linjc16/ctgov huggingface dataset:
Efficiency and Safety of Water Birth

Study Overview
=================
Brief Summary
-----------------
Water birth are not risks factors for newborns.

Detailed Description
-----------------
Investigators will study medical records of woman who have water birth and evaluate different parameters. Study lasts from February 2020 till April 2021. The questionnaire contain information about woman's expectations of labour Number of participant is approximately 500.

Official Title
-----------------
Efficiency and Safety of Water Birth in Maternity Hospitals in Uncomplicated Pregnancy.

Conditions
-----------------
Water Birth

Intervention / Treatment
-----------------
* Behavioral: Delivery in water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: delivery alive newborn in water age 18-45 single pregnancy Exclusion Criteria: antenatal death dead fetus age under 18 and up 45 multiple pregnancy somatic diseases preeclampsia mental diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main group<br>The participant in main group have water labour | Behavioral: Delivery in water<br>* Participants delivery in water<br>|
| No Intervention: Control group<br>The participant in control group will not have water labour | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal trauma | The number and percentage of perineal trauma during labour | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episiotomy | The number and percentage of episiotomy trauma during labour | 1 day | 
| Newborns wellbeing | Apgar scale | 1 day | 
| Infections complications from newborns | The number of Infections complications | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
water birth
Covid-19 Infection in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by COVID-19 infection at various gestational ages. The follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.

Detailed Description
-----------------
Pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or Ministry of health (MOH) laboratories will be followed up till delivery and discharge from the hospital. They will be followed up for hospitalization, intensive care unit (ICU) admission, any complications (organ failure, DIC, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (IUGR), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, APGAR score at 1 and 5 minutes, neonatal infection with covid-19, neonatal ICU admission and breast feeding. Those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. There will be no exclusion of cases.

Official Title
-----------------
Fetomaternal Outcomes of Pregnancies Complicated by COVID-19 Infection; Prospective Study in a Tertiary University Hospital

Conditions
-----------------
Perinatology

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: COVID-19 test|Naso-pharyngeal swab test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feto-maternal outcome | fetal and maternal consequences of the infection | 1 year |
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.

Detailed Description
-----------------
A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale score (0-10), total opioid consumption, complication and bleeding also recorded.

Official Title
-----------------
Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion

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

Intervention / Treatment
-----------------
* Drug: Parecoxib
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing lumbar spinal fusion for one to three levels ASA class I or II Exclusion Criteria: History of allergy to Sulfa group History of allergy to OPOID or NSAIDs Contraindicate to NSAIDs use History of coagulopathy or platelet disfunction

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parecoxib<br>Parecoxib | Drug: Parecoxib<br>* Parecoxib 40 mg intravenous<br>* Other names: Dynastat;|
| Experimental: Ketorolac<br>Ketorolac | Drug: Ketorolac<br>* Ketorolac 30 mg intravenous<br>* Other names: Ketolac;|
| No Intervention: No medication<br>No medication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | recorded as Verbal Numerical Rating Scare 0-10 | Postoperative time up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of opioid consumption postoperatively |  | Postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preemptive analgesia, lumbar fusion, Parecoxib, Ketorolac
Stroke Thrombectomy and Aneurysm Registry

Study Overview
=================
Brief Summary
-----------------
This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

Official Title
-----------------
Stroke Thrombectomy and Aneurysm Registry

Conditions
-----------------
Thromboses, Intracranial, Stroke, Aneurysm, Brain

Intervention / Treatment
-----------------
* Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgical intervention for central nervous system vascular lesion Between 1 and 120 years of age Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 120 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 |
| --- | --- |
| Stroke<br> | Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures<br>* Participants are retrospectively and/or prospectively entered into registry based on disease indication and respective surgical procedure.<br>|
| Thrombectomy<br> | Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures<br>* Participants are retrospectively and/or prospectively entered into registry based on disease indication and respective surgical procedure.<br>|
| Aneurysm<br> | Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures<br>* Participants are retrospectively and/or prospectively entered into registry based on disease indication and respective surgical procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure hemorrhage rate changes | Researchers examine changes in hemorrhage rates in post-stroke patients | 90 days | 
| Occlusion rates | Measure of how thrombectomy procedure success in relation to reduced occlusion | 90 days | 
| Complication rates | Measure of post-procedure complication rates in stroke/aneurysm patients | 90 days | 
| Retreatment rates | Measure of patient retreatment post-procedure | 90 days |
A Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The primary aim of the proposed research is to investigate the extent to which a one-week online gratitude intervention can improve levels of wellbeing in individuals living with Inflammatory Bowel Disease (IBD). A secondary aim was to investigate the extent to which dispositional gratitude influences levels of coping and wellbeing and to what extent this mediates the effect of the intervention. Participants with IBD will be randomized to either treatment or control group. Participants will complete measures pre- and post- intervention, and follow-up (eight weeks) measuring: gratitude (state and trait), illness severity, mood, stress and coping.

Official Title
-----------------
A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease

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

Intervention / Treatment
-----------------
* Behavioral: Gratitude diary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of inflammatory bowel disease from a clinician. Exclusion Criteria: No access to internet via smartphone, tablet or computer. Cannot read English

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Online daily gratitude journal. | Behavioral: Gratitude diary<br>* The intervention involves keeping a record of three things that the individual feels grateful for during that day. This can be completed daily, and for the purpose of this study will be completed every evening for the duration of one week.<br>* Other names: Count your blessings;|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Depression Anxiety and Stress Scale- 21 | Change in wellbeing | 1 week, and 8 weeks follow up. | 
| Change in the Inflammatory Bowel Disease Questionnaire UK | Change in health | 1 week, and 8 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the IBD Self-efficacy scale | Change in coping | 1 week and 8 weeks follow up | 
| Change in the Gratitude Questionnaire 6 | Change in gratitude | 1 week and 8 weeks follow up | 
| Change in the Gratitude Adjectives Checklist | Change in gratitude | 1 week and 8 weeks follow up | 
| Change in Emotion Regulation Questionnaire-Revised | Change in emotion regulation | 1 week and 8 weeks |
A Study of KCT-0809 in Patients With Dry Eye Syndromes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: KCT-0809
* Drug: KCT-0809
* Drug: KCT-0809
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal and conjunctival damage Insufficiency of lacrimal secretion or tear film instability Ocular symptom Exclusion Criteria: Severe ophthalmic disorder Punctual plugs or surgery for occlusion of the lacrimal puncta

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: KCT-0809 ophthalmic solution, low dose<br> | Drug: KCT-0809<br> <br> |
| Experimental: KCT-0809 ophthalmic solution, medium dose<br> | Drug: KCT-0809<br> <br> |
| Experimental: KCT-0809 ophthalmic solution, high dose<br> | Drug: KCT-0809<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal-conjunctival staining scores |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival diseases
Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation

Study Overview
=================
Brief Summary
-----------------
Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. The objective of this prospective randomized study was to compare the clinical outcome after nonoperative treatment with restricted vs. free range of motion (ROM) for primary traumatic patellar dislocation.

Official Title
-----------------
RESTRICTED VS. FREE KNEE RANGE OF MOTION FOR PRIMARY TRAUMATIC PATELLAR DISLOCATION: A PROSPECTIVE RANDOMIZED STUDY

Conditions
-----------------
Patellar Dislocation

Intervention / Treatment
-----------------
* Procedure: Locked knee brace
* Procedure: Locked knee brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A primary (first-time) patellar dislocation verified by clinical examination Signs of patellar dislocation in MRI Exclusion Criteria: anyone with previous patellar instability osteochondral fracture requiring surgery associated knee injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: Knee brace<br> | Procedure: Locked knee brace<br> <br> |
| Active Comparator: Locked knee brace<br> | Procedure: Locked knee brace<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patellar redislocation | The number of patients with patellar redislocation after initial treatment. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patella, Knee, Brace
Molecular and Cellular Analysis of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the different types and subtypes of cells found in breast tumors. The investigators will do this using a variety of molecular analysis tools that may allow for improved tests. The different types of cells in breast cancer impacts the way individuals respond to various treatments.

Official Title
-----------------
Molecular and Cellular Analysis of Breast Cancer

Conditions
-----------------
Breast - Female, Breast - Male

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of breast cancer or a carcinoma of unknown primary consistent with the presentation of a primary breast malignancy. 18 years of age or older. Ability to understand and the willingness to sign a written informed consent do Exclusion Criteria: None

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

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 |
| --- | --- | --- |
| levels of GM-CSF in plasma | We will be measuring levels of GM-CSF (Granulocyte-macrophayge colony stimulating factor) from the plasma of the patient before during and after the irradiation treatment to study if there is any increase in the GM-CSF production | 10 years |
Neurophysiological Intraoperative Monitoring During Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate if the motor-evoked potentials/motor action potential amplitude ratio and motor action potential amplitude measurement are useful in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery. The secondary objective is to evaluate the presence of a correlation between neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and physiologic changes) in order to find which factor is the most important in determining spinal cord ischemia. This study is an observational, single-center, prospective study on patients with thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked potentials and somatosensory evoked potentials monitoring.

Official Title
-----------------
Neurophysiological Intraoperative Monitoring During Aortic Surgery

Conditions
-----------------
Aortic Aneurysm, Thoracic

Intervention / Treatment
-----------------
* Procedure: Aortic Aneurysm, Thoracic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: satisfied criteria for Intraoperative neurophysiological monitoring; sign a written informed consent to participate in the study. Exclusion Criteria: No exclusion criteria

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

| Intervention/Treatment |
| --- |
|Procedure: Aortic Aneurysm, Thoracic surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the motor-evoked potentials/motor action potential amplitude ratio | The goal of this study is to evaluate the efficacy of different neurophysiological parameters in predicting patient outcome. In particular, our objective is to verify if a better identification of peripheral nerve ischemia during TAAA procedure can improve the sensibility of Intraoperative neurophysiological monitoring in detecting spinal cord ischemia and predicting clinical outcome. Exploratory univariate analyses will be performed using logistic regression to calculate odds ratios to evaluate neurophysiological parameters associated with poor outcome. Factors that will be found to be significant at p < 0.05 will be then examined in subsequent multivariate analyses to determine significant independent predictors of poor outcome. | During thoracoabdominal aortic aneurysms surgery |