linjc16/ctgov huggingface dataset:
The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications. The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery. In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.

Official Title
-----------------
Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer

Conditions
-----------------
Morality, Gastric Cancer, Complication,Postoperative, Complications; Gastrointestinal, Postoperative

Intervention / Treatment
-----------------
* Other: MELD-Na score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing gastrectomy due to gastric cancer Exclusion Criteria: Patients with pulmonary, hepatic and renal disfunctions, Patients with diagnosed with a different cancer in the last 5 years and Pregnant patients

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with postoperative complications | Other: MELD-Na score<br>* MELD-Na scores will be compared between the groups<br>|
| Group 2<br>Patients without postoperative complications | Other: MELD-Na score<br>* MELD-Na scores will be compared between the groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MELD-Na score difference between the groups | Importance of MELD-Na score in predicting postoperative complications in patients with gastric cancer | 30 days |
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.

Official Title
-----------------
A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: TAS266


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of solid tumors 18 years or older ECOG performance status of 0, 1 or 2 Adequate bone marrow, hepatic and renal function Obtained written informed consent Exclusion Criteria: Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met. Major surgery within 4 weeks before study treatment Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations Impaired cardiac functions Previous hepatitis viral infection such as hepatitis B or hepatitis C Diagnosis of HIV infection Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS266<br> | Drug: TAS266<br>* TAS266 IV infusions given weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and characteristics of Dose limiting toxicities at each dose level |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, frequency, and severity of AEs, changes in laboratory and clinical assessments |  | 2 years | 
| TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266 | 1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment | 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment | 
| Presence and concentration of anti-TAS266 antibodies |  | 2 Years | 
| Tumor response |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biologic,, solid tumors,, Death Receptor 5 agonist,, caspase-8
Multiple Myeloma Turkish Prospective Patient Registry

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey

Detailed Description
-----------------
In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end. All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.

Official Title
-----------------
Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study

Conditions
-----------------
Multiple Myeloma, Relapse Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as multiple myeloma Patients signed informed consent form Patients received no more then 2 lines of therapy Exclusion Criteria: Patients below 18 years old

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

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 | Time from the diagnosis to the death | [Time Frame: 5 Years] | 
| Progression Free Survival | Time from the initiation of treatment to the death from any cause or progression | [Time Frame: 5 Years] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MM, multiple myeloma, Registry, Turkey
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey

Study Overview
=================
Brief Summary
-----------------
In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order to understand attitudes toward reproduction, potential treatments and genetic testing in order to improve the understanding of the decisions that XLHED carrier females make regarding their reproductive future.

Detailed Description
-----------------
The full survey is available here: https://www.surveymonkey.com/s/X-CORS For more questions or more details you may contact the Principal Investigator, Carrie Milliard: MILLIC@mmc.org or 207-662-6712

Official Title
-----------------
Survey of X-Linked Hypohidrotic Ectodermal Dysplasia Carrier Women's Outlook Towards Reproduction, Potential XLHED Treatments and Genetic Testing

Conditions
-----------------
Hypohidrotic Ectodermal Dysplasia, X-Linked Hypohidrotic Ectodermal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide signed informed consent; 18 years of age or older Females with: the clinical characteristics of HED, including at least two of the following characteristics: clinical signs and symptoms of HED: a history of decreased sweating; abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns); sparseness of scalp and body hair; AND a clinical diagnosis from a healthcare professional; or at least one HED affected family member OR genetically confirmed HED or XLHED;

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

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

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 |
| --- | --- | --- |
| To study the outlook of XLHED carrier females toward reproduction, potential XLHED treatments and genetic testing. | Survey results will be collected during the 1 day of subject involvement. | study day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HED, XLHED
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

Study Overview
=================
Brief Summary
-----------------
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.

Official Title
-----------------
Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: Adriamycin
* Drug: Ifosfamide
* Drug: Etoposide
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed STS with locally advanced non-resectable disease Metastatic disease is allowed in case of solitary resectable metastases Grading according to Coindre > II° Measurable tumor lesions Age > 18 through 65 years Karnofsky status > 70 % Written informed consent Exclusion Criteria: Prior chemotherapy Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease Insufficient liver-, renal or bone marrow function Evidence of pregnancy Treatment within another clinical trial Uncontrolled viral Infections (HIV,HBV, HCV) other malignancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adriamycin|nan|
|Drug: Ifosfamide|nan|
|Drug: Etoposide|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.

Official Title
-----------------
An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)

Conditions
-----------------
Abdominal Aortic Aneurisms

Intervention / Treatment
-----------------
* Drug: CRD007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infra-renal abdominal aortic aneurysm Exclusion Criteria: Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRD007 10 mg<br>CRD007, 10 mg tablet, single dose | Drug: CRD007<br> <br> |
| Experimental: CRD007 25 mg<br>CRD007, 25 mg tablet, single dose | Drug: CRD007<br> <br> |
| Experimental: CRD007 40 mg<br>CRD007, 40 mg tablet, single dose | Drug: CRD007<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - maximum plasma concentration (Cmax) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured | Pre-dose and until 12 hours post-dose | 
| Pharmacokinetics - time to maximum plasma concentration (tmax) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured. | Pre-dose til 12 hours post-dose | 
| Pharmacokinetics - Area under the plasma concentration curve (AUC) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured. | Pre-dose until 12 hours post-dose | 
| Pharmacokinetics - elimination half life (t1/2) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured | pre-dose until 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose linearity | Evaluation of dose linearity in the dose range 10 - 40 mg | Pre-dose and until 12 hours post-dose | 
| Potential for accumulation | To estimate the accumulation of CRD007 in the dose range 10 - 40 mg | Pre-dose untill 12 hours post-dose |
Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.

Study Overview
=================
Brief Summary
-----------------
Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.

Official Title
-----------------
Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.

Conditions
-----------------
Right Hemicolectomy

Intervention / Treatment
-----------------
* Procedure: Intracorporeal anastomosis
* Procedure: Extracorporeal anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malignant or benign neoplasm located in right side of the colon Exclusion Criteria: stage IV disease conversion inflammatory bowel diseases corticosteroid intake immunodeficiency emergency surgery neoadjuvant therapy no technical possibility to perform either anastomosis

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal anastomosis<br> | Procedure: Extracorporeal anastomosis<br>* Anastomosis performed through a minilaparotomy<br>|
| Experimental: Intracorporeal anastomosis<br> | Procedure: Intracorporeal anastomosis<br>* Anastomosis performed totally laparoscopically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first stool |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus |  | 5 days | 
| Complications |  | 30 day | 
| Length of surgery |  | 1 day | 
| Length of hospital stay |  | 30 day |
Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The proposed research will use a double-blind randomized controlled design to pilot test a model for how stories shared by a panel of HCT survivors impact the psychosocial well-being of the digital stories (DS) intervention condition of 55 patients who recently underwent HCT and their respective caregivers compared with 55 people in an information control (IC) condition and their caregivers (total 220 participants; N=110 per condition). Participants, recruited from the Mayo Clinic Arizona Cancer Center, will be randomly assigned to one of two conditions: the DS intervention or the IC video condition. Participants will questionnaires at baseline (T1), after the 4-week intervention (T2), and 3 months (100 days) later (T3).

Official Title
-----------------
Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Conditions
-----------------
Stem Cell Transplant

Intervention / Treatment
-----------------
* Behavioral: Digital stories
* Behavioral: Informational videos


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject population (children, adults, groups): All patients and caregivers undergoing HCT at Mayo Clinic in Arizona for hematological disorders. Inclusion (patients): recently underwent HCT (within a month after hospital discharge) are able to speak, read, and write in English are 18 years or older have access to a working phone and e-mail account. Inclusion (caregivers): family caregivers who are identified as a primary caregiver by a patient, and have primary responsibility for the care of patients throughout the HCT process, including basic medical procedures, taking the patient to and from the hospital frequently as well as other household and other role responsibilities are able to speak, read, and write in English are 18 years or older have access to a working phone and e-mail account. Exclusion Criteria: Participants who are not identified as primary caregivers Participants with a visual or hearing impairment

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Behavioral: Digital stories<br>* Digital story telling videos<br>|
| Sham Comparator: Comparator<br> | Behavioral: Informational videos<br>* Informational videos<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Profile of Mood States | anxiety and depression subscales | from baseline to 4 weeks and 3 months after the intervention |
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

Study Overview
=================
Brief Summary
-----------------
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

Official Title
-----------------
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Drug: Viaskin Peanut 250µg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed the PEPITES study. Exclusion Criteria: Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viaskin Peanut 250µg<br> | Drug: Viaskin Peanut 250µg<br>* DBV712 250 µg, once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE |  | Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, food allergy, viaskin, peanut, epicutaneous