linjc16/ctgov huggingface dataset:
Bright Light Therapy for Individuals With Dementia

Study Overview
=================
Brief Summary
-----------------
Many older adults with dementia living in long-term care facilities experience depression and agitation, which cause angst and personal suffering. Prior to this research, evidence was inconclusive but indicated that bright light exposure may reduce depression and agitation in long-term care residents with dementia. The purpose of this study was to determine if the degree of improvement in depression and agitation scores over the course of eight weeks was significantly greater in persons with dementia receiving bright light exposure than in persons with dementia receiving placebo light exposure. Sixty individuals participated in the study, with 30 in the bright light group and 30 in the low level light group.

Official Title
-----------------
Bright Light Therapy for Individuals With Dementia

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: Bright Light
* Behavioral: Placebo Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria were age 60 or older; diagnosis of dementia; ophthalmology screening indicating that the individual was able to perceive light and did not have cataracts, glaucoma, macular degeneration, or retinal problems; able to sit up and keep eyes open; and not too restless to sit for 30 minutes. Exclusion criteria were age 59 or younger; no diagnosis of dementia; presence of cataracts, glaucoma, macular degeneration, or retinal problems; unable to sit up and keep eyes open; and too restless to sit for 30 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Bright Light Group<br>Bright Light Exposure | Behavioral: Bright Light<br> <br> |
| Placebo Comparator: Control Group<br>Placebo Light Exposure | Behavioral: Placebo Light<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptom Assessment for Older Adults |  | After the eight-week experiment | 
| Cohen-Mansfield Agitation Inventory (Frequency) |  | After the eight-week experiment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Depression, Agitation, Bright Light
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term results after transcatheter aortic valve replacement

Detailed Description
-----------------
Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.

Official Title
-----------------
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: CE certified transcatheter ( aortic valve replacement)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic valve stenosis transcatheter aortic valve replacement Exclusion Criteria: no written informed consent

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
Intervention Model: Single Group Assignment
Interventional Model Description: TAVR
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcatheter aortic valve replacement<br>Patients receive transcatheter aortic valve replacement. | Device: CE certified transcatheter ( aortic valve replacement)<br>* Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cerebral and cardiac events. |  | 1-5 years |
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

Official Title
-----------------
A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension

Conditions
-----------------
Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: brinzolamide 1.0%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma or ocular hypertension patients Exclusion Criteria: Women of childbearing potential History of bronchial asthma, or severe chronic obstructive pulmonary disease Presence of acute glaucoma

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

| Intervention/Treatment |
| --- |
|Drug: brinzolamide 1.0%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP-lowering at 8 and 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety throughout the 16 weeks of the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Hypertension Patients
TDM of Asparaginase in ALL2008

Study Overview
=================
Brief Summary
-----------------
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented. Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018. From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future. A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.

Official Title
-----------------
Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL treated on the NOPHO ALL2008 protocol, age 1-45 years. Exclusion Criteria: No samples sent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on |  | 2018-2021 |
Endosponge Vacuum Therapy (E-VAC) Registry of Intestinal Anastomotic Leaks and Perforations

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to collect data on the clinical use of endoluminal vacuum (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.

Official Title
-----------------
Prospective Registry The Treatment Of Upper And Lower Intestinal Anastomotic Leaks And Perforations

Conditions
-----------------
Intestinal Anastomotic Leak, Intestinal Perforations

Intervention / Treatment
-----------------
* Other: No interventions are done


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing E-Vac Therapy Age > 17 years Exclusion Criteria: 17 years of age or younger Undergone an E-Vac placement > 14 days before consenting

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 |
| --- |
|Other: No interventions are done|No intervention is done. This is a registry study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital survival-rate |  | 6 months |
Telephone-Based Support for Caregivers of Patients With Dementia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.

Detailed Description
-----------------
Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.

Official Title
-----------------
A Telephone Intervention for Dementia Caregivers

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: Cognitive-Behavioral Family Systems Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Inclusion Criteria: DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease) Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers 50 years old or older Resides in Southeastern New England Caregiver Inclusion Criteria: Living with a person with dementia Provides care for at least 6 months for at least 4 hours a day English as primary language Telephone access Resides in Southeastern New England Patient Exclusion Criteria: Major acute medical condition affecting independent functioning Caregiver Exclusion Criteria: Acute medical illness Cognitive impairment as defined by an MMSE score < 25

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive-Behavioral Family Systems Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Intensive Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit. Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample. Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay

Detailed Description
-----------------
see brief summary

Official Title
-----------------
The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients

Conditions
-----------------
the Maintenance of Normoglycemia, the Incidence of Ventilator Associated Pneumonia (VAP), Treatment Period in the Intensive Care Unit

Intervention / Treatment
-----------------
* Procedure: glucontrol (insulin therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical patients mechanical ventilated both sex older than 18 Exclusion Criteria: non-surgical patients non mechanical ventilated younger than 18 pregnant women

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

| Intervention/Treatment |
| --- |
|Procedure: glucontrol (insulin therapy)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements of glucose in capillary blood sample |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumonia, mechanical ventilated, surgical patients, blood glucose, insulin infusion, hospital stay
Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

Study Overview
=================
Brief Summary
-----------------
This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed Description
-----------------
This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusions of insulin determined by the control algorithm of the artificial pancreas.

Official Title
-----------------
Prevention for Surgical Site Infection After Hepatic Resection

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. Exclusion Criteria: weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>received programmed infusions of insulin determined by the control algorithm of the artificial pancreas | Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)<br>* artificial pancreas<br>* Other names: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan);|
| No Intervention: 2<br>glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of surgical site infection |  | 30th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hypoglycemia and cost during the hospitalization |  | during the hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical, site, infection
Taping for Children With and Without Movement Clumsiness

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).

Official Title
-----------------
The Effects of K-Tape on Walking Pattern, Muscle Activity, and Motor Performance in Children With and Without Developmental Coordination Disorder: a Randomized Controlled Trial

Conditions
-----------------
Developmental Coordination Disorder

Intervention / Treatment
-----------------
* Other: K tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with DCD and typically developing children will need to score <16 percentile and >25 percentile, respectively, on MABC-2 Study in mainstream schools No intellectual disabilities Exclusion Criteria: Subjects who are receiving regular treatments Demonstrate excessive disruptive behaviour Unable to follow instructions Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal children with K Tape<br> | Other: K tape<br>* Applying K tape to children to the lower limb muscles during motor activities.<br>|
| No Intervention: Normal children without K Tape<br> | |
| Experimental: DCD with K Tape<br> | Other: K tape<br>* Applying K tape to children to the lower limb muscles during motor activities.<br>|
| No Intervention: DCD without K Tape<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lower limb muscle activation as measured by electromyography | Post K Tape lower limb muscle activity - pre K Tape lower limb muscle activation | Day 1 and day 2 (ms) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in balance performance as measured by force plate | Post K Tape balance performance - pre K Tape balance performance | Day 1 and day 2 | 
| Foot posture as assessed by clinical observation |  | Day 1 and Day 2 | 
| Body composition as assessed by DXA |  | Day 1 and Day 2 | 
| Change in walking pattern as assessed by a motion analysis system | Post K Tape walking pattern - pre K Tape walking pattern | Day 1 and day 2 |