linjc16/ctgov huggingface dataset:
Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

Detailed Description
-----------------
The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake and eating behavior before and after bariatric surgery. The consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.

Official Title
-----------------
Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Conditions
-----------------
Adolescent Obesity, Eating Behavior, Dietary Intake

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years old or younger have a BMI > 30 kg/m2 have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management. must demonstrate reasonable decision making abilities must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation). Participants will be from all racial and ethnic groups and be both male and female. Exclusion Criteria: We will not exclude participants from this trial based on health status or medication usage. Instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 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 |
| --- | --- |
| 1<br>Surgery group | |
| 2<br>Control - Lifestyle modification program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary intake |  | BL, 3, 6, 12, and 24 mo | 
| eating behavior |  | BL, 3, 6, 12, and 24 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea, vomiting, and gastric dumping |  | BL, 3, 6, 12 and 24 mo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent obesity, eating behavior, dietary intake
Study on Immediate Loading of Immediately Placed Single Implants.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.

Detailed Description
-----------------
The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges. The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.

Official Title
-----------------
Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Procedure: Immediate implant and socket preservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Single-tooth implant restorations in the aesthetic zone Exclusion Criteria: Medical risk patient Smoking

Ages Eligible for Study
-----------------
Minimum 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
Intervention Model: Single Group Assignment
Interventional Model Description: Immediate loading
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nobel Active®<br>Immediate implant and socket preservation | Procedure: Immediate implant and socket preservation<br>* Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability quote (ISQ) measurements. | Measured by Ostell® Mentor Device. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic Results and Patient Satisfaction | Bone crest level changes measured by standardized intraoral radiographs. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Implants, Single-Tooth, Bone Regeneration, Dental Restoration, Socket preservation
Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.

Official Title
-----------------
Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Device: TOF-Watch SX (Acceleromyography)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Ideal weight +/-20% Both arms available for neuromuscular monitoring Surgery in supine position Participated surgery time more than 30 min Exclusion Criteria: Pregnant and breast-feeding women Patients with known illness or use of medications known to influence the neuromuscular transmission Known significant renal or hepatic dysfunction Allergy to medications used in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG<br>Acceleromygraphy monitoring | Device: TOF-Watch SX (Acceleromyography)<br>* Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.<br>|
| Active Comparator: MMG<br>Mechanomyography monitoring | Device: TOF-Watch SX (Acceleromyography)<br>* Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ED50 with the two methods |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ED95 with the two methods |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acceleromyography, Mechanomyography, Neuromuscular block, Neuromuscular monitoring, Dose-response, Potency, Rocuronium
NovaTears® Eye Drops Observational Study

Study Overview
=================
Brief Summary
-----------------
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

Official Title
-----------------
NovaTears® Observational Study

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Device: NovaTears® Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to NovaTears® instruction for use ≥ 18 years Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days Ability and willingness to provide written Informed Consent Ability and willingness to participate in all examinations Willingness and ability to return for follow up visit Exclusion Criteria: Patients with hypersensitivity to any of the components of NovaTears® Patients with contact lenses, pregnancies, or who are breast feeding Patients with non evaporate dry eye disease Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| NovaTears®<br> | Device: NovaTears® Eye Drops<br>* Topical eye drops for lubrication of the ocular surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured by routine ophthalmological assessment | Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia. | 5 to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tolerability measured by ophthalmological assessment |  | 5 to 7 weeks |
The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress

Study Overview
=================
Brief Summary
-----------------
In the present study the main goal has been to clarify the effect of the probiotic bacteria Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative marker of stress. The hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress. By contrast, the salivary IgA levels were expected to increase in the test group in comparison to the placebo group.

Official Title
-----------------
The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress

Conditions
-----------------
Stress Reaction

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic (Lactobacillus Plantarum)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults studying at the University in Lund participation in ongoing examination period Exclusion Criteria: pregnancy intake of antibiotics medication with cortisone during the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Capsules containing potato starch as a filler and Lactobacillus plantarum | Dietary Supplement: Probiotic (Lactobacillus Plantarum)<br> <br> |
| Placebo Comparator: Placebo<br>Capsules containing potato starch | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva. |  | Change from baseline in cortisol levels at 14 days |
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.

Official Title
-----------------
The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male & Females aged 65 and older Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks Patients must have had a colonoscopy within the past 5 years Patients must pass a balloon expulsion test at screening Patients must be able to comply and understand the use of a diary Exclusion Criteria: Patients with a clinically significant medical condition that would interfere with the patient completing the trial Patients with loose stools at least once per week Patients with IBS Known allergies to the same class of drug and/or allergies to eggs Patients who require the use of manual maneuvers to have a bowel movement Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore

Study Overview
=================
Brief Summary
-----------------
To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore

Detailed Description
-----------------
A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital. Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease. GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies. The medical records of all patients diagnosed with the disease at the two centres will be reviewed. Analysis of the results aims to: to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature. to compare the treatment regimen and results of our centres compared to others to review the role of chemotherapy in the adjuvant settings in the centres.

Official Title
-----------------
A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore.

Conditions
-----------------
Gastrointestinal Stromal Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Gastrointestinal stromal tumor.
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 |
| --- | --- | --- |
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs

Study Overview
=================
Brief Summary
-----------------
We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.

Detailed Description
-----------------
We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. The patients received a headache diary for the following 12 hours after infusion.

Official Title
-----------------
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs

Conditions
-----------------
Headache, Migraine, Vasoactive Intestinal Peptide, Ultrasonography, Doppler, Transcranial

Intervention / Treatment
-----------------
* Drug: Vasoactive intestinal peptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: migraineurs Exclusion Criteria: cerebrovascular disorders, pregnancy, nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vasoactive intestinal peptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache |  |  | 
| Intra- and extracranial vasodilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood pressure |  |  | 
| heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, VIP, Transcranial Doppler, Headache