linjc16/ctgov huggingface dataset:
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

Detailed Description
-----------------
Moderate to severe ulcerative colitis patients admitted in Inflammatory Bowel Disease (IBD) center will be enrolled in this study. Eligible patients had active UC with a Mayo score of 6-12 points (moderate or severe disease activity). The investigators will evaluate whether CMV-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Official Title
-----------------
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis (ACE-UC)

Conditions
-----------------
Ulcerative Colitis, Cytomegalovirus Infections, Disease Exacerbation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe UC require hospitalization age 16 or more agree with written informed consent Exclusion Criteria: pregnancy foreign immunosuppressed patients

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| CMV infection | CMV colitis (CMV disease involving the colon) was diagnosed by colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) in accordance with current European guidelines | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance from colonic mucosa | Viral clearance from colonic mucosa was diagnosed as negative by immunohistochemistry (IHC) after a ganciclovir treatment | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Breakthrough CMV infection | Breakthrough CMV colitis was diagnosed by newly positive colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) at the time of second colonic biopsy | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

Study Overview
=================
Brief Summary
-----------------
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.

Official Title
-----------------
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

Conditions
-----------------
Elevated Metabolic Cost

Intervention / Treatment
-----------------
* Other: Gait Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Unilateral traumatic trans-tibial or transfemoral amputation Independent ambulation without an assistive device for a minimum of three months Ability to ambulate continuously for a minimum of 15 minutes Trans-femoral participants must use an ischial containment socket VAS Pain scores on the involved side of less than 4/10 Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test. Exclusion Criteria: Blindness TBI-Glascow Coma Scale score of 12 or lower at the time of injury Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Gait Training<br> | Other: Gait Training<br>* 12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Oxygen Consumption |  | 3 weeks | 
| Gait Oxygen Consumption |  | Immediately prior to start of 3 week training. | 
| Gait Oxygen Consumption |  | Immediately post training | 
| Gait Oxygen Consumption |  | 3 weeks later from first post training testing |
Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior Uveitis

Study Overview
=================
Brief Summary
-----------------
Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis. Presence of vision threatening complications may indicate immunosuppressive therapy. In this study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.

Official Title
-----------------
Efficacy and Adverse Effects of Cyclosporine A in the Treatment of Chronic Anterior Uveitis in Patients With Juvenile Idiopathic Arthritis

Conditions
-----------------
Uveitis, Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: Cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uveitis JIA

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine A|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
-----------------
uveitis, jia, Cyclosporine A, MTX
Job-Seekers Training for Patients With Drug Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effectiveness of a 12-hour basic job-training program designed to give drug abuse treatment patients the skills they need to find and secure a job and set vocational goals and methods for locating employment. The intervention to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been tested in trials.

Official Title
-----------------
Job Seekers Training for Patients With Drug Dependence

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DSM-IV drug/alcohol abuse/dependence enrolled in drug treatment for at least 30 days unemployed or underemployed expressed interest in employment demonstrate English comprehension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment or Job Training Program |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

Study Overview
=================
Brief Summary
-----------------
This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

Official Title
-----------------
A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults

Conditions
-----------------
Infection, Human Immunodeficiency Virus I, HIV Infection

Intervention / Treatment
-----------------
* Drug: GW640385
* Drug: Ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: HIV-1 infected subjects. Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening. CD4+ cell count >/= 200 cells/mm3 at Screening. Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen. Willing and able to provide signed and dated written informed consent prior to study entry. Exclusion criteria: Active CDC Class C disease. Pregnant or breastfeeding women. Protocol-specified laboratory abnormalities at Screening. Personal or family history of autoimmune disease. History or current indication of thyroid dysfunction or current thyroid gland abnormalities.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW640385|nan|
|Drug: Ritonavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure. |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 protease inhibitor GW640385 ritonavir RTV
Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Osteocalcin is a type of vitamin K2-dependent protein, and many studies have confirmed that vitamin K2 has anti-osteoporosis effects, and has preventive and therapeutic effects on a variety of diseases such as nervous system, cardiovascular disease, immune disease, and glucose metabolism. However, as a pleiotropic vitamin and nutrient, vitamin K2 does not have an exact normal range like other vitamins, when it needs to be supplemented, and in what regimen. Different organizations have different opinions on the recommended intake of vitamin K. Thus, this study intends to preliminarily obtain the reference interval of serum vitamin K2 by conducting clinical research in healthy people in the Beijing-Tianjin-Hebei region, and analyzes different factors, such as gender, age, and place of residence, to compare their level differences and changing trends, and to provide data reference for the recommended intake of vitamin K2 for people with vitamin K2 deficiency.

Official Title
-----------------
Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults

Conditions
-----------------
Health, Subjective

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People aged over 18. People with normal routine blood test. Willing to participate in this study. Exclusion Criteria: Subjects with congenital metabolic problems and endocrine diseases. Treatment with any investigational drug within the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of vitamin K2 | Vitamin K2 concentration in serum | During the procedure of regular physical checkups |
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

Study Overview
=================
Brief Summary
-----------------
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.

Official Title
-----------------
FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Other: Fecal microbiota transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Candidates for the bariatric surgery BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease. Availability of consecutive fecal samples during one year Compliance to attend gastroscopy and FMT 18-65 years Exclusion Criteria: Unable to provide informed consent Pregnancy Type I Diabetes Mellitus Severe renal insufficiency, GFR<30% Chronic or recurrent bacterial infection needing antimicrobial treatment Large hiatal hernia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Intervention arm<br>Fecal transplant from a thin donor | Other: Fecal microbiota transplantation<br>* Fecal microbiota transplantation administered in gastroscopy<br>|
| Placebo Comparator: Placebo arm<br>Fecal transplant made from patients own feces | Other: Fecal microbiota transplantation<br>* Fecal microbiota transplantation administered in gastroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of weight |  | 1,5 years |
A Study of the Natural Progression of Interstitial Lung Disease (ILD)

Study Overview
=================
Brief Summary
-----------------
We propose to acquire data and blood samples on all patients being cared for by the Interstitial Lung Disease (ILD) program. Additionally, we will collect data and blood samples from a control group for comparator purposes. In doing so, we will be able to describe the phenotypic expression of these diseases.

Official Title
-----------------
A Study of the Natural Progression of Interstitial Lung Disease (ILD)

Conditions
-----------------
Sarcoidosis, Interstitial Lung Diseases, Idiopathic Pulmonary Fibrosis, Connective Tissue Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Interstitial lung disease Exclusion Criteria: Does not have Interstitial lung disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of course of disease in patients with Interstitial lung disease (ILD) | We assess mortality roughly yearly but duration is unlimited | Yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial lung diseases, idiopathic pulmonary fibrosis, Sarcoidosis, mRNA and cytokine expression
Persistent Pain After Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment

Official Title
-----------------
Neurophysiological Characterization of Persistent Pain After Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Pain, Postoperative, Neuropathic Pain, Postherniotomy Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients > 18 yrs No sign of hernia recurrence Chronic groin pain lasting more than 3 months Moderate/severe pain related impairment of everyday activities Exclusion Criteria: Other causes of persistent pain in groin region (hip, other surgical procedures) Drug or alcohol abuse Conflicting neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persistent Pain patients<br>Patients with persistent postherniotomy pain after laparoscopic operation and pain related impaired daily function | |

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
-----------------
Groin hernia, Chronic pain, QST, Quantitative sensory testing, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Postherniotomy Pain after laparoscopic inguinal herniotomy, laparoscopic inguinal hernia repair
Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.

Detailed Description
-----------------
A systematic unenhanced abdominal CT is performed in elderly patients admitted to the emergency patients with acute abdominal symptoms. Accuracy of unenhanced CT is assessed by comparing diagnosis and therapeutic management recorded before and after unenhanced CT versus gold standard diagnosis and management. Gold standard diagnosis and management are established at 3 month follow up, based on patient's medical records and a systematic telephone interview.

Official Title
-----------------
Accuracy of Unenhanced CT in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Symptoms

Conditions
-----------------
Abdominal Pain

Intervention / Treatment
-----------------
* Device: Unenhanced abdominal Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly patients admitted to the emergency department (aged 75 year old and older) acute abdominal pain informed consent Exclusion criteria: traumatic pain symptom duration of more than a week unability for the patient to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 75 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

| Intervention/Treatment |
| --- |
|Device: Unenhanced abdominal Computed Tomography|Systematic Unenhanced abdominal Computed tomography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Emergency Department (ED) diagnosis made prospectively by the attending ED physician both before and after unenhanced abdominal CT is compared to the reference diagnosis established at 3 month follow-up. Both ED diagnosis and reference diagnosis are recorded using a standardized diagnosis list. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic management accuracy | Therapeutic management made by the attending ED physician both before and after unenhanced abdominal CT is compared to reference management established at 3 month follow-up. Therapeutic management is assessed by patient orientation following ED admission, need for hospitalization and surgical or medical treatment. | 3 months |