linjc16/ctgov huggingface dataset:
COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic represents a threat to rheumatology patients. National advice for patients to 'shield' is based on risk stratification of therapies and other risk factors. While the epidemiology of COVID-19 in the rheumatological population is largely unknown large case registries are beginning to show potential drug treatment interactions. Strict self-isolation (shielding) has been recommended for those deemed 'high risk' although its impact on the likelihood of COVID-19 infection and health related quality of life (HRQoL) is unclear. The study aims to explore how this unprecedented situation has impacted the Trust patients primarily evaluating prevalence of the infection, effect of stringent social distancing (shielding) and Quality of Life (QOL). This will be done via a voluntary questionnaire, sent via text messaging at 6 and 12 months.

Official Title
-----------------
COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing

Conditions
-----------------
Covid19, Rheumatic Diseases

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number Exclusion Criteria: Patients without a validated mobile phone number linked to their hospital record

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Survey<br>Survey to be distributed at 6 and 12 months | Other: Questionnaire<br>* Questionnaire to be completed at 6 and 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of COVID 19 | percentage of cases | 1 year | 
| Mortality rates from COVID 19 | number of deaths per 1000 individuals | 1 year | 
| Health related quality of life - Short Form 12 | mental and physical component scores through patient reported outcomes. Normative score set at 50 with minimum score being 0 and maximum score being 100. Scores >50 indicate better mental or physical health than the mean. Scores <50 indicate worse mental or physical health than the mean | 1 year |
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.

Official Title
-----------------
A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Zotepine
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 65 years, male or female In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60. Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4 Exclusion Criteria: Patients with history of seizure or with alcohol or substance abuse in the last 6 months Diabetes, Parkinson's disease or phaeochromocytoma Patients with hypertension and current use of antihypertensive agents Women who are pregnant, lactating or intend to become pregnant during the study period Poor response to two different antipsychotics in full dose and full course or use of clozapine previously Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Zotepine<br> | Drug: Zotepine<br>* Oral<br>* Other names: Nipolept®;|
| Active Comparator: 2. Risperidone<br> | Drug: Risperidone<br>* Oral<br>* Other names: Risperdal®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the total score of Positive and Negative Syndrome Scale |  | 6 Weeks | 
| Change from baseline on Clinical Global Impression (CGI) |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, zotepine, risperidone, second generation antipsychotic
A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.

Official Title
-----------------
A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

Conditions
-----------------
Breast Lesions

Intervention / Treatment
-----------------
* Device: Intact Breast Lesion Excision System (BLES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age ≥ 18 years BIRADS ≤ 5, as initially imaged Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used Exclusion Criteria: Male Subjects with subglandular (pre-pectoral, or single plane) breast implants Subjects with electronic implantable devices (such as pacemakers and defibrillators) Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females, 18 years of age or older<br>Females, 18 years of age or older, who will undergo the Intact procedure | Device: Intact Breast Lesion Excision System (BLES)<br>* Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion BIRADS score | Diagnostic imaging result | Weeks prior to the Intact procedure | 
| Imaging lesion size | Measured in mm | Weeks prior to the Intact procedure | 
| Lesion histology | Lesion biopsy results | Weeks prior to the Intact procedure | 
| Tissue margin (as reported from histology) rate | Procedure margin vs. margin size, measured in mm | Weeks after the Intact procedure, up to approximately 12 weeks | 
| Underestimation rate | Compared to maximum lesion size, measured in mm | Weeks after the Intact procedure, up to approximately 12 weeks |
Perspectives Patient Education Randomized Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial evaluating the educational program called My Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.

Official Title
-----------------
Perspectives Post Percutaneous Coronary Intervention Randomized Study

Conditions
-----------------
Medication Adherence

Intervention / Treatment
-----------------
* Device: MyIDEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during a hospitalization for the PCI procedure, were greater than 50 years old (funding agency requirement), spoke and understood English. Exclusion Criteria: inability to give informed consent allergy to aspirin

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyIDEA<br>Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment. | Device: MyIDEA<br>* An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.<br>|
| No Intervention: Treatment as normal<br>The research participants were given the chance to play games on the tablet and received normal clinical education. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study design engaging elderly patients in novel tablet based education. | Would research participants enroll and follow up in a study of tablet based education. Do patients think they know everything? Would patients enrolled in the control arm still follow up in the study? | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | A measure of Pharmacy days covered for DAPT medication. The patients after recieving a Drug Eluting Stent need to adhere to Dual Antiplatlet Therapy (DAPT) to prevent restenosis of the stent. PDC is a calculation of the DAPT which is Aspirin and an ADP receptor antagonist. As aspirin is over the counter, the pharmacy does not have a record of purchase so the PDC was calculated for the ADP receptor antagonis. | 3 months |
Sexaffectivity in Autistic Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised. People with Autism Spectrum Disorder (ASD) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. The consolidated prejudices and social myths related to the sexual affectivity of people with ASD, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs. Main objectives: to understand the experience lived by young people with ASD and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with ASD. Mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with ASD, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. The second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of Interaction in the affective expression, by means of questionnaires and self-administered scales. It will be necessary to sign the Informed Consent by all the participants, with the specific acceptance of the project by the CEIC of the investigator's center.

Official Title
-----------------
Sexaffectivity in Autistic Spectrum Disorder: Observed Behaviors and Referred Needs in Adolescence

Conditions
-----------------
Autistic Disorders Spectrum, Sexual Behavior, Adolescent Development, Sexual Inadequacy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents with ASD. 12-18 years old Exclusion Criteria: Non defined

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- | --- |
| Sexual Behaivor Scale | The measure utilized was developed specifically for this research - the Sexual Behaviour Scale (SBS; see Appendix) - and was based upon previous studies and the issues these studies identified (cf. Haracopos and Pedersen, 1992; Ruble and Dalrymple, 1993). The SBS examined parents' reports of their child's: (1) social behaviour; (2) privacy awareness; (3) sex education; and (4) sexual behaviour; as well as (5) parental concerns about outcomes for their child. | 12-18 years old |
Characteristics of Patients With Necrotizing Soft Tissue Infections

Study Overview
=================
Brief Summary
-----------------
To study the demographic characteristic of patients with necrotizing soft tissue infections.

Detailed Description
-----------------
At Aarhus University Hospital, Denmark, all patients with necrotizing soft tissue infections will be registered in a database in order to be able to describe their symptoms, demographic variables and thier treatment (surgery, time to surgery, antibiotics, intensive care unit, laboratory data etc).

Official Title
-----------------
Demographic Characteristics, Symptoms, Treatment and Mortality of Patients With Necrotizing Soft Tissue Infections

Conditions
-----------------
Necrotizing Soft Tissue Infection

Intervention / Treatment
-----------------
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with necrotizing soft tissue infections and treated at Aarhus Universital Hospital
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Surgery|All patients in the database undergo surgery due to a suspicion of necrotizing soft tissue infections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that dies within 1 year following admission date | The risk of death within 1 year | 12 months following admission date |
Admission Glucose ICU Study

Study Overview
=================
Brief Summary
-----------------
Determine if routine BG testing at the time of ICU admission is being done on all patients, irrespective of a prior diagnosis of diabetes mellitus, and whether it provides clinically important information.

Detailed Description
-----------------
This prospective, observational study was performed in the medical-surgical ICU of a single hospital within a large multi-specialty healthcare system. It was determined that it was not standard care to do glucose testing on all patients admitted to medical/surgical ICU's who did not have diagnosed diabetes and varied widely with the admitting service. The primary objective of the study was to assess the availability and clinical value of blood glucose testing at the time of ICU admission after testing was implemented as routine care in the ICU.

Official Title
-----------------
Evaluation of Admission Blood Glucose Levels in the Intensive Care Unit

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Procedure: BG Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU Admission Exclusion Criteria: < 18 years of age

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

| Intervention/Treatment |
| --- |
|Procedure: BG Test|nan|

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
-----------------
ICU, Admission, BG
Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19

Study Overview
=================
Brief Summary
-----------------
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.

Official Title
-----------------
The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study

Conditions
-----------------
Coronavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants were diagnosed as COVID-19; Participants received anti-SARS-CoV-2 inactivated convalescent plasma Written the informed consent. Exclusion Criteria: Participants lacked detailed medical history
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 |
| --- | --- | --- |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 | The SARS-CoV-2 nuclei acid was quantified using RT-PCR | 1 day after receiving plasma transmission | 
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 |  | 3 days after receiving plasma transmission | 
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 |  | 7 days after receiving plasma transmission | 
| Numbers of participants with different Clinical outcomes | Clinical outcomes include death, critical illness, recovery | From receiving plasma transmission to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |  | 4 weeks after receiving plasma transmission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plasma transfusion, Coronavirus
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection.

Study Overview
=================
Brief Summary
-----------------
The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care. So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery. Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain. This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.

Official Title
-----------------
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection

Conditions
-----------------
Liver Cancer, Adult

Intervention / Treatment
-----------------
* Drug: RopivacaIne chlorhydrate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatectomy or segmentectomy Exclusion Criteria: Sepsis uncontrolled current Overdose in anticoagulant during general anesthesia Thrombocytopenia <50 g / dl Severe renal impairment: Cockcroft <30 ml / min history of ventricular arrhythmia serious unexplained .* Allergy to local anesthetics of the amide Contraindication to remifentanil and morphine Hypovolemia

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 |
| --- | --- |
| Experimental: ropivacaïne chlorhydrate monohydrate<br> | Drug: RopivacaIne chlorhydrate<br>* 3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48<br>* Other names: 3mg/kg;|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* injection Hour (H) 0, H12 ; H24, H36 ; H48<br>* Other names: NaCl 0,9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of morphine over the first 48 hours postoperative. |  | at 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic of ropivacaine (plasma concentrations) |  | 1, 2, 3, 6, 10, 24, 36, 48 hours post-dose |