linjc16/ctgov huggingface dataset:
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Demographics data; Nutritional evaluation data; All biochemical monitoring data during the study period; All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene. A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline. We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling. Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization

Conditions
-----------------
Nutrition Therapy for Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18-70 patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation receive parenteral or enteral nutrition > 3 days Exclusion Criteria: has metabolic disorders: diabetes, thyroid disease Pregnant or breastfeeding The presence of drug or alcohol dependence The presence of tuberculosis, HIV infection and other acute infectious disease Serious liver, kidney, heart and other vital organ failure

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications after the operation | intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection | three years |
Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough due to acute or chronic bronchitis

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

Conditions
-----------------
Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

Intervention / Treatment
-----------------
* Drug: Levotuss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate, severe, very severe non-productive cough patients Exclusion Criteria: Patients receiving a concomitant therapy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levotuss CR tab<br>oral taken | Drug: Levotuss<br>* oral taken<br>|
| Active Comparator: Levotuss syrup<br>oral taken | Drug: Levotuss<br>* oral taken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough severity check |  | 6 hours |
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser

Study Overview
=================
Brief Summary
-----------------
This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.

Detailed Description
-----------------
Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser. Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the study eye. Only the study eye will receive bromfenac drops during the study. Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.

Official Title
-----------------
A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Bromfenac ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Center-involved macular edema secondary to diabetes mellitus Exclusion Criteria: Study eye with edema amenable to focal laser Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days Current eye infections

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bromfenac ophthalmic solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events. |  | Baseline to month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in retinal leakage as determined by fluorescein angiography |  | Baseline to month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic macular edema, bromfenac ophthalmic solution
Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk

Official Title
-----------------
Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Drug: cefuroxime
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age older than 18 spinal surgery for herniated disk Exclusion Criteria: known or suspected hypersensitivity to cephalosporins type I hypersensitivity to betalactamic antibiotics severe renal function impairment acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression antibiotic therapy for concomitant infection at the time of surgery pregnancy refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>intravenous 1.5g cefuroxime | Drug: cefuroxime<br>* preoperative intravenous 1.5g cefuroxime<br>|
| Placebo Comparator: 2<br>intravenous placebo | Drug: placebo<br>* preoperative intravenous placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a surgical site infection |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a post-operative infection other than surgical site infection |  | 6 monts | 
| Serious adverse event |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]
The Role of Therapy for Muscle Tension Dysphagia

Study Overview
=================
Brief Summary
-----------------
Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing function as evidenced by videofluoroscopic swallow study. These patients also demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the unloading of the supraglottic muscle tension has been shown to be highly effective in symptom resolution per the investigators' clinical experience. The study is designed to answer efficacy of treatment being offered to patients with muscle tension dysphagia.

Official Title
-----------------
Muscle Tension Dysphagia Treatment Efficacy

Conditions
-----------------
Muscle Tension Dysphagia

Intervention / Treatment
-----------------
* Behavioral: Voice therapy for Muscle Tension Dysphagia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18-99 Diagnosed with Muscle Tension Dysphagia Exclusion Criteria Physical or emotional disorder preventing the completion of therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voice Therapy for Muscle Tension Dysphagia<br>Voice therapy for Muscle Tension Dysphagia patients. | Behavioral: Voice therapy for Muscle Tension Dysphagia<br>* Voice therapy for Muscle Tension Dysphagia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of dysphagia measured via patient self-report measures | Number of participants who report improvement of dysphagia symptoms following therapy. | Duration of therapy, approximately 2 months |
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

Official Title
-----------------
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Conditions
-----------------
Juvenile Idiopathic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Diagnosis of JIA (any subtype) Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial Parent or legally acceptable representative willing to participate in the study and sign the informed consent Exclusion Criteria: Pregnant or nursing female at the time of enrollment Prior malignancies if the patient has not been malignancy free for at least 5 years. Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study Known poor compliance with clinic visits (based on physician judgment)

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Patients with JIA who are treated with Abatacept<br>Patients with JIA who are treated with Abatacept according to physicians'/families' decisions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of serious infections |  | 10 years | 
| Incidence rate of malignancies |  | 10 years | 
| Incidence rate of autoimmune disorders |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | 10 years | 
| Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections) |  | 10 years |
The Movement Control Training Associated With Conventional Physical Therapy is More Effective Than Conventional Physical Therapy Alone in Pain and Functional Performance?

Study Overview
=================
Brief Summary
-----------------
Assess pain, performance function, hip and knee strength and kinematics of trunk and lower limbs during single leg hop test after movement control training associated to hip and knee muscle strengthening.

Conditions
-----------------
Patellofemoral Pain Syndrome

Intervention / Treatment
-----------------
* Other: Conventional Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary women, Previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping Exclusion Criteria: Lower limb surgery, Patella displacement Knee instability Heart or locomotor disorders which might influence the evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Conventional Physical Therapy<br>Strength, this arm will receive hip and knee muscle strengthening with and without weight bearing. | Other: Conventional Physical Therapy<br> <br> * Other names: hip abductors, lateral hip rotators and knee extensors strengthing exercises with and without weightbearing;|
| Active Comparator: Movement control training<br>Movement control training, this arm will receive movement control training associated to muscle strengthening. | Other: Conventional Physical Therapy<br> <br> * Other names: hip abductors, lateral hip rotators and knee extensors strengthing exercises with and without weightbearing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | NRPS Score | 4 weeks | 
| Functional Performance | Single leg hop test distance | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength of hip and knee extensor muscles measured through hand-held dynamometer |  | 4 weeks | 
| 3D kinematic range of motion of hip adduction during single leg hop test |  | 4 weeks | 
| 3D kinematic maximum angular value of hip adduction during single leg hop test |  | 4 weeks |
Home Usability Study of the SARS-CoV-2 (COVID-19) Test

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.

Detailed Description
-----------------
This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.

Official Title
-----------------
Usability Study of Home Collection and Mailing With SARS-CoV-2 Test Specimen Collection Materials (2020-06)

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent Exclusion Criteria: Prior medical or laboratory training Prior experience with COVID-19 specimen self-collection Prior SARS-CoV-2 testing

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV-2|Determine usability of study materials and kit|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valid SARS-CoV-2 Test | The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive) | Subjects are assessed at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Sample Collection, Human Factors Study, Nasal Swab
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE. The objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.

Official Title
-----------------
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrollment in OSCILLATE (NCT01506401) Exclusion Criteria: inability to provide blood samples

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- |
| Conventional lung protective ventilation<br>Critically-ill patients with the acute respiratory distress syndrome randomized to the conventional lung protective ventilation arm of the OSCILLATE trial. | |
| High frequency oscillation ventilation<br>Critically-ill patients with the acute respiratory distress syndrome randomized to the high frequency oscillation ventilation arm of the OSCILLATE trial. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in biomarkers of ventilator-induced lung injury | The following biomarkers will be measured in patients enrolled in both arms of the OSCILLATE trial (high frequency oscillation ventilation and conventional lung protective ventilation) at randomization and again at 24 hrs post randomization: IL-1β, IL-6, IL-8, IL-10, IFN-γ, TGF-β, TNF-α, VEGF, sICAM-1, surfactant protein D (SP-D), Krebs von den Lungen protein (KL-6), Clara cell 16 kD protein (CC16), Angiopoietin-1, Angiopoietin-2, and vWF. | 24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute respiratory distress syndrome, high frequency oscillation ventilation, ventilator-induced lung injury, biomarkers