linjc16/ctgov huggingface dataset:
the Effect of Opioid-free General Anesthesia

Study Overview
=================
Brief Summary
-----------------
This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

Detailed Description
-----------------
The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

Official Title
-----------------
the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy

Conditions
-----------------
Gynecologic Disease

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine Hydrochloride
* Drug: Lidocaine Hydrochloride
* Drug: Remifentanil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for gynecological laparoscopic surgery Exclusion Criteria: refusal to participate in this study emergent surgery chronic pain requiring for pain killer psychiatric disease preoperative bradycardia or hypotension allergy or history of the adverse effect to study drug pregnancy or lactation

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: opioid-free anesthesia<br>The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. | Drug: Dexmedetomidine Hydrochloride<br>* dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia<br>* Other names: precedex;Drug: Lidocaine Hydrochloride<br>* lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia<br>* Other names: lidocaine;|
| Active Comparator: opioid anesthesia<br>The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy. | Drug: Remifentanil Hydrochloride<br>* remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia<br>* Other names: remifentanil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quality of recovery | The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery. | at 24 hour after the completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine | as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha. | during surgery |
Bloodstream Infections in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Study of incidence and risk factors of staphylococcus aureus bacteremia in patients with rheumatoid arthritis compared with the general population in a nationwide cohort of all adult members of the population from 1996 until 2017 using national registries

Official Title
-----------------
Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population

Conditions
-----------------
Rheumatoid Arthritis, Staphylococcus Aureus Bacteremia

Intervention / Treatment
-----------------
* Other: Risk factors in RA cohort
* Other: Risk factors in general population


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All members of the adult Danish population Exclusion Criteria: Staphylococcus aureus bacteremia prior to inclusion. Rheumatoid arthritis diagnosed prior to inclusion.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients<br>Incident patients with rheumatoid arthritis as identified by the Danish National Patient Registry and the rheumatology registry, DANBIO. | Other: Risk factors in RA cohort<br> <br> * Other names: Other comorbid conditions and surgical/dialysis procedures;|
| General population<br>All other adults, as Identified by the Civil Registration System. Patients who develop RA contribute person-years in the general population cohort until RA diagnosis | Other: Risk factors in general population<br> <br> * Other names: Other comorbid conditions and surgical/dialysis procedures;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of staphylococcus aureus bacteremia |  | 0-21 years | 
| Incidence rate ratios | Comparing rheumatoid arthritis patients with the general population | 0-21 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of staphylococcus aureus bacteremia | Identification of risk factors both universal to both the general population and rheumatoid arthritis (RA) cohorts and RA disease specific factors (disease duration, disease activity, smoking, joint erosions, etc.) | 0-21 years |
Splenic Hilar Nodes in Splenic Flexure Cancer

Study Overview
=================
Brief Summary
-----------------
Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.

Official Title
-----------------
Aberrant Lympahtic Drainage of Splenic Flexure Cancer: Are Splenic Hilar Nodes Metastases an Underecognized Phenomenon?

Conditions
-----------------
Colon Cancer, Metastases, Lymphatic

Intervention / Treatment
-----------------
* Other: Review of records and follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All splenic flexure cancer patients Exclusion Criteria: No consent to data utilization
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Splenic flexure cancer patients<br>Splenic flexure cancer patients | Other: Review of records and follow up<br>* Follow up to identify patients who developed splenic hilar nodal metastases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Splenic hilum nodal metastases | Splenic hilum nodal metastases | 5 years |
ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Study Overview
=================
Brief Summary
-----------------
The main purpose of the PICASSO-project is to facilitate future psoriasis-research in dermatology. This register biobank will enable us to perform research in the field of metabolomics, mRNA-expression, cardiovascular impact and the microbiome. The final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

Detailed Description
-----------------
The PICASSO-project is a prospective register with extensive biobanking in which patients with a recent onset of psoriasis (<3 years) can be enrolled. Participants are followed for a period of 10 years, with scheduled visits every 2.5 years. The same protocol is followed for every visit. The registry captures patient demographics, medical history (personal and family), details of psoriasis treatment (previous and current), physical examination, disease activity scores and PROMs. Some patients (substudy) will undergo ultra-sound to determine carotid intima media thickness. Biobanking in this project encompasses extensive biosampling of multiple tissues. It is not within the scope of this project to administer study medication: patients receive standard of care treatment as prescribed by their physician.

Official Title
-----------------
ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical signs of Psoriasis since >3 years adults (70 years old or less) and children (>12 years old) willing and able to understand and sign the informed consent (plus legal representative in case of a minor) Exclusion Criteria: unwilling or unable to understand and sign the informed consent disease duration longer than 3 years

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| We hypothesize that metabolic state in early disease (<3 years of disease onset) is linked to and predictive of more severe course of psoriasis after five years. | To describe the presence/absence of metabolic syndrome (defined by clinical parameters and cut-off levels of associated adipokines (see section 'Background': ref 8-11)) in early disease, and link it to disease severity (eg. mild psoriasis (PASI 0.1-4); moderate psoriasis (PASI 4.1-9.9); severe psoriasis (PASI 10 and above OR receiving systemic treatment/biologics); BSA: mild to moderate (0.1-5%); moderate to severe (5 and above)). It is within the primary endpoint of this project to re-evaluate both MetS- and psoriasis-parameters after 2.5, 5, 7.5 and 10 years | 10 years |
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

Study Overview
=================
Brief Summary
-----------------
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Detailed Description
-----------------
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Official Title
-----------------
An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel

Conditions
-----------------
Meningitis/Encephalitis

Intervention / Treatment
-----------------
* Device: QIAstat-Dx® Meningitis/Encephalitis (ME) Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles. Exclusion Criteria: Specimens not fitting criteria outlined above. CSF obtained from an external ventricular drain or shunt source. Lack of clear subject identification or label on residual banked CSF specimen. Specimen has been centrifuged. Obvious physical damage of banked residual specimen. Repeat specimens from the same subject.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: QIAstat-Dx® Meningitis/Encephalitis (ME) Panel|The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPA | positive percentage agreement | 6 months | 
| NPA | negative percentage agreement | 6 months |
Identifying Good and Poor Surgical Behaviour in the Danish Operating Room

Study Overview
=================
Brief Summary
-----------------
Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery. Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with empirical background knowledge of observed surgical behaviour as well as an understanding of surgical culture. The knowledge will be used to qualify the interviewguide. 8 semi-structured group interviews and 3 individual interviews will be conducted and tape recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as a co-moderator. The groups will contain 4 - 12 participants. The interview guide will be developed with a Scottish behavioural marker system as a framework, drawing upon the literature as well as the observations. It will contain questions regarding leadership, communication, teamwork, situation awareness and decision making to facilitate a discussion about surgeons' good and poor behaviours. Material: Data will be collected in two hospitals in the capital Region of Denmark, Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups is included to get the perspectives of the surgeons' team members since international studies have demonstrated differences of opinion regarding the perceived quality of teamwork amongst operating theatre staff. This study will be the first to build in the opinions of the team members into a behavioural marker system. 3 individual interviews with surgeons will afterwards conducted in one of the hospitals to get a more in-depth discussion. Data analysis and statistics: The interviews will be fully transcribed and analysed using qualitative method of systematic text condensation. Power calculations are not relevant in this qualitative study. Accepted guidelines state that the number of participants in each group should range between 5 and 15 and the data are from two large university hospitals receiving different patient categories to ensure a certain representative sample of informants.

Conditions
-----------------
Surgical Behaviour in the Operating Room

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical professionals at Rigshospitalet and Herlev Hospital
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Metabolic Disorders in Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance.

Detailed Description
-----------------
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. PCOS is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). Fifty percent of all patients with PCOS are obese, and the presence of obesity affects the clinical manifestations of PCOS. The underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with PCOS.

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Oligomenorrhea ( less than 6 times spontaneous MC per year) or Amenorrhea. 2. Hyperandrogenism (either clinical or biochemistry. 3. PCO by ultrasound. 4.After menarche, before menopause. Exclusion Criteria: 1. hormone therapy in the past 6 months. 2. Pregnancy in the past 6 months 3.Acute illness found in the past 3 months. 4.Systemic disease including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
Effect of Xen Implantation on the Aqueous Humor Proteome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.

Detailed Description
-----------------
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.

Official Title
-----------------
Effect of Xen Implantation on the Aqueous Humor Proteome

Conditions
-----------------
Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Xen
* Device: Aqueous shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any racial or ethnic origin, 18 years or older Able to provide written informed consent. Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt Exclusion Criteria: History of conjunctivitis or any ocular infection within the past 3 weeks. Any active inflammation of the cornea or the anterior chamber (uveitis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Xen<br>Patients treated with a Xen microstent for glaucoma. | Device: Xen<br>* Xen microstent implantation<br>|
| Aqueous shunt<br>Patients treated with an aqueous shunt for glaucoma. | Device: Aqueous shunt<br>* Aqueous shunt implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous humor proteome | The aqueous humor proteome will be assessed with liquid chromotography/mass spectometry (quantitative LC-MS/MS). | Change from baseline at 6 months |
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.

Detailed Description
-----------------
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.

Official Title
-----------------
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Device: Prevention of Diabetic Ulcers


Participation Criteria
=================
Eligibility Criteria
-----------------
Diabetics with foot ulcerations

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Prevention of Diabetic Ulcers|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
-----------------
Foot ulcers, amputation prevention, diabetes, footwear, insoles
Pattern of Admission and Outcome of Patients Admitted to the Intensive Care

Study Overview
=================
Brief Summary
-----------------
The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript.

Detailed Description
-----------------
The study was conducted at a teaching University hospital in a low-resource setting retrospectively on admission to ICU over the last five years. samples were selected using a simple random sampling technique to come up with the desired number.

Official Title
-----------------
Pattern of Admission and Outcome of Patients Admitted to the Intensive Care Unit of a Tertiary Hospital in Low Resource Setting. A Cohort Study

Conditions
-----------------
Respiratory Failure, Treatment Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete medical record admission to ICU Exclusion Criteria: patients who were transferred or self discharged

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alive and Dead<br>Following ICU admission patients are followed until discharge with the outcome of alive or dead | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pattern of admission and outcome of patients admitted to the Intensive care Unit of a tertiary hospital in Low resource setting. A cohort study | a retrospective cohort study | 1 month |