linjc16/ctgov huggingface dataset:
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Detailed Description
-----------------
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups: A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol. Primary endpoints: postoperative abilities over time discharge time from PACU according to fixed criteria consumption of analgesics and antiemetics in the PACU Secondary endpoints: degree of nursing requirements at the PACU General tolerability of the regimes

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: S-ketamine
* Drug: Lidocaine
* Drug: Droperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective laparoscopic cholecystectomy Age above 18 years Written informed consent ASA class I-III Exclusion Criteria: Planned abdominal cholecystectomy Intraoperative conversion of laparoscopic to laparotomic cholecystectomy Allergy to part of the treatment regimens Previous reactions to opioids (nausea, cognition)

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gabapentin|nan|
|Drug: S-ketamine|nan|
|Drug: Lidocaine|nan|
|Drug: Droperidol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. postoperative abilities over time in PACU |  |  | 
| 2. discharge time from PACU according to fixed criteria |  |  | 
| 3. consumption of analgesics and antiemetics in the PACU |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Degree of nursing requirements in the PACU |  |  | 
| 2. General tolerability of the regimens |  |  |
Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
As part of the internal quality management (QM project), this retrospective cohort study examines the adherence to Standard Operating Procedures (SOP) of the COVID-19 patients treated since January 1st, 2020 to February 28th, 2021 in intensive care units of the Clinic for Anesthesiology m.S. operative intensive care medicine CCM / CVK.

Official Title
-----------------
Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: During the intensive care stay with SARS-CoV-2 infected intensive care patients of the Charité - Universitätsmedizin Berlin, admitted to the intensive care units of the Department of Anesthesiology and operative intensive care medicine (CCM / CVK) Treatment period: 01/01/2020 to 02/28/2021 At least 18 years old Exclusion Criteria: • Incomplete electronic documentation

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 |
| --- | --- | --- |
| SOP Analgesia, sedation, delirium and pain therapy | SOP adherence to the selected SOP Analgesia, sedation, delirium and pain therapy. Process: daily implementation yes / no - yes> 70% | 01.01.2020 - 28.02.2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOP Treatment of acute respiratory distress syndrome (ARDS) | SOP adherence to the selected SOP Treatment of acute respiratory distress syndrome (ARDS) Process: daily implementation yes / no - yes> 70% | 01.01.2020 - 28.02.2021 | 
| SOP Infectious treatment | SOP adherence to the selected SOP Infectious treatment Process: daily implementation yes / no - yes> 70% | 01.01.2020 - 28.02.2021 | 
| SOP Weaning | SOP adherence to the selected SOP Weaning | 01.01.2020 - 28.02.2021 | 
| SOP Nutrition | SOP adherence to the selected SOP Nutrition Process: daily implementation yes / no - yes> 70% | 01.01.2020 - 28.02.2021 | 
| SOP Sepsis | SOP adherence to the selected SOP Sepsis Process: daily implementation yes / no - yes> 70% | 01.01.2020 - 28.02.2021 |
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

Study Overview
=================
Brief Summary
-----------------
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

Detailed Description
-----------------
study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.

Official Title
-----------------
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

Conditions
-----------------
Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Device: band implantation
* Device: rigid ring implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate or severe tricuspid regurgitation Exclusion Criteria: refusal to participate in the study

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: band<br> | Device: band implantation<br> <br> |
| Active Comparator: Rigid ring<br> | Device: rigid ring implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tricuspid regurgitation |  | 12 months | 
| death |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricle function |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tricuspid Regurgitation, Insufficiency, Tricuspid Valve, Valvular Annuloplasty, Cardiac Valve Annulus Repair
Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

Study Overview
=================
Brief Summary
-----------------
This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.

Official Title
-----------------
Efficacy of Diclofenac Potassium Versus Nimesulide in the Treatment of Fever and Pain in Children Aged 3 to 7 Years With Community Acquired, Non-complicated, Upper Respiratory Tract Infection

Conditions
-----------------
Upper Respiratory Tract Infections

Intervention / Treatment
-----------------
* Drug: diclofenac potassium
* Drug: nimesulide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who present community acquired, non-complicated, upper respiratory tract infection: rhino-sinusitis, pharyngitis, tonsillitis, ear infection or the combination of these. Child must present axillary temperature ≥ 37.5°C. Exclusion Criteria: Prior history of allergic reaction to the components of the study medication. Use of any NSAID or pharmacologic agent in the 24 hours prior to visit 1. Subjects who, in the opinion of the investigator, have developed, or are at risk of developing, a complicated infection and are not suitable subjects for the purposes of the study. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: diclofenac potassium<br> | Drug: diclofenac potassium<br> <br> |
| Active Comparator: nimesulide<br> | Drug: nimesulide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of fever as measured by axillary temperature |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain as measured by visual analog scale |  | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper respiratory tract infections, diclofenac potassium, nimesulide, fever, pain
Bordetella Pertussis Carriage in College-aged Students

Study Overview
=================
Brief Summary
-----------------
The objective in this observational cohort study of young adults sampled at three intervals during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic individuals. We hypothesize that in asymptomatic college students there is no carriage of B. pertussis detectable by polymerase chain reaction (PCR) assay.

Official Title
-----------------
Bordetella Pertussis Carriage in College-aged Students

Conditions
-----------------
Carriage of Bordetella Pertussis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and above Not immunosuppressed Not HIV positive (not known to be/self-reported) Able to tolerate swab procedures Able to provide consent Exclusion Criteria: No antimicrobial or immunosuppressive medications taken for chronic conditions

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 |
| --- | --- |
| No treatment<br>Young adults tested by PCR for B. pertussis carriage | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint | Participants will be tested for B. pertussis by PCR at one visit in October 2014, 30 minutes. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint | Participants will be tested for B. pertussis by PCR at one visit in January 2015, 30 minutes. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bordetella pertussis, Carriage rates in young adults
Improving Outcomes for Hypertensive Children

Study Overview
=================
Brief Summary
-----------------
Approximately 200 children age 6 - <18 years receiving medications for essential hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained with the ABPM will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. Kappa statistic will be utilized to compare differences in documented BP control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the ABPM readings. The overall goal is to confirm that ABPM leads to an increased detection of uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive medication regimens.

Official Title
-----------------
Improving Outcomes for Hypertensive Children

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit Arm circumference measurement of 15-50 cm (limits of SpaceLabs ABPM cuffs). Exclusion Criteria: Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study. Secondary HTN from all causes (excluding obesity-related HTN). This includes but is not limited to renovascular HTN, chronic kidney disease, coarctation of the aorta, and monogenic forms of HTN. Physical limitations prohibiting placement of the ABPM monitor. Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Study Overview
=================
Brief Summary
-----------------
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

Official Title
-----------------
Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Exclusion Criteria: • Breast feeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Patients taking immunosuppressives or biological therapies Addiction to alcohol and / or drugs Known allergy to the studied medications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>this group will take mesalamine 1 gm three times daily for 6 months | |
| Active Comparator: metformin group<br>this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months | Drug: Metformin<br>* metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change in partial mayo score index | The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha | The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha | 6 months |
Input of C11-Choline PET/CT in Localization of Parathyroid Adenoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA). Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US. Currently, the conventional technique for localization of a PTA is a dual-isotope scan with Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera. In addition, there is no anatomical imaging and further correlation with US is usually recommended. In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection, and provides data of higher resolution of functional (PET) and anatomical imaging (CT). Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of a chest is: 0.3128 - 0.8628rem.

Conditions
-----------------
Hyperparathyroidism

Intervention / Treatment
-----------------
* Procedure: C11-Choline PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevation of a calcium and parathyroid hormone in the serum

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperparathyroidism<br>Patients with hyperparathyroidism, prior to surgery. | Procedure: C11-Choline PET/CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved localization of a parathyroid adenoma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facilitation of detection of the parathyroid adenoma at surgery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.
Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

Detailed Description
-----------------
Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.

Official Title
-----------------
Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Conditions
-----------------
Hepatitis C Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment. Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment. 10 normal healthy controls- Hep C neg and without osteoarthritis (OA). Exclusion Criteria: HIV patients Those with concomitant alcoholic liver disease Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.

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 |
| --- | --- |
| Hepatitis C with Arthritis<br> | |
| Hepatitis C without Arthritis<br> | |

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
-----------------
Hepatitis C, Arthritis