linjc16/ctgov huggingface dataset:
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.

Official Title
-----------------
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail

Conditions
-----------------
Pregnancy, Ectopic

Intervention / Treatment
-----------------
* Drug: Single
* Drug: Multipe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unruptured tubal EP gestational mass of less than or equal to 3.5 cm in ultrasonography report Exclusion Criteria: hemodynamic instability contraindications related to the use of MTX hepatic renal and active pulmonary diseases peptic ulcer immune deficiency status alcohol abuse blood dyscreasia
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: Multiple dose mtx<br>mtx | Drug: Multipe<br>* In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained<br>|
| Experimental: Single Dose<br>In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved | Drug: Single<br>* In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hCG level decrease |  | 4 days after administration |
Variations in Anesthesia Care for Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation.

Detailed Description
-----------------
To evaluate the sources of variance in utilization of neuraxial anesthesia the investigators will use multilevel multivariable modeling strategies. This will allow identification of sources of variation (hospital, vs physician, vs patient characteristics), as well as identification of independent predictors of neuraxial use at each of these three levels. The investigators will also evaluate the independent association of hospital level variation in neuraxial use on our outcomes of interest using multilevel multivariable regression.

Official Title
-----------------
Sources of Variation in Anesthesia Care for Hip Fracture Surgery and the Association With Outcomes

Conditions
-----------------
Hip Fractures, Anesthesia, Death

Intervention / Treatment
-----------------
* Procedure: Neuraxial anesthesia
* Procedure: General anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had hip fracture surgery Admitted to hospital on a non-elective basis Exclusion Criteria: Do not hold a valid provincial health insurance account

Ages Eligible for Study
-----------------
Minimum Age: 66 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 |
| --- | --- |
| Neuraxial anesthesia<br>Participants in this group will be those who had a spinal or epidural anesthetic without concurrent general anesthesia | Procedure: Neuraxial anesthesia<br> <br> * Other names: epidural anesthesia;|
| General anesthesia<br>Participants in this group will be those who had general anesthesia, including those who had a general plus a concurrent spinal or epidural anesthetic. | Procedure: General anesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause 30-day mortality |  | Day of surgery to day of death, or up to 365 days, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare costs from the perspective of the universal healthcare system, using standardized methods (Health System Performance Research Network 2013) |  | Day of surgery to day of death, or 30 days after surgery, whichever comes first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, geriatric, epidemiology, practice variation, anesthesia
Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function?

Study Overview
=================
Brief Summary
-----------------
Systolic function is a substantial determinant of overall hemodynamics and organ function. Therefore assessment of left ventricular systolic function (LVF) has been of central interest in Echocardiography. Ejection fraction (EF) measurement has been the gold standard echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load dependent measure. Global longitudinal peak systolic strain average is a new parameter derived from speckle tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an equivalent to EF measurement, but maybe less load dependend. The aim of the study is to investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in cardiac and non-cardiac cases).

Official Title
-----------------
Is Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography a Reliable Measure of Systolic Function? A Multicenter-Study to Compare GLPSS With Ejection Fraction Derived From Biplane Simpson´s Method on TTE and TEE in Patients Undergoing Elective Cardiac and Non-Cardiac Surgery

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients in the age from 19-90 years Cardiac and non-cardiac surgery, where intubation is indicated Surgical procedures with a minimum duration of 30 min Elective cardiac surgery on patients scheduled for correction of: coronary artery disease with and without previous myocardial infarction dilated cardiomyopathy; HOCM disorders of the atrial or ventricular septum disorders of the aortic root or the aorta left and right heart valvular disease including stenotic and/or regurgitant valvular diseases. Exclusion Criteria: No patient´s consent Contraindications for TEE (esophageal-, gastric disorders, haematologic disorders with increased bleeding incidence; ENT-surgery, surgery of the esophageus or stomach) Contraindications for positioning (e.g. clinical signs of acute lung edema/acute failing left or right heart, acute coronary syndrome, myocardial infarction in recent history = within 2 weeks prior to operation date)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| multivariate regression-analysis |  | 1, 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LVF, Left ventricular systolic function
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study

Study Overview
=================
Brief Summary
-----------------
Primary objective: To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression. Secondary objective: To assess long-term safety of venous stenting

Official Title
-----------------
Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression

Conditions
-----------------
Post-thrombotic Syndrome, Iliac Vein Compression Syndrome

Intervention / Treatment
-----------------
* Device: sinus-Obliquus Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults aged ≥18 years Post-thrombotic syndrome (Villalta score >4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis Evidence of venous stenosis in common iliac vein >50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS) Use of sinus-Obliquus stent for unilateral common iliac vein stenosis If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses >50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins Exclusion Criteria: Pregnancy, breast-feeding or birth-giving during the last 30 days Life expectancy <6 months Iliofemoral DVT less than 3 months ago Permanently immobile patient (wheelchair user or bed-ridden patient) Allergy to Nitinol Patient's target vessel(s) has/have been stented before Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study Patients in custody by juridical or official order

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 |
| --- |
|Device: sinus-Obliquus Stent System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Rate |  | After 3 months up to a follow-up of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Assisted Patency Rate |  | After 3 months up to a follow-up of 2 years. | 
| Secondary Patency Rate |  | After 3 months up to a follow-up of 2 years. |
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

Study Overview
=================
Brief Summary
-----------------
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

Official Title
-----------------
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

Conditions
-----------------
Wet Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Eyp-1901
* Drug: Aflibercept 2Mg/0.05Ml Inj,Oph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit. Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit. BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1. Exclusion Criteria: Central subfield thickness (CST) > 350 µm in the study eye at the Screening Visit or Day 1. Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma). Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.

Ages Eligible for Study
-----------------
Minimum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYP-1901 2060 ug<br>EYP-1901 2060 ug, single dose | Drug: Eyp-1901<br>* Intravitreal Injection<br>|
| Experimental: EYP-1901 3090 ug<br>EYP-1901 3090 ug, single dose | Drug: Eyp-1901<br>* Intravitreal Injection<br>|
| Active Comparator: Aflibercept<br>Aflibercept 2 mg [0.05mL] every 8 weeks | Drug: Aflibercept 2Mg/0.05Ml Inj,Oph<br>* Intravitreal Injection<br>* Other names: Eylea;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in best corrected visual acuity (BCVA) |  | Week 28 and Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best corrected visual acuity (BCVA) |  | Baseline, Week 56 | 
| Mean change in central retinal thickness on optical coherence tomography (OCT) |  | Baseline, Week 56 | 
| Number of rescue injections |  | Week 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wAMD, EYP-1901, EyePoint
A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon

Study Overview
=================
Brief Summary
-----------------
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Detailed Description
-----------------
Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Official Title
-----------------
A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Device: tulipon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 years Regular menstrual cycles (21-35 days) Uses tampons every month for the last 2 months to handle their monthly bleeding. Active Bleeding lasts at least 3 days Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants) Non-pregnant, with no intentions to get pregnant during the clinical trial Willing to use pads provided thought the study only for the duration of this study Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study Signed written informed consent form (ICF) to participate in the study Exclusion Criteria: Pregnant or lactating women Gave birth less than a 12 month prior to the study. Virgin Using medications to manage pain during active bleeding Using intrauterine device or intrauterine device with hormones (Mirena) Had experienced Toxic shock syndrome (TSS) Previous diagnosis of primary or secondary dysmenorrhea Previous diagnosis of endometriosis Experiences urinary incontinence Suffers from uterus or urine prolapse Abnormal findings following the gynecological exam Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton) Been through a vaginal operation in the last 6 months prior to the study. Participation in current or recent clinical trial within 30 days prior to baseline visit

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: tulipon|Tulipon is a new kind of hygienic device, used to collect the secreted menses during the bleeding phase of the menstruation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and efficacy of the Tulipon. | We will take vaginal cultures to show no vaginal infection. By questionnaire we will find out about leakage of period blood from the Tulipon. | 1 month |
Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Study Overview
=================
Brief Summary
-----------------
This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

Detailed Description
-----------------
The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.

Official Title
-----------------
The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: frozen-thawed healthy blastocyst Exclusion Criteria: post thawed not survival healthy blastocyst

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: natural cycle<br>Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer | Other: embryo transfer<br>* healthy blastocyst transfer in natural and hormonal cycle<br>* Other names: drug adminstration, clinical controls;|
| Active Comparator: hormonal cycle<br>Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer | Other: embryo transfer<br>* healthy blastocyst transfer in natural and hormonal cycle<br>* Other names: drug adminstration, clinical controls;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity |  | 12 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live-birth rate confirmed by the number of born |  | term pregnancy delivery | 
| cost-benefit of two endometrial preparation protocol | Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling | 30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test | 
| The number of patients with the anxiety and depression increase | the psychological questionnaire (HADS) administered on four time point | Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test |
The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum

Study Overview
=================
Brief Summary
-----------------
The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

Detailed Description
-----------------
In pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; After the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.Our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.

Official Title
-----------------
The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum

Conditions
-----------------
Healthy Diet, Thyroid Hypertrophy, Pregnancy Emesis

Intervention / Treatment
-----------------
* Diagnostic Test: Maternal thyroid volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-49 years old pregnant women 11-14 Gestational week of pregnancy Do not use medication, have no history of illness, who participated in face-to-face meetings with a dietician, who want to be included in the study, No smoking or alcohol consumption Patients with a BMI between 15-25 Exclusion Criteria: Pregnant women who are not between 15-49 years old, patients with chronic disease such as heart disease, diabetes, Patients who do not agree to meet with a dietician, patients who do not agree to be included in the study, smoking and alcohol use --Morbid-obese patients (BMI greater than 25)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Low eating index scores(50-70) | Diagnostic Test: Maternal thyroid volume<br>* Maternal thyroid volume measurement<br>|
| 2<br>High eating index scores(Above 70) | Diagnostic Test: Maternal thyroid volume<br>* Maternal thyroid volume measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on Maternal Thyroid volume measures | Maternal Thyroid volume measures | 11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio | Comparision of low and High eating index groups(Under 60 (low),Above 60(High)) | 11-14 gestational week of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid volume, , Healty eating index, , Pregnancy