linjc16/ctgov huggingface dataset:
Absolute Bioavailability Study With Bexagliflozin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.

Official Title
-----------------
A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Bexagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 no nicotine and tobacco consumption in the past 3 months willing and able to be confined to the clinical research facility as required by the protocol Exclusion Criteria: clinically significant history of allergy to drugs or latex history of alcohol or drug dependence in the past 12 months. donation of a significant amount of blood in the past 2 months willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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: Bexagliflozin<br>Each subject will receive a single oral dose of bexagliflozin tablets, 20 mg, followed by a single IV dosing of < 30 ug 14C-bexagliflozin in 0.9% saline solution). | Drug: Bexagliflozin<br>* Bexagliflozin tablets, 20 mg, and bexagliflozin by IV<br>* Other names: EGT0001442, EGT0001474;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute bioavailability (Fp.o.) of bexagliflozin tablets | oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity) | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | adverse event as a measure of safety and tolerability of treatment | Up to 3 days |
New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body. Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.

Detailed Description
-----------------
In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands). With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer. The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).

Official Title
-----------------
Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.

Conditions
-----------------
Cervical Cancer Cin Grade

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall Exclusion Criteria: does not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control 1<br>standard recall letter to perform HPV test at the clinic | |
| Intervention 1<br>direct mailing of the self sampling device at home | |
| intervention 2<br>invitation to retire the self sampling device in local pharmacy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performing a HPV test within 3 months since the recall letter |  | up to december 2012 (up to 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before) |  | up to december 2012 (up to 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer, prevention, screening
L-PRF for Increasing Keratinised Mucosa Around Implants

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the potential of L-PRF in increasing the width of the keratinsed mucosa around implants. Furthermore, it was assessed whether this surgery was associated with significantly less post-operative discomfort for the patient compared to Free Gingival Graft surgery. L-PRF for increasing keratinised mucosa around implants.

Official Title
-----------------
L-PRF Membranes for Increasing the Width of Keratinised Mucosa Around Implants: A Split-mouth, Randomized, Controlled Pilot Clinical Trial

Conditions
-----------------
Implantation Complication

Intervention / Treatment
-----------------
* Procedure: L-PRF membranes
* Procedure: Free Gingival Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in need of bilateral enlargement of keratinsed tissues around implants Exclusion Criteria: smokers

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: Single Group Assignment
Interventional Model Description: split-mouth trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-PRF membranes<br>Intra-oral split thickness preparation - apically repositioned to the periosteum. L-PRF membranes will be used to cover the site. Free Gingival Grafts will be used to cover the site. | Procedure: L-PRF membranes<br>* split-mouth design, randomized L-PRF membranes vs. free gingival graft<br>Procedure: Free Gingival Graft<br>* split-mouth design, randomized L-PRF membranes vs. free gingival graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of keratinised tissues | measurements of changes in amount of keratinised tissues | Measurements were performed pre-operatively (using lugol staining) and 3 months after surgery (using lugol staining). Results will be presented in the final paper. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op pain assessment | Post-operative pain assessment via VAS-scales | Visual analogue scales were handed out after surgery and were collected 1 week post-operatively. Results will be presented in the final paper. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratinised tissues, implant, free gingival graft, L-PRF
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

Official Title
-----------------
Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Procedure: Mesh repair for primary inguinal hernia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral inguinal hernia suitable for open mesh repair in local anesthesia as well as laparoscopic repair ASA score I-III informed consent Exclusion Criteria: ASA score IV (not suitable for TEP) bilateral hernias (laparoscopic repair preferable) recurrent hernia (primary repair affects preferable treatment) large scrotal hernias (not suitable for local anesthesia) earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein in local anesthesia (LLA)<br>Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein | Procedure: Mesh repair for primary inguinal hernia<br>* Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh<br>* Other names: TEP;|
| Active Comparator: TEP<br>Patient receives a totally extraperitoneal laparoscopic repair | Procedure: Mesh repair for primary inguinal hernia<br>* Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh<br>* Other names: TEP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term post operative pain |  | 6 wks, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness of the separate procedures |  | 6wks, 1year |
Ascorbic Acid Levels in MDS, AML, and CMML Patients

Study Overview
=================
Brief Summary
-----------------
This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.

Detailed Description
-----------------
It has previously been established that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) often exhibit severe vitamin C deficiency from a cohort of patients in Copenhagen. In this study, the investigators aim to determine if those results are conserved in another population/geographical location.

Official Title
-----------------
Collection of Peripheral Blood From Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia for Measuring Baseline Ascorbic Acid Levels and Future Epigenetic Cancer Research

Conditions
-----------------
MDS, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, AML, CMML

Intervention / Treatment
-----------------
* Other: Peripheral blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients actively receiving treatment for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). Patients diagnosed with AML, MDS, or CMML and are treatment naïve. Patients who are 18 years old or older. Exclusion Criteria: Patients deemed as too ill to participate as determined by the clinical investigator. Non-English speaking patients Patients unable to provide 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AML, MDS, and CMML patients<br>Patients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). | Other: Peripheral blood collection<br>* Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood ascorbic acid levels | The level of ascorbic acid | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of human endogenous retroviral sequences (HERVs) expression |  | 1 year | 
| Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, Ascorbic Acid, Epigenetics, 5-hydroxymethylcytosine, 5-methylcytosine
Evaluation of Vitamin D Status in Children With Acute Burns

Study Overview
=================
Brief Summary
-----------------
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

Detailed Description
-----------------
The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Official Title
-----------------
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention

Conditions
-----------------
Burns, Bone Demineralization

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D2
* Dietary Supplement: Vitamin D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child is > 6 months of age but < 19 years old Burn injury > 30% total body surface area Admitted to SHC within 4 days of injury Attending physician decision that patient is likely to survive Parents or legal guardian give informed consent along with assent of the child as applicable Exclusion Criteria: Attending physician decision that patient is not likely to survive Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Vitamin D2|Daily enteral dose of 100IU/kg|
|Dietary Supplement: Vitamin D3|Daily enteral dose of 100IU/kg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels |  | During acute phase postburn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers |  | During acute phase postburn | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D
Biomarkers of Mild and Moderate Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.

Official Title
-----------------
Biomarkers of Mild and Moderate Traumatic Brain Injury

Conditions
-----------------
Brain Injuries, Traumatic

Intervention / Treatment
-----------------
* Other: Head CT scan and blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age and no more than 80 years of age. Closed injury to the head within 4 hours from symptom onset. Glasgow Coma Scale (GCS) Score of 9-15. Head Computerized Tomography (CT) performed as part of routine care. Subject is willing to undergo the Informed Consent process prior to enrollment. Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study. Exclusion Criteria: Participating in another clinical study that may affect the results of either study. Time of injury cannot be determined. Head CT not done as part of clinical emergency care. Primary diagnosis of ischemic or hemorrhagic infarct. Not available for 35 day follow-up visit. Venipuncture not feasible. Blood donation within 1 week of screening. The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Traumatic Brain Injury<br>Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury | Other: Head CT scan and blood draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of putative TBI markers relative to diagnosis |  | within 24 hours and at Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT) |  | within 24 hours and at Day 35 |
Activity of the Auditory Cortex During Speech Perception and Speech Production in Stuttering

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to examine the cortical activity during speech perception and speech production in idiopathic stutterers compared to fluent speakers. Therefore, the noninvasive method of magnetoencephalography (MEG) is used. A better understanding for the complexity of speech perception and its pathology should be developed. Fundamental properties of stuttering are repetitions, prolongations, and blocks. In most cases stuttering emerges between 2 and 5 years of age. The auditory feedback should become less important during development, as soon as information about mispronounced words does not occur anymore. During speech development this control function should be adopted by other systems. In stutterers the dominance of the acoustic control should remain. Brain imaging studies with positron emission tomography (PET) or magnetic resonance imaging (MRI) show defects in the network of motor system, in the lateralization of speech areas, and functions of the auditory cortex. Magnetoencephalographic studies describe a similar variety as cause of stuttering. There may be defects in the auditory feedback, a modification of the lateralization of speech areas, or an alteration of co-action of motor planning and auditory system. The benefit of magnetoencephalography is a very good temporal resolution in the range of milliseconds combined with good spatial resolution. Therefore, it is well suited to examine the dynamics of cortical processing during stuttering. In this study evoked components of the auditory systems related to complex sounds, vocals, consonant-vocal combinations, and single words are analyzed. Differences of these components in the auditory cortices of stutterers and fluent speakers are hypothesized as well in temporal structure as in localization and lateralization.

Official Title
-----------------
Evoked and Induced Auditory Cortical Activity During Speech Perception and Speech Production in Stuttering

Conditions
-----------------
Stuttering

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with idiopathic stuttering (for the group of stutterers) Fluently speaking subjects (for the control group) Right handed Normal hearing Exclusion Criteria: Neurological diseases Psychiatric diseases Medication with neurological effective drugs Implants with magnetic impact

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetoencephalography, Auditory cortex, Stuttering, Non stuttering