louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05001152: Taste Assessment of Ozanimod
Official title: An Open-Label Taste Assessment of Ozanimod in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Ozanimod
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 7
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the taste characteristics of ozanimod formulations, alone and mixed, in order to develop a pediatric oral form of ozanimod.


Eligibility criteria: Inclusion Criteria:

* Men and women, between 25 and 80 years of age.
* Participant is a qualified sensory panelist selected by Senopsys based on training and experience

Exclusion Criteria:

* Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that might confound the results of the study or places the panelist at unacceptable risk if he or she were to participate in the study.
* Participant is a female that is pregnant, nursing, or planning to become pregnant during the study.

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Taste evaluation - Aromatic identity
timeFrame: Up to 6 months
measure: Taste evaluation - Amplitude
timeFrame: Up to 6 months
measure: Taste evaluation - Off-notes
timeFrame: Up to 6 months
measure: Taste evaluation - Aftertaste
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Local Institution - 0001
state: Massachusetts
city: Woburn
country: United States
facility: Senopsys LLC
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03928652: Prognostic Biomarker for CRC
Official title: Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly histologically confirmed colorectal cancer and no evidence of distant metastasis

Brief summary: The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

Detailed description: This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
2. Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
3. Sufficient surgical tissue samples are available for testing;
4. untreated colon or rectal cancer patients;
5. Patient able to understand and sign written informed consent
6. No evidence of distant metastasis (M0)

Exclusion Criteria:

1. Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
2. Other malignant tumors;
3. Pregnant women;
4. Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome

Primary outcomes:
measure: Failure-free Survival
timeFrame: 3 years
measure: Tumor regression grade
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yet-sen University
Study officials:
References:
Clinical trial NCT00344552: Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer
Official title: Phase II Study to Evaluate Efficacy and Safety of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer. This Study is an Extension Study for Japanese Registration Only.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Patients must have measurable disease
* Patients must have experienced on pervious chemotherapy regime
* Men and Women, with the age 20 years or older
* ECOG PS: 0-1

Exclusion Criteria:

* Patients with previous therapy with Taxanes

Primary outcomes:
measure: Overall response rate
timeFrame: at the end of the study
measure: Safety
timeFrame: at the end of the study
Secondary outcomes:
measure: Response duration
timeFrame: at the end of the study
measure: Time to progression (TTP)
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Kashiwa-Shi
country: Japan
facility: Local Institution
state: Chiba
city: Sagamihara-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Osaka-Sayama City
country: Japan
facility: Local Institution
state: Osaka
city: Suita-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Takatsuki-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Sunto-Gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Local Institution
state: Tochigi
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Osaka
country: Japan
facility: Local Institution
city: Saitama
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02784652: Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors
Official title: Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Metastasis
Gastrointestinal Cancer
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 60
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: Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis.

The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone.

Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with radiologic detectable bone metastasis (spine or non-spine)
* Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
* Patients over 20 years of age of both genders
* ECOG: 0 \~ 2
* Pain: worst pain score on BPI ≥3

Exclusion Criteria:

* Undetectable bone metastasis on radiologic study
* Patients who have previous surgery history at same site
* Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
* Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
* Patients who have treatment history with zoledronic acid or other bisphosphonate
* Abnormal renal function or history of kidney transplantation
* Patients with metabolic bone disease
* Synchronous symptomatic brain metastasis
* Women who are pregnant, breast-feeding, or possible pregnancy

Primary outcomes:
measure: Pain relief rate
timeFrame: Change from baseline pain extent at 1,3,6 months
Secondary outcomes:
measure: skeletal related events (fracture and spinal cord compression)
timeFrame: at 18months after the IRB approval
measure: Overall survival
timeFrame: at 18months after the IRB approval
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06423352: A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mild to Moderate Hypertension
Keywords: High blood pressure
Hypertension
Hypertensive
siRNA
Angiotensinogen
AGT
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.


Eligibility criteria: Inclusion Criteria:

* Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
* Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
* Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication

Exclusion Criteria:

* Has secondary hypertension, symptomatic orthostatic hypotension
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
* Has elevated serum potassium \>5 mmol/L
* Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
* Has received an investigational agent within the last 30 days
* Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
* Has history of intolerance to SC injection(s)

Primary outcomes:
measure: Frequency of Adverse Events (AEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6
timeFrame: Baseline and Month 3 and Month 6
measure: Change from Baseline at Month 3 and Month 6 in 24-hour Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: Baseline and Month 3 and Month 6
measure: Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure
timeFrame: Baseline and Month 3 and Month 6
measure: Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration
timeFrame: Predose and up to 3 days postdose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Clinical Trial Site
city: Osaka
country: Japan
facility: Clinical Trial Site
city: Tokyo
country: Japan
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03380052: OLGA and OLGIM Stage System for Gastric Cancer
Official title: The Evaluation of OLGA and OLGIM Stage Systems for Prediction of Gastric Cancer Risk and Interaction With Other Risk Factors According to Lauren's Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasms
Atrophic Gastritis
Intestinal Metaplasia
Keywords: OLGA
OLGIM
Helicobacter pylori
Gastric cancer
pepsinogen
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: National Clinical Research Coordination Center, Seoul, Korea
First posted: 2017-12-20
Enrollment: 2900
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visited gastroenterology department complaining of gastrointestinal symptoms and underwent esophagogastroduodenoscopy (EGD)

Brief summary: To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

Detailed description: To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric cancer risk according to Lauren's histologic classification in South Korea, where the incidence rate of GC is high. In addition, the investigators attempted to investigate the interaction among the several risk factors including OLGA or OLGIM staging system for the risk of GC to help establish surveillance strategy.

Eligibility criteria: Inclusion Criteria:

* Control group

  * those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper gastrointestinal endoscopy
* Gastric cancer group

  * Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old.

Exclusion Criteria:

* history of previous gastrointestinal surgery,
* any other malignancy
* cardia cancer
* who do not perform endoscopic biopsy
* pathologically proven gastric dysplasia

Primary outcomes:
measure: The evaluation of OLGA and OLGIM stage systems with serum pepsinogen for prediction of gastric cancer risk
timeFrame: per 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Officials Officials, Officials
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06058052: Prevalence of OSA in Patients of ILD
Official title: Pattern Of Association Between Obstructive Seep Apnea and Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OSA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Assiut University Hospital diagnosed as interstitial lung disease risky for OSA will be included from June 2023 to January 2024.

Brief summary: To evaluate the clinical predictors of OSA in patients with ILD

Detailed description: Interstitial lung diseases (ILDs) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma.

Obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway.

It was found that the prevalence of OSA is as high as 80% among patients with idiopathic pulmonary fibrosis (IPF). Despite this common association, there is limited research in this field. There is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.

Eligibility criteria: Inclusion Criteria:

* Patients presented to Chest Department with interstitial lung disease will be included, screened for OSA.

Exclusion Criteria:

* Age: less than 18 years. Unstable patients or need for ICU admission

Primary outcomes:
measure: Predictors of OSA in patients with ILD
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of OSA among patients with ILD Presented To Chest Department in Assiut University Hospital
timeFrame: base line
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed yassen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05532852: Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
Official title: Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Pneumonia
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.

Exclusion Criteria:

* Age \< 18 years-old;
* Pregnancy;
* Data missing \> 20%.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days since the diagnosis of COVID-19
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Medical School of Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,
name: Jieming Qu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835052: QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care
Official title: Quality of Life Assessment in Cancer Survivors Integrated Into Routine Clinical Care Implementation in an Integrated Health System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Survivorship
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 500
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: Patients meeting criteria identified through the use of analytics querying the central data architecture of health system

Brief summary: This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Patients with high-risk for unmet needs or distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer Survivorship Clinic. This is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the Geisinger Cancer Institute.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignancy in the last 18 months, treated with curative intent

Exclusion Criteria:

* Patients treated with palliative intent, metastatic disease at the time of diagnosis

Primary outcomes:
measure: Survivorship Care Plan (SCP) is completed and given to the patient
timeFrame: Within 12 months of date of diagnosis
Secondary outcomes:
measure: Oncology Behavioral Health Referral Follow-up
timeFrame: Within 30 days of administration of FACT-GP
measure: Emergency Department utilization, 30 days after completion of SCP
timeFrame: Within 30 days of receipt of Supportive Care Plan
Other outcomes:
measure: Multidisciplinary Cancer Survivorship Clinic Utilization
timeFrame: Within 30 days of administration of FACT-GP
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Christian S Adonizio, MD
role: STUDY_CHAIR
References: