cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.

This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.

Study purpose:

This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.

Objectives:

Primary:

To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA \< 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.

Secondary:

1. To observe the treatment outcomes.
2. To validate the result of super-responder trial.
3. To validate the Roadmap Concept.

Population:

The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 65 years of age
* Documented chronic hepatitis B defined by ALL of following:

  1. Clinical history compatible with compensated chronic hepatitis B
  2. Detectable serum hepatitis B surface antigen (HBsAg)\> 6 months and at the screening visit.

Exclusion Criteria:

* Pregnant or nursing
* co-infection with hepatitis C virus (HCV) or HIV
* Clinical or imaging diagnosis of cirrhosis
* Evidence of decreased renal function of creatinine \>(=)2x ULN
Drainage of Tuberculous Pleural Effusions

Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of tuberculous pleurisy

Exclusion Criteria:

* History of invasive procedures directed into the pleural cavity
* Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
* Use of streptokinase in the previous 2 years
* Lack of clinical symptoms caused by effusions
HSK16149 for Perioperative Analgesia in Orthopedic Surgery

This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.

This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h.

Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period.

Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.

After the treatment period, the subjects will be followed up.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 18 and 75 years (included);
2. Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;
3. 18kg/m\^2≤BMI≤30 kg/m\^2;
4. American Society of Anesthesiologists (ASA) grade I and II;

Exclusion Criteria:

1. Any of the following medical histories or conditions prior to screening:

   * Long history of chronic pain;
   * history of severe cardiovascular or respiratory disease;
   * history of neurological or psychiatric disorders;
   * history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system;
   * major surgery within 3 months;
   * patients with high bleeding risk;
   * history of renal disease treated with dialysis within 28 days before surgery;
   * have active infection within the past 2 weeks;
2. Use of any of the following medications or treatments:

   * opioid analgesics for more than 10 consecutive days within 3 months prior to screening;
   * other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label);
3. Abnormal laboratory tests during screening:
4. Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;
5. A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
6. Participated in another clinical trial and received IMP within 30 days prior to screening;
7. Pregnant or lactating women;
8. Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;
The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS

This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients.

This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units.

All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood culture and specialized tests are conducted.

Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen - both use peripheral blood as the clinical sample. The diagnostic performance of the two experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used in any clinical decision-making.

This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint measures.

Eligibility Criteria:
Inclusion Criteria:

1. 18-89 years old on the day of enrollment.
2. Currently admitted to study designated medical or surgical ward
3. Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
4. Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
5. Completed SBAR handover (Situation, Background, Assessment, Recommendation)
6. SIRS present as defined by the presence of two or more of the following:

   * Temperature \> 38°C or \< 36°C
   * Heart Rate \> 90 beat/min
   * Tachypnea \> 20/min or PaCO2 \< 32 mmHg
   * WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)

Exclusion Criteria:

1. Consent not provided
2. Patients less than 18 years of age, or 90 years of age or older.
3. Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
4. Patients that are not located in the designated medical or surgical ward associated with the study.
5. Patients listed for "Comfort Measures Only".
6. Less than 2 SIRS criteria
7. Commencement of narrow spectrum directed antibiotics prior to screening.
Comparison of Immediate Effects of Different Shoulder Stretching Techniques in Overhead Athletes

81 overhead athletes with Glenohumeral Internal Rotation Deficit (GIRD) will be included in this study. Participants will be randomly divided into 3 different groups of 26 people. In each group will be applied posterior shoulder stretching exercises (PSSE) performed with different Muscle Energy Techniques (MET).

Post Isometric Relaxation Group (PIRG) participants will perform a PSSE with post isometric relaxation (PIR) technique, Isolytic Stretching Group (ISG) participants will perform a PSSE with isolytic stretching technique and Static Stretching Group Group (SSG) participants will perform a PSSE with static stretching technique. All exercises will be performed in the modified cross-body position. Subacromial space and posterior capsule thickness will be measured using a 7-12 MHz linear transducer with USG (LOGIQ e Ultrasound, GE Healthcare, USA). Athletes' GIRD results and rotational ROM measurements will be measured and recorded using a bubble inclinometer (Fabrication End Inc, New York, USA). The upper extremity functional performance of the athletes will be evaluated with the Functional Throwing Performance Index (FTPI). Evaluations will be repeated tree times before, after the stretching exercise and 30 minutes later and the effects of different muscle energy techniques (MET) will be compared. Investigators hypothesized PSSE made with different MET techniques have different effects on Acromio-Humeral Distance, posterior capsule thickness, rotational ROM measurements and performance on overhead athletes with GIRD and the effects of MET would be superior to static stretching.

Eligibility Criteria:
Inclusion Criteria:

* Being overhead athlete
* Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º

Exclusion Criteria:

* Shoulder pain required medical attention for the last year.
* Current shoulder pain
* Cervical pain during upper extremity movement
* History of fracture to the shoulder girdle
* Systemic musculoskeletal disease
* History of shoulder surgery,
* Glenohumeral instability (positive apprehension, relocation, or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test, or marked weakness with shoulder external rotation)
Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation

Purpose: To determine the surgical outcomes of the grading versus classic Inferior Oblique Anterior Transposition (IOAT) technique in treatment of patients with asymmetric dissociated vertical deviation (DVD) and inferior oblique overaction (IOOA).

Methods: In this randomized clinical trial, a total of 38 patients with IOOA of \>+1 and a minimum DVD difference of 5pd between their two eyes will be included. Comprehensive ophthalmic examinations including visual acuity assessment, measurements of noncyclo- and cycloplegic refraction as well as ocular deviation, biomicroscopic and funduscopic evaluation will be performed at baseline and repeated three months after the surgery. The function of extra ocular muscles will be evaluated by duction and version movements denoting from -4 (underaction) to +4 (overaction) grades. Also, IOOA will be graded as +1 to +4 according to the covering of the cornea under the superior eyelid during the ocular movement towards supra-nasal direction. The difference of DVD≥5pd between two eyes will be considered as asymmetric DVD. All patients will be randomized in the two groups to undergo IOAT surgical procedure; in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes; while in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.


Eligibility Criteria:
Inclusion Criteria:

- Overaction of inferior oblique muscle ≥+1 and asymmetric dissociated vertical deviation \>5pd between their two eyes.

Exclusion Criteria:

* Mental retardation
* Nystagmus
* Cerebral palsy
* History of ptosis and previous surgery on any cyclovertical muscle
* Restrictive or paralytic ocular deviations
* Inability to maintain fixation by each eye
* Best corrected visual acuity \<20/200
* Ocular and/or systemic anomalies
* Follow up less than three months
Oral Peanut Immunotherapy

Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims:

1. Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
2. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
3. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
4. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of peanut allergy by a positive prick skin test to peanut (\> 8 mm reaction wheal) or CAP FEIA \>10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
2. Ability to provide informed consent.
3. Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.

Exclusion criteria:

1. Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
2. Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
3. Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
4. Diagnosis of other severe or complicating medical problems
5. Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
6. Primary Immune Deficiency
7. Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
8. Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
9. Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair
Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
* Atopic lesion localisation: arms; additional legs, neck

Exclusion Criteria:

* SCORAD \> 40
* Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
* Active immunosuppression or cancer
* Narcotics- or Alcohol abuse
* Participation in another clinical trial until one month prior inclusion
* Known allergies against an ingredient of the investigational medicinal product
* Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
* Pregnancy or lactation
A Study of Cisapride in Premature Infants With Feeding Problems

The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0.2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q.i.d. schedule).

Eligibility Criteria:
Inclusion Criteria:

* Must be hospitalized and on continuous cardiac monitoring for the duration of the study
* Patient has demonstrated feeding intolerance as defined by the protocol
* Patient's parent or legal guardian must sign the informed consent form

Exclusion Criteria:

* Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)
Seven Year Update of Macular Degeneration Patients

The purpose is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.

This is a cross-sectional cohort study of exudative age-related macular degeneration (AMD) patients seven or more years after initiation of the intravitreal ranibizumab regimen in the treatment arms of the pivotal ANCHOR or MARINA studies, who had subsequent follow up in the HORIZON Study. While the MARINA and ANCHOR studies established the benefit of ranibizumab at 2 years, many patients in the U.S. have now undergone treatment for many years, and the longer-term outcomes for this chronic disease remain unknown. Despite earlier hopes for limited duration treatment, subsequent clinical experience suggests that many patients require continued treatment. The patient population for this study is unique, in that the patients in the treatment arms of MARINA and ANCHOR are some of the earliest treated patients, providing the longest-term data available for AMD patients receiving ranibizumab. Patients recalled into this study will be evaluated to provide an update on their current visual acuity, disease activity status, anatomic characteristics, and genotype. There is a single study visit to extend the clinical history and to perform vision testing, ophthalmologic examination, and retinal imaging studies, including high-resolution spectral-domain OCT and fundus autofluorescence imaging, technologies unavailable at the time of the original ANCHOR and MARINA Trials. Genetic analysis will be performed for known AMD risk genes as well as candidate genes to study genotypic profiles associated with AMD disease progression and long-term treatment response. Understanding the course of 7-plus years of current generation AMD treatment will serve physicians in the ongoing management of this chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* previous participants in the ANCHOR or MARINA studies, and...
* who were assigned to one of the ranibizumab treatment arms, and...
* who were enrolled in the HORIZON extension study with a current SEVEN UP investigator
* ability to provide written informed consent and comply with study assessments

Exclusion Criteria:

* any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial
Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.

This parallel study is conducted in a single hospital. The participants are divided into two groups. One group is provided with Xarelto, and the other one group is provided without any prophylactic antithrombotic. To check the presence of a deep vein thrombosis of the lower limb, bilateral sonographic examinations are arranged for all participants preoperatively and at 3 and 14 days postoperatively. One radiologists who was blinded to the nature of the study interpreted the results of the sonographic examination. The present of pulmonary embolism, DVT-related symptoms, and complications are recorded during the 3-months follow-up in orthopedics outpatients. The symptom which associated with DVT is defined as the signs of leg such as unusual pain, edema, swelling, warm skin, and red or discolored skin. Complications related to Xarelto include major bleeding, infection, and non-healing wound. The expected number of participants in each group is 89, which is calculated by G \* Power version 3.1. The intention to treat analysis is used in this study. The investigators compare the incidences of DVT, pulmonary embolism, and complications between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Undergo total knee replacement or total hip replacement

Exclusion Criteria:

* Recent antithrombotics use
* A history of a coagulopathy
* Recent thromboembolic disease
* Preoperative deep vein thrombosis screening presents positive
* Age below 20