linjc16/ctgov huggingface dataset:
Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion

Study Overview
=================
Brief Summary
-----------------
Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level.

Detailed Description
-----------------
To assess the effects of continuous patient monitoring using a contactless monitor in a medical-surgical unit on transfers and length of stay at higher level of care units

Official Title
-----------------
Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion

Conditions
-----------------
Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, Death

Intervention / Treatment
-----------------
* Device: EverOn (EarlySense) contactless monitoring device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>before-after (retrospective) and concurrent controls as comparators with a prospective intervention group | |
| Active Comparator: Study unit<br>Hospitalized patients in the study group will be continously monitored / supervised by the contact-free device | Device: EverOn (EarlySense) contactless monitoring device<br>* Hospitalized patients on the study unit are monitored by a contactless device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of benefit to caregivers and patients |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All hospitalized patients in a general Med/ Surg unit
Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion

Study Overview
=================
Brief Summary
-----------------
To assess the levels of TNF- α in vitreous samples of patients with retinal vein occlusion prior to administration of intravitreal anti-VEGF and compare them to levels in vitreous samples of normal subjects so as to investigate the association of vitreous tumor necrosis factor with the pathogenesis of retinal vein occlusion.

Official Title
-----------------
Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion

Conditions
-----------------
Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with retinal vein occlusion not older than 6 months with no history of Anti-VEGF injection Exclusion Criteria: Diabetic patients. Other causes of retinal vascular diseases. Patients with history of treatment of retinal vein occlusion. Previous intraocular surgery except cataract surgery performed 6 months before the study. Subjects with severe systemic inflammatory diseases Retinal vein occlusion secondary to retinal vasculitis. All retinal pathologies. Patients receiving Systemic steroids or Immunosuppressive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| cases<br>patient with retinal vein occlusion | Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha<br>* measurement of vitreous level of tumor necrosis factor alpha using ELISA technique<br>|
| control<br>cataract patient undergoing cataract surgery | Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha<br>* measurement of vitreous level of tumor necrosis factor alpha using ELISA technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery |  | single measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor necrosis factor alpha
Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The patients were recruited from women attending labor ward to undergo cesarean section.

Official Title
-----------------
Role of Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section in Patients At Risk of Uterine Atony A Randomized Controlled Trial

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Procedure: bilateral uterine artery ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included: Maternal anemia (not less than 7 gm %). Macrosomic baby >4kgs. Twin pregnancy and high order pregnancy. Polyhydramnios. Grand multipara. Previous history of atonic postpartum hemorrhage. Prolonged vaginal delivery. Emergency cesarean. Chorioamnionitis. Exclusion Criteria: - Placenta previa. Patients with bleeding tendency (congenital or acquired) Ante-partum hemorrhage. Patients with no risk for uterine atony.
Sexes Eligible for Study
-----------------
Female

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: study group<br>patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin. | Drug: Oxytocin<br>* 20 units by slow intravenous drip injection<br>Procedure: bilateral uterine artery ligation<br>* • The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.<br>|
| Active Comparator: control group<br>patients at risk of uterine atony undergoing cesarean section received oxytocin only. | Drug: Oxytocin<br>* 20 units by slow intravenous drip injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean Blood loss after placental separation | by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set | 30 minutes |
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora. A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.

Official Title
-----------------
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

Conditions
-----------------
Vaginal Lesion

Intervention / Treatment
-----------------
* Biological: Bacteriological analysis of vaginal sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital Exclusion Criteria: Patient under judicial protection Adult patient under any kind of guardianship Patient refuses participation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 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 |
| --- | --- |
| Cases<br>The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. Cases are classified as those with a vaginal lesion due to delivery. | Biological: Bacteriological analysis of vaginal sample<br>* Bacteriological analysis of vaginal sample<br>|
| Controls<br>The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. Controls are classified as those without a vaginal lesion due to delivery. | Biological: Bacteriological analysis of vaginal sample<br>* Bacteriological analysis of vaginal sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of a vaginal lesion due to delivery |  | Upon delivery (Day 0) | 
| Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file | Record of routine analysis of vaginal samples during pregnancy will be used. | Upon delivery (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recorded qualitative and quantitative analysis of vaginal flora in patient's file |  | Upon delivery (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perineal tear, Perineal lesion, Vaginal flora, Birth
Metacognitive Therapy for Comorbid Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.

Detailed Description
-----------------
This study is a randomized controlled trial with 50 patients with a psychiatric disorder and insomnia. The patients will be randomized into two groups of 25 patients. The first group receives meta-cognitive therapy, whereas the second group will be assigned to a waiting list control.

Official Title
-----------------
Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.

Conditions
-----------------
Secondary Insomnia

Intervention / Treatment
-----------------
* Behavioral: meta-cognitive therapy
* Other: waiting list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia secondary to a primary psychiatric disorder Exclusion Criteria: substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meta-cognitive therapy<br>meta-cognitive therapy | Behavioral: meta-cognitive therapy<br>* Meta-cognitive therapy<br>|
| Active Comparator: waiting list<br>waiting list control | Other: waiting list<br>* waiting list control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on rating scales for sleep quality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing. |  | one year |
Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Official Title
-----------------
An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: lamotrigine extended-release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Confident diagnosis of epilepsy. Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs). Exclusion Criteria: Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lamotrigine extended-release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax and fluctuation index of lamotrigine |  |  | 
| Adverse events, changes in blood pressure and heart rate |  |  | 
| Change in seizure frequency during each of the study phases |  |  | 
| Subject preference at End of Baseline and Extended-Release Treatment Phases |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
once daily dosing, seizure, pharmacokinetics, epilepsy
Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT

Study Overview
=================
Brief Summary
-----------------
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Beyond that, changes of therapists were documented.

Official Title
-----------------
Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT

Conditions
-----------------
Borderline Personality Disorder, Psychotherapy, Dropout

Intervention / Treatment
-----------------
* Behavioral: Dialectical Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: three or more criteria for BPD as defined by DSM-5 (Borderline Personality characteristics; BPC) Exclusion Criteria: inability to contract and consent, other severe mental disorders (bipolar disorder, acute psychosis), current alcohol, illicit or not prescribed drug use, simultaneous participation in other treatment studies, pregnancy or breastfeeding, an inability to negotiate a non-suicide agreement, ongoing traumatic contact with the perpetrator, and a Body Mass Index < 16.5.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialectical Behavior Therapy<br>The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD. | Behavioral: Dialectical Behavior Therapy<br>* DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Dropout | premature termination of treatment | 8-10 weeks |
This Prospective Study Has 2 Objectives: First, to Assess the Post-obturation Pain Utilizing Bioceramic Sealer and One Cone Technique. Second, to Compare the Intensity of Post-obturation Pain Following Unintentional Sealer Extrusion

Study Overview
=================
Brief Summary
-----------------
Root canal treatment is essential step to eliminate pain and preserve tooth structures. However, errors could happen unintentionally such as ledge, perforation and sealer extrusion. Pain through an endodontic treatment is one of the elements that most of the patients seek treatment to be relived. One the current systemic review analyzed the pain after root canal treatment could be up to half the patients. The purpose of this study is to evaluate and record the postoperative pain among patients who are undergoing root canal treatment.

Official Title
-----------------
Postoperative Pain Assessment Following Unintentional Bioceramic Sealer Extrusion

Conditions
-----------------
Pain, Postoperative, Endodontic Overfill

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary root canal Asymptomatic tooth with or without apical radiolucency Patient older than 18 and younger than 70 American Society of Anesthesiology (ASA) Class I or II Exclusion Criteria: Patient with preoperative pain Periodontal probing more than 5mm When patency could not be achieved pregnant patient., patients who could not properly follow the instructions for filling the visual analog card (VAS) were excluded. Previously treated or initiated

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each patient was given visual assessment scale to analyze the postoperative pain and assessing the change in different time intervals (6 hours,24 hours,2 days,3days and 4 days) | Visual analogue card scales contains numbers range from 0-10 1-3 indicates mild pain, while 4-6 suggests moderate pain and 7-10 specify sever pain. | Five times intervals were recorded at the following: 6 hours following the treatment,1 day,2days,3days and 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sealer extrusion, Postoperative pain
Clinical Guidelines in Premedication Visit

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the frequency with which individual guideline recommendations on preoperative evaluation of patients scheduled for non-cardiac surgery are implemented as well as identifying the guidelines that are most frequently violated.

Detailed Description
-----------------
This study is a monocentric retrospective analysis. Data are extracted from the electronic premedication protocol (premedication patient data management system, PDMS). A total of 2000 adult patients are randomly selected who were seen in the premedication outpatient clinic of Klinikum rechts der Isar between June 2018 and June 2020. The information from the premedication questionnaire will be transferred to a new premedication module. The new premedication software then outputs the appropriate guideline recommendations that would have been applicable in the particular case. Using a logic stored in this system, the current guideline recommendations of the European Society of Anaesthesiology (ESA) (De Hert, Staender et al. 2018) and the recommendations of the German Society for Anesthesiology and Intensive Care Medicine (DGAI) (Geldner 2017) that apply to the respective case are pointed out on the basis of the patient data entered, for example the recommendation to discontinue or change medication or the order of additional examinations such as pulmonary function testing or echocardiography. By comparison with the old premedication sheet, it is determined which guideline recommendations were followed and which were not. The respective guideline recommendations and their compliance or non-compliance are transferred to a table for further evaluation. A random sample of 2000 patients will be studied. Guideline adherence to each recommendation is determined, as well as the possible organizational reasons for not following them.

Official Title
-----------------
Determining Guideline Adherence During the Premedication Visit

Conditions
-----------------
Adults, Non-cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen in the outpatient clinic between June 2018 and June 2020 Exclusion Criteria: age<18

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 |
| --- | --- | --- |
| Guideline adherence | Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented. | June 2018-June2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premedication, guidelines, software