linjc16/ctgov huggingface dataset:
Influence of Bottle-Type on Infant Feeding Behaviors

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.

Official Title
-----------------
Influence of Bottle-Type on Infant Feeding Behaviors

Conditions
-----------------
Conventional Clear Bottle, Opaque Weighted Bottle

Intervention / Treatment
-----------------
* Behavioral: Bottle Type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers must be 18 years or older Infants must be between 0- and 6-months of age Infants must be prior to the introduction of solid foods Exclusion Criteria: Preterm birth Medical conditions that interfere with feeding

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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: Clear versus Opaque Bottle<br>This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants. | Behavioral: Bottle Type<br>* Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant intake within a feeding (mL) | assessed by weighing the bottle before and after a feeding | 3-hour period | 
| Maternal responsiveness to infant cues during a feeding | assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale | 3-hour period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal perception/acceptance of the bottles during a feeding |  | 3-hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, intake, satiation, mother, feeding practices, bottle feeding, formula feeding, maternal responsiveness, infant cues
Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

Detailed Description
-----------------
57 patients will be included in this 36 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device. Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Official Title
-----------------
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Cilioscleral Interposition Device (CID) SV22 in Glaucoma Patients Refractory to Topical Therapy

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: Interposition supraciliary implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Primary Glaucome Schafer 1 to 4 Medicated IOP ≥ 21 naive of any glaucoma surgery Exclusion Criteria: Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interposition supraciliary implant<br>Any patients corresponding to inclusion / exclusion criteria | Device: Interposition supraciliary implant<br>* Surgical placement of SV22 interposition supraciliary implant in the supraciliary space<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess post-op IOP reduction | Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy outcomes between POAG and PNAG sub-groups | Absolute differences in IOP | 6 months |
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
Brittle bone disease also known as osteogenesis imperfecta (OI) is characterised by a defect in the bone tissue that leads to recurrent fractures and significant bone deformities in children. These fractures include vertebral (spinal) fractures. As a result, child with OI require regular clinic surveillance that includes repeated xrays of the spine. in our pilot study the investigators plan to use a thermal imaging camera that can pick up changes in temperature to 0.03 degrees to determine whether the investigators can accurately identify vertebral fractures without the need for radiation. in the first part of the study the investigators will compare the thermal images from the camera with the xrays to see if the investigators can pick up the vertebral fractures seen on the xray picture. If this is possible, then the investigators will move on to phase 2 of the study which will investigate the ability of the thermal camera to pick up vertebral fractures without prior knowledge of where the fractures are located. If this approach is successful this will help us to develop a nonradiation, lowcost painless way of identifying vertebral fractures in children with OI.

Official Title
-----------------
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Device: Thermal imaging device


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study. Patients with Osteogenesis Imperfecta for phase 2 of the study In both groups patients will be aged 5 years and over

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients aged 5-18 years<br>Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study. Patients with Osteogenesis Imperfecta for phase 2 of the study In both groups patients will be aged 5 years and over | Device: Thermal imaging device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal imaging device | The ability to pick up vertebral morphology and fractures in relation to spine X-rays | 15 minutes |
Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Study Overview
=================
Brief Summary
-----------------
Water imbalance and consecutive electrolyte disturbances are common in the postoperative course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may complicate the postoperative course in as many as 30% of patients. Early and accurate diagnosis of water and electrolyte disturbances postoperatively is important for an adequate fluid and drug administration. However, identifying the causes is challenging/ ambiguous in clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus and SIADH) in a cohort of patients undergoing intracranial tumor surgery.

Official Title
-----------------
Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Conditions
-----------------
Pituitary Adenoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients who undergo surgery for an intra- or suprasellar lesion, either by craniotomy or by transphenoidal resection.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| neurosurgical patients<br>Patients undergoing transphenoidal pituitary adenoma resection and patients with transcranial surgery of tumors close to the pituitary gland and hypothalamus. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy, i.e. difference of copeptin levels between patients without and patients with postoperative DI, of copeptin in the diagnosis of water disturbance in neurosurgical patients | daily blood sampling will allow to diagnose DI or SIADH during hospital stay. Copeptin levels will be compared between patients with uncomplicated postoperative course and patients with development of DI or SIADH. | daily during hospital stay of the patient, on average 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes insipidus, copeptin, SIADH, transphenoidal pituitary adenoma resection, pituitary adenoma, tumors close to pituitary gland, tumors close to hypothalamus
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans

Study Overview
=================
Brief Summary
-----------------
Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.

Official Title
-----------------
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent 18FDG-PET/CT scan year between 2008-2010 Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) Diabetes Stage 2 hypertension Severe renal or hepatic disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAT<br>brown adipose tissue detected, undetected | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence metabolic syndrome |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 5 months | 
| visceral fat area |  | 5 months | 
| adipokines |  | 5 months | 
| sarcopenia |  | 5 months |
A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.

Official Title
-----------------
A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arterial hypertension without previous regular treatment Urinary albumin excretion rate above 30 mg / 24h 30-65 years old Exclusion Criteria: Reno-vascular arterial hypertension Therapy resistant edema Chronic heart failure, angina pectoris Diabetes mellitus Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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: valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin excretion after 24 weeks |  |  | 
| Change from baseline in an ultrasound measurement of blood flow after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of blood pressure changes on urine albumin excretion rate and blood vessel function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
albuminuria, arterial hypertension, valsartan
Assessment of Health Literacy Among Adult Patients in the United Arab Emirates to Facilitate Clinical Trials Recruitment.

Study Overview
=================
Brief Summary
-----------------
Health Literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health informatin can overwhelm even people with advanced literacy skills. About one third of the adult population in the United States has limited health literacy.

Detailed Description
-----------------
Health literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health information can overwhelm even people with advanced literacy skills. About one third of the adult population in the United States has limited health literacy (Berkman ND, Davis TC, McCormack L. Health literacy:what is it? J Health Commun. 2010; 15 Suppl 2: 9-19). Initial assessment of regulatory compliance in research studies in the UAE indicated poor understanding of medical information by patients/subjects (AAMDHREC 12/55). Health Literacy Survey (HLS) will be conducted on adults visiting the participating UAE hospitals/clinics. The survey will be conducted by a trained bilingual healthcare professional such as a team of medical residents. The investigators study attempts to identify the population that are unable to understand health information or are impaired in their understanding of health information.

Official Title
-----------------
Assessment of Health Literacy Among Adult Patients in the United Arab Emirates to Facilitate Clinical Trials Recruitment.

Conditions
-----------------
UAE, Health Literacy, Adult, Disease, Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and above Willing to consent Exclusion Criteria: Less than 18 Severly ill Unable to consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young, 18 to 30<br> | |
| Middle, 31 to 50<br> | |
| Older, 51 to 70<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient unable to read and write. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Health Literacy, UAE, Disease, Age
Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Official Title
-----------------
The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Conditions
-----------------
Non-muscle-invasive Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine 1000 mg, Docetaxel 37.5g


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCG-naive patients with high-risk non-muscle invasive bladder cancer Exclusion Criteria: patients in whome cystectomy is planned

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients receive same intervention throughout the trial. | Drug: Gemcitabine 1000 mg, Docetaxel 37.5g<br>* 6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.<br>* Other names: Sequential intravesical chemotherapy GEM/DOCE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reccurence free survival | Patients with no bladder cancer reccurence during therapy | 2 years |
The Short-term Effects of Trunk Kinesio Taping on Trunk Muscle Endurance and Postural Stability in Healthy Young Adults

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate the short-term effects of trunk kinesio taping on trunk muscle endurance and postural stability in healthy young adults.

Official Title
-----------------
Assistant Professor, Physioterapist, PhD

Conditions
-----------------
Kinesio Taping

Intervention / Treatment
-----------------
* Other: Kinesio taping
* Other: Sham Kinesio taping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young volunteers aged between 18-25 years Exclusion Criteria: Having disc hernias, any spinal pain complaint, spinal deformity, history related to spinal surgery, vestibulopathy, musculoskelatal injuries related to ankle, knee and hip joints, orthopedic and/or neurological problems and allergy to the kinesio tape

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Kinesio taping group<br>Kinesio taping was applied on trunk muscles | Other: Kinesio taping<br>* Kinesio taping was applied on both sides of rectus abdominus, obliquus internus, obliquus externus and sacrospinalis muscles with muscle technique<br>|
| Sham Comparator: Control group<br>Sham Kinesio taping was applied on trunk muscles | Other: Sham Kinesio taping<br>* Kinesio taping was applied on both sides of rectus abdominus, obliquus internus, obliquus externus and sacrospinalis muscles without any technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk muscle endurance | Trunk muscle endurance with McGill's trunk muscle endurance tests (seconds) was assessed | Change from Baseline taping at 1 hour after the taping | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural stability | Postural stability as static using a force platform when eyes open and eyes closed was assessed | Change from Baseline taping at 1 hour after the taping |