thyriod disorders, significant renal or hepatic dysfunction.
* Platelet dysfunction syndrome, critical thrombocytopenia.
* Septicemia and local infection at the site of the procedure.
* Systemic corticosteriod adminstiration or local injection at the suspected treatment site within the last month.
* Recent fever or illness.
* Hemoglobin level less than 10 g/dl, platelet count less than 105-109/L.

Primary outcomes:
measure: Change in severity of pain after injection
timeFrame: baseline, 15 days, 1 month, 2 months, 3 months
Secondary outcomes:
measure: total neuropathy score
timeFrame: baseline, 15 days, 1 month, 2 months, 3 months
measure: The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)
timeFrame: baseline, 15 days, 1 month, 2 months, 3 months
measure: Nerve conduction study
timeFrame: baseline, 3 months
measure: A 7- point Likert like verbal rating scale
timeFrame: baseline, 15 days, 1 month, 2 months, 3 months
Other outcomes:
Locations:
Study officials:
References: