linjc16/ctgov huggingface dataset:
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.

Official Title
-----------------
A Phase 1 Clinical Study to Evaluate the Tolerability, Safety,Immunogenicity and Efficacy of the Neoantigen mRNA Personalised Cancer Vaccine SW1115C3 in Patients With Advanced Malignant Solid Tumours

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: Neoantigen mRNA Personalised Cancer SW1115C3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are 18 to 80 years old (including boundary values), without limitation of sex at time of consent. Based on the RECIST 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration. Exclusion Criteria: Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3 with the following exceptions: Adverse reactions induced by previous anti-tumour treatments have not yet recovered to Grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI [or designee], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.

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
Intervention Model: Sequential Assignment
Interventional Model Description: 30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoantigen mRNA Personalised Cancer<br>This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days. | Drug: Neoantigen mRNA Personalised Cancer SW1115C3<br>* Subcutaneous Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ，Dose-limiting toxicity incidence (participants who experience DLT) |  | 21 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) assessment per RECIST Version 1.1 |  | 1 year |
Predictors of Respiratory Failure in SARS-Cov-2 Infection

Study Overview
=================
Brief Summary
-----------------
The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia. A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

Detailed Description
-----------------
The study will compared patients with and without respiratory failure in order to find risk factors for need for ICU admission. A simple score based on risk factors will be created from a multicenter Italian cohort and validated in a multicenter international cohort.

Official Title
-----------------
Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection

Conditions
-----------------
SARS-CoV-2 Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection Age > 17 years Exclusion Criteria: Invasive mechanical ventilation within 12 hours from hospital admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Derivation cohort<br>Derivation cohort: Italian retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from February 20 to March 19 2020. . | |
| Validation cohort<br>Validation cohort: European and non-European retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from March 19 to April 18 2020. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory failure | Composite of ICU admission or SpO2<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate >30 bpm, respiratory distress | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of bacterial superinfection | Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia | 14 days |
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.

Official Title
-----------------
Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery

Conditions
-----------------
Enteral Nutrition Regimen Prior to Surgery

Intervention / Treatment
-----------------
* Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective laparoscopic cholecystectomy Exclusion Criteria: bile duct stones ileus conditions affecting gastric emptying severe, organ-specific disorders HIV inherited metabolic disorders known intolerance against or allergy to any component of the investigational feeds

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>oral nutritional supplement (assignment: according to consecutive random numbers) | Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)<br>* 3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia<br>|
| Placebo Comparator: Control<br>placebo (assignment: according to consecutive random numbers) | Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)<br>* 3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters reflecting pathophysiological functions of the liver |  | day -1, 0, 1, and 7 | 
| Gastrointestinal tolerance |  | day 0 before and 6-8h after surgery | 
| Metabolic parameters in serum, liver and muscle tissue |  | on day -1, 0, 1, and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical parameters (infectious and non-infectious complications) |  | until day 7 |
Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong

Study Overview
=================
Brief Summary
-----------------
This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis in our hospital clusters.

Detailed Description
-----------------
Renal stone is a common condition in Hong Kong, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc. Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference. Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for internal audit, treatment comparison and also patient education.

Official Title
-----------------
A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong

Conditions
-----------------
Urolithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at the age of 18 or above Exclusion Criteria: Patient is unable to give consent

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 |
| --- | --- | --- |
| Target Stone status | The fragmentation rate of target stone | At 3 months | 
| Recurrence of stone | Stone recurrent rate | At 12 months | 
| Treatment related complication | The 30-day complications will be graded according to the Clavien-Dindo classification | Thirty days after the operation |
Study of the Effect of the Supine Position at Brain Velocities in Noncerebro - Injured Patient

Study Overview
=================
Brief Summary
-----------------
To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia.

Conditions
-----------------
Anesthesia General

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum 18 years old, maximum 45 years old for men and 55 years old for women. surgery with supine position. Exclusion Criteria: refusal to participate failure of measurement brain velocity Penthotal or de kétamine before measurment Cardiac or pulmonary desease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| pulsatility index mesured with doppler ultrasound<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation the pulsatility index after setting prone position in non brain-injured patient |  | 10 minutes |
A Brain Imaging Study of Nicotine Release in Cigarette Smokers

Study Overview
=================
Brief Summary
-----------------
Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with [11C] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased [11C] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with [I123] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.

Official Title
-----------------
A Brain Imaging Study of Nicotine Release in Cigarette Smokers

Conditions
-----------------
Nicotine Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic smokers and healthy non-smokers. Exclusion Criteria: Pregnant and breast feeding women. Age below 20. Neurological disorders. Others drugs.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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
-----------------
Nicotine, Dopamine, IBZM
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

Study Overview
=================
Brief Summary
-----------------
The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.

Detailed Description
-----------------
Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter

Official Title
-----------------
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Device: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center. Only eyes with postoperative follow-up period more than 6 months were included. Exclusion Criteria: Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: vitrectomy<br> | Device: optical coherence tomography<br>* spectral-domain optical coherence tomography<br>* Other names: vitreous surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best-corrected visual acuity |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cone outer segment tips line, inner segment/outer segment junction line, optical coherence tomography, epiretinal membrane
The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

Study Overview
=================
Brief Summary
-----------------
The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.

Official Title
-----------------
A Randomised Trial of Peri-operative Nerve Block and Continuous Infusion of Local Anaesthetic Via Wound Catheter Versus Epidural in Patients Undergoing Open Liver Resection.

Conditions
-----------------
Open Liver Resection

Intervention / Treatment
-----------------
* Device: Wound catheter
* Device: Epidural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing open hepatic resection for benign or malignant conditions. Exclusion Criteria: Patients with contraindication to either epidural or wound catheter techniques. Inability to give written, informed consent. Jaundice (Bilirubin > 100 μmol/L) Liver resection combined with secondary surgical procedure. Age < 18 years Pregnant women patients on long term opiates for chronic pain

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound catheter<br>Wound catheter | Device: Wound catheter<br>* Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.<br>* Other names: On-Q Painbuster;|
| Active Comparator: Epidural<br>Standard epidural, pre-operative insertion, to be run for 48 hours | Device: Epidural<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days (to nearest half day) patients stay in hospital. | Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Visual analogue scores of pain experienced. | Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery. | 
| Molecular response to surgery | HMGB1, RAGE and cytokines | Days 0, 1 and 3 | 
| Central Venous Pressure | Mean Central Venous Pressure during liver transection will be quantified and compared between groups. | During liver transection | 
| Estimated Blood Loss |  | Intra-operative | 
| Operative field asessment |  | During liver transection | 
| Pringle time |  | Intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidurals, wound catheters, liver resection, liver surgery
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.

Official Title
-----------------
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a muscle biopsy for IRB11-00203.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine 1 mcg/kg<br>Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. | Drug: Ketamine<br>* 1 mg/kg IV, additional doses of 0.5 mg/kg as needed<br>Drug: Dexmedetomidine<br>* 0.5 mcg/kg/hr IV<br>|
| Experimental: Dexmedetomidine 0.5 mcg/kg<br>Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr. | Drug: Ketamine<br>* 1 mg/kg IV, additional doses of 0.5 mg/kg as needed<br>Drug: Dexmedetomidine<br>* 0.5 mcg/kg/hr IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Sedation Score of 3-4 | The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure. | Immediately prior to incision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Change After Dexmedetomidine Loading Dose | Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose. | Baseline to immediately post dexmedetomidine infusion. | 
| Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose | Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff. | Baseline to immediately post dexmedetomidine infusion. | 
| Oxygen Saturation Change After Dexmedetomidine Loading Dose | Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion. | Baseline to immediately post dexmedetomidine infusion. | 
| EtCO2 Change After Dexmedetomidine Loading Dose | Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion. | Baseline to immediately post dexmedetomidine infusion. |