linjc16/ctgov huggingface dataset:
Effect of CI on Prognosis in the Elderly Patients With ACS

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the incidence and characteristics of cognitive Impairment(CI) in the elderly patients with acute coronary syndrome (ACS), and to determine whether CI are predictive of the prognosis of major adverse cardiovascular events (MACE) and mortality.

Official Title
-----------------
Effect of Cognitive Impairment (CI) on Prognosis in the Elderly Patients With Acute Coronary Syndrome (ACS)

Conditions
-----------------
Acute Coronary Syndrome, Cognitive Impairment, Elderly

Intervention / Treatment
-----------------
* Diagnostic Test: MMSE and MoCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥65yr Confirmed ACS diagnosis （include unstable angina, ST-segment elevation myocardial infarction and Non ST-segment elevation myocardial infarction） fulfilled MMSE or MoCA patients agreed and provided informed consent Exclusion Criteria: Type 2 myocardial infarction and Acute nonischemic myocardial injury past history of malignant tumors Past history of stroke or dementia Hepatic insufficiency (ALT>8ULN or ALT>3ULN and TBIL>2ULN) Renal insufficiency (GFR<15 ml/min/1.73m2)

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Participates<br>This is an observational study | Diagnostic Test: MMSE and MoCA<br>* This is an observational study. All the patients evaluate with MMSE (Mini-mental State Examination) and MoCA (Montreal Cognitive Assessment), and investigate the incidence and characteristics of cognitive and MACE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiovascular events) | Myocardial infarction, revascularization, stroke, cardiac death, all cause of death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive level decline | Evaluate with MMSE (Mini-mental State Examination) | 12 months | 
| Cognitive level decline | Evaluate MoCA (Montreal Cognitive Assessment). | 12 months |
Multimodal Assessment of Liver Volume and Function

Study Overview
=================
Brief Summary
-----------------
In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and the correlation between volume and function is not always accurate. Several techniques to assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced CT and ICG, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.

Official Title
-----------------
Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases

Conditions
-----------------
Colorectal Cancer, Liver Metastases

Intervention / Treatment
-----------------
* Diagnostic Test: Multimodal liver function assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Multimodal liver function assessment|HBS, MRI, CE-CT and ICG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HBS and MRI in assessment of FLR function preop | HBS, MRI, CT and ICG performed the day before surgery | Preop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HBS and MRI in assessment of FLR function POD 7 | HBS, MRI, CT and ICG performed 7 days after surgery | POD 7 | 
| Correlation between HBS and MRI in assessment of FLR function POD 28 | HBS, MRI, CT and ICG performed 28 days after surgery | POD 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver function, Future liver remnant, Chemotherapy
PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI

Official Title
-----------------
PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Respiration, Artificial, Acute Kidney Injury

Intervention / Treatment
-----------------
* Procedure: PEEP changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to ICU with expected mechanical ventilation >48h Exclusion Criteria: Ultrasound RRI evaluation non available Patients with arrhythmia Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Critically ill ventilated patients<br>Patients admitted to ICU with expected mechanical ventilation >48h | Procedure: PEEP changes<br>* All patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of AKI | AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria | once a day until day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RRI at different level of PEEP | To compare median difference of RRI at PEEP 5 and PEEP 15 in patients who will develop (or not) AKI | One a day until day 5 |
Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG). The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.

Detailed Description
-----------------
PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG). Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment. The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement. The secondary objective is to evaluate predictive factors

Official Title
-----------------
Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

Conditions
-----------------
Gastrostomy Complications, Gastrostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Needing a radiologic gastrostomy under local anesthesia Age ≥ 18 years old Read, write and understand the French language Exclusion Criteria: Patient under guardianship, deprived of liberty, safeguard of justice Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator) Refusal to participate in research

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| single group assignment<br>only one arm. Each patient complete numerical scale questionnaire (0-10) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal pain | numerical scale 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. | 7 days | 
| predictive factors | determine predictive factors of pain suspected in advance: Fasting anterior stomach wall depth estimated during the ultrasound survey(mm) Gastric topography determined under X-ray (subcostal / partially retrohepatic) Topography of the anchors: large tuberosity / antrum Distance of anchors from each other (mm) Depth of the anchors (mm) Skin depression of anchors: (with depression, without depression) Intraparietal length of the gastrostomy tube (mm) | DAY 1 |
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.

Study Overview
=================
Brief Summary
-----------------
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.

Official Title
-----------------
A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects

Conditions
-----------------
Obstetric Labour, Premature, Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: GSK557296


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males who are 18 to 45 years of age Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician Non-smokers Exclusion Criteria: Alcohol consumption averaging more than 7 drinks per week Positive for Hepatitis C antibody, Hepatitis B antigen or HIV Any use of prescription drugs or non prescription drugs

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK557296|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs |  | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood tests to study how long the drug stays in your blood |  | 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects,, Safety,, Tolerability,, Pharmacokinetics
Phase II Exploratory Clinical Study of KUX-1151

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: KUX-1151


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese HU patients (Outpatient) Patients who meet the following criteria concerning serum uric acid levels at the screening [1) Gout: > 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL] Exclusion Criteria: Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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 |
| --- | --- |
| Experimental: KUX-1151, Low dose<br> | Drug: KUX-1151<br> <br> |
| Experimental: KUX-1151, Middle dose<br> | Drug: KUX-1151<br> <br> |
| Experimental: KUX-1151, High dose<br> | Drug: KUX-1151<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL |  | 14 weeks | 
| Percent change from baseline in serum uric acid level |  | 14 weeks | 
| Change from baseline in serum uric acid level |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperuricemia
Capsule Endoscopic Miss Rates Determined by Back-to-Back Capsule Endoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the missing rate of capsule endoscopy using back-to-back capsule endoscopy.

Official Title
-----------------
Capsule Endoscopic Miss Rates Determined by Back-to-Back Capsule Endoscopy

Conditions
-----------------
Capsule Endoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with obscure gastrointestinal bleeding Exclusion Criteria: Intestinal stenosis or obstruction Swallowing difficulty History of abdominal surgery History of radiation therapy for abdominal or pelvic lesion Age < 15 years Pregnancy Unstable vital sign or massive hematochezia Bleeding lesion, mass > 2 cm, or intestinal stenosis found by CT angiography

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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
-----------------
Capsule endoscopy, Missing rate
Growth in Children With HLHS

Study Overview
=================
Brief Summary
-----------------
Children with HLHS have a history of poor enteral intake and growth. Over the past several years a modification to the Norwood operation was instituted (RV to PA shunt in place of the standard Blalock-Taussig shunt). The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood.

Detailed Description
-----------------
The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood. Also, the standard of care has changed to GT/Nissen operation to facilitate safe feeding in those patients who are not able to feed by mouth (po feed). A second aim of this study is to evaluate whether children who are GT fed have improved growth compared to those who are not. We wish to review all patients who underwent Norwood procedure from January 1, 2001 to March 31, 2005.

Official Title
-----------------
Growth in Children With HLHS

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at Children's Healthcare of Atlanta, Egleston Norwood procedure between Jan. 1. 2001 and March 31.2005 Exclusion Criteria: Those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Cardiac, Norwood operation modification, GT/Nissen operation, Po feed, GT fed
Remifentanil for Sedation of Patients With Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
This is a descriptive retrospective study designed to measure the efficacy of remifentanil sedation and the ability to perform frequent neurological examinations of patients with traumatic brain injuries.

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously admitted to the hospital presenting with traumatic brain injury (TBI) Patients who have undergone sedation after presenting with TBI Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remifentanil<br>Patients sedated using Remifentanil | Drug: Remifentanil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of Sedation | Sedation scores will be assessed. | Every 24 hrs until discharged from the PICU, up to 1 month. |
Examination of B Cell Responses in Human Blood

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.

Detailed Description
-----------------
Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.

Official Title
-----------------
Gewinnung Humaner antikörperproduzierender Zellen Aus Dem Blut

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected individuals controls Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| HIV infected individuals, HIV controllers<br>CD4+ T cell count > 350/µl, HIV load < 1000 copies/ml | |
| HIV infected individuals, early progressors<br>CD4+ T cell count > 350/µl, HIV load > 1000 copies/ml | |
| HIV infected individuals, late progressors<br>CD4+ T cell count < 200/µl | |
| HIV infected individuals, late progressors with therapy<br>CD4+ T cell count < 200/µl, under ART | |
| Healthy individuals<br>Uninfected | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen specific B-cell responses |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, B-lymphocyte
Temporally Splitting Ovarian Stimulation and Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.

Official Title
-----------------
Temporally Splitting Ovarian Stimulation and Embryo Transfer

Conditions
-----------------
Splitting of Ovarianstimulation and Embryotransfer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for IVF/ICSI Age 18-36 years <= three earlier unsuccessful IVF/ICSI treatments with embryo transfer BMI 20-30 Regular cycle with ovulation (28-35 days) Progesterone >7ng/ml at the beginning of stimulation Informed consents Exclusion Criteria: PCOS (polycystic ovarian syndrome Endometrioses >= grade 3 Known poor response syndrome History of ovariectomy Severe endocrinopathie

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 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 |
| --- | --- |
| 1<br>10 women with indication for ART with ICSI or IVF | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | November 2008- May 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitrification, ovarian stimulation, reproductive medicine