linjc16/ctgov huggingface dataset:
The Influence of Needle Diameter on Post Dural Puncture Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.

Official Title
-----------------
The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial

Conditions
-----------------
Post-Dural Puncture Headache

Intervention / Treatment
-----------------
* Device: G25 pencil point needle
* Device: G27 pencil point needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy pregnant spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4) informed consent Exclusion Criteria: chronic headache (attempt to) epidural anesthesia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G25 pencil point needle<br>healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle | Device: G25 pencil point needle<br> <br> |
| Active Comparator: G27 pencil point needle<br>healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle | Device: G27 pencil point needle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of attempts until successful injection |  | 0 (injection time before delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post dural puncture headache |  | 48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery, obstetric, Analgesia, Epidural, Injections, Epidural, Needles, Cesarean Section
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome

Study Overview
=================
Brief Summary
-----------------
This pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. Stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.

Official Title
-----------------
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome

Conditions
-----------------
Diabetes, Obesity

Intervention / Treatment
-----------------
* Other: commercially-available diet soda
* Other: carbonated water (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged 18-35 years Consume less than 1 food/beverage with non-nutritive sweeteners per month Able and willing to consume diet soda three times daily for 1 week Exclusion Criteria: Recent diet or significant weight change Antibiotic use in the past 3 months Diarrhea in the past two weeks Use of medications known to affect metabolism or weight Weight < 50 kg (110 lbs.) History of metabolic complications including high blood sugar, elevated cholesterol, or liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Soda<br>Consumption of diet soda three times daily for one week | Other: commercially-available diet soda<br>* Subjects are asked to consume diet soda three times daily for one week.<br>|
| Placebo Comparator: Carbonated Water<br>Consumption of plain, unsweetened, carbonated water three times daily for one week | Other: carbonated water (control)<br>* Subjects are asked to consume carbonated water three times daily for one week.<br>* Other names: seltzer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taxa abundance before and after one-week of three times daily diet soda consumption | 16S rRNA and metagenomics sequencing will be used to determine microbial composition of stool samples before and after the one week intervention. | one week |
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Study Overview
=================
Brief Summary
-----------------
This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

Official Title
-----------------
Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Conditions
-----------------
Uveitis, SCAD, Addison Disease, Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome, Celiac Disease, Crohn Disease, Dermatomyositis, Polymyositis, Guillain-Barre Syndrome, Hepatitis, Autoimmune, Graves Disease, Hashimoto Thyroiditis, Multiple Sclerosis, Myasthenia Gravis, Pernicious Anemia, Polymyalgia Rheumatica, Primary Biliary Cirrhosis, Psoriasis, Rheumatoid Arthritis, Systemic Sclerosis, Sjögren Syndrome, Systemic Lupus Erythematosus, Takayasu Arteritis, Type 1 Diabetes Mellitus, Ulcerative Colitis, Vasculitis, Vitiligo, Raynaud

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 to 110 Residence in Olmsted County. Note: if sufficient numbers cannot be reached using only Olmsted County, will expand to the 27-county region. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCAD cases<br>SCAD cases will be identified based on presence of at least one diagnosis code for SCAD followed by manual verification by a trained individual, OR, inclusion in the previously validated SCAD cohort (Tweet 2012). | |
| Controls without SCAD<br>Potential controls will be identified based on absence of any SCAD diagnosis codes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds of autoimmune disease in SCAD cases compared to controls |  | Through study completion, or approximately 50 years (average age of study participants) | 
| Incidence Rate of SCAD |  | Through study completion, or approximately 50 years (average age of study participants) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCAD recurrence |  | Through study completion, or approximately 50 years (average age of study participants) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spontaneous coronary artery dissection, autoimmune, incidence
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2

Study Overview
=================
Brief Summary
-----------------
The investigators study aims to test the correlation between the Hemochron Signature point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.

Official Title
-----------------
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2

Conditions
-----------------
Anticoagulation With Direct Oral Anticoagulants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events Age ≥ 18 years Exclusion Criteria: Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation Low-molecular weight heparin ≤ 24 hours Unfractionated heparin ≤ 12 hours Abnormal coagulation values at baseline (Quick < 70% or activated thromboplastin time (aPTT) > 40sec.) History of coagulopathy

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 |
| --- | --- |
| Rivaroxaban<br>N=20 | |
| Apixaban<br>N=20 | |
| Dabigatran<br>N=20 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect/Correlation of direct oral anticoagulants (DOAC) on Hemochron Signature point-of-care testing (POCT) result | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels |  | 24h | 
| Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay |  | 24h |
Retrospective Study of Brachytherapy

Study Overview
=================
Brief Summary
-----------------
Brachytherapy for gynecological cancers will be studied retrospectively.

Official Title
-----------------
A Retrospective Study of Brachytherapy in Gynecological Cancers

Conditions
-----------------
Brachytherapy, Uterine Cervical Neoplasms, Uterine Neoplasms, Vulvar Cancer, Vaginal Cancer, Ovarian Neoplasms, Gynecologic Neoplasm

Intervention / Treatment
-----------------
* Radiation: Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 80 female Underwent brachytherapy With gynecological cancer Exclusion Criteria: Refusal to enter this trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Cervix radical BT<br> | Radiation: Brachytherapy<br>* Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy<br>|
| Cervix adjuvant BT<br> | Radiation: Brachytherapy<br>* Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy<br>|
| Cervix palliative BT<br> | Radiation: Brachytherapy<br>* Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy<br>|
| Uterus BT<br> | Radiation: Brachytherapy<br>* Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy<br>|
| Other GO cancer BT<br> | Radiation: Brachytherapy<br>* Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | the percentage of participants in the group who survives | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate | the percentage of participants in the group whose disease is likely to remain stable | 5-year | 
| Side effects | side effects associated with treatment | 5-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brachytherapy, Cervical Cancer, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Image Guided, 3D Print
Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population

Official Title
-----------------
Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

Conditions
-----------------
Desaturation

Intervention / Treatment
-----------------
* Device: High flow nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged <7 years ASA class I, II Exclusion Criteria: Respiratory disease Pneumothorax Increased ICP Nasal bleeding Previous airway surgery Trauma Pulmonary hypertension

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%. | |
| Experimental: High flow (HF) group<br>Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%. | Device: High flow nasal cannula<br>* Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturation | Incidence of peripheral pulse oximeter value lower than 95% | During deep sedation (during approximately 1 hour after propofol infusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum pulse oximeter value |  | During deep sedation (during approximately 1 hour after propofol infusion) | 
| Incidence of peripheral pulse oximeter value lower than 90% |  | During deep sedation (during approximately 1 hour after propofol infusion) | 
| Incidence of changes in oxygen flow (control group) or FiO2 (HF group) |  | During deep sedation (during approximately 1 hour after propofol infusion) | 
| percutaneous CO2 value |  | During deep sedation (during approximately 1 hour after propofol infusion) | 
| Oxygen reserve index value |  | During deep sedation (during approximately 1 hour after propofol infusion) | 
| Incidence of manual ventilation |  | During deep sedation (during approximately 1 hour after propofol infusion) |
Adherence Improvement in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.

Official Title
-----------------
Adherence Improvement in Glaucoma Patients

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Use of TravAlert dosing aid with or without drop guider


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis glaucoma or ocular hypertension Treatment with travoprost or travoprost/timolol Exclusion Criteria: High risk of side effects expected from travoprost or travoprost/timolol Absolute inability to administer eye drops Difficulty in reading or speaking Dutch

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: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Use of TravAlert dosing aid with or without drop guider<br>* Each patient will use a dosing aid and/or drop guider for 6 months<br>|
| Experimental: 2<br> | Device: Use of TravAlert dosing aid with or without drop guider<br>* Each patient will use a dosing aid and/or drop guider for 6 months<br>|
| Experimental: 3<br> | Device: Use of TravAlert dosing aid with or without drop guider<br>* Each patient will use a dosing aid and/or drop guider for 6 months<br>|
| Experimental: 4<br> | Device: Use of TravAlert dosing aid with or without drop guider<br>* Each patient will use a dosing aid and/or drop guider for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information with regard to the use of eye drops from data generated by the TravAlert dosing system |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Adherence
Prediction of Adverse Perinatal Outcome for Preeclampsia in Sichuan Province of China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted with preeclampsia or had developed preeclampsia after admission Exclusion Criteria: admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data
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 |
| --- | --- | --- |
| maternal mortality |  | within 48h of eligibility | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious central nervous system morbidity |  | within 48h of eligibility | 
| serious cardiorespiratory morbidity |  | within 48h of eligibility | 
| serious hepatic morbidity. |  | within 48h of eligibility | 
| serious renal morbidity |  | within 48h of eligibility | 
| serious haematological morbidity |  | within 48h of eligibility |
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

Study Overview
=================
Brief Summary
-----------------
Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Official Title
-----------------
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids

Conditions
-----------------
Femoral Neck Fracture

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femoral neck fracture Fracture due to low energy trauma Ability to understand danish and give informed consent Ability to walk before trauma Indication for osteosynthesis ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points Informed consent Exclusion Criteria: Drug or medical abuse Drug intolerance Pathological fractures Inflammatory arthritis Patient included in the study with the contralateral hip
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- |
| Active Comparator: Ropivacaine<br> | Drug: Ropivacaine<br> <br> |
| Placebo Comparator: Saline<br> | Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of opioids |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral neck fracture, Hip fracture