linjc16/ctgov huggingface dataset:
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).

Official Title
-----------------
Phase IV Open Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

Conditions
-----------------
Rubella, Mumps, Measles

Intervention / Treatment
-----------------
* Biological: MMR vaccine (Priorix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female infant between 12 and 18 months of age at the time of the vaccination Written informed consent obtained from the parents or guardians of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine Previous vaccination against mumps and/or rubella History of, or intercurrent, measles, mumps, and/or rubella disease Known exposure to measles, mumps or rubella within 30 days prior to the start of the study Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MMR vaccine (Priorix)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentration to all vaccine antigens after vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mumps, Singapore, Rubella, Measles
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution

Official Title
-----------------
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

Conditions
-----------------
Heart Failure, Cohort Study

Intervention / Treatment
-----------------
* Drug: Candesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure Exclusion Criteria: patients included in a clinical trial the last 30 days before consultation patients unable to answer the questions for linguistic or cognitive reasons patients who will be difficult to follow during the one year study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure | Drug: Candesartan<br>* Oral tablets<br>* Other names: Atacand;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of patients treated with candesartan for heart failure |  | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring |  | 6 and 12 months after | 
| Percentage of patients stopping its treatment and reasons why |  | 12 months after | 
| Percentage of hospitalisations due to heart failure and cardiovascular deaths |  | 12 months after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
candesartan, heart failure, cohort study, France
Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

Detailed Description
-----------------
The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

Official Title
-----------------
Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Device: Stereotactic Radiosurgery (Cyberknife)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Pancreatic tumors not to exceed 7.5 cm. Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met). Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA). Patients with metastatic disease may be treated if they are symptomatic from the primary tumor. Eastern Clinical Oncology Group performance status 0, 1 or 2. Exclusion Criteria:Chemotherapy within 1 month of registration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- |
|Device: Stereotactic Radiosurgery (Cyberknife)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery |  |  |
Omics4Aging: Stratification of Frailty Population

Study Overview
=================
Brief Summary
-----------------
The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.

Detailed Description
-----------------
This exploratory study will investigate ways to better characterize the frailty phenotype by a combination of i) geriatric assessment (here only: frailty criteria according to Fried), ii) clinical surrogate markers (including those of inflammation), iii) body composition, iv) nutritional profiling, v) metabolite profiling using a metabolomics approaches.

Official Title
-----------------
Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline

Conditions
-----------------
Malnutrition, Intellectual Frailty of Aging, Bone Fragility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unless otherwise specified, subjects who fulfill all of the following will be included: Caucasian Male or female between the ages of 65 and 79 years old Three or more Fried Frailty Criteria (as diagnosed by investigator) Informed consent obtained Exclusion Criteria: Any of the following criteria would render a subject ineligible for inclusion: Dementia (previously diagnosed by general practitioner) Hb1c (glycate Haemoglobin) >7.5% (>58 mmol/mol). End stage disease (1 year after last chemotherapy treatment for cancer) Drug abuse (alcohol - assessed by investigator) Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease) Chronic Active hepatitis Kidney failure in Dialysis treatment Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| Comparison of Metabonomics, at baseline, among frail population. | Analysis of Metabolites in blood | 1 year |
An Electronic Alert System for In-Hospital Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.

Official Title
-----------------
An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >=18 years Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours. Exclusion Criteria: Dialysis order within 24 hours of admission Dialysis order prior to AKI onset Initial creatinine >=4.0mg/dl Prior admission in which patient was randomized. Nephrectomy during the admission Admission to hospice service Admission to observation status

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 |
| --- | --- |
| Experimental: Alert<br>Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine. | Other: Alert<br> <br> * Other names: Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.;|
| No Intervention: Usual Care<br>Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Within 7 Days | This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis. | From start of AKI to 7 days later | 
| Death |  | 7 days of randomization | 
| Relative Maximum Change in Creatinine |  | 7 days of randomization |
Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.

Official Title
-----------------
CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?

Conditions
-----------------
Hysteroscopy, Distension Medium, Pain

Intervention / Treatment
-----------------
* Procedure: diagnostic hysteroscopy
* Drug: physiological solution
* Drug: carbon dioxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected uterine pathologies infertility Exclusion Criteria: pregnancy severe hypertension, cardiovascular disease or respiratory disease

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carbon dioxide<br>Diagnostic hysteroscopy performed with the carbon dioxide (gas) | Procedure: diagnostic hysteroscopy<br>* Endoscopic procedure to visualize uterine cavity<br>Drug: carbon dioxide<br> <br> |
| Active Comparator: physiological solution<br>Diagnostic hysteroscopy performed with liquid solution (physiologic solution) | Procedure: diagnostic hysteroscopy<br>* Endoscopic procedure to visualize uterine cavity<br>Drug: physiological solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain discomfort during the procedure assessed through visual analogue scale (VAS) |  | up to six months |
Giardia Induced Fatigue and Functional Gastrointestinal Diseases

Study Overview
=================
Brief Summary
-----------------
A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance: Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae. Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors. Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.

Official Title
-----------------
Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Other: Psycoeducation/counseling
* Behavioral: Cognitive behavioural therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Problems with fatigue of any severity after Giardia infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psycoeducation/counseling<br> | Other: Psycoeducation/counseling<br>* 2 days of education on mechanisms of illness and coping strategies<br>|
| Active Comparator: Cognitive behavioural therapy<br> | Behavioral: Cognitive behavioural therapy<br>* 4 days intensive training in understanding and behavioural changes<br>* Other names: CBT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement minimum 6 points in Chalder Fatigue scale score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CFS, Giardia, Fatigue, Cognitive behavioural therapy, CBT, Chronic fatigue syndrome
Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

Study Overview
=================
Brief Summary
-----------------
This prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (ICIs) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. This study aimed to assess the use, effectiveness, and safety of ICIs for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of ICIs for the treatment of cancer patients in the real-world setting.

Official Title
-----------------
Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years. Pathologically confirmed diagnosis of a solid tumor cancer. Patients receiving treatment with immune checkpoint inhibitors. Ability to understand and willingness to provide the informed consent. Exclusion Criteria: Age < 18 years. Patients with hematological malignancies or solid benign tumors. Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

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 | OS was defined as the time from the date of first administration of immunotherapy until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | PFS was measured from the date of first administration of immunotherapy to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging. | Three years | 
| Overall Objective Response Rate | ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | At least 6 weeks after start of treatment | 
| Percentage of Participants With Adverse Events | Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0. | Three years |
Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Null Hypothesis: There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy. Alternate Hypothesis: There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.

Detailed Description
-----------------
The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy. Endpoints: Primary Endpoint CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation. Secondary Endpoints Patient and allograft survival based on donor/recipient CMV status Incidence of graft rejection and loss associated with CMV infection Time to hepatitis C virus (HCV) occurrence Incidence of HSV, EBV and VZV reactivations Severity of HCV occurrence based on biopsy reports based on the Knodell score Safety and tolerability of oral valganciclovir and ganciclovir

Official Title
-----------------
Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir

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

Intervention / Treatment
-----------------
* Drug: oral Valganciclovir vs oral Ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All liver transplants will be performed at Oregon Health & Science University (OHSU) and the OHSU surgical and medical staff will treat patients. Exclusion Criteria: Portland Veterans Affairs Medical Center liver transplant recipients Patients deceased within thirty days of receiving liver allograft Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-) Patients undergoing re-transplantation Lost to follow-up (minimum follow-up is 1 year) History of CMV infection or disease Anti-CMV therapy within the past 30 d Severe, uncontrolled diarrhea or evidence of malabsorption.

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

| Intervention/Treatment |
| --- |
|Drug: oral Valganciclovir vs oral Ganciclovir|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
-----------------
Valganciclovir, Oral Ganciclovir, Liver transplant