linjc16/ctgov huggingface dataset:
To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations

Study Overview
=================
Brief Summary
-----------------
Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints. In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.

Official Title
-----------------
The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations

Conditions
-----------------
Progression of Rheumatoid Arthritis, Osteoarthritis of Multiple Joints

Intervention / Treatment
-----------------
* Procedure: The examinations for bones in joints of OA and RA patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA and/or OA Exclusion Criteria: N/A
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 |
| --- | --- |
| RA and OA<br>Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA. | Procedure: The examinations for bones in joints of OA and RA patients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bone signal changes detected by MRI in OA and/or RA patients |  | 1 year |
T Cell Response in Hypersensitivity Syndrome

Study Overview
=================
Brief Summary
-----------------
immunological study of the T cell repertoire phenotype and functionality in hypersensitivity syndrome.

Official Title
-----------------
Characterization of T Cell Response in Hypersensitivity Syndrome

Conditions
-----------------
Hypersensitivity, Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 cutaneous eruption lymph nodes hepatitis interstitial pneumonia nephritis cardiopathy eosinophilia hyperlymphocytosis Exclusion Criteria: age minor to 18 HIV +

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 |
| --- | --- | --- |
Descriptive Study of Multiligamentary Reconstruction of the Knee

Study Overview
=================
Brief Summary
-----------------
Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft. There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.

Official Title
-----------------
Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.

Conditions
-----------------
Injury, Knee

Intervention / Treatment
-----------------
* Other: Clinical and radiologic evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury >18 years old Exclusion Criteria: Neurological or vascular injury during trauma. Fracture of the femur or both bones of the leg. Ligamentous lesion on the contralateral knee. History of surgery on the affected knee.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clinical and radiologic evaluation<br>Follow up post surgery: clinical and radiologic evaluation | Other: Clinical and radiologic evaluation<br>* Follow up post surgery: clinical and radiologic evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint mobility of both knees | Postoperative knee function assessed by clinical examination | 2 years | 
| Postoperative laxity in varus, valgus, anterior and posterior drawer | Postoperative knee function assessed by clinical examination | 2 years | 
| Postoperative knee function assessed by scores |  | 2 years |
Evaluation of Filtering Blebs Using the Wuerzburg Bleb Classification Score Compared to Other Clinical Findings, e.g. the Intraocular Pressure (IOP)

Study Overview
=================
Brief Summary
-----------------
It is well established to assess the functionality of a filtering bleb by intraocular pressure (IOP), either as an absolute value or as a percent reduction, and by the need of additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a clinical score, e.g. the Wuerzburg bleb classification score (WBCS). The purpose of this study was to find out whether there is a correlation between clinical findings, in particular IOP and the WBCS. 100 eyes within two years after trabeculectomy were included into the study. Using colour photographs the filtering bleb was evaluated according to the WBCS from two different examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical history were taken by another examiner. Trial with surgical intervention

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Trabeculectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of glaucoma, status post trabeculectomy Exclusion criteria: age <18 Jahre, other optic neuropathy than glaucoma

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: Trabeculectomy|A scleral flap is created. The aqueous humor is so guided under the conjunctiva to lower IOP.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

Study Overview
=================
Brief Summary
-----------------
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Detailed Description
-----------------
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Official Title
-----------------
An Observational, Retrospective, Clinical Performance Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel

Conditions
-----------------
Meningitis/Encephalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that had not been centrifuged Adequate residual volume (≥400 μl) Exclusion Criteria: Specimens not fitting criteria outlined above CSF obtained from an external ventricular drain or shunt source Lack of clear subject identification or label on residual banked CSF specimen Obvious physical damage of banked residual specimen Repeat specimens from the same subject
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 |
| --- | --- | --- |
| sensitivity | positive percentage agreement | 6 weeks | 
| specificity | negative percentage agreement | 6 weeks |
Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.

Official Title
-----------------
LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: LY2062430
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 50 years of age and diagnosed with mild to moderate Alzheimer's disease or healthy volunteers fluent in reading and speaking English AD patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements AD patients who have received AChEIs or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug Exclusion Criteria: Have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years Have serious or uncontrolled health problems or laboratory tests Multiple or severe drug allergies Prior participation in an active immunization study

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: LY2062430<br>* 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks<br>|
| Experimental: 2<br> | Drug: LY2062430<br>* 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks<br>|
| Experimental: 3<br> | Drug: LY2062430<br>* 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks<br>|
| Experimental: 4<br> | Drug: LY2062430<br>* 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* 5: Placebo QW IV for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the plasma pharmacokinetics of LY2062430 |  | 1 year | 
| To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations |  | 1 year | 
| To evaluate the changes in thinking and memory |  | 1 year |
Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

Official Title
-----------------
Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)

Conditions
-----------------
Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced, Meniere Disease

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Hyaluronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry Patients whose hearing has not been restored after standard treatment Patients do not participate in clinical trials within 6 months Exclusion Criteria: Patients with retrocochlear lesion Patients with history of hypersensitivity to the ingredients of this drug Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone+Saline<br> | Drug: Dexamethasone<br>* Dexamethasone 5mg/ml<br>|
| Experimental: Dexamethasone+Hyaluronic Acid<br> | Drug: Dexamethasone<br>* Dexamethasone 5mg/ml<br>Drug: Hyaluronic acid<br>* Hyaluronic Acid 20mg/2ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verification of tympanic membrane with endoscopy (Safety) | Confirming healing time of perforation and inflammation | 3-4 weeks after intratympanic injection | 
| Confirmation of inflammation and drug with CT imaging (Durability) | Checking a time duration of drug in middle and inner ear | 1 day and/or 1 weeks after intratympanic injection | 
| Valuation of hearing threshold with Pure tone audiometry (Efficacy) | Verifying therapeutic effect of intratympanic drug delivery vehicle | 3-4 weeks after intratympanic injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection
Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome

Study Overview
=================
Brief Summary
-----------------
Klinefelter syndrome, a congenital chromosomal abnormality with one or more extra X chromosomes, occurs in out of 400 live male births. The majority of Klinefelter men present with a 47, XXY karyotype. The poly-X variant, with the 49,XXXXY karyotype is uncommon. This syndrome, where subjects have two or more X chromosomes presents with primary hypogonadism, and, particularly if associated with the 49,XXXXY karyotype, significantly impacts life skills across a variety of dimensions, including areas of communication, community use, functional academics, home/school living, health and safety, leisure, self-care, self direction, and work. Adaptive behavior abnormalities in 46,XXY men are well known and described. In the poly-X variant of the 49,XXXXY karyotype, adaptive behavior abnormalities are expected to be much more significant, making these patients eligible for services and Social Security benefits. In 49,XXXXY men no study to date has examined these areas of inquiry in a large patient population, using a psychometrically sound instrument in a large patient population. Current publications are limited to individual case reports or small case summaries. It is important to study the adaptive behavior in its highly abnormal presentation in 49,XXXXY men in order to learn more about the effect of additional X chromosomes on adaptive skills, which determine how an individual responds to daily demands and in order to develop treatment and training goals.

Official Title
-----------------
Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome

Conditions
-----------------
Klinefelter Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any Klinefelter male with proven 49,XXXXY karyotype, who does not present with and is not being treated for significant physical/mental illness which might affect his adaptive behavior, who or whose parent or primary caretaker is able to provide informed consent to participate in the study and who or whose parent or primary caretaker has adequate command of the English language, to provide meaningful information will be invited to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 Years

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

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
-----------------
Kleinfelter
Primordial Dwarfism Registry

Study Overview
=================
Brief Summary
-----------------
The goal of this registry is to collect information on individuals with Microcephalic Osteodysplastic Primordial Dwarfism Type II (also called MOPDII) and other forms of microcephalic primordial dwarfism. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

Detailed Description
-----------------
The goal of this registry is to collect information on individuals with Microcephalic Osteodysplastic Primordial Dwarfism Type II (also called MOPDII) and other forms of microcephalic primordial dwarfism. The registry will enable detailed natural history studies of MOPD II and associated conditions. The study team hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses. This study is limited to chart review, after signed informed consent obtained. There will be no additional visits or time in clinic because of participation in this registry. This study involves only the collection and storage of data extracted from the medical record. Records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, CT/MRI/MRA imaging. There are no special procedures, visits, or expectations of the individual as a result of participation in this registry. No one will be asked to have any specific testing for the sole purposes of this research.

Official Title
-----------------
Primordial Registry at Nemours/Alfred I. duPont Hospital for Children

Conditions
-----------------
MOPDII, RNU4atac-opathy (e.g. MOPDI/III, Lowry-Wood Syndrome, Roifman Syndrome), Meier-Gorlin Syndrome, Saul-Wilson Syndrome, Ligase 4 Syndrome, Microcephalic Primordial Dwarfism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with MOPDII, MOPDI/III, Meier-Gorlin syndrome, or unclassified or closely related types of microcephalic primordial dwarfism as diagnosed by a medical provider are eligible for this registry. Exclusion Criteria: individuals without microcephalic primordial dwarfism or closely related conditions
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 |
| --- | --- | --- |
| Characterization of the natural history of various forms of primordial dwarfism | Data will be collected at enrollment, and over time, to allow for analysis of associated concerns throughout the lifespan | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcephalic primordial dwarfism