linjc16/ctgov huggingface dataset:
Improving the Accuracy of Revised Cardiac Risk Index With HbA1C:Hemoglobin Ratio (HH Ratio)

Study Overview
=================
Brief Summary
-----------------
Retrospective observational study on the effects of altering components of RCRI to improve the predictive capacity.

Detailed Description
-----------------
The current Lee's Revised cardiac risk index (RCRI) was created in 1999. Validation studies have found RCRI to be only moderately discriminant. The Diabetes Mellitus on insulin component of the score does not accurately reflect the severity of the disease. A previously studied HbA1C:Hemoglobin ratio shows an improved association with outcomes than individual components alone and could be potentially used as a new marker for severity of the disease. A retrospective cohort study was performed in consecutive diabetic patients undergoing non-cardiac surgery. Ethics approval was obtained. The objective of the study is to compare the predictive value of RCRI and substitution of the DM on insulin component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).

Conditions
-----------------
Risk Stratification, Perioperative Medicine

Intervention / Treatment
-----------------
* Other: Modified RCRI risk stratification


Participation Criteria
=================
Eligibility Criteria
-----------------
Above 18 years old Past medical history of Diabetes Mellitus or preoperative HbA1C > 6.5% (within 3 months of surgery) Had HbA1C done within 3 months prior to date of surgery Undergoing non cardiac surgery Emergency and elective surgery EXCLUSION: If patient is below 18 years old no History of DM No HbA1C done within 3 months prior to date of surgery

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 |
| --- |
|Other: Modified RCRI risk stratification|The objective of the study is to compare the predictive value of RCRI and substitution of the DM on insulin component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | To compare the predictive value of RCRI and substitution of the DM on insulin component with HH ratio for 30- and 90-day mortality | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | To compare the predictive value of RCRI and substitution of the DM on insulin component with HH ratio for postoperative acute myocardial injury(AMI) and acute kidney injury(AKI). | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCRI, HbA1C: Hemoglobin ratio (HH ratio), Risk model
Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.

Detailed Description
-----------------
OBJECTIVES: I. Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) at first and subsequent relapse. II. Make these specimens available to qualified researchers to study the biology of ALL. OUTLINE: This is a multicenter study. Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment. Patients are followed periodically for up to 10 years.

Official Title
-----------------
A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

Conditions
-----------------
Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse No concurrent systemic antileukemic treatment administered for current relapse Intrathecal chemotherapy allowed On-therapy relapse allowed

Ages Eligible for Study
-----------------
Maximum Age: 30 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 |
| --- | --- |
| Ancillary-Correlative (Collecting and banking ALL specimens)<br>Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment. | Other: Cytology Specimen Collection Procedure<br>* Correlative studies<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Banking of tumor cells and germline DNA |  | Not Provided |
Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1). Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples. Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.

Official Title
-----------------
Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest

Conditions
-----------------
Heart Arrest, Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years witnessed cardiac arrest interval form emergency call to return of spontaneous circulation 10-45 minutes Exclusion Criteria: severe pre-arrest disability leading to withdrawing treatment in prehospital phase no concent from next of kin

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 |
| --- | --- | --- |
| Change in level of insulin |  | 60 minutes | 
| Change in level of glucagon |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood cortisol level |  | 60 minutes after ROSC | 
| Blood interleukin-6 level |  | 60 minutes after ROSC | 
| Change in blood glucose level |  | 60 minutes | 
| Change in level of GLP-1 |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose, cardiac arrest, resuscitation, insulin, GLP-1
Technique And Results In Endothelial Keratoplasty

Study Overview
=================
Brief Summary
-----------------
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.

Official Title
-----------------
Technique And Results Evaluation In Endothelial Keratoplasty

Conditions
-----------------
Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy

Intervention / Treatment
-----------------
* Procedure: Descemet Stripping Automated Endothelial Keratoplasty
* Procedure: Descemet Membrane Endothelial Keratoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation. Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives. Exclusion Criteria: N/A

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DSAEK group<br>Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty. | Procedure: Descemet Stripping Automated Endothelial Keratoplasty<br>* Descemet Stripping Automated Endothelial Keratoplasty<br>* Other names: DSEK;|
| Experimental: DMEK group<br>Subjects operated of Descemet Membrane Endothelial Keratoplasty. | Procedure: Descemet Membrane Endothelial Keratoplasty<br>* Descemet Membrane Endothelial Keratoplasty<br>* Other names: DMEK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | First six months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density |  | First six months postoperatively | 
| Intraoperative complications |  | First six months postoperatively | 
| Postoperative complications |  | First six months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fuchs' Endothelial Dystrophy, Lamellar Keratoplasty, Corneal Endothelial Cell Loss, Descemet Stripping Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty, Minimal Surgical Procedure
SMART Trial: Community Stigma Reduction

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.

Official Title
-----------------
SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level

Conditions
-----------------
Opioid-use Disorder, Stigma, Social

Intervention / Treatment
-----------------
* Behavioral: Opioid Use Disorder Stigma Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identify as African American or Mixed race Reside in Frayser or Orange Mound Communities Access to telephone for follow-up assessment Exclusion Criteria: Unable to understand consent procedures

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants assigned to intervention or control based on zip code of primary residence.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month. | Behavioral: Opioid Use Disorder Stigma Reduction<br>* Billboards with destigmatizing language regarding opioid use disorder placed in the community.<br>|
| No Intervention: Control<br>Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stigma score | Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale | Change from baseline stigma score at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stigma, opioid use disorder, community
Genetic Study of Amyotrophic Lateral Sclerosis in Norway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.

Detailed Description
-----------------
After being informed about the study and potential risks, all patients giving written informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn. Blood samples, questionnaires, clinical information and signed consent is send to Department of Medical Genetics, Telemark Hospital Trust were the genetic analysis is performed successively throughout the recruitment period. Patients can choose to have their genetic results returned in a diagnostic setting.

Official Title
-----------------
Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probable or definite ALS Eligible to consent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Individuals diagnosed with ALS<br>Individuals diagnosed with ALS that are being followed through the Norwegian health-care system. ALS patients ( probable or definite per El-Escorial criteria) | Other: Observation<br>* Observation of genetic characteristics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene frequency | Number of patients with disease causing mutations in high penetrant ALS genes | 2020-2023 | 
| Genetic risk factors | Identify genetic risk factors for ALS in Norway. | 2022-2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurology, Genetics, Amyotrophic Lateral Sclerosis, Clinical genetics
Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia

Study Overview
=================
Brief Summary
-----------------
Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia. Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).

Official Title
-----------------
Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia

Conditions
-----------------
Labor, Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy women American Society of Anesthesiologists physical status class I or II Body weight less than 110 kg In active labor (including induced labor and premature rupture of membranes) Cervical dilatation at 2-6 cm Regular contractions Age between 18 and 40 years old Gestational age greater than 36 completed weeks Singleton pregnancy and vertex presentation Exclusion criteria: Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy) Narcotic administration in the previous 2 hours Previous uterine surgery Pre-eclampsia and the inability to adequately understand the consent form Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Epidural group | Drug: Bupivacaine epidural<br>* Bupivacaine 0.1%, fentanyl 1 mic/kg<br>|
| Active Comparator: 2<br>Remifentanil iv PCA | Drug: Remifentanil<br>* 40-50 mic per 1-2 min via PCA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary analgesia end-point: VAS pain Score |  | 1-6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidural, Labor, Remifentanil
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
Examine the ability of thymopentin (Timunox) to: Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

Official Title
-----------------
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

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

Intervention / Treatment
-----------------
* Drug: Thymopentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Treatment: Allowed: Aerosolized pentamidine. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS as defined by the CDC (except for those with HIV wasting syndrome). Significant hepatic disease. Thrombocytopenia (< 75000 platelets/mm3). Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry. Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. Known hypersensitivity to thymopentin. Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Patients must not have: AIDS as defined by the CDC (except for those with HIV wasting syndrome). Significant hepatic disease. Thrombocytopenia (< 75000 platelets/mm3). Patients with the following conditions are included: Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions. HIV wasting syndrome. Must voluntarily sign consent. History of intravenous drug abuse.

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
Masking: Double


Arms and Interventions

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

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
-----------------
Thymopentin, Acquired Immunodeficiency Syndrome
Efficacy of Probiotics on Iron Status During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.

Conditions
-----------------
Prevention of Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, pregnant women, aged 18-42 years, with a singleton gestation Inclusion at 10-12 weeks of gestation BMI ≥ 18 and ≤ 30 at baseline Provide signed and dated informed consent form Willing to comply with all study procedures Exclusion Criteria: Serum ferritin level <20 µg/L or Hb<110 g/L at baseline (visit 1) Chronic diseases associated with anemia Known Thalassemia Hyperemesis gravidarum Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease) Known gluten intolerance, lactose intolerance, milk protein allergy Taking antibiotics within four weeks before inclusion Blood or plasma donation within three (3) months prior to baseline History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study Smoking or use of nicotine-containing products (currently or during the last three [3] months) History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator Hypersensitivity to any of the ingredients in the study products Any other reason for exclusion, as judged by the Investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Capsule with probiotics | Dietary Supplement: Probiotics<br> <br> |
| Placebo Comparator: Placebo<br>Capsule with placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin level |  | Week 28 of gestation |