linjc16/ctgov huggingface dataset:
Omecamtiv Mecarbil Post-trial Access Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

Detailed Description
-----------------
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Official Title
-----------------
Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF

Conditions
-----------------
Chronic Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
-----------------
* Drug: Omecamtiv mecarbil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures. Participant has completed GALACTIC-HF. Exclusion Criteria: Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason. Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment. Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment. Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test. Participant has known sensitivity to any of the products or components to be administered during dosing. History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omecamtiv mecarbil<br>All subjects will be assigned to OM | Drug: Omecamtiv mecarbil<br>* Film-coated tablet administered orally.<br>* Other names: AMG 423;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants administered omecamtiv mecarbil during the treatment period | Primary analysis is based on the exploratory outcome measure. | Up to 252 weeks |
Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models

Study Overview
=================
Brief Summary
-----------------
Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.

Official Title
-----------------
Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models

Conditions
-----------------
Anesthesia, Acute Pain, Risk Reduction

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery. Exclusion Criteria: The basic information such gender, age, height, weight, and body mass index (BMI) were missing. Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Numeric Rating Scale (NRS) score after surgery <4<br> | Other: No intervention<br>* No intervention<br>|
| Numeric Rating Scale (NRS) score after surgery ≥ 4<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve | It measures the prediction effect of the algorithm model | April 2020 to May 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Data Platform, Machine Learning, Postoperative Acute Pain
Molecular Profiling of Metastatic Cancer in Pleural Effusion and Ascites

Study Overview
=================
Brief Summary
-----------------
Cancers are among the most frequent leading causes of death in Taiwan, and many of them show their respective unique epidemiological and pathophysiological features in Taiwanese population. One of the distinguishing features of cancers includes their potential to metastasize outside the primary tumor. Pleural cavity and peritoneum are two of the most frequent sites of metastases when serosal surfaces are involved. The prognoses of such patients are extremely poor with a median survival of months. The understandings of cancer biology of tumor metastasis demand more in-depth studies at the molecular and cell levels. Studies based on cell culture are excellent approaches for this purpose as the cell culture provides a relevant and renewable model for studying the pathological and molecular changes underlying human malignant tumors.

Detailed Description
-----------------
Due to their easy accessibility, pleural effusions and ascites are two important clinical sources of metastatic cancer cells, which upon isolation, permit comparative studies between the biology nature of primary tumor and metastatic ones. In this study, we will try to isolate cancer cells from human malignant effusions, said to be pleural effusions and/or ascites. We will establish phenotypic alterations along the progression of malignant tumors with serosal metastasis, with special emphasis on expression of some proteases, laminin receptors and transcription factors involved in the process of invasion and metastasis. We would also perform clinical correlations, including tumor type, staging, status of lymph node metastasis and histopathological differentiation and grading, etc.

Official Title
-----------------
Molecular Profiling of Metastatic Cancer in Pleural Effusion and Ascites

Conditions
-----------------
Metastatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patients pleural effusion or peritoneal effusion Exclusion Criteria: infected and fever patients anticoagulant treatment patients patients don't attend this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Cancer
The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean

Study Overview
=================
Brief Summary
-----------------
Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management. Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment. Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance. the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor. The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).

Conditions
-----------------
Orotracheal Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing general anesthesia with orotracheal intubation Exclusion Criteria: patient who have facial anomaly , 2. patients who required a rapid sequence induction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| ULBT group<br>344 adult patients undergoing general anesthesia with orotracheal intubation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack and Lehane grade | When the patients undergoing general anesthesia with orotracheal intubation, after obtained glottis view with direct laryngoscopy, the performer assessed Cormack and Lehane grade. (It takes about 1 minutes). A grade 1 and 2 were rated as an easy laryngoscopy. Difficult laryngoscopy was defined as the inability to visualize the vocal cords, each includes Grades 3 and 4. | glottis view with direct laryngoscopy for 1 minute during anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ULBT, diffficult laryngoscopy, Predictive Value of Tests
Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients

Study Overview
=================
Brief Summary
-----------------
Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.

Official Title
-----------------
Comparison of Two Different Acrylate Intraocular Lenses in Cataract Surgery in Patients With Non-infectious Uveitis

Conditions
-----------------
Uveitis, Cataract

Intervention / Treatment
-----------------
* Device: intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non infectious uveitis no active inflammation significant visual disturbance related to lens opacification Exclusion Criteria: vitreous opacification ocular hypertension/glaucoma

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| cell deposits on anterior IOL surface |  |  | 
| posterior capsular opacification |  |  |
Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

Detailed Description
-----------------
Sepsis involves an overactive inflammatory response to severe bacterial infection that can compromise vascular integrity and cause tissue edema, organ dysfunction and death. Adrenomedullin (ADM) has attracted the interest of researchers because of its powerful physiological functions. An anti-ADM antibody reduced the norepinephrine infusion rates required to achieve hemodynamic targets, increased urine flow and improved creatinine clearance, which ultimately resulted in attenuated systemic inflammation and tissue apoptosis, during resuscitated cecal ligation and puncture (CLP)-induced septic shock in mice. In humans, plasma ADM has been determined only in a small number of sepsis patients, and - except from one study - the assays used did not selectively measure the bioactive ADM form and have been considered not reliable. Therefore, the potential value of determining plasma ADM in such patients cannot yet be ascertained and the optimal cut off needs to be validated in future studies

Official Title
-----------------
Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Patients admitted in intensive care unit for severe sepsis or septic shock according to international, standardized criteria,transferred from another intensive care unit less than 24 hours after the primary admission, or being treated with vasopressors for less than 24 hours in the prior ICU Signed Consent form Exclusion Criteria: Age < 18 years Severe sepsis or septic shock patients transferred from another intensive care unit later than 24 hours after the primary admission or being treated with vasopressors for more than 24 hours in the prior ICU Pregnant women Vegetative coma Participation in an interventional clinical trial in the preceding month

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of all-cause mortality |  | Day 28. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe sepsis, septic shock, adrenomedullin, organ dysfunction
Relationship Between Muscle Mass and Muscle Relaxation Time

Study Overview
=================
Brief Summary
-----------------
Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find relationship between muscle mass and muscle relaxation time.

Detailed Description
-----------------
Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find relationship between muscle mass and muscle relaxation time. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Official Title
-----------------
Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Inbody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient who undergo general anesthesia. Male; weight 70-75kg , height 170-175cm Female; weight 53-58kg , height 158-163cm Exclusion Criteria: Liver and kidney disease Any types of muscle disorder. Metal materials or pacemaker in body

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inbody<br>Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. | Device: Inbody<br>* Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0) | T1 and T0 is obtained by train of four which is commonly used neuromuscular monitoring device. | two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completely suppression time of result of first stimulus(T1). | T1 is obtained by train of four which is commonly used neuromuscular monitoring device. | ten minutes |
Non-invasive Negative Pressure Treatment for Pectus Excavatum

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment

Official Title
-----------------
Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum

Conditions
-----------------
Pectus Excavatum

Intervention / Treatment
-----------------
* Device: Vacuum Bell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of co-morbidities that may interfere with proper placement or function of the apparatus test negative for pregnancy in women of childbearing age Exclusion Criteria: skeletal diseases like osteogenesis imperfecta or osteoporosis clotting disorders such as hemophilia or thrombopathia skin diseases or infections of the anterior chest wall angiopathies or vascular fragility obesity important with BMI greater than 30 precarious commitment to the prolonged use of the device protocol

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 35 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 |
| --- | --- |
| Other: Vacuum Bell<br>Patients with pectus excavatum will be treated with the Vacuum Bell device | Device: Vacuum Bell<br>* Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the reduction in the deepness of the pectus excavatum | The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life related to self-esteem | The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
Ulimorelin Study of Efficacy and Safety (ULISES 008)

Study Overview
=================
Brief Summary
-----------------
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

Conditions
-----------------
Gastrointestinal Dysmotility

Intervention / Treatment
-----------------
* Drug: Ulimorelin Intravenously (IV)
* Drug: Ulimorelin Invtravenously (IV)
* Drug: 5% dextrose in water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women, 18 to 80 years of age, inclusive Scheduled to undergo open bowel resection with colonic anastomosis For women who can potentially become pregnant a pregnancy test at screening and admission must be negative Exclusion Criteria: Weight more than 200kg (441 pounds) Pregnant or breastfeeding Known history of drug or alcohol abuse within the previous year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Experimental 1<br> | Drug: Ulimorelin Intravenously (IV)<br>* 160 µg/kg daily (QD)<br>|
| Experimental: Experimental 2<br> | Drug: Ulimorelin Invtravenously (IV)<br>* 480 µg/kg daily (QD)<br>|
| Placebo Comparator: Placebo<br> | Drug: 5% dextrose in water<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of GI Function |  | up to 7 days of dosing or until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ancillary GI Functions |  | up to 7 days of dosing or hospital discharge |