linjc16/ctgov huggingface dataset:
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function

Study Overview
=================
Brief Summary
-----------------
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms

Official Title
-----------------
An Exploratory, 14-week, Open-label Clinical Food Study to Evaluate the Effects of KB295 in Adult Patients With Ulcerative Colitis (UC) Presenting With Mild-to-moderate UC Symptoms

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: KB295


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be male or female, ≥18 and ≤75 years of age Confirmed diagnosis of UC (>6 months) by endoscopy Mild-to-moderate UC with at least 4 weeks of UC symptomatology prior to screening Stable medication regimen for at least 2 weeks prior to screening, if on medication for UC Exclusion Criteria: Possible or confirmed diagnosis of Crohn's disease or indeterminate disease History of isolated distal proctitis Use of any antidiarrheal medications within the last 1 week prior to screening Antibiotic treatment within the past 28 days prior to screening Any non-UC related immunosuppressive medications other than purine analogs. Systemic corticosteroids including prednisone > 10 mg per day are excluded. Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results Treatment with any other investigational drugs within 28 days prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: KB295<br> | Other: KB295<br>* KB295 is a novel glycan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing any treatment-emergent adverse events (TEAEs) |  | Day -1 to Day 84 | 
| Number of patients experiencing discontinuations due to adverse events (AEs) |  | Day -1 to Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kaleido, Microbiome, Ulcerative Colitis, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Mild-to-moderate UC
Hyper-CVAD Treatment in Lymphoblastic Lymphoma

Study Overview
=================
Brief Summary
-----------------
Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.

Detailed Description
-----------------
We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.

Official Title
-----------------
The Clinical Outcomes of Hyper-CVAD Treatment in Lymphoblastic Lymphoma

Conditions
-----------------
Lymphoblastic Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 at diagnosis Pathologically proven lymphoblastic lymphoma Exclusion Criteria: proven HIV infection pretreatment with other regimens

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 |  | 3-year | 
| Progression free survival |  | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult lymphoblastic lymphoma, Hyper-CVAD, first-line treatment
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis

Study Overview
=================
Brief Summary
-----------------
Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.

Official Title
-----------------
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis

Conditions
-----------------
Lower Extremity Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Diagnostic Test: Bedside Compression Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis. - 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active<br> | Diagnostic Test: Bedside Compression Ultrasonography<br>* Point of Care Ultrasound (Bedside Compression Ultrasonography) vs formal lower extremity Doppler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disposition | We measured the time to disposition from the emergency department for point of care ultrasound (POCUS) vs formal lower extremity (LE) doppler in radiology department. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of POCUS vs formal LE doppler | We examined the accuracy of POCUS vs formal doppler in making the diagnosis of lower extremity deep vein thrombosis. | 3 months |
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

Study Overview
=================
Brief Summary
-----------------
By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.

Official Title
-----------------
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Aerobic walking program
* Behavioral: Standard physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Independent ambulation before stroke Be able to understand and follow verbal commands in English Have physicians' approval for exercise, and be in stable medical condition Participant's first stroke Unable to walk independently according to Functional Ambulation Category (FAC) (<2) after in-patient rehabilitation treatment Between 6 weeks to 5 years after stroke onset Exclusion Criteria: Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago Musculoskeletal disorder which prevents subjects from participating in the exercise Resting blood pressure more than 200/110 mm Hg Current or previous pulmonary diseases in the past two years Osteoporosis and restricted passive movement in the major joints of the lower limbs Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device. | Behavioral: Aerobic walking program<br>* Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.<br>|
| Active Comparator: Control Group<br>The control group will receive standard physical therapy (PT). | Behavioral: Standard physical therapy<br>* Participants will receive standard care they normally would after a stroke.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Heart Rate |  | Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting blood pressure |  | Change from Baseline to Week 8 | 
| Change in vital capacity (VC) |  | Change from Baseline to Week 8 | 
| Change in forced vital capacity (FVC) |  | Change from Baseline to Week 8 |
Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled anaesthetic agent. The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon dioxide.

Official Title
-----------------
Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Other: Inhaled anaesthetic agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective coronary artery by-pass graft surgery elective valve replacement surgery normal left ventricular ejection fraction on preoperative echocardiography Exclusion Criteria: obstructive lung disease restrictive lung disease

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled anaesthetic agent<br>The group where the investigators adds inhaled anaesthetic agent when using the anaesthetic gas reflector (AnaConda). | Other: Inhaled anaesthetic agent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of carbon dioxide rebreathing from an anesthetic gas reflector | Tidal carbon dioxide volume rebreathed from an anesthetic gas reflector correlated to concentration of delivered anesthetic gas. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector. | Changes of tidal volume required to maintain constant alveolar ventilation will be assessed by continuous measurement of exhaled tidal carbon dioxide volume, the latter to be maintained at a constant value. | 2 hours |
The Evaluation of Stimulant Withdrawal

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine whether Carvedilol, an FDA approved beta blocker, when administered for an 8-week period to veterans currently undergoing treatment for methamphetamine dependence (1) improves their ability to stay in treatment longer, (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the time they remain abstinent from methamphetamine.

Official Title
-----------------
Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse

Conditions
-----------------
Anxiety, Relapse, Substance Addiction

Intervention / Treatment
-----------------
* Drug: Coreg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have entered treatment into the outpatient Clinical Addiction Rehabilitation Section (CARS) through the US Portland Veterans Affairs Medical Center Must meet the clinical definition for methamphetamine dependence Self-reported methamphetamine use within 10 days of entering the study Must be able to understand and sign the consent form Exclusion Criteria: Dependent on any other drug except nicotine, caffeine, marijuana and alcohol Pregnant or nursing mothers Psychosis Dementia Any serious medical condition that could be aggravated by the study protocol (Allergic reaction, Hypotension, Asthma, Bronchospastic conditions, Angina, Bronchitis, Emphysema, Bradycardia, Heart or blood vessel disease, Diabetes mellitus, Low blood sugar, Kidney disease, Liver disease or Overactive thyroid) History of withdrawal seizures or delirium tremors Use of MAO inhibitors within the last two weeks Considerable hepatocellular injury, including cirrhosis of the liver or liver function test levels higher than 2 times normal

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CTRL<br> | Drug: Coreg<br> <br> |
| Experimental: TREAT<br> | Drug: Coreg<br> <br> |

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
-----------------
Methamphetamine, Coreg, Withdrawal, anxiety, Substance Addiction
Feasibility of a Smart Device Application for Home-based Prehabilitation

Study Overview
=================
Brief Summary
-----------------
To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity.

Official Title
-----------------
Feasibility of a Smart Device Application for Home-based Prehabilitation in Patients Undergoing Lung Cancer Surgery: A Prospective Observational Pilot Study

Conditions
-----------------
Cancer, Prehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (19-70) who are scheduled for elective cancer surgery American Society of Anesthesiologists (ASA) physical status classification I or II Patients who can use a smartphone application Patients who can perform an exercise program for at least 3 weeks from the first visit to the preoperative clinic to elective surgery Exclusion Criteria: Patients who are unable to communicate Patients under the age of 19 and over 70 Patients who have a major medical or psychiatric disorder that is expected to affect exercise Patients with contraindications to the general rehabilitation program

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Compliance of a smartphone application | Based on the data saved in the application, when the program started and ended, how many steps and distance the patient exercised per day, how many sets patient did muscle exercise per day and week will be collected to calculate the compliance. | A day before surgery at ward | 
| Satisfaction of a smartphone application | Using the questionnaire that we made to evaluation the satisfaction of a smartphone application. | A day before surgery at ward | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-EORTC QLQ C-30 | EORTC QLQ C-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 A questionnaire which is designed to assess the different aspects that define the QoL of cancer patients. (Total score ranging 0 to 100, A high score for a functional scale represents a high level of functioning) | 4 weeks before the surgery at clinic, a day before the surgery at ward | 
| 6-minute walk test | The distance that patient can walk during 6 minutes. | 4 weeks before the surgery at clinic, a day before the surgery at ward | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer patient, Cancer Surgery, Prehabilitation
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.

Conditions
-----------------
Streptococcus Pneumoniae

Intervention / Treatment
-----------------
* Biological: pneumococcal conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent for participation in the study; ages between 50 and 80 years at recruitment Exclusion Criteria: Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent. Current participation in any other clinical trial Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study) Prior pneumococcal conjugate vaccine (PNC) 23 valent pneumococcal vaccine(PPV) in last 5 years Severe general or local reaction to a previous dose of PNC or PPV Patients currently immunocompromised as listed in UK Handbook Immunisation Against Infectious Disease ed 1996 Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook Immunisation Against Infectious Disease Deferral of vaccination if acute systemic illness or temperature >38C on day of vaccination

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pneumococcal conjugate vaccine|Pneumococcal conjugate vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | ELISA based asssay for serotype specific pneumococcal responses | Completed by dec 2008 |
IV Acetaminophen in Children Undergoing Palatoplasty

Study Overview
=================
Brief Summary
-----------------
This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

Official Title
-----------------
A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty

Conditions
-----------------
Cleft Palate

Intervention / Treatment
-----------------
* Drug: IV acetaminophen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II Presenting for repair of palatoplasty with Drs. Kirschner or Pearson Exclusion Criteria: ASA physical status > II Underlying Syndrome Significant co-morbid diseases (cardiac, pulmonary, neurological disease) Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV acetaminophen<br>IV acetaminophen administered q 4 hrs. for a total of 24 hrs. | Drug: IV acetaminophen<br> <br> * Other names: Ofirmev;|
| Placebo Comparator: Placebo<br>Normal saline administered IV every 4 hrs. for a total of 24 hrs. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain scores will be assessed. | 24 hrs. post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | 24 hrs. post-op |