linjc16/ctgov huggingface dataset:
SELF-BREATHE RCT for Chronic Breathlessness

Study Overview
=================
Brief Summary
-----------------
A feasibility RCT comprising two groups: Intervention (SELF-BREATHE in addition to standard NHS care) Control group (standard / currently available NHS care)

Official Title
-----------------
A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial

Conditions
-----------------
Cystic Fibrosis, Cancer, COPD, Asthma, Bronchiectasis Adult, Interstitial Lung Disease, Chronic Heart Failure, Sickle Cell Disease, Renal Failure, Liver Failure, Post COVID-19, Dyspnea

Intervention / Treatment
-----------------
* Other: SELF-BREATHE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years of age, with the ability to read and type in English Access to a computer, or tablet or smart phone, with internet access and the ability to email Chronic breathlessness (CB) defined as; breathlessness that persists (>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19 Chronic breathlessness at rest or on exertion; MRC dysponea score >2 Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE) Able to provide informed consent Exclusion Criteria: Breathlessness of unknown cause A primary diagnosis of chronic hyperventilation syndrome Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation

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
Interventional Model Description: A feasibility RCT comprising two groups: Intervention (SELF-BREATHE in addition to standard NHS care) Control group (standard / currently available NHS care)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELF-BREATHE<br>Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE | Other: SELF-BREATHE<br>* A self -guided, internet -based intervention for patients with chronic breathlessness<br>|
| No Intervention: Control<br>standard / currently available NHS care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: the number of patients recruited into this study over a 12-month period | The number of patients recruited into this study over a 12-month period | 12 months |
A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.

Conditions
-----------------
Sedation; Aged; Hemodynamics

Intervention / Treatment
-----------------
* Drug: dexmedetomidine alone or dexmedetomidine + midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥ 65 years ASA physical status class I-II the patients who want sedation during elective lower limb surgery under spinal anesthesia Exclusion Criteria: contraindication to spinal anesthesia neurologic or cognitive dysfunction severe cardiovascular or pulmonary disease refusal to participation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine alone<br>dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion | Drug: dexmedetomidine alone or dexmedetomidine + midazolam<br> <br> |
| Experimental: dexmedetomidine + midazolam<br>normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion | Drug: dexmedetomidine alone or dexmedetomidine + midazolam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability | comparison of bradycardia incidence | 4 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Observer Assessment of Alertness/Sedation (MOAAS) scale |  | 4 hour |
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Official Title
-----------------
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Nexavar for unresectable or advanced renal cell carcinoma Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients who have received Nexavar for unresectable or advanced RCC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar |  | After Nexavar administration, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)] |  | After Nexavar administration, up to 1 year | 
| Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC] |  | After Nexavar administration, up to 1 year | 
| The status of therapy with Nexavar [duration of treatment, daily dose] |  | After Nexavar administration, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexavar, Unresectable or advanced renal cell carcinoma
Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.

Official Title
-----------------
The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer

Conditions
-----------------
Nutrition Disorders

Intervention / Treatment
-----------------
* Procedure: perioperational nutrition surpport


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; age 18-75 years; pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease; no history of treatment with neoadjuvant chemotherapy and/or radiotherapy PG-SGA score ≥2，<9 Exclusion Criteria: patients requiring conversion to open gastrectomy excessive bleeding (˃ 500 mL);and patients opting out of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperational nutrition support group<br>Scored patient-generated subjective global assessment(PG-SGA) ≥2，<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation | Procedure: perioperational nutrition surpport<br>* Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation<br>|
| No Intervention: Conventional group<br>PG-SGA ≥2，<9 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | fever；wound infection；post-operation bleeding；ileus；stenosis；leakage | 30 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, Enhanced recovery after surgery
Catechin Containing Mask for the Prevention of Influenza Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.

Detailed Description
-----------------
Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.

Official Title
-----------------
The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection

Conditions
-----------------
Influenza Infection

Intervention / Treatment
-----------------
* Dietary Supplement: tea catechin extracts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Possible to wearing mask for three months Possible to fill out a questionnaire personally Obtained written informed consent before participation Exclusion Criteria: Possessing some infectious diseases in need of therapy Possessing tea or catechin allergy diagnosed as inadequate for other reasons to participate the study by principal investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tea catechin extracts containing mask<br>wearing the tea catechin extracts containing mask | Dietary Supplement: tea catechin extracts<br>* catechins are composed of tea catechin extracts available in grren tea supplements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rate of influenza infection during the study |  | assessed at each month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rates of upper respiratory tract infections |  | assessed at each month | 
| the severity of the symptoms and the duration of the cold among incident cases |  | assessed at each month | 
| he incidence-free time for influenza or upper respiratory tract infections after the intervention |  | assessed at each month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prophylaxis, influenza infection, catechins, prophylaxis of influenza infection
Barrett's Esophagus Patient Registry

Study Overview
=================
Brief Summary
-----------------
The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.

Official Title
-----------------
Barrett's Esophagus Patient Registry

Conditions
-----------------
Barrett Esophagus, Esophageal Adenocarcinoma, Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria. Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma. The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus. Exclusion Criteria: Inability or unwillingness to provide blood samples. History of known bleeding disorders. Currently awaiting organ transplantation. Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Barrett's Esophagus/Esophageal Adenocarcinoma<br>Patients who have Barrett's esophagus or esophageal adenocarcinoma. | |
| Healthy control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to esophageal adenocarcinoma |  | 5 years (on average although follow-up will continue) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy |  | 5 years on average | 
| Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases |  | 5 years on average |
Vitality Trial - Sampling Examination Data

Study Overview
=================
Brief Summary
-----------------
This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.

Conditions
-----------------
Cardiac Event

Intervention / Treatment
-----------------
* Device: cardiac ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent. Exclusion Criteria: no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiac ultrasound examination<br> | Device: cardiac ultrasound examination<br>* cardiac ultrasound examination to examine the vitality<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitality data |  | 1 day (at time of examination) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac ultrasound, vitality, data, patients, examined
Effect of Brimonidine on Corneal Thickness

Study Overview
=================
Brief Summary
-----------------
Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is widely used in glaucoma treatment. Although it is known that it is quickly taken up by the cornea following topical administration and that the cornea has alpha-2 adrenoceptors there are only few studies available on the impact brimonidine has on the cornea. The aim of the study is to find out whether topical administration of brimonidine results in interaction with corneal alpha-2 adrenoceptors in terms of an increase in corneal thickness and whether there are any differences between the response corneal epithelium, stroma and endothelium show to alpha-2 adrenoceptor stimulation.

Official Title
-----------------
Effect of Brimonidine on Corneal Thickness

Conditions
-----------------
Impact of Brimonidine on the Cornea

Intervention / Treatment
-----------------
* Drug: brimonidine 0.1%
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, 18-99 years, normal ophthalmologic history, consent to participate in the study Exclusion Criteria: any serious medical or neurologic conditions and/or regular use of local or systemic medications

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| verum<br>brimonidine 0.1% eye drops twice daily | Drug: brimonidine 0.1%<br>* brimonidine 0.1% eye drops twice daily<br>|
| placebo<br>sodium hyaluronate 1.8mg/ml eye drops twice daily | Drug: placebo<br>* sodium hyaluronate 1.8mg/ml eye drops twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal thickness |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brimonidine, alpha-2 adrenoceptor, cornea, corneal thickness