linjc16/ctgov huggingface dataset:
NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)

Study Overview
=================
Brief Summary
-----------------
The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life. The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.

Official Title
-----------------
NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)

Conditions
-----------------
Neonatal Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies having a routine NBS screening test. Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset & parts of Wiltshire) Exclusion Criteria: Parent decides to opt-out of the blood glucose test feasibility study.
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 |
| --- | --- | --- |
| Normal range of capillary blood glucose in newborns at day 5 of life |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of laboratory procedures |  | 12 months |
Discordance of Obesity in Adolescent Sibilngs

Study Overview
=================
Brief Summary
-----------------
This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).

Detailed Description
-----------------
This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight). To accomplish this, siblings attend four laboratory sessions where they consume one of two types of kool-aid, smell the pizza, or rest quietly. Siblings then eat a dinner meal. Siblings also wear an activity monitor for one week and record their physical activity and sedentary activities in a habit book.

Official Title
-----------------
Non-shared Environments and Discordance of Obesity in Adolescent Sibilngs

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Kool-aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 13-17 years old Have discordant same gender sibling (one is below 70th percentile, one is above 85th percentile Speak/read English Moderate or greater liking of study foods Exclusion Criteria: No current diagnosis of a psychiatric or eating disorder. No dieting, dietary restrictions, or allergies that would interfere with study participation. No medications or conditions that could influence taste or appetite. No health concern or physical disability that would limit participation in physical activity. No endocrine or central nervous system disorder that could produce overweight. No current use of tobacco or nicotine products by the adolescent siblings.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Siblings<br>Siblings will consume four test meals after 4 different exposures, including two types of koolaid, a control and a smell condition. | Other: Kool-aid<br>* Participant drank two different types of kool-aid (sugar free and regular)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal and external satiety calories consumed | Calories consumed during ad libitum meals are measured after consumption of a high energy dense preload and a low energy dense preload and also after an external cue (smell) and a control condition. | Calories consumed are measured at week 1, week 2, week 3 and week 4. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
siblings, overweight, adolescent
Native Hawaiian Diabetes Intervention Program

Study Overview
=================
Brief Summary
-----------------
The Native Hawaiian Diabetes Intervention Program is a project focused on determining whether a cultural-based, healthy lifestyles program with family support will have a positive effect on lifestyle behaviors and psychosocial and clinical outcomes. A culturally sensitive, lifestyle intervention program was administered via community peer educators to a population of Native Hawaiians with or at risk for diabetes. The effect of this intervention program on selected outcomes is being compared to a ''standard'' program given to a similar population in a second Native Hawaiian community.

Official Title
-----------------
Cultural-based Diabetes Program for Native Hawaiians

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

Intervention / Treatment
-----------------
* Behavioral: 'Ohana (Family) Support Lifestyle Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be a Native Hawaiian adult 30 years of age or older residing in the research community and have diabetes or at-risk for diabetes. Family support member must be 18 years or older and live in the study community and be willing to go through the entire program with the participant as their support person. Physician clearance to participate in the program. Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 'Ohana (Family) Support Lifestyle Intervention|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Native Hawaiian, Diabetes Mellitus, Lifestyle Intervention, Family Support, Diabetes Mellitus, at-risk
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Study Overview
=================
Brief Summary
-----------------
The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.

Official Title
-----------------
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Conditions
-----------------
Cataract, Pseudophakia

Intervention / Treatment
-----------------
* Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients able to sign informed consent Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation. Exclusion Criteria: Inability to sign informed consent Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA Unable to return for light treatments

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision|Subjects will receive bilateral implantation of a commercially available Light Adjustable Intraocular lens at the time of cataract surgery. Subsequently, they will undergo light adjustment of the lens to target binocular custom vision.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular uncorrected distance, intermediate, and near visual acuity |  | Through Month one post-op | 
| Binocular uncorrected depth of focus |  | Through Month one post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manifest refraction |  | Through Month one post-op | 
| Monocular uncorrected distance visual acuity |  | Through Month one post-op | 
| Monocular best corrected distance visual acuity |  | Through Month one post-op | 
| Visual Satisfaction | Visual satisfaction will be obtained using a visual questionnaire | Through Month one post-op | 
| 4th order total eye spherical aberration (Z12) |  | Through Month one post-op |
Effect of Turmeric on Pruritus in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether turmeric can be effective in treatment of pruritus in hemodialysis patients.

Detailed Description
-----------------
pruritus is a common in hemodialysis patients and many treatment recommended for it . as turmeric has anti-inflammatory , anti-cytokine and anti-oxidant effect it may effective in treatment of uremic pruritus. thus we compared turmeric with placebo in this study

Conditions
-----------------
End Stage Renal Failure

Intervention / Treatment
-----------------
* Drug: turmeric
* Drug: placebo
* Drug: turmeric


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis for more than 3 months More than 18 years old Pruritus Exclusion Criteria: Use other treatment for pruritus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: turmeric<br>turmeric 500 mg tid orally for 8 weeks | Drug: turmeric<br>* turmeric 500 md tid orally for 8 weeks<br>Drug: turmeric<br>* 500 mg tid orally for 8 weeks<br>|
| Placebo Comparator: plasebo<br>placebo tid orally for 8 weeks | Drug: placebo<br>* placebo 3 time orally for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in pruritus |  | 6 mo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, turmeric, pruritus
Gabapentin Pretreatment for Staged Bilateral Cataract Operations

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients undergoing staged bilateral cataract operations under monitored anesthesia care

Detailed Description
-----------------
It has been reported that patients with bilateral cataract complained more pain and discomfort during the second consecutive eye surgery compared to the first eye surgery. Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative analgesia, and anxiolysis. Therefore, the investigators conducted this randomized, controlled study to evaluate the effects of gabapentin premedication on patients' subjective sensations, including intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract operations.

Official Title
-----------------
The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations

Conditions
-----------------
Hyperalgesia, Cataract Bilateral Nos

Intervention / Treatment
-----------------
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged over 60 years, who undergoing staged bilateral cataract operations under monitored anesthesia care ASA physical status of I, II, and III Exclusion Criteria: undergoing other eye operations together besides cataract operation patients with creatinin clearance lower than 30ml/min patients with CNS inhibitors medication patients with previous gabapentin medication pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Gabapentin premedication group | Drug: Gabapentin<br>* Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations<br>|
| No Intervention: No medication<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | intraoperative pain perception evaluated by VAS in first and second cataract surgery | during the operation |
Value of Radionuclide Cisternography

Study Overview
=================
Brief Summary
-----------------
Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus. In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF unlike other reference tests. In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and throat of the patient to collect a possible flow of CSF. These samples are analysed by radioactivity measurements and bring an added value to the exam. The interest of this examination for management of CSF leak/fistula remains unclear. The aim of this study is to identify and analyse results of all RC examinations performed since 2005 in the Nuclear Medicine department of the Neurological Hospital. The full analysis of patients will allow discussing the role of RC in management of CSF leak/fistulae in clinical practice.

Official Title
-----------------
VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK

Conditions
-----------------
CSF Leak, Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who received a convocation for realization of RC (extraction with GERA, software of Nuclear Medicine) Exclusion Criteria: patients who received a convocation for realization of RC with valve protocol
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 |
| --- | --- | --- |
| RC /SPECT/CT imaging | Results of RC including results of SPECT/CT imaging and results of swabs counting (nasal cavities and throat or ear if applicable) | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radionuclide cisternography, CSF leak, imaging
Use of the Free Dorsal Digital Flap Including Both Dorsal Branches of the Proper Digital Nerves for Reconstruction of Volar Soft Tissue Defect of Digits

Study Overview
=================
Brief Summary
-----------------
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.

Detailed Description
-----------------
Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.

Conditions
-----------------
Nerve Injury, Digital Pulp Defect

Intervention / Treatment
-----------------
* Procedure: Free dorsal digital flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: soft tissue defects in the fingertip, pulp, or volar surface of the digits; a defect > 2 cm in length; unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and the patient refuses to use tissues from the toe. Exclusion Criteria: soft tissue defects in the dorsum of the digits; a defect < 2 cm in length; homodigital and heterodigital island flaps are available.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Procedure: Free dorsal digital flap|The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static 2-point discrimination (2PD) test | The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. | 25 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dorsal digital free flap, dorsal branch of proper digital nerve, dorsal branch of proper digital artery, proper digital artery
CNAP in Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation. Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).

Official Title
-----------------
Noninvasive Blood Pressure Measuring

Conditions
-----------------
Transfemoral Implantation of Aortic Valves

Intervention / Treatment
-----------------
* Other: different blood pressure intervals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included. The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg. Exclusion Criteria: an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome) arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| different blood pressure intervals<br> | Other: different blood pressure intervals<br>* In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | blood pressure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | descriptive data | age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CNAP, continuous non-invasive arterial pressure, IAP, blood pressure, analgosedation, high-risk patients, rapid-pacing