linjc16/ctgov huggingface dataset:
Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

Study Overview
=================
Brief Summary
-----------------
We plan to analyze the data to meet the primary objective of the study: To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children. In addition, we plan to analyze the data to meet 2 secondary objectives of the study: To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

Detailed Description
-----------------
We plan to analyze the data to meet the primary objective of the study: To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children. In addition, we plan to analyze the data to meet 2 secondary objectives of the study: To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

Official Title
-----------------
Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

Conditions
-----------------
HIV-Infected Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Data Analysis Only
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Data Analysis
Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the accuracy of anterior nasal swab in rapid antigen (Ag)-tests in a low SARS-CoV-2 prevalence and massive screened community.

Official Title
-----------------
Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Citizens, above 18 years of age, who had self-booked an appointment for COVID-19 test at Testcenter Taastrup, Copenhagen, Denmark, in the period of 2nd of March to 22nd of March were offered to participate in the project Exclusion Criteria: Patients referred to COVID-19 testing by a doctor with symptoms of COVID-19 were tested in a separate section of the test centers and are not included in this study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of anterior nasal swab in rapid antigen (Ag)-tests |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rapid antigen test
Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.

Study Overview
=================
Brief Summary
-----------------
Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes

Official Title
-----------------
Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Evogliptin
* Drug: Evogliptin
* Drug: Metformin and Evogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is aged ≥19 years The subject has type 2 diabetes mellitus Exclusion Criteria: 1. The subject has a contraindication

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Group A<br>Patients who receive Double therapy or Insulin | Drug: Evogliptin<br>* Evogliptin<br>* Other names: Sugamet XR;|
| Group B<br>Patients who receive DPP-4 inhibitor | Drug: Evogliptin<br>* Evogliptin<br>* Other names: Sugamet XR;|
| Group C<br>Drug-naïve patients | Drug: Metformin and Evogliptin<br>* Metformin and Evogliptin<br>* Other names: Sugamet XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | To assess change from baseline in HbA1c | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | To assess change from baseline in HbA1c | at 24 weeks | 
| The percentage of patients with HbA1c <7.0% and <6.5% | To assess the percentage of patients with HbA1c <7.0% and <6.5% | at 12 and 24 weeks | 
| Change in FPG | To assess change from baseline in fasting plasma glucose (FPG) | at 12 and 24 weeks |
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure. AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory. PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep. EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.

Official Title
-----------------
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

Conditions
-----------------
Chronic Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines. Exclusion Criteria: Decompensated respiratory failure attested by a pH <7.35, Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection, Respiratory frequency >30/min.

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic respiratory failure, Noninvasive ventilation, Patient-ventilator interactions, Sleep, Sleep fragmentation
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.

Official Title
-----------------
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Diagnostic Test: Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above or equal to 18 years Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab) Life expectancy above 3 months Active (relapsing or refractory) and measurable disease (on 18F-FDG PET/CT (performed within 4 weeks prior SSTR PET/CT) and biologically) Adequate renal function with GFR above or equal to 30mL/min/1.73m² Bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive SSTR2 IHC Exclusion Criteria: Pregnant or lactating patients Other active neoplastic disease Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT Eastern Cooperative Oncology Group Performance Status above or equal to 3 Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT|Assess somatostatin receptor expression|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatostatin receptor expression | Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images | through study completion, an average of 1,5 year |
Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients

Official Title
-----------------
Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Conditions
-----------------
Dry Eye, Tear Film, Lipid Layer, Liposic, Tears Naturale Forte

Intervention / Treatment
-----------------
* Drug: Liposic
* Drug: Tears Naturale Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range from 20 year to 40 years The value of OSDI is over 12 NBUT is less 5 seconds Schirmer 1 test is less 10mm The basical lipid layer grade is 1-2 Exclusion Criteria: Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patien 's lipid layer; Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Liposic<br>Liposic was applied to one eye of patients in this group | Drug: Liposic<br>* one eye of the participant recieved Lipoic<br>* Other names: Carbomer;|
| Experimental: Tears Naturale Forte<br>Tears Naturale Forte was applied to one eye of patients in this group | Drug: Tears Naturale Forte<br>* the other eye of the participant recieved Tears Naturale Forte<br>* Other names: DEXTRAN/HYPROMELLOSE/GLYCERIN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale of Schirmer I test |  | up to 3 months after tear substitutes apply | 
| scale of corneal fluorescein staining |  | up to 3 months after tear substitutes apply | 
| scale of noninvasive tear breakup time |  | up to 3 months after tear substitutes apply | 
| scale of tear meniscus height |  | up to 3 months after tear substitutes apply | 
| lipid layer grade |  | up to 3 months after tear substitutes apply | 
| questionnaire of ocular surface disease index |  | up to 3 months after tear substitutes apply | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective comfort |  | up to 3 months after tear substitutes apply |
Maternal and Neonatal Microbiome

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.

Official Title
-----------------
The Neonatal Microbiome and Its Influence on the Post-partum Period

Conditions
-----------------
Microbiota

Intervention / Treatment
-----------------
* Other: non invasive sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit at Hadassah University Hospital, Mount Scopus and their mothers. The control group: Neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section at Hadassah University Hospital, Mount Scopus and their mothers. Exclusion Criteria: Neonates with congenital anomalies or metabolic conditions.

Ages Eligible for Study
-----------------
Maximum Age: 50 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 |
| --- | --- |
| Premature infants<br>premature infants ≤ 34 weeks of gestation | Other: non invasive sampling<br> <br> |
| Term infants<br>neonates ≥ 37 weeks gestation | Other: non invasive sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition the flora comprising the microbiome of premature and term babies |  | birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the microbiome of the infants born vaginally and via caesarian section |  | birth | 
| Change in the flora that constitutes the microbiome of premature babies |  | birth until adjusted age of 40 weeks gestation |
Samsca PMS in ADPKD Patients

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.

Official Title
-----------------
Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD

Conditions
-----------------
Safety

Intervention / Treatment
-----------------
* Drug: Tolvaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease. Patients who need to be prescribed by Investigators who got registered in Risk Management Plan. Patients who have agreed and signed on conditions specified in Risk Management Plan. Exclusion Criteria: Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines or to any ingredient of the drug Patients requiring urgent intervention to raise serum sodium acutely. Inability of the patient to sense or appropriately respond to thirst. Hypovolemic hyponatremia Concomitant use of strong CYP3A(Cytochrome P450, family3, subfamily A) inhibitors Anuric patients Volume depletion patients Hypernatremia patients Women who are pregnant or possibly pregnant and lactation Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolvaptan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR) | All adverse events (AEs) observed during/after the administration will be analyzed as safety assessment. The number of patients and the number of AE, ADR, Serious AE·ADR, Unexpected AE·ADR will be calculated (frequency and percentage). | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Marketing Surveillance
Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity

Study Overview
=================
Brief Summary
-----------------
Owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly. The incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention. However, if hemothorax that occurs is missed, it can result in increased mortality and morbidity. Furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery. The aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.

Detailed Description
-----------------
We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.

Official Title
-----------------
Perioperative Management in Terms of Hemothorax Caused by Posterior Correction

Conditions
-----------------
Spinal Deformity, Hemothorax Postoperative

Intervention / Treatment
-----------------
* Procedure: posterior correction surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: posterior correction surgery|Cases of hemothorax developing after posterior correction surgery for spinal deformities|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemothorax | hemothorax caused by posterior correction surgery for spinal deformity | 2016-2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal deformity, posterior correction surgery, hemothorax