linjc16/ctgov huggingface dataset:
Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption. Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?

Official Title
-----------------
A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

Conditions
-----------------
Postoperative Pain, Opioid Use

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesia physical status class I & II Age > 18 years English-speaking Capability to operate a patient-controlled analgesia (PCA) device Exclusion Criteria: Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents) Morbid Obesity (Body Mass Index ≥ 45 kg/m2) History of a seizure disorder Current therapy with pregabalin, gabapentin, or any opioid Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* lactulose placebo<br>|
| Experimental: 2<br>Pregabalin 75 mg | Drug: Pregabalin<br>* pregabalin 75 or 150 mg<br>|
| Experimental: 3<br>Pregabalin 150 mg | Drug: Pregabalin<br>* pregabalin 75 or 150 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo? |  | 1 year |
Nordic Luveris Study

Study Overview
=================
Brief Summary
-----------------
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Official Title
-----------------
Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial

Conditions
-----------------
Infertility, In Vitro Fertilization

Intervention / Treatment
-----------------
* Drug: recombinant luteinizing hormone (Luveris)
* Drug: recombinant follicle stimulating hormone (Gonal-f)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 40 Infertility treatable by IVF or ICSI Regular cycles Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: A,1<br>rFSH + rLH arm | Drug: recombinant luteinizing hormone (Luveris)<br>* 75 iu/day form cycle day 6<br>* Other names: Luveris;|
| Placebo Comparator: A,2<br>rFSH alone | Drug: recombinant follicle stimulating hormone (Gonal-f)<br>* rFSH 150 iu/day<br>* Other names: Gonal-f;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate per started stimulation cycle |  | ultrasound showing ongoing pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy in subgroups of patients with lo0w serum LH levels |  | ultrasound for ongoing pregnancy in subgroups | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, in vitro fertilization, LH supplementation, Benefits
Case Series of New Alloplastic Bone Graft Material

Study Overview
=================
Brief Summary
-----------------
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.

Official Title
-----------------
Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation

Conditions
-----------------
Periodontology, Oral Surgery

Intervention / Treatment
-----------------
* Device: easy-graft (beta-Tricalcium Phosphate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have read, understood and signed a consent form. 18-75 years of age Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present. Exclusion Criteria: Active caries or endodontic lesions in adjacent teeth Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes) Taking any medication known for gingival hyperplasia for past 3 months. Any systemic contraindications to surgery Subject smokes > 10 cigarettes per day.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: New alloplastic bone graft material<br> | Device: easy-graft (beta-Tricalcium Phosphate)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Radiographic Measurement of Alveolar Ridge Height | Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration). | Change from baseline to 6 months |
Accuracy Study for Enhanced Meter Feature

Study Overview
=================
Brief Summary
-----------------
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control. This study will evaluate a user's ability to obtain the enhanced meter feature.

Official Title
-----------------
Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: AgaMatrix Blood Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type I or type II diabetes inclusive of the following populations: Mixed insulin therapies Basal insulin therapies Continuous subcutaneous insulin infusion therapies Multiple daily injection therapies Non-insulin diabetic treatments (oral and injectable) Life style (exercise and diet) diabetes management New diagnosis of diabetes Non diabetics Able to speak and read English proficiently Subjects must be willing to: once a month, perform a 7 point blood glucose profile over the course of one day perform fasting blood glucose tests every day complete baseline and follow-up questionnaires consent to baseline HbA1c assays Exclusion Criteria: Pregnant Hct <20 or >60 Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) Homeless Incarcerated Mentally ill Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enhanced meter feature usability<br>Home diabetes monitoring by patient using provided blood glucose monitoring system. | Device: AgaMatrix Blood Glucose Monitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User's ability to obtain the enhanced meter feature |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, glucose, glucometer
Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

Study Overview
=================
Brief Summary
-----------------
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)

Official Title
-----------------
Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study

Conditions
-----------------
Self Management of Oral Anticoagulation With VKA Therapy

Intervention / Treatment
-----------------
* Device: Patient Self-Management of VKA therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation. Signed informed consent Exclusion Criteria: 1. Patients younger than 18 years old

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: Patient Self-Management of VKA therapy|Trained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic events | Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism | since 1 of july of 2002 to 30th of june of 2018 | 
| Major hemorrhagic event | Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale | since 1 of july of 2002 to 30th of june of 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from any cause | since 1 of july of 2002 to 30th of june of 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Self-management, Acenocoumarol, Warfarin
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies

Study Overview
=================
Brief Summary
-----------------
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

Detailed Description
-----------------
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Official Title
-----------------
Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies

Conditions
-----------------
Fetal Sex Determination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18-45 years of age inclusive Subject is female Subject is pregnant Gestational age can be determined via IVF or IUI Subject is 36-42 days pregnant as determined by IVF transfer or IUI Subject agrees to provide 3 separate blood and urine samples Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women who have conceived via ART and are between days 36 and 56 of gestation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a prenatal sex test using blood and/or urine samples from pregnant women. |  | 36 to 56 days of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance. |  | 36 to 56 days of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assisted Reproductive Technology, circulating cell free fetal DNA, First trimester
The 2015 Pelotas (Brazil) Birth Cohort Study

Study Overview
=================
Brief Summary
-----------------
This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.

Detailed Description
-----------------
The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since 1982. Data is being collected with a focus on maintaining fidelity to the tools and instruments used in the previous cohorts with minimal adaptations when necessary. All children born in Pelotas during 2015 were included in the cohort, and the cohort has been followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study identified and interviewed 73.8% of the mothers that subsequently delivered children that are now part of the cohort. The 4275 children included in the cohort are part of extensive assessments that include information on antenatal health and care, pregnancy health, gestational age, physical activity, sleep, health behaviours, socio-demographic characteristics, perinatal conditions, child anthropometry, delivery information, child mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development, access to health services, medicine use by both mother and child and genetic material. The cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is starting to be analyzed and, among other findings, confirm the already alarming trends in surgical deliveries, amounting to 65.2% of all deliveries in 2015.

Official Title
-----------------
The 2015 Pelotas (Brazil) Birth Cohort Study

Conditions
-----------------
Mother-Child Relations, Preterm Birth, Infant Development, Breast Feeding, Physical Activity, Pregnancy Related, Medicine, Narrative

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: live births mothers living in urban area of the city delivered during 2015 Exclusion Criteria: stillbirths below 500g mothers living outside Pelotas
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Births before 37 weeks of pregnancy | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activities performed during pregnancy | Second trimester of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort studies, infant development, pregnancy, Brazil, observational studies, epidemiology, maternal health
Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

Official Title
-----------------
A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 weeks HbA1c: 8.0-10.0% Current treatment with OAD on monotheray or OAD on combination therapy Body mass index (BMI): 21.0-35.0 kg/m2 Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Recurrent major hypoglycaemia as judged by the Investigator Uncontrolled hypertension Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: repaglinide|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 18 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Prandial Plasma Glucose |  |  | 
| Fasting Plasma Glucose (FPG) |  |  | 
| Safety profile |  |  |
Which Physical Activity Influences Achilles Tendon Blood Flow the Most?

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Therefore, knowledge about activities which increase blood flow in the AT could be useful in the development of a solid warming-up programme for the AT. The aim of this investigation was to define the influence of different kinds of physical activity on the vascularisation of the AT in a healthy asymptomatic population. Subjects performed five activities in randomized order: running, static stretch, dynamic stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before, immediately after, five and ten minutes after activity to investigate the duration of the vascular response to activity.

Official Title
-----------------
Effect of Warming-up Activities on the Vascularisation of the Achilles Tendon: a Cohort Study

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Other: physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no history of Achilles tendon complaints healthy and active adolescents Exclusion Criteria: history of Achilles tendon pain or current complaints not healthy or not active population children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy active participants<br> | Other: physical activity<br>* Subjects performed five activities: running, static stretch, dynamic stretch, cycling and rope skipping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Achilles tendon blood flow | measured with the non-invasive O2C device | 3 minutes before and immediately (0 minutes) after the physical activity to assess the change in blood flow due to the physical activity | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles tendon, Warming-up, Vascularisation, Physical activity, Oxygen-to-See (O2C)