linjc16/ctgov huggingface dataset:
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

Conditions
-----------------
Cystitis, Interstitial

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test Exclusion Criteria: Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components) History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state Vaginitis or vaginal infection within 1 month before randomization

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

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

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

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: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Levels of urinary antiproliferative factor (APF) |  |  | 
| Peripheral blood mononuclear cell (PBMC) gene expression profiles |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and urinary biomarkers of IC |  |  | 
| Clinical Activity: |  |  | 
| Global Response Assessment (GRA) |  |  | 
| O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index |  |  | 
| Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale |  |  | 
| Female Sexual Function Index (FSFI) |  |  | 
| Voiding Diary |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystitis
Gender-specific Associations Between Quality of Life and Leukocyte Telomere Length

Study Overview
=================
Brief Summary
-----------------
Quality of life (QoL) is an important factor for successful aging. Telomere length is an indicator of cellular aging and cumulative biological stress and is thus related to health status and survival. However, the relationship between QoL and telomere length has not yet been examined. In this study we investigated the relationship between leukocyte telomere length (LTL) and QoL. However, the relationship between overall QoL and LTL has not previously been investigated. Therefore, this study was conducted to examine the relationship between LTL and QoL. QoL was measured by the Korean version of the 36-item short-form health survey (SF-36), which is a multidimensional scale consisting of subjective evaluation.

Official Title
-----------------
Gender-specific Associations Between Quality of Life and Leukocyte Telomere Length: A Cross-sectional Study

Conditions
-----------------
Apparently Healthy People Aged 55 and Over

Intervention / Treatment
-----------------
* Other: quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: married couple apparently healthy subjects above 55 years Exclusion Criteria: Subjects who had experienced hormone therapy Subjects who had been diagnosed with dementia, Parkinson's disease, stroke, ischemic heart disease, congestive heart failure, arrhythmia, depression, cancer, thyroid disorders, or chronic renal disease

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: quality of life|Quality of life which was measured by the Korean version of the 36-item short-form health survey (SF-36)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukocyte telomere length | Leukocyte telomere length was measured as telomere repeat copy number relative to single gene copy number by quantitative real-time PCR | 8months |
Effects of Music Intervention on the Brain Development of Preschool Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn more about the effects a musical intervention has on typical brain development in preschool-aged children.

Detailed Description
-----------------
This study will advance the science on brain research in young children by determining the effects of a musical intervention or training on children's brain development. The study will investigate how regular instruction in the Suzuki-like method of violin affects brain structure and function over the course of approximately five (5) months in preschool-aged children participating in an Early Childhood/Headstart preschool program when compared to a control group of their peers.

Official Title
-----------------
Effects of Music Intervention on the Brain Development of Preschool Children

Conditions
-----------------
Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are between the ages of 3 and 4.5 years old and are involved in the intervention arm of the Avera Family Wellness Program Children who are between the ages of 3 and 4.5 years old and are involved in the control arm of the Avera Family Wellness Program Exclusion Criteria: Unable to provide written consent to participate in the research project Unable to complete the MRI scan

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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 |
| --- | --- |
| Intervention children<br>Children who are receiving a Suzuki-like violin instruction through their participation in an Early Childhood/Headstart preschool program | |
| Control Group<br>Preschool-age children who are not receiving Suzuki-like violin instruction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical mantle thickness | Measure cortical mantle thickness in unsedated preschool-age children with an initial magnetic resonance imaging (MRI) scan and compare to measured cortical mantle thickness after a second MRI scan in the same children after 5 months | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal volume | Measure hippocampal volumes in unsedated preschool-age children with an initial MRI scan and compare hippocampal volumes in the same children with a second MRI scan after 5 months | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain, brain development, MRI, preschool children, cortical mantle thickness, hippocampal volume
Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects

Study Overview
=================
Brief Summary
-----------------
vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane

Detailed Description
-----------------
there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique

Official Title
-----------------
Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study

Conditions
-----------------
Periodontal Bone Loss, Periodontal Pocket

Intervention / Treatment
-----------------
* Dietary Supplement: locally injected vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with infrabony vertical defects systemically free patients periodontally affected patients Exclusion Criteria: patients with systemic diseases smokers pregnency

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-surgical periodontal regeneration<br>non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect | Dietary Supplement: locally injected vitamin D<br>* locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects<br>* Other names: non-surgical periodontal rgeneration;|
| Active Comparator: surgical peridoontal regeneration<br>surgical periodontal regeneration using bone graft and collagen barrier | Dietary Supplement: locally injected vitamin D<br>* locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects<br>* Other names: non-surgical periodontal rgeneration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic interproximal bone level | radiographic interproximal bone level | 6 months |
Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

Study Overview
=================
Brief Summary
-----------------
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.

Official Title
-----------------
Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

Conditions
-----------------
Infant

Intervention / Treatment
-----------------
* Other: Infant Formula milk based
* Other: Infant formula milk based


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures. Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids. Exclusion Criteria: Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Infant has been treated with antibiotics 3 days prior to enrollment. Infant has received probiotics-containing products 3 days prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 84 Days
Maximum Age: 159 Days

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercially available infant formula A<br>Varying fat blend from comparator product | Other: Infant Formula milk based<br>* Consume ad lib<br>|
| Active Comparator: Commercially available infant formula B<br> | Other: Infant formula milk based<br>* consume ad lib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium absorption |  | 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium retention, fat absorption, tolerance |  | 18 days |
Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

Detailed Description
-----------------
Symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum. About 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization. Critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects. Acute respiratory distress syndrome represents the most common complication in patients with severe disease. Several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population. The purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with SARS-CoV-2 admitted to the Intensive care Unit requiring invasive mechanical ventilation using vein ultrasonography.

Official Title
-----------------
Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With SARS-CoV-2 Infection

Conditions
-----------------
SARS Virus

Intervention / Treatment
-----------------
* Other: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to the Intensive Care Unit laboratory confirmed SARS-CoV-2 infection invasive respiratory support Exclusion Criteria: none

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 |
| --- |
|Other: Ultrasonography|Venous compression ultrasonography using real-time B-mode and colour doppler in transverse and longitudinal views|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period prevalence of deep vein thrombosis (DVT) | Percent (%) of patients with a DVT | From date of inclusion in the study until the date of development of a DVT, date of death from any cause, or date of discharge from the ICU, whichever came first, assessed up to 3 months |
To Study the Mechanisms of Acupuncture Through Functional Magnetic Resonance Imaging and Peripheral Neurosensory Testing

Study Overview
=================
Brief Summary
-----------------
Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both the peripheral and the central nerve systems

Official Title
-----------------
Healthy Subject Studies to Assess the Effect of Different Electroacupuncture Parameters on Analgesia, Peripheral Sensory Thresholds and Central Pain Processing.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Electroacupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 80 Male and female No acupuncture treatment for the past 2 weeks No analgesics for the past 2 weeks Absence of neuropathic pain states Exclusion Criteria: History of psychological illness History of Claustrophobia Lack of ability to understand the experimental protocol and to adequately communicate in English Pregnancy Pending litigation History of head trauma History of trauma or surgery to lower extremities and pelvic area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Electroacupuncture|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Analgesia, Functional magnetic resonance imaging (fMRI), Neuronal Mechanisms, Quantitative Peripheral Sensory Testings, Normal Volunteers
Autoimmune Thyroid Disease Genetic Study

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this project is that specific genes can be identified that contribute to genetic susceptibility to autoimmune thyroid disease (AITD) in different populations. The specific aim of this project is carry out one or more genomewide association studies (GWAS) to map and ultimately identify genes that confer susceptibility to AITD. AITD consists principally of Hashimoto's Thyroiditis (HT) and Graves' Disease (GD), characterized clinically generally by hypothyroidism and hyperthyroidism, respectively. Both HT and GD are autoimmune diseases characterized by infiltration of the thyroid by T and B cells that are reactive with thyroid antigens and by the production of thyroid autoantibodies (TAB). While there is some evidence that there may be genes specific to either GD or HT, other genes appear to be common to both, and some genes may furthermore be in common to susceptibility to other autoimmune diseases. Genes known to play a role in AITD include HLA, CTLA4, thyroglobulin (TG), THSR, and CD40, PTPN2, and PTPN22, several of which are also involved in susceptibility to other autoimmune diseases. All of these genes interact in a complex manner that has yet to be understood. Furthermore, it seems clear that relatively few of the genes involved in susceptibility to AITD have thus far been discovered.

Official Title
-----------------
Autoimmune Thyroid Disease Genetic Study

Conditions
-----------------
Hashimoto's Disease, Graves' Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of abnormal thyroid function (hypo or hyperthyroidism) due to autoimmune thyroid disease Exclusion Criteria: Lack of documentation of abnormal thyroid function or clear evidence of autoimmune etiology

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| Autoimmune Thyroid Disease<br>Patients with Hashimoto's disease or Graves' disease | |
| Unaffected Population<br>Population not known to be affected by Hashimoto's Disease or Graves' Disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Map and identify genes that confer susceptibility to Autoimmune Thyroid Disease (AITD) | SNP genotypes (allele frequencies, genotype frequencies) will be compared in cases versus controls. | Approximately one year after all samples are collected |
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

Study Overview
=================
Brief Summary
-----------------
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.

Official Title
-----------------
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

Conditions
-----------------
Gaucher Disease

Intervention / Treatment
-----------------
* Drug: Taliglucerase alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003 The subject signs an informed consent Exclusion Criteria: Currently taking another investigational drug for any condition. Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taliglucerase alfa 30 units/kg<br>Subjects randomized to receive 30 units/kg | Drug: Taliglucerase alfa<br>* Taliglucerase infusion every two weeks for 21 months<br>|
| Experimental: Taliglucerase alfa 60 units/kg<br>Subjects randomized to 60 units/kg | Drug: Taliglucerase alfa<br>* Taliglucerase infusion every two weeks for 21 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spleen Volume | Spleen volume measured by MRI | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Volume | Liver volume by MRI | 60 months | 
| Platelet Count | Platelet count measure annually | 60 months | 
| Hemoglobin | Hemoglobin measure yearly | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enzyme replacement therapy