linjc16/ctgov huggingface dataset:
An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using Beside Gastric Ultrasound

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.

Official Title
-----------------
An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using

Conditions
-----------------
Aspiration; Gastric Contents, Anesthesia

Intervention / Treatment
-----------------
* Other: liberal hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned caesarean delivery under regional anaesthesia adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids Exclusion Criteria: age less than 18 inability to understand English

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: liberal hydration|evaluate the effect of 'Sip Til Send' on overall gastric volume pregnant women undergoing elective caesarean delivery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric volume | whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section. | 3 months |
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.

Official Title
-----------------
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study

Conditions
-----------------
Vulvar Cancer

Intervention / Treatment
-----------------
* Procedure: ICG alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women (18 years of age) with FIGO Stage IB (> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of < 4 cm). Exclusion Criteria: Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential ICG and Technetium Detection<br> | Procedure: ICG alone<br>* SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin | This will be calculated as the number of groins for which positive SLN were missed using ICG alone; i.e. the number of groins for which ICG did not detect a positive SLN but was detected by ICG and Technetium, divided by the number of groins for which surgery was performed. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium. | the unit of analysis is the number of SLN for each groin. | 2 years |
Revealing Engagement Dynamics Among Diabetic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The study intends to investigate the personal experiences of diabetic kidney disease patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal. The data collected from this study will help improve future outcomes for all diabetic kidney disease as well as those in under-represented demographic groups.

Official Title
-----------------
Studying Patterns in Patient Engagement and Participation in Diabetic Kidney Disease Clinical Trials

Conditions
-----------------
Diabetic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with diabetic kidney disease Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. Exclusion Criteria: Refusal of consent Women of childbearing potential without a negative pregnancy test; or women who are lactating. Any serious and/or unstable pre-existing medical disorders

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 |
| --- | --- | --- |
| Number of patients who decide to enroll in a diabetic kidney disease clinical research |  | 3 months | 
| Rate of patients who remain in a diabetic kidney disease clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic kidney disease
Muscle Mechanical Response in Exercise.

Study Overview
=================
Brief Summary
-----------------
The muscular response on the main muscles of the propulsive phase of the upper limb in crawl has been evaluated by tensiomyography (TMG), which was carried out through three parameters: activation time (Td), contraction time (Tc) and maximum deformation (Dm). The objective of this study is to evaluate the hypothesis of changes produced between lactic resistance training with passive rest and lactic resistance training with active rest. For this, thirty swimmers participated, with an average age of 20 years.

Official Title
-----------------
Muscle Mechanical Response in Active vs. Passive Resting Exercise

Conditions
-----------------
Muscle Weakness

Intervention / Treatment
-----------------
* Other: Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 18 and 25 years old. have a minimum mark or have participated by ranking in a crawl event in the territorial championship of Madrid in the current season belong. to the male gender. Exclusion Criteria: subjects who did not meet the minimum age and did not obtain the minimum mark and did not sign the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| active rest<br>patients taking an active rest after swimming sets | Other: Activity<br>* patients taking an active rest after swimming sets<br>|
| passive rest<br>patients taking a passive rest after swimming sets | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activation time | activation time measured by tensomiography | 15 minutes | 
| contraction time | contraction time measured with tensomiography | 15 minutes | 
| maximum deformation | maximum deformation measured with tensomiography | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tensiomyography, triceps, dorsal, exercise, pectoral
Erector Spina Plane Block for Multilevel Major Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Detailed Description
-----------------
Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.

Official Title
-----------------
Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.

Conditions
-----------------
Pain, Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III patients Agreed to participate in the study Exclusion Criteria: Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure Patients with heart disease Patients who have previously undergone surgery from the same area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>No block was performed | Procedure: Control<br>* Erector spinae plane block was not applied.<br>|
| Active Comparator: Erector spinae plane block<br>Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. | Procedure: Erector spinae plane block<br>* Erector spinae plane block was performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump. | up to 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, postoperative analgesia, Erector spinae plane block, posterior spinal instrumentation
The Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population

Study Overview
=================
Brief Summary
-----------------
This study aimed to assess the level of knowledge and awareness of myofascial pain syndrome (MPS) among the Turkish population.

Detailed Description
-----------------
The study will employ a cross-sectional design to assess the level of knowledge and awareness of myofascial pain syndrome (MPS) in the Turkish population. A representative sample of individuals will be selected for participation in the survey. A structured questionnaire will be developed specifically for this study, consisting of questions related to the understanding, recognition, and management of MPS. The questionnaire will be administered through face-to-face interviews. Data collected from the survey will be analyzed using appropriate statistical methods to determine the overall level of knowledge and awareness of MPS among the Turkish population.

Official Title
-----------------
The Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Other: Myofascial Pain Syndrome Knowledge and Awareness Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Giving consent. Exclusion Criteria: Not giving consent. Any illness or disability that can prevent filling out the form or communicating.

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 |
| --- | --- |
| Patients admitted to the physical medicine and rehabilitation outpatient clinic.<br>Patients admitted to the physical medicine and rehabilitation outpatient clinic and gave consent to participate. | Other: Myofascial Pain Syndrome Knowledge and Awareness Questionnaire<br>* Myofascial Pain Syndrome Knowledge and Awareness Questionnaire is a questionnaire consisting of a total of 14 questions created by the researchers who are specialized in the field. The correct answer to each question is one point. A high score indicates a high level of knowledge and awareness, while a low score indicates a low level of awareness and knowledge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population | By using the data gained with the Myofascial Pain Syndrome Knowledge and Awareness Questionnaire and using the suggested statistical methods by the statistics expert, this study will aim to determine the level of knowledge and awareness of myofascial pain syndrome in the Turkish population. | 1 day |
Social Effects of Alcohol

Study Overview
=================
Brief Summary
-----------------
In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

Detailed Description
-----------------
The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.

Official Title
-----------------
Social Effects of Alcohol

Conditions
-----------------
Alcohol Drinking

Intervention / Treatment
-----------------
* Drug: Alcohol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-problem alcohol consumption of 2-20 drinks per week high school diploma or equivalent BMI between 19 and 26 verbal fluency in English Exclusion Criteria: High blood pressure Any medical condition requiring regular medication Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis Women who are pregnant or trying to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol-alcohol<br>Both conversation partners receive alcohol | Drug: Alcohol<br>* Alcohol (0.8g/kg)<br>|
| Placebo Comparator: placebo-placebo<br>Both conversation partners receive placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: alcohol-placebo<br>participant receives alcohol and conversation partner receives placebo | Drug: Alcohol<br>* Alcohol (0.8g/kg)<br>|
| Experimental: placebo-alcohol<br>participant receives placebo and conversation partner receives alcohol | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| facial emotional responses | alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions | during the length of the conversation (45 min) | 
| self-reported feelings of connection | self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection | at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed |
Biomarker Study of ATH434 in Participants With MSA

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy

Official Title
-----------------
An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy

Conditions
-----------------
Multiple System Atrophy

Intervention / Treatment
-----------------
* Drug: ATH434


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has clinical features of parkinsonism. Participant has evidence of orthostatic hypotension and/or bladder dysfunction. Participant has ataxia and/or pyramidal signs on neurological examination. Participant has biomarker evidence of MSA in biologic fluid and on MRI. Exclusion Criteria: Participant is unable to swallow study drug. Participant is unable to attend study visits or complete study procedures. Participant has structural brain abnormality on MRI. Participant has any significant neurological disorder other than MSA. Participant has an unstable medical or psychiatric illness. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATH434<br> | Drug: ATH434<br>* ATH434 taken by mouth two times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iron content as measured by brain MRI |  | Change from Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aggregating alpha-Synuclein Levels |  | Change from Baseline to Week 52 | 
| Change in Neurofilament Light Chain Levels |  | Change from Baseline to Week 52 | 
| Change in Unified MSA Rating Scale (UMSARS) Score |  | Change from Baseline to Week 52 | 
| Change in 36-Item Short Form Survey (SF-36) Score |  | Change from Baseline to Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism, Biomarkers
DMT310-009 Topical in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris

Official Title
-----------------
A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: DMT310
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient sex at birth, male or non-pregnant female at least 9 years of age Clinical diagnosis of moderate to severe acne vulgaris as determined by: Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face Patient is willing to apply the Investigational Product as directed Patient is willing and able to comply with the protocol Exclusion Criteria: Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's acne

Ages Eligible for Study
-----------------
Minimum Age: 9 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMT310 Topical Powder<br>DMT310 Powder mixed with Hydrogen Peroxide | Drug: DMT310<br>* Topical Powder<br>|
| Experimental: Placebo Topical Powder<br>Placebo powder mixed with Hydrogen Peroxide | Drug: Placebo<br>* Placebo Topical Powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by lesion counts | Inflammatory and Noninflammatory | 12 weeks | 
| Efficacy as measured by Investigator Global Assessment (IGA) | 0 Clear No evidence of facial acne vulgaris Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events as a measure of safety and tolerability | Incidence of adverse events as a measure of safety and tolerability | 12 weeks |