cyrilzakka/clinical-trials huggingface dataset:
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease

Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease .

The median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. The patients with interstitial lung disease had significantly higher serum baseline KL-6 and MMP-7 levels compared with healthy control.They divided into progressive group and non-progressive group according to disease change. Serum KL-6 and MMP-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .Binary logistic regression showed △KL-6 and △MMP-7 were significant predictors for disease progression. Multivariate Cox analysis showed KL-6 and MMP-7 were significantly associated with survival along with other variables.

The serum levels of KL-6 and MMP-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. The rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.Therefore，Serial measurements of biomarkers contribute to the disease monitoring in clinical management.

Eligibility Criteria:
Inclusion Criteriar:

* Clinical diagnosis of interstitial lung disease

Exclusion Criteria:

* Diagnosise of interstitial lung disease acute excerbation
* Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Good health with the exception of bronchial asthma (for at least 6 months)
* FEV1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only)
* FEV1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
* Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
* Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
* Use of other drugs not allowed
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
Comparison of Pantomiming and Easy Onset Treatment

This research will give in-depth understanding of pantomiming and easy onset method as an intervention of stuttering and especially blocking. And by comparing both methods, It will also determine that which method is more effective. This research will also improve the overall awareness regarding stuttering

Research participants will be divided into two groups through randomization, Group A \& Group B. Base line assessment will be conducted. Intervention will be provided (thrice a week on alternative days).post assessment will be taken and data will be analyzed through SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be added into the study.
* School aged children and adolescents ages between 6 to 18 years(both genders) who stutter with blocking symptoms
* Participant who will be at moderate level of stammering will be included

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.
* Participants with any other medical condition will be excluded
Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts

This is a randomized controlled, multi-center, non-blinded non-inferiority study examining the utility of telemetry monitoring in patients admitted who are low risk for acute coronary syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their admission. Research study coordinators will enroll patients and then follow them throughout their hospital course and record primary and secondary end point events.

This is a randomized controlled, multi-center, non-blinded non-inferiority study examining the utility of telemetry monitoring in patients admitted who are low risk for acute coronary syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their admission. Research study coordinators will enroll patients and then follow them throughout their hospital course and record primary and secondary end point events.

The research coordinators will collect information on the following items for data collection: age, gender, smoking history, history of hypertension, history of diabetes mellitus, history of hypercholesterolemia, and history of family member with early heart disease or myocardial infarction, and body mass index. Research coordinators will document if the patient had any of the following events during their hospital course: death, myocardial infarction (MI), upgrade to a higher level of care, dysrhythmia, results of any stress testing or cardiac catheterization. In addition patients will be contacted at 30 days and 365 days to inquire about MI, needing for percutaneous coronary intervention (PCI), or revascularization (CABG).

Based on previous studies, we hypothesize that patients aged 18-49 years who are at low risk for Acute Coronary Syndrome (ACS) are unlikely to benefit from continuous heart monitoring while admitted to the hospital for chest pain. We suspect that the rate of significant events may approach zero in this group of participants. This study aim is to show that a bed without remote monitoring- telemetry- is adequate when these low risk participants with chest pain are hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be admitted for chest pain and evaluation of acute coronary syndrome

Exclusion Criteria:

* History of coronary artery disease, previous myocardial infarction, or any percutaneous intervention either documented in the medical report or verbal report by patient
* Have an initial troponin serum value above the threshold for that hospital's normal limit
* Have used cocaine in the previous 14 days (patient report)
* Have an abnormal ECG as determined by attending emergency physician
* Unable to consent for the study due to language barrier or mental incapacity
* Admitting attending physician does not agree with randomization of the patient into either study arm
* Pregnancy
Effect of Release of Upper Track of Deep Front Facial Line Versus Myofascial Release With IASTM on Patients With Upper Cross Syndrome

this study will be conducted to compare the effect of release of upper track of deep front facial line versus myofascial release with IASTM on patients with Upper Cross Syndrome.

Upper cross syndrome is a postural dysfunction that can cause a variety of upper-body musculoskeletal problems. Early detection and physiotherapy can help to prevent further complications. Maintaining bad posture over an extended duration can cause postural dysfunction and misalignment.

The first and most obvious sign of upper crossed syndrome is the characteristic postural dysfunction of protracted scapulae, medially rotated humeri, hyperkyphotic upper thoracic spine, and a protracted/ anteriorly held head, which is created by hypo lordosis or even kyphosis (excessive flexion) of the lower cervical spine, hyper lordosis of the upper cervical spine and head, and anterior translation of the head upon the atlas.

The available treatments for upper cross syndrome are Stretching, strengthening, myofascial release, postural relaxation exercise, electrical stimulations, and deep neck flexors activations are the most used techniques. Numerous studies have highlighted various benefits in terms of time efforts, and prognosis. Those are corrective exercise, Kinesio taping, scapular stabilization exercise, and PNF techniques.

Studies have demonstrated the role of fascia in various musculoskeletal dysfunctions as the fascial tissues connect the skeletal muscles forming a body-wide web in a pattern called myofascial meridians. As fascia is able to modify its tensional state, strain transmission along the meridians might occur in response to changes in muscle activity.

Deep fascia tends to be highly vascularized and contain well developed lymphatic channels. In some instances, deep fascia can even contain free encapsulated nerve endings, such as Ruffini and Pacinian corpuscles. It is present in our body in different tissue planes and in different forms with specific function and the musculoskeletal fascial system can be affected by various localized disorders with variable time course and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-40 years old
* All participants had forward head, craniovertebral angle \< 50.
* All participants had rounded back (kyphosis angle ≥ 42°)
* Based on assessment of upper cross syndrome by photogrammetric analysis.
* The subjects were chosen from both genders.

Exclusion Criteria:

* History of trauma or surgery in cervical region.
* Bone fractures or acute soft tissue injuries.
* Osteoporosis.
* Heart attack.
* Unstable angina pectoris -Implanted pacemaker or defibrillator- -Cancer-
* Rheumatoid arthritis
* Connective tissue disease: This includes diseases such as osteomyelitis, lupus and scleroderma -Neurological conditions-
rTMS on Mismatch Negativity of Schizophrenia

Auditory mismatch negativity deficit is a robust neurophysiological biomarker of schizophrenia. Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulation method and can be used to modulate excitability of specific brain cortical region. We hypothesize that MMN deficit of schizophrenia is related to inferior frontal gyrus (IFG) hypofunction, and this deficit can be improved by using rTMS to enhance IFG function.

It is a randomized, double-blinded, sham-controlled clinical trial. Forty-eight schizophrenia patients with MMN deficits (mean amplitude at FCz \> -0.7 ㎶) will be recruited and then randomized at a 1:1 ratio to rTMS group and sham-stimulation group. Subjects in rTMS group will receive high frequency rTMS over IFG, while in the other group subjects will receive sham stimulation at IFG. Frameless stereotaxy navigation will be used to guide the rTMS coil to IFG. The primary outcome is the change of MMN mean amplitude at FCz after stimulation. We hypothesize that the change of MMN mean amplitude is significantly larger in rTMS group than in sham-stimulation group. Their cognitive function and clinical condition will be evaluated carefully before and after experiments.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
* mean amplitude of MMN at FCz greater than -0.7 ㎶
* moderate or milder disease severity (scoring 4 or below according to clinical global rating scale)

Exclusion Criteria:

* unwillingness or inability to cooperate with the experiments
* with mental retardation, epilepsy, or other major brain pathology (e.g. cerebrovascular accidents or major head injury)
* with alcohol or other illicit substance abuse
* with major debilitating systemic diseases or difficulties in ambulation
* with hearing impairments as screened by audiometry over 500 Hz, 1000 Hz and 6000 Hz
* with pacemaker, intra-ocular metal foreign body, intracerebral vessel clip, artificial cardiac valve, electronic implant in the body, claustrophobia, or previous surgery involving the brain
* being pregnant or to be pregnant during the clinical trial. A pre-TMS evaluation scale will be applied to ensure the safety
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.

The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-80 years old;
2. Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
3. Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
4. Some active pro-supination range of motion;
5. Some active metacarpal-phalangeal joint in the hemiparetic hand;
6. Intact cognitive function to understand the robotic therapy procedures (MMSE\>23 and able to follow 3 step command) during initial evaluation visit;

Exclusion Criteria:

1. Undergoing upper-limb rehabilitation therapy during the period of the study.
2. Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
3. Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
4. Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
5. Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
6. Individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection;
7. Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
Subclinical Diabetes Confirmed by 75gm-OGTT Influence on the Prognosis of Decompensated Cirrhosis

Disorders of glucose metabolism, such as impaired glucose intolerance (IGT) and diabetes mellitus (DM), frequently occur in cirrhosis. However, it has been underestimated when fasting plasma glucose (FPG) levels are considered. We aimed to evaluate who needs to be undertaken a 75-g oral glucose tolerance test (OGTT) to find underlying subclinical diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Admitted to a hospital

Exclusion Criteria:

* Previously confirmed DM
* Being treated for DM
* Standard risk factors of T2DM, such as high body mass index and family history of diabetes
* Symptoms of DM, such as increased thirst and the need to urinate
* Either hepatocellular carcinoma or other malignancy
* Hepatic failure or uncontrolled decompensation \[that is, refractory ascites or active variceal hemorrhage\]
* Significant illnesses such as sepsis that may have interfered with glucose metabolism
* Pancreatic dysfunction such as acute/chronic pancreatitis that may have affected glucose metabolism.
Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial

1. Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's effectiveness in the Asian countries, where most firstly recorded rhythm in out-of-hospital cardiac arrests patients were asystole/pulseless electric activity rather than ventricular fibrillation / ventricular tachycardia, were not explored yet.
2. This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency medical technicians improves the outcome of all out-of-hospital cardiac arrest patients in an Asian metropolitan city.

1. Different from data from the Western countries, non-shockable rhythm (Asystole/pulseless electric activity) was responsible for most out-of-hospital cardiac arrest patients(80%\~90%) in metropolitan Taipei.
2. Response time in Taipei emergency medical service was longer than 5 minutes.
3. Bystander cardiopulmonary resuscitation rate were relatively low in Taipei.
4. Cardiopulmonary resuscitation is the only known method to save out-of-hospital cardiac arrest patients with asystole/pulseless electric activity. For those suffered from ventricular fibrillation/ ventricular tachycardia,previous studies revealed pre-shock cardiopulmonary resuscitation may have the potential to improve the outcome.
5. Study hypothesis: Compared with current standard resuscitative sequence (basic life support protocol in Guideline 2005), longer pre-shock cardiopulmonary resuscitation provided to all out-of-hospital cardiac arrest patients in Taipei may improve the outcome of them.

Eligibility Criteria:
Inclusion Criteria:

* Patients with out-of-hospital cardiac arrest

Exclusion Criteria:

* Trauma
* Age \< 18y/o
* Airway obstruction
* Submersion
* Sign of obvious death
* existing do not resuscitate (DNAR) order
* family refusal
* preceding CPR by BLS teams for longer than 2 minutes.
Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease

In recent years, the incidence of Inflammatory Bowel Disease (IBD) has been increasing in China, which poses great challenges and burdens to the medical community due to its unknown etiology, recurrence and incurability. Co-infection is one of the important causes in IBD development. IBD accompanied with Clostridium Difficile Infection (CDI) can significantly decrease the treatment efficiency, leading to increased surgical rate, increased mortality, prolonged hospital stay, and increased hospital costs. Recently, several Chinese clinical guidelines about IBD or CDI have been published, but these guidelines are mainly based on the foreign studies. Compared with the developed countries, the lack of multi-center, large-scale and multi-test clinical trials and cohort studies caused limited understanding for IBD-CDI in China. Therefore, it is of great importance to carry out the multi-center clinical trials and analysis on IBD-CDI to improve the diagnostic and therapeutic efficiency in IBD-CDI patients

Objective:

1. To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..
2. To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.
3. To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.


Eligibility Criteria:
Inclusion Criteria:

* 1.Inpatients with diagnostic criteria for ulcerative colitis and Crohn's disease in accordance with the consensus opinion on the diagnosis and treatment of inflammatory bowel disease in China in 2012
* 2.Willing to participate in the study;
* 3. Have the ability to understand and sign informed consent.

Exclusion Criteria:

* 1.Patients with infectious enteritis, intestinal tuberculosis, lymphoma, Behcet's disease or other intestinal diseases except inflammatory bowel disease;
* 2.Pregnant or lactating women;
* 3.Severe circulatory system, respiratory system, blood system, immune system, urinary system and other combined diseases or serious psychosomatic diseases.
Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses

The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast.

As a major oncology and hepatology center, the investigators perform about 3-5 guided biopsies for liver tumors weekly. Ultrasound is the preferred modality for imaging biopsies due to its ability to visualize and position the biopsy needle in real time with high accuracy and safety, is nonionizing, and is quicker compared to other techniques, especially CT-guided biopsies. The failure rate of ultrasound guided liver biopsies (including cases where biopsy was declined to be performed due to lack of lesion visibility) is about 10%. By comparison, in the investigators' practice genotyping of metastatic tumors, with multiple core biopsies, is often requested for entry into oncology trials, and failure of tumor genotyping after biopsy is estimated to be about 30%.

Recently, the first ultrasound contrast agent was FDA-approved for characterization of liver lesions \[sulfur hexafluoride lipid-type A microspheres (Lumason, Bracco Diagnostics, Monroe Township, NJ)\]. The microbubble agent is deemed safe, including in cardiac failure patients and those with chronic airway obstruction. Injecting microbubbles may allow better visualization of lesions and adjacent vasculature by enhancing the microvasculature and adjacent vessels and potentially reduce incidence of failed biopsy or bleeding complications. In addition, determination of necrotic regions in a lesion may allow better direction of biopsy.

Yet there is limited literature on the use of ultrasound contrast agents for improving targeted liver biopsies. The investigators intend to prospectively assess the non-diagnostic biopsy and complication rates in a group of patients who undergo contrast-enhanced ultrasonography (CEUS) using microbubbles at the time of biopsy. The investigators will then compare the results from this group with the failure and complication rate from a control group of patients undergoing the standard US-guided biopsy procedure. Over 12 months the investigators expect to perform approximately 200 biopsies. Power analysis suggests that 125 patients in both contrast-enhanced sonography and control groups, each, are required. The investigators should be able to enroll sufficient patients in 18 months

Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Age 18 years or greater
3. Scheduled to undergo liver biopsy with ultrasound guidance at a performance site

Exclusion Criteria:

1. Liver biopsy is not intended to obtain tissue from a specific lesion
2. Known or suspected cardiac shunt
3. History of hypersensitivity to any active or inactive ingredients in Lumason