linjc16/ctgov huggingface dataset:
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve

Study Overview
=================
Brief Summary
-----------------
Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.

Detailed Description
-----------------
An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

Official Title
-----------------
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery

Conditions
-----------------
Thyroid Intra-Operative Injury

Intervention / Treatment
-----------------
* Drug: sugammadex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy Exclusion Criteria: Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced recovery<br>rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv) | Drug: sugammadex<br>* standard general anesthesia protocol with sugammadex<br>* Other names: Bridion;|
| No Intervention: Conventional anesthesia<br>standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium | Electromyography signal to assess the quality of neuromonitoring | 1 month each case | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative neural monitoring
Critical Incidents Related to Anesthesia and Intensive Care: A Study in a Tertiary Hospital

Study Overview
=================
Brief Summary
-----------------
Critical incidents in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies in this regards are retrospective with many drawbacks and pitfalls like absence of information in the records of the patients. In the investigators' study, the investigators will follow the critical incidents among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018, by examining the patients records from the hospital database and recording the events that occur to the patients.

Detailed Description
-----------------
Over the forthcoming two years, the investigators will study in details critical incidences that may occur to patients in the perioperative period like; acute hypoxic event, acute major hemorrhage, acute airway obstruction and others that may endanger the life or one of the patient organs and whether the patient survive the acute event or die. These critical incidences will be collected and all information about it will be known in order to be studied and to know were was the defect and eventually to improve the safety of practice of anesthesia and surgery.

Official Title
-----------------
Critical Incidents Related to Anesthesia and Intensive Care: A Prospective Study in a Tertiary Hospital

Conditions
-----------------
Critical Incident

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who undergo anesthesia and surgery patients who are exposed to a critical incidence Exclusion Criteria: patients who undergo anesthesia and surgery and do not expose to critical incidents.
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 |
| --- | --- | --- |
| number of anesthetized patients who have perioperative critical incidence. | Critical incidence will include: Aspiration , Laryngospasm , Hypoxemia, Hypoventilation , Hypertension , Hypotension, Myocardial ischemia / infarction, Cardiac arrhythmia, Acute cardiac decompensation , Dental lesion , Nerve / skin / cornea lesion , Lesion through needle puncture , Hypothermia , Conversion of regional anesthesia / inadequate block, Urinary retention , Inadequate postoperative analgesia , Postoperative agitation ,) Awareness , Allergic reaction, Transfusion / mediation error, Miscellaneous. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.

Detailed Description
-----------------
Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those with evidence of hypoxemia will be randomized into two groups. One group will receive standard medical care. The other group will receive standard medical care as well as receiving low flow oxygen during sleep.

Official Title
-----------------
Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Other: Low flow nocturnal oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Standard Medical care | |
| Active Comparator: Low Flow Nocturnal Oxygen<br>This group will receive standard medical care as well as low flow oxygen during sleep. | Other: Low flow nocturnal oxygen<br>* Nocturnal low-flow oxygen via nasal cannula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Score |  | 3 months |
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Detailed Description
-----------------
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Official Title
-----------------
Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

Conditions
-----------------
Opioid Dependence, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Completion of Cooperative Study 1008 A/B Exclusion Criteria: - Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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: Buprenorphine/Naloxone<br> | Drug: Buprenorphine/naloxone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Retention |  |  | 
| Opioid withdrawal |  |  | 
| Subjective rating |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Dependence
Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan

Study Overview
=================
Brief Summary
-----------------
To study the association between aristolochic acid and urothelial carcinoma in Taiwan

Official Title
-----------------
Observational Study of Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan

Conditions
-----------------
Urothelial Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the resected kidney tissue in the tissue bank Exclusion Criteria: the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urothelial carcinoma<br>The DNA samples extracted from the urothelial carcinoma tissue | |
| RCC<br>the DNA sample extracted from RCC | |
| Non-cancer<br>The DNA sample extracted from the non-cancerous kidney tissue | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of aristolochic-acid DNA adduct in the samples |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urothelial carinoma, aristolochic acid, DNA, adduct
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

Study Overview
=================
Brief Summary
-----------------
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.

Official Title
-----------------
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA (Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety. In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study. Exclusion criteria Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Have not been registered by 3 months after the full code-breaking of the preceding study Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA (Tocilizumab)<br>* 8mg/kg/4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria |  | throughout study | 
| Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions |  | throughout study | 
| Pharmacokinetics of the serum MRA concentration |  | 0W,4W,8W,12W,LOBS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set |  | 0W,4W,8W,12W,LOBS |
Placement of CS/LV Pacing Leads With EnSite NavX Guidance

Study Overview
=================
Brief Summary
-----------------
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.

Official Title
-----------------
Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: EnSite NavX-Guided CRT implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients schedule to undergo CRT implant (per established guidelines) Exclusion Criteria: Standard exclusions to CRT implant procedures
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 |
| --- |
|Device: EnSite NavX-Guided CRT implant|LV lead placement during CRT implant using EnSite NavX|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy and procedure time |  | Procedural |
Evaluation of Homecare Reablement, the Trondheim Model

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. The model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.

Official Title
-----------------
Evaluation of Homecare Reablement, the Trondheim Model

Conditions
-----------------
Mobility Limitation, Asthenia

Intervention / Treatment
-----------------
* Other: Homecare reablement
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receive homecare services live within the catchment area Exclusion Criteria: In-patient length of stay (IPLOS) score > 2.0 severe dementia

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homecare reablement<br>Receives comprehensive assessment and individualized follow-up according to a plan with short and longterm goals. | Other: Homecare reablement<br> <br> |
| Active Comparator: Usual care<br>Receives normal care | Other: usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activity level (measured by body-worn sensors) | measured by body-worn sensors over 4 days | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical performance battery score | Performance based test of lower extremity function | 1 year | 
| Change in received hours with homecare services | Including nursing, assistance in activities of daily living and domestic work | 1 year | 
| Qualys (EQ- 5D) | EQ- 5D | 1 year | 
| Change in IPLOS score | A composite score on level of dependency in 17 different areas related to activities of daily living, including cognitive function | one year | 
| Change in cognitive function (Subscore of the Iplos score) | Subscore of the Iplos score | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Evaluation studies, Home care services
Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

Detailed Description
-----------------
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Official Title
-----------------
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx

Conditions
-----------------
Nasopharynx Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Nasopharynx cancer. Exclusion Criteria: Evidence of distant metastasis. Previous radiation for head and neck cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Photon/Proton Radiation Therapy<br>Photon/Proton Radiation Therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze morbidity outcomes |  | After radiation therapy, every 4 months for at least 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze tumor control outcomes |  | 12 months and 24 months after radiation therapy then annually for 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharynx Cancer, Proton Radiation, Outcomes
Comparative Genomic and Genetic Analysis of Paired Primary Breast - Metastatic Tumor Specimens Using High-throughput Platforms

Study Overview
=================
Brief Summary
-----------------
Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for gene expression analysis. This has clinical relevance as gene expression signatures may then be profiled using archival tumor blocks, which are more readily available than frozen tissues.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Breast Tumor Blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No participants are involved. Exclusion Criteria: No participants are involved.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Tumor<br>Breast Tumor Blocks | Other: Breast Tumor Blocks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Clinical Study of Novosis in Posterolateral Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion

Official Title
-----------------
The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion

Conditions
-----------------
Posterolateral Fusion

Intervention / Treatment
-----------------
* Device: Novosis
* Procedure: Iliac crest bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 80 aged patients needed single-level posterolateral fusion at L1 S1 A subject who provided written informed consent to participate in this study Exclusion Criteria: Patients with BMD T-score < -3.0 Women who are pregnant or plan to be pregnant within study period

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novosis<br>Bongros/rhBMP-2 | Device: Novosis<br> <br> |
| Active Comparator: Iliac crest bone graft<br>Iliac crest bone graft | Procedure: Iliac crest bone graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion grade by CT assessments after surgery |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion grade by Radiographic assessments after surgery |  | 24 weeks |