linjc16/ctgov huggingface dataset:
Continuous Fascia Iliaca Compartment Block in Geriatric Hip Fracture

Study Overview
=================
Brief Summary
-----------------
The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB at Emergency Department or patient's ward. The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.

Detailed Description
-----------------
The Enhance Recovery Program of pain management in geriatric hip fracture has been set up as a part of fast track at Siriraj Hospital since September 2017. The ultrasound-guided (USG) fascia iliaca compartment block (FICB) is routinely offered to patients with a hip fracture by acute pain service (APS) anesthesiologist. The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB. The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.

Official Title
-----------------
Pain Management in Geriatric Hip Fracture Patients With Ultrasound-guided Continuous Fascia Iliaca Compartment Block

Conditions
-----------------
Hip Fractures, Acute Pain Due to Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient age equal or more than 65 years old patient with acute hip fracture within 7 days patient with NRS ≥ 5 Exclusion Criteria: patient refusal history of local anesthetic allergy inability to communicate or cognitive dysfunction multiple fracture involvement

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| numerical rating scale at rest | numerical rating scale 0-10 (0=no pain, 10=worst pain) | Change from baseline numerical rating scale at 30 minutes post-block | 
| numerical rating scale during movement | numerical rating scale 0-10 (0=no pain, 10=worst pain) | Change from baseline numerical rating scale at 30 minutes post-block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale during movement | numerical rating scale 0-10 (0=no pain, 10=worst pain) | Within 48 hours postoperative | 
| Rate of complications of continuous fascia iliaca compartment analgesia | local anesthetic systemic toxicity, leakage, infection | Within 48 hours postoperative | 
| Duration of hospital admission | number of days | from hospital admission until hospital discharge, an average of 1 week | 
| Number of participants with morbidity and mortality | myocardial disease, deep vein thrombosis, delirium, death | 6 weeks after hospital discharge |
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.

Detailed Description
-----------------
During cardiac surgery, a substance called complement is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.

Conditions
-----------------
Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency

Intervention / Treatment
-----------------
* Drug: TP10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB) CABG alone or with valve surgery Exclusion Criteria: Acute myocardial infarction (heart attack) within a 3 days of entering the study Conditions that may interfere with interpretation of electrocardiogram data History of immune deficiency syndrome Planned supplemental cardiac surgery or other surgery Pregnancy or lactation

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TP10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in death & myocardial infarction (MI) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac bypass, CABG, complement activation
COVID-19 in Nursing Homes 2020 and 2021

Study Overview
=================
Brief Summary
-----------------
To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.

Detailed Description
-----------------
Retrospective descriptive cohort study in Östergötland County Council, Sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. All residents in any of these NHs who had a laboratory confirmed COVID-19 diagnosis between March 2020 to April 2021 and who died within 30 days after the verified diagnosis are included. The study is undertaken as a retrospective record review. From the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.

Official Title
-----------------
Association Between COVID-19 Vaccination and Reduced Mortality in Nursing Home Facilities.

Conditions
-----------------
Comorbidities and Coexisting Conditions, Frailty, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents in any of 136 nursing homes in Östergötland County Council, Sweden who had a laboratory confirmed COVID-19 diagnosis and who died within 30 days after the verified COVID-19 were included in three separate periods: First period from March 31 to June 30 2020; second period from October 15 2020 to January 15 2021; third period from January 16 to April 18 2021. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Comorbidity | Number of diagnoses bedisde COVID-19 | March 2020 to April 2021 | 
| Frailty | The combined assessment of performance status and frailty was adapted to the record review method | March 2020 to April 2021 | 
| Cause of death | assessment of cause of death | March 2020 to April 2021 |
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol. Postoperative pain 24 hours after surgery and hospital stay will be assessed.

Detailed Description
-----------------
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia). Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.

Official Title
-----------------
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Combination Product: ERAS protocol
* Combination Product: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) >40 Kg/m2 BMI >35 Kg/m2 with obesity-associated comorbidities Exclusion Criteria: Patients undergoing other bariatric procedures Patients undergoing bariatric revisional surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS protocol<br>ERAS protocol includes early oral intake (6 hours after surgery), early deambulation (6h after surgery) and multimodal analgesia (port-sites infiltration with Bupivacain 0.5% combined with postoperative intravenous analgesia) | Combination Product: ERAS protocol<br>* ERAS protocol includes early oral intake and deambulation and multimodal analgesia<br>|
| Active Comparator: Standard care<br>Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs | Combination Product: Standard care<br>* Oral intake and deambulation 24h after surgery and only intravenous analgesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Evaluated by Visual Analogic Scale | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Days | Days until patients´discharge: 2 days or more than 2 days |
Expanded Access to VAL-083

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to VAL-083

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: VAL-083


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has relapsed/refractory disease and exhausted all standard treatments. Exclusion Criteria: Patient is eligible for a VAL-083 clinical trial. Patient has previously received VAL-083 for the same disease.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VAL-083|VAL-083 will be administered intravenously|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP

Study Overview
=================
Brief Summary
-----------------
Nursing study, prospective, randomized, two-center open-label. Patients will be randomized into two groups during their first laying Qutenza®: Patients receiving the laying of Qutenza® without refrigerated cushion Patients receiving the laying of Qutenza® associated with a refrigerated cushion The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.

Official Title
-----------------
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP

Conditions
-----------------
Localized Neuropathic Pain

Intervention / Treatment
-----------------
* Other: refrigerated cushion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Do not opposing the participation in the study Monitoring in the case of localized neuropathic pain Diagnostic with neuropathic pain score ≥ 4 Neuropathic pain conventional treatment failure of first-line Front advantage of laying a first patch Qutenza® With ability to understand the proposed study Exclusion Criteria: Patch Installation on the feet, face, mucous membranes Eutectic mixture of local anesthetics (EMLA) Pose premedication Having Already received prior to the installation of a patch of Qutenza® Allergy to components Qutenza® Known and poorly stabilized hypertension Known cryoglobulinaemia Pregnant or lactating women Patient enjoying a measure of legal protection (guardianship, guardianship ...) Private Patient freedom No affiliation to a social security scheme. Refusal to participate in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Qutenza® without refrigerated cushion<br>Qutenza® without refrigerated cushion | |
| Experimental: Qutenza® with refrigerated cushion<br>Qutenza® with refrigerated cushion | Other: refrigerated cushion<br>* refrigerated cushion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue pain scale (burning pain) | visual analogue pain scale (burning pain) | after 1 hour of installation of Qutenza patch |
18432-Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose(MPPD).

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. Formulation number SR15-40-Z12-006.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment DArkening Dose (MPPD) |  | Up to 15 minutes |
Efficacy and Safety of Tetrabenazine in Chorea

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea

Conditions
-----------------
Huntington's Disease

Intervention / Treatment
-----------------
* Drug: tetrabenazine or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older suffer from manifest HD as confirmed by genetic testing Meet chorea and total functional capacity scores on Unified Huntington's Disease Rating Scale Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale dysphagia and dysarthria scale Independently ambulatory Exclusion Criteria previous treatment with tetrabenazine unstable or serious medical or psychiatric illness concomitant use identified drugs untreated depression lack of caregiver

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tetrabenazine or placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.

Detailed Description
-----------------
Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression. Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder

Conditions
-----------------
Depression, Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Ethyl-eicosapentanoic acid (ethyl-EPA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depressive disorder Exclusion Criteria: Serious comorbid psychiatric disorder Unstable medical illness Prior use of any omega-3 fatty acid product

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethyl-eicosapentanoic acid (ethyl-EPA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alleviation of depressive symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatty Acids, Omega-3, Antidepressive Agents, Eicosapentanoic Acid