linjc16/ctgov huggingface dataset:
Artificial Shrinkage for Human Blastocyst Prior Vitrification

Study Overview
=================
Brief Summary
-----------------
Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Detailed Description
-----------------
Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming an outer layer called trophotoderm that will form the placenta in case of successful implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in the center, and a surrounding zone pellucida from which the embryo hatches to implant in the uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters the infiltration of vitrification solution during the vitrification procedures leading to ice crystal formation. Therefore, investigators need to compare blastocyst survival, clinical pregnancy and implantation rates between vitrified untreated expanded blastocysts and vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to vitrification

Official Title
-----------------
Removal of Blastocoel Fluid Before Blastocyst Vitrification by Laser Pulse and Its Effect on Clinical Outcomes

Conditions
-----------------
Vitrification

Intervention / Treatment
-----------------
* Procedure: Artificial shrinkage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of ≤ 32 Exclusion Criteria: Non-expanded blastocysts. Women who had uterine pathology or abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial shrinkage<br>Elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification. | Procedure: Artificial shrinkage<br>* Artificially eliminated blastocoelic fluid before vitrification procedures.<br>|
| No Intervention: Without Artificial shrinkage<br>Vitrify expanded blastocysts. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | number of intrauterine gestational sacs over the total number of embryos transferred | 1 month |
Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
This project will conduct a series of analysis of physiological and clinical data on tracheostomy patients who receive prolonged mechanical ventilation, hoping to find out the different manifestations of patients through the investigation by a variety of physiologic measurements, so as to understand whether different types of patients phenotype to derive different clinical strategies for liberation of the mechanical ventilator.

Official Title
-----------------
The Difference and Prognostic Significance of Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation

Conditions
-----------------
Prolonged Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least 10 days of mechanical ventilation at the intensive care unit of National Taiwan University Hospital and transferred to the Respiratory Care Center of National Taiwan University Hospital for weaning training Patients who have undergone tracheostomy and still have a tracheotomy tube Are at least 20 years old Stable respiratory condition with inspired oxygen fraction not exceeding 50% Exclusion Criteria: Hemodynamic instability or continuous use of vasopressors Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Liberation from mechanical ventilation at discharge from the weaning unit | At least five consecutive days of free from mechanical ventilation ventilation | Five days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilation, mechanical ventilation, weaning, oxygen uptake
Kinetics of Biomarkers in Acute Pyelonephritis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to explore the kinetics of biomarkers in 30 adult female patients with uncomplicated acute pyelonephritis.

Detailed Description
-----------------
We will measure c-reactive protein, procalcitonin, pyuria and a new blood biomarker (Signature TM) everyday till normalization of these markers in 30 adult female patients with uncomplicated acute pyelonephritis.

Official Title
-----------------
Kinetics of Procalcitonin, C-reactive Protein and Pyuria in Uncomplicated Pyelonephritis in Women: A Pilot Study

Conditions
-----------------
Pyelonephritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Flank/loin pain or tenderness, or both and fever > 38°C during the last 48 hours and pyuria Exclusion Criteria: Pregnancy Presence of indwelling catheters Known polycystic kidney disease or any malformation of the urinary tract, or single kidney; renal transplant recipients; acute or chronic renal failure requiring dialysis Recent discharge from hospital (during the last 10 days); ongoing antibiotic treatment Known severe immunosuppression: Receiver of solid-organ or hematopoietic stem cells transplants; neutropenia ( < 1 G neutrophils / L); chronic (more than 14 days) use of systemic glucocorticoids (>10 mg/d of prednisone); active use of immunosuppressive therapy for the treatment of auto-immune or inflammatory disease; HIV infection with < 350 CD4+ cells / ml or unknown CD4+ status Pyelonephritis initially identified as complicated: obstruction of urinary tract, urinary stone; history of renal infection in the last 15 days Patient with severe sepsis or septic shock

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute uncomplicated pyelonephritis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria |  | Daily till day 15. |
Risk Factors for Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Deep venous thrombosis is the presence of blood clots, usually in the legs that lead to either local problems or breathing problems if the clot moves to the lungs. This study is designed to assess both clinical conditions as well as common genetic factors that lead to more risk of deep venous thrombosis. Clinical conditions of venous thrombosis include: stroke, malignancy, and situations such as surgery, pregnancy, trauma, or travel.

Official Title
-----------------
2779 Epidemiology of Genetic and Acquired Risk Factors for Venous Thrombosis

Conditions
-----------------
Deep Venous Thrombosis, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must be 18 years with the ability to understand and consent to questionnaire and blood draw, including understanding of genetic testing..

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coagulation, thrombosis genetic markers
co2 Gap and co2/o2 Ratio in Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .

Detailed Description
-----------------
use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%. Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.

Official Title
-----------------
Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Diagnostic Test: Fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients post liver transplantation serum lactate >2mmol/L Exclusion Criteria: age less than 18 years patients with fulminant liver failure.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Fluid challenge with assessment of change of co2 gap
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 gap<br>The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them. | Diagnostic Test: Fluid challenge<br>* Fluid challenge and measure change in co2 gap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| co2gap | Difference between arterial and venous co2 gap | 30 minuets after fluid bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume | Stroke volume assessed by cardiometry | Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus |
Incretins and Metabolism

Study Overview
=================
Brief Summary
-----------------
Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic endocrine function and incretin metabolism are impaired. The investigators hypothesize that extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in subjects with type 2 diabetes. Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief, somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP. Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and abdominal adipose biopsies will be taken to examine intracellular signalling.

Official Title
-----------------
The Extrapancreatic Metabolic Effects of Incretin Hormones

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years BMI 18-35 kg/m2 NGT or T2DM as classified by ADA criteria Exclusion Criteria: Insulin dependency Smokers History of or presentation with cardiovascular disease, cancer, and chronic hematological, renal, hepatic, pulmonary disease Weight loss (>2 kg in previous 6 months) Physical activity (>150 mins/week)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Glucose Tolerance<br> | |
| Type 2 Diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose turnover | Rates of appearance and disappearance (g/min) will be measured by examining [6,6-2H2]glucose enrichment in plasma. | 0, 1, 2, 3, 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow and flow-mediated dilation |  | 0, 1, 2, 3, 4 hours | 
| Palmitate turnover and oxidation | Rates of appearance and disappearance (g/min) will be measured by examining [U13C]palmitate enrichment in plasma. Rate of oxidation (g/min) will also be measured by examining 13C incorporation into CO2 in expired breath. | 0, 1, 2, 3, 4 hours |
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711

Study Overview
=================
Brief Summary
-----------------
This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.

Official Title
-----------------
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711 in Chinese Healthy Volunteers

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: BPI-7711
* Drug: BPI-7711
* Drug: Itraconazole
* Drug: Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, aged from 18 to 45 years BMI from 18.5 to 28.0 kg/m2 Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance Exclusion Criteria: Subjects with clinical significant diseases Subjects with allergic disease history Subjects with gastrointestinal disease history that can affect study drug absorption Subjects with drug abuse history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itraconazole and BPI-7711<br>BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone. | Drug: BPI-7711<br>* BPI-7711 60 mg<br>* Other names: BPI-7711 capsule;Drug: Itraconazole<br>* Itraconazole 200 mg<br>* Other names: Itraconazole capsule;|
| Experimental: Rifampicin and BPI-7711<br>BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone. | Drug: BPI-7711<br>* BPI-7711 180 mg<br>* Other names: BPI-7711 capsule;Drug: Rifampicin<br>* Rifampicin 600 mg<br>* Other names: Rifampicin capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration | Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose | 
| AUC(0-last) | Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint | Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose |
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland

Study Overview
=================
Brief Summary
-----------------
All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.

Official Title
-----------------
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Surgical resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer resected by local resection Exclusion Criteria: All other types of resection or treatment for rectal cancer
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with TEM - transanala microsurgery<br>Early rectal cancer treated with TEM - full thickness resection | Procedure: Surgical resection<br>* Surgical resection with either of the above mentioned techniques<br>|
| Patients treated with ESD<br>Early rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection | Procedure: Surgical resection<br>* Surgical resection with either of the above mentioned techniques<br>|
| Patients treated with EMR<br>Early rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection | Procedure: Surgical resection<br>* Surgical resection with either of the above mentioned techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological clear margins | Pathological examination of the specimen showing free margins | 1-2 months after surgery | 
| Complications after surgery | Complications graded using the Clavien Dindo classification | 90 days after surgery |
PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in samples from patients treated for prostate cancer on trial ECOG-E9802.

Detailed Description
-----------------
OBJECTIVES: Primary To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802. Secondary To characterize the concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory. OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI Immunology Laboratory. Results are compared between the laboratories.

Official Title
-----------------
Evaluation of PSA Antibody on E9802: Confirmation and Concordance

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA Progression after Local Therapy for Prostate Cancer) PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIB prostate cancer, stage III prostate cancer, recurrent prostate cancer, stage I prostate cancer, stage IIA prostate cancer