linjc16/ctgov huggingface dataset:
Factors Affecting the Endodontic Treatment Outcome

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.

Conditions
-----------------
Apical Periodontitis, Apical Granuloma, Apical Cyst

Intervention / Treatment
-----------------
* Procedure: primary endodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients referred to the private endodontic specialist office for endodontic treatment written informed consent was obtained prior beginning of the treatment. Exclusion Criteria: preoperative advanced periodontal disease prior microsurgical root-end resection performed apices of the tooth were not clearly discernible on any of periapical radiographs endodontic treated teeth were extracted for non-endodontic reason the patient did not attend a follow-up examination.

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 |
| --- |
|Procedure: primary endodontic treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcome based on strict combined radiographic and clinical criteria | Successful treatment outcome is defined as an absence of radiographic sign of apical periodontitis (periapical index PAI <= 2) and clinical signs of inflamation (swelling, sinus tract, tenderness to periapical palpation and percussion, pain) on follow-up examination 1-4 years postoperatively | 1-4 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
root canal treatment, outcome, success
Diagnosis of Mucopolysaccharidosis Disorders in Patients Presenting With Bilateral Hip Disease

Study Overview
=================
Brief Summary
-----------------
BACKGROUND/OBJECTIVE: Quantitative urine screening for mucopolysaccharides (MPS) has been the primary method for detecting mucopolysaccharidoses in children. This method may not be sufficiently sensitive and may miss some patients with arylsulfatase B (ARSB) deficiency. Investigators propose to identify patients retrospectively and prospectively who carry a diagnosis of spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral proximal femoral epiphyseal dysplasia, or bilateral Legg-Calve-Perthes. For these patients, investigators will perform enzyme testing on a blood sample which will identify MPS VI or IVA. Patients who have an earlier diagnosis of MPS are likely to have better health outcomes with medical management. Therefore, it is important to determine effective diagnostic methods. Investigators believe that bilateral hip involvement should alert the clinician to the possibility of MPS VI and further examination. The purpose of this study is to test the hypothesis that the correct diagnoses of two MPS storage disorders are delayed in patients with bilateral proximal femoral epiphyseal dysplasia and normal quantitative urine MPS studies.

Official Title
-----------------
Diagnosis of Mucopolysaccharidosis Disorders in Patients Presenting With Bilateral Hip Disease

Conditions
-----------------
Mucopolysaccharidosis IV A, Mucopolysaccharidosis VI

Intervention / Treatment
-----------------
* Other: Enzyme testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 21 years of age Diagnosis of spondyloepiphyseal dysplasia or multiple epiphyseal dysplasia or bilateral Legg-Calve-Perthes disease or bilateral proximal femoral epiphyseal dysplasia. Exclusion Criteria: Definitive etiology for above-mentioned diagnosis (i.e. other MPS disease, known chondrodysplasia, Meyer's dysplasia)

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Diagnosis of hip disease<br>Diagnosed with spondyloepiphyseal dysplasia or multiple epiphyseal dysplasia or bilateral Legg-Calve-Perthes disease, or bilateral proximal femoral epiphyseal dysplasia | Other: Enzyme testing<br>* Leukocyte activity measurement of Arylsulfatase B and N acetyl galactosamine 6 sulfatase (GALNS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects identified with MPS IVA or VI |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral Legg Calve Perthes, bilateral proximal femoral epiphyseal dysplasia, GALNS
An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the treatment pattern and patient characteristics in real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel IR in Sweden.

Detailed Description
-----------------
An epidemiological registry study to evaluate clinical practice treatment in patients with Bipolar Disorder treated with quetiapine XR and/or quetiapine IR

Official Title
-----------------
An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of BD. Exclusion Criteria: Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.
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 |
| --- | --- | --- |
| Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before, at and after the index date. |  | 1st of January 2009 to 31st of December 2010. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before and at the index date. |  | 1st of January 2009 to 31st of December 2010. | 
| Description of the detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD, including all drug treatment after the index date |  | 1st of January 2009 to 31st of December 2010. | 
| Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD, including all drug treatment before and at the index date |  | 1st of January 2009 to 31st of December 2010. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real life setting, Bipolar Disorder, Registry based Data Base Audit
Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

Official Title
-----------------
A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator

Conditions
-----------------
Arrhythmias

Intervention / Treatment
-----------------
* Drug: azimilide dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who completed at least 12 months on study 2000098 before inclusion in this study Exclusion Criteria: breast feeding or plan to become pregnant used ticlopidine were taking Class I or other Class III drugs

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>125 mg azimilide | Drug: azimilide dihydrochloride<br>* oral, once daily until sponsor stopped the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of azimilide in this patient population |  | 1 year |
Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.

Official Title
-----------------
A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Tasocitinib (CP-690,55) plus Ketoconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years Exclusion Criteria: Clinically significant disease Recent history of serious infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasocitinib (CP-690,550) plus Ketoconazole<br> | Drug: Tasocitinib (CP-690,55) plus Ketoconazole<br>* Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of tasocitinib (CP-690,550) |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax, and Tmax of tasocitinib (CP-690,550) |  | 5 days | 
| Safety: laboratory tests, AE reporting and vital signs |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-Drug Interaction, Healthy Volunteers, Tasocitinib (CP-690, 550), Ketoconazole
Validation of the Sickle Cell Disease Pain Burden Interview

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview (SCPBI), which can be used in the clinical and/or research settings to assess the impact of pain on children with sickle cell disease.

Conditions
-----------------
Sickle Cell Disease, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented sickle cell disease 7 years old or greater Primary caregiver present at the first visit for children < 18 years of age Exclusion Criteria: Primary language spoken other than English Patient is in acute pain episode at time of initial visit

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Correlation with validated measures of pain interference, function, quality of life, and mood. |  | Quarterly |
Effects of Providing Preprint Preoperative Anesthetic Risk Information

Study Overview
=================
Brief Summary
-----------------
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group

Official Title
-----------------
Effects of Providing Preprint Preoperative Anesthetic Risk Information

Conditions
-----------------
Preoperative Anxiety

Intervention / Treatment
-----------------
* Other: preprint preoperative anesthetic risk information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia Low to moderate risk surgery Exclusion Criteria: Patient's refusal Patients scheduled for cardiovascular surgery and neurosurgery Patients with consciousness change following surgery Emergency case CNS or psychological diseases

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| Placebo Comparator: 1<br>Routine anesthetic risk information | Other: preprint preoperative anesthetic risk information<br>* preprint preoperative anesthetic risk information<br>|
| Active Comparator: 2<br>Preprint preoperative risk information | Other: preprint preoperative anesthetic risk information<br>* preprint preoperative anesthetic risk information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spielberger State Trait Anxiety Inventory Scale |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, preprint anesthetic risk information
Detection of Small Fiber Neuropathy Using Skin Properties

Study Overview
=================
Brief Summary
-----------------
Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

Detailed Description
-----------------
Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection. The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies. This approach can improve the availability of diagnosis of small fiber neuropathy.

Official Title
-----------------
Detection of Small Fiber Neuropathy Using Skin Properties

Conditions
-----------------
Small Fiber Neuropathy

Intervention / Treatment
-----------------
* Other: Image processing of skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age 18 year or older Patients that sign the informed consent form to participate in this study Patients completed the autonomic testing with skin biopsies Exclusion Criteria: Patients with significant hairs at the legs that will cover the skin Any dermatological disorder that can affect the skin composition The use of skin lotion

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: Image processing of skin|Image processing will be used to extract skin features that correlate with loss of small skin fibers.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of image processing | The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference. | 2 years |
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.

Detailed Description
-----------------
This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively). A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.

Official Title
-----------------
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Conditions
-----------------
Leukemia/Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR) Adults ≥18 years of age with either CTCL or ATLL; AlloHCT performed from January 2012 onward. Exclusion Criteria: • Patients without consent for research.

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 |
| --- | --- |
| Transplant Arm<br>Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT | |
| Control Arm<br>Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination | This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study. | one year prior to alloHCT to within 18 months after alloHCT |