linjc16/ctgov huggingface dataset:
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State

Study Overview
=================
Brief Summary
-----------------
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 (5/1000 mg x1 tablets) at fasting state.

Official Title
-----------------
An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-1229_01 5/1000mg (Before)
* Drug: DA-1229_01 5/1000mg (After)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A(Before→ After)<br> | Drug: DA-1229_01 5/1000mg (Before)<br>* single dose administration (one tablet once a day)<br>Drug: DA-1229_01 5/1000mg (After)<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B(After→ Before)<br> | Drug: DA-1229_01 5/1000mg (Before)<br>* single dose administration (one tablet once a day)<br>Drug: DA-1229_01 5/1000mg (After)<br>* single dose administration (one tablet once a day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 96 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 96 hours post-dose |
Light and Sleep Fragmentation

Study Overview
=================
Brief Summary
-----------------
This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.

Official Title
-----------------
Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults

Conditions
-----------------
Sleep, Mild Cognitive Impairment, Mood Disorders

Intervention / Treatment
-----------------
* Behavioral: Light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild Cognitive Impairment Age >65 Exclusion Criteria: Severe depression Unstable psychiatric or medical disease Acute infection

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>One hour of daily bright light exposure beginning one hour after wake time. | Behavioral: Light therapy<br>* One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor<br>|
| Experimental: Stepped care<br>One hour of daily bright light exposure in the afternoon | Behavioral: Light therapy<br>* One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep fragmentation | 24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition | Performance on the WAIS-4 | 6 months | 
| Mood | Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology | 6 months |
Muscle Parameters and Pathological Response in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Detailed Description
-----------------
In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Official Title
-----------------
The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response

Conditions
-----------------
Neoadjuvant Chemotherapy

Intervention / Treatment
-----------------
* Other: Neoadjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy. Exclusion Criteria: Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pathologic complete response (pCR)<br>Patient with complete pathological response | Other: Neoadjuvant therapy<br>* To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.<br>|
| Pathologic incomplete response (non-pCR)<br>Patient with partial pathological response | Other: Neoadjuvant therapy<br>* To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sarcopenic index | skeletal muscle area (cm2)/height (m2) et L3 level | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | weight (kg)/height (m2) | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
operable breast cancer, skeletal mass index, neoadjuvant chemotherapy, pathologic response, L3 vertebra
Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation

Study Overview
=================
Brief Summary
-----------------
This is an open, one-arm study to evaluate the safety and efficacy of mRNA personalized tumor vaccine (tumor vaccine) encoding neonatal antigen in combination with Sintilimab injection for adjuvant prevention of postoperative recurrence of hepatocellular carcinoma.

Official Title
-----------------
Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer

Conditions
-----------------
Posto Perative Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are ≥18 years old (including boundary values), without limitation of sex at time of consent. The patient was confirmed as hepatocellular carcinoma by histopathology or cytology after surgery, and the lesion was completely resected by surgery R0 (no residual tumor under postoperative microscope and naked eye), and no residual lesion or extrahepatic metastasis was confirmed by postoperative imaging (CT/MRI). The patient is at high risk of postoperative recurrence, and the tumor must meet the following characteristics: Patients with hepatocellular carcinoma IIb/IIIa as defined by the 2019 Chinese Staging System. The Eastern Oncology Consortium Physical State Score (ECOG PS) is 0 or 1, and the Child-Pugh rating is A Exclusion Criteria: Known allergy to any tumor vaccine, adjuvant, Stintilimab Injection formulation, fluorouracil inj, oxaliplatin injcalcies; Tumor mutation load (TMB) was less than 2.0/Mb or neonatal antigen load (TNB) was less than 0.5/Mb or the predicted number of neonatal antigens was less than 15;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: 12 18 participants in Cohort . C1:50 ug of PCV; C2: 100 ug of PCV ; C3: 150 ug of PCV.Extended research phase:49 participants in Cohort.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3+3<br>Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. This study is a 3+3 dose escalation design.Participants will receive a total of 6 cycles of PCV every 21 days | Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection<br>* Subcutaneous Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year recurrence-free survival rate (RFS); |  | 1 year | 
| Overall survival (OS) after initial administration. |  | 1 year |
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

Study Overview
=================
Brief Summary
-----------------
In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.

Official Title
-----------------
Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion

Conditions
-----------------
Glioblastoma, Glioma, Malignant

Intervention / Treatment
-----------------
* Other: Biological sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: o be enrolled in the study patients must: Have a radiological diagnosis of supratentorial glioblastoma, or Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria (Wen, 2010); Be a candidate to neurosurgery for glioblastoma; Be of an age of 18 years or above; Provide written informed consent for participation to the study. Exclusion criteria To be enrolled in the study patients must not: Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator; Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 WHO classification.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biological sample collection<br>Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation | Other: Biological sample collection<br>* Collection of biological samples<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasion | Distance travelled by glioma stem cells into brain organoids | through study completion, an average of 4 years | 
| Gene assessment | Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis | through study completion, an average of 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioma stem-like cells, brain organoids, brain invasion, ciliogenesis
Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19

Study Overview
=================
Brief Summary
-----------------
Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.

Detailed Description
-----------------
Introduction: COVID 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in December 2019. Many studies were conducted to identify the predictive factors of mortality of those infected with the virus. The previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19. Methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of Mohamed VI Oujda, in Morocco, from March 2020 to October 2021, including all the patients tested positive for the infection.

Official Title
-----------------
Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19: Retrospective Cohort Study of 415 Cases

Conditions
-----------------
COVID-19 Pandemic, Obesity

Intervention / Treatment
-----------------
* Device: Obesity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting an infection with SARS-CoV-2 that were hospitalized in the intensive care unit. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Obesity|the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity: An underappreciate risk factor for severe form of COVID-19: Retrospective cohort study of 415 cases | Is obesity a predictive factor of need of intensive care, in addition to the mortality of covid 19? | in all the 22 mounths | 
| Risk factor for severe form of COVID-19 | identify the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19. | in all the 22 mounths |
A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
On February 11th, 2020, the International Classification of Viruses named the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as novel coronavirus (COVID-19, Covid-19 for short). At present, COVID-19 has become a global pandemic. However, the persistent replication of HIV in PLWH and the cellular immunodeficiency and persistent inflammation caused by it may have different effects on the susceptibility, severity and course of Covid-19. Several large cohort studies have found evidence of increased risk of hospitalization and death in patients with HIV and Covid-19 co-infection. Meanwhile, a meta-analysis of 22 studies shows that HIV infection is still an important risk factor for acquiring Covid-19 infection, and it is associated with a higher risk of death in COVID-19. In order to further clarify the clinical features and prognosis of HIV co-infection with Covid-19 and explore its immune mechanism, so we will carry out the study.

Official Title
-----------------
The Second Affiliated Hospital of Chongqing Medical University

Conditions
-----------------
PLWH, Covid-19, Clinical Features, Prognosis

Intervention / Treatment
-----------------
* Other: SARS-CoV-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines. Exclusion Criteria: Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLWH<br>the people living with HIV | Other: SARS-CoV-2<br>* a virus infection<br>|
| HC<br>the people without disease | Other: SARS-CoV-2<br>* a virus infection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical features and prognosis | the clinical features and prognosis between healthy people and PLWH infected with Omicron | 2022.11-2023.1 | 
| antibody titer | the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron | 2022.11-2023.1 |
Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma

Study Overview
=================
Brief Summary
-----------------
Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated. Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and genetic alterations of CRNEC. Through the depiction of the genomic landscape and transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were performed to confirm the genetic alterations.

Official Title
-----------------
Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma

Conditions
-----------------
Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - tissues from colorectal neuroendocrine carcinomas Exclusion Criteria: - no
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2010-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive genomic and expression panels (AmoyDx® Master Panel) for dna and rna detection |  | 2020 |
Expanded Access to Ziftomenib

Study Overview
=================
Brief Summary
-----------------
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL), with appropriate mutations, or Acute Myeloid Leukemia (AML), with NPM1 mutations. To request access, use Responsible Party contact information provided in this record. Expanded access for ziftomenib is only available in the United States

Official Title
-----------------
Expanded Access to Ziftomenib

Conditions
-----------------
Acute Lymphoblastic Leukemia, With Appropriate Mutations, Acute Myeloid Leukemia, With NPM1 Mutations

Intervention / Treatment
-----------------
* Drug: ziftomenib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/Exclusion Criteria: Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Adult, ages 18+ Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations. Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology For AML patients: Does not have KMT2A rearrangement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ziftomenib|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |