linjc16/ctgov huggingface dataset:
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.

Official Title
-----------------
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Conditions
-----------------
Hepatectomy, Surgical Blood Loss, Terlipressin

Intervention / Treatment
-----------------
* Drug: Terlipressin
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension Exclusion Criteria: Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terlipressin<br>Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours | Drug: Terlipressin<br>* Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.<br>* Other names: glipressin;|
| Placebo Comparator: Control<br>same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours. | Drug: normal saline<br>* Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | blood loss in ml | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood units transfused | number of packed RBCs units transfused | intraoperative period | 
| lactate level | lactate level in blood gas sample in mmol/L | at start and end of resection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatectomy, Surgical Blood Loss, terlipressin
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A

Study Overview
=================
Brief Summary
-----------------
Comparison of prophylaxis and on-demand treatment in children with moderate to severe hemophilia A. This study determines to compare the efficacy of prophylaxis and on-demand treatment in moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok, Thailand

Official Title
-----------------
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A

Conditions
-----------------
Prophylaxis, Hemophilia A

Intervention / Treatment
-----------------
* Other: prophylaxis treatment, on demand treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 6 months to 18 years Diagnosis severe and moderate hemophilia A Exclusion Criteria: platelet < 100,000/mm3 No factor VIII inhibitor

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 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: On demand treatment, prophylaxis treatment<br>On demand treatment arm:Patients received factorVIII concentrate(Hemofil M) when they had bleeding episodes. Prophylaxis arm: patients received factorVIII concentrate (Hemofil M) 30-35 unit/kg once a week | Other: prophylaxis treatment, on demand treatment<br> <br> * Other names: Hemofil M;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding episodes require treatment |  | one year | 
| number of school days lost |  | one year | 
| Number of admission days |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint scores |  | one year | 
| Quality of life score |  | one year | 
| Amount of Facter VIII concentration used |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis treatment, On demand treatment, Severe hemophilia A, Moderate hemophilia A
Prognosis in UC After First Biological

Study Overview
=================
Brief Summary
-----------------
To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.

Detailed Description
-----------------
UC patients treated with at least one biological in Tampere University Hospital between January 2009 and January 2020 were identified and reviewed from patient records.

Official Title
-----------------
The Long-term Outcome of Patients With Ulcerative Colitis Treated With First Trial of Biological.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Biological: infliximab, adalimumab, golimumab, vedolizumab, ustekinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated for ulcerative colitis for the first trial of biological Exclusion Criteria: Age under 16 years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: infliximab, adalimumab, golimumab, vedolizumab, ustekinumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment | Need for colectomy or enhancement of treatment within follow-up | within 5 years | 
| Side-effects | treatment related side-effects reported | within 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib
Multicenter Clinical Trial of Buprenorphine - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the efficacy and safety of buprenorphine.

Detailed Description
-----------------
12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in the 1 year extension)

Official Title
-----------------
Multicenter Clinical Trial of Buprenorphine

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 21-50. opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Opiate use |  |  | 
| Opiate craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Buprenorphine, Opioid
Upper Limb Reeducation Across Life Span

Study Overview
=================
Brief Summary
-----------------
Program Ready2E.A.T. was developed to be tested in the upper limb reeducation on population at risk, such as: Children with dysfunction Cognitive impaired elderly Dementia people

Detailed Description
-----------------
Program Ready2E.A.T. consists on the training of specific upper limb tasks, including: reaching during attention tasks reaching during memory tasks reaching during sequential motor tasks reaching during fine hand movements This program has been tested as a measure of functional status (cognitive and motor habilities) in population with different risks; It also has been tested as an effective program for reeducation in cognitive affected population.

Official Title
-----------------
Effect of Ready2E.A.T. in Risk Populations

Conditions
-----------------
Upper Extremity Dysfunction, Dementia, Cerebral Palsy, Cognitive Decline, Eating Disorders

Intervention / Treatment
-----------------
* Other: Ready2E.A.T. PROGRAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people with 60years old with cognitive decline children aging 6-10 years old with cognitive and motor dysfunction dysfunction in feeding participation Exclusion Criteria: participants that do not understand 2 simnultaneous verbal commands
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional therapy<br>Group doing conventional rehabilitation was assessed at T0 and then after 6 weeks of conventional therapy (occupational therapy, physical therapy, aquatic therapy, musicotherapy, others) | Other: Ready2E.A.T. PROGRAM<br>* Training tasks based on: reaching activities during attention tasks, memory tasks, sequential tasks This group was assessed at T0 and then after 6 weeks of conventional therapy.<br>|
| Ready2E.A.T. therapy<br>Group doing Ready2E.A.T. program received a mean of 1 hour per week and was assessed at T0 and then after 6 weeks of this program implementation. | Other: Ready2E.A.T. PROGRAM<br>* Training tasks based on: reaching activities during attention tasks, memory tasks, sequential tasks This group was assessed at T0 and then after 6 weeks of conventional therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video analysis of feeding performance | performance of several feeding steps | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontal assessment battery | Assessment of Executive Functions | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eating, upper limb, reeducation
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.

Official Title
-----------------
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: ONO-1101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-74 years old Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room Exclusion Criteria: Previous allergic reactions to contrast agent Renal failure Asthma Other exclusion criteria as specified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONO-1101|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  |  | 
| image quality |  |  | 
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-1101, Landiolol Hydrochloride, Multi-slice CT, Coronary Artery Disease
Massachusetts Healthy Families Evaluation-2

Study Overview
=================
Brief Summary
-----------------
Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births.

Conditions
-----------------
Adolescent Parenting

Intervention / Treatment
-----------------
* Other: Home visiting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 16 and 21 years first-time parent Exclusion Criteria: cognitive delay not fluent in either Spanish or English

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 20 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visiting Group<br> | Other: Home visiting<br> <br> |
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child abuse and neglect |  | 24 months post-enrollment |
Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability. In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Detailed Description
-----------------
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery. Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae. Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

Official Title
-----------------
Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery

Conditions
-----------------
Ophthalmological Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subject with a minimum age of 22 years Planned natural lens replacement with posterior chamber IOL implantation Clear intraocular media other than cataract Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit Ability to consent to the participation in study Signed informed consent Exclusion Criteria: Corneal pathology/ectasia Prior ophthalmic surgery Zonular-defects, unstable bag Macular pathologies Expected Visual acuity of less than 0.63 (decimal) Glaucoma Use of systemic or ocular medication that might affect vision Patient is pregnant, plans to become pregnant, is lactating Concurrent participation in any other clinical trial with an investigation product

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tilt and decentration of intraocular lens measured in degrees | Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery | 1 month post surgery compared with 12 months post surgery |
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)

Conditions
-----------------
Chronic Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: Placebo Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation Exclusion Criteria: History of refractive surgery (including LASIK procedures) within the past 2 years History of retinal detachment, diabetic retinopathy, or active retinal disease Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit Use any of the disallowed medications during the period indicated History of IOP increase as a result of steroid treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-DP<br>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: PV<br>PV (placebo drug delivery vehicle) | Other: Placebo Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching | 3 minutes | 
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching | 5 minutes | 
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching | 7 minutes |
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

Study Overview
=================
Brief Summary
-----------------
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Topical anaesthetic drop with placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age below 32 weeks or birth weight below 1500 grams Exclusion Criteria: congenital anomalies, necrotising enterocolitis, surgical problems

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: local anasthetic drops<br>topical anaesthetic drop with placebo | Drug: Topical anaesthetic drop with placebo<br> <br> |
| Active Comparator: Paracetamol<br>Topical anaesthetic drop with Paracetamol | Drug: Paracetamol<br>* paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing pain assessment score |  | 2 weeks |