linjc16/ctgov huggingface dataset:
Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.

Conditions
-----------------
Vaccination Adverse Events, Vaccination Failure, Specific Antibody Response

Intervention / Treatment
-----------------
* Biological: biological monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Military volunteers No recently immunized Exclusion Criteria: Pregnancy Documented immunodepression Documented allergy or hypersensitivity to vaccines

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm :vaccinated<br>military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy | Biological: biological monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunomediated disorders related to multiple vaccination |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of multiple vaccination |  | Three years | 
| immunogenicity of multiple vaccination |  | Three years |
Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues

Study Overview
=================
Brief Summary
-----------------
to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment.

Detailed Description
-----------------
50 hair follicle dissection - human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery , without any relation to our study. The study will be planned according to Helsinki declaration for Paraffin embedded LTS tissue sections (4 µ) will be processed and examined in immunohistochemistry lab. FP receptor proteins expression, using subtype-specific polyclonal antibodies, will be detected by the light microscopic level, according to manufacturer instruction.

Official Title
-----------------
Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues

Conditions
-----------------
Malposition of the Lower Lid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years malposition of lower eyelid Exclusion Criteria: age < 18 years

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 |
| --- | --- | --- |
Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ocular hypertension or glaucoma in each eye Requires IOP-lowering treatment in both eyes Exclusion Criteria: Use of dorzolamide or carbonic anhydrase within 4 weeks Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye) Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted) Use of oral, injectable or topical ophthalmic steroids within 21 days Any eye laser surgery within 3 months Any intraocular surgery (eg cataract surgery) within 6 months

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: Triple Combination Therapy<br>Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. | Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution<br>* 1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Intraocular Pressure (IOP) |  | Baseline, Week 12 |
The Effects of LAF237 on Gastric Function in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.

Official Title
-----------------
A Double Blind, Cross Over, Placebo Controlled, Multiple-dose Study to Evaluate the Effects of LAF237 on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: LAF237 = vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LAF237 = vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Emptying |  |  | 
| Gastric accommodation |  |  | 
| Satiety |  |  | 
| Gastrointestinal Symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal Appearance Rate |  |  | 
| Glucose Disappearance |  |  | 
| Endogenous Glucose Production |  |  | 
| Insulin Secretion |  |  | 
| Glucagon Secretion |  |  |
TNS for Treating Major Depressive Disorder in the Elderly

Study Overview
=================
Brief Summary
-----------------
This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.

Official Title
-----------------
Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial

Conditions
-----------------
Major Depressive Disorder, Elderly

Intervention / Treatment
-----------------
* Device: Transcutaneous Trigeminal Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between 65 and 99 years patients with a diagnosis of depression according to the SCID score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode) agreement to participate in the study as recommended in the IC. Exclusion Criteria: patients with psychiatric indication for hospitalization patients with psychiatric comorbidity patients with a diagnosis of personality disorder presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 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: ACTIVE tNS<br>TNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed on the forehead just above the supraorbital foramen bilaterally. The study protocol will follow the rational of our previous trials with TNS. | Device: Transcutaneous Trigeminal Nerve Stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depressive Rating Scale version 17 items (HDRS-17) | This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in elderly patients with moderate / severe depressive episode | Change from baseline in depressive symptoms at 2 weeks ] |
Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

Study Overview
=================
Brief Summary
-----------------
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life. In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated. Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term. the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques

Official Title
-----------------
Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

Conditions
-----------------
Arthrodesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subjects> 18 years old Subject operated at HUS between 01/01/2010 to 31/12/2020 Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

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 |
| --- | --- | --- |
| Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies |  | Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthrodesis, degenerative lumbar scoliosis, Scoliosis, spinal dysmorphism
Post Market Observational, Prospective, Multi-center Study

Study Overview
=================
Brief Summary
-----------------
This registry is a post market observational, prospective, multi-center registry. It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.

Official Title
-----------------
Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Device: PneumRx Coil System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion and exclusion criteria in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.

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 |
| --- | --- |
| Treatment<br>Patients treated with PneumRx Coil System | Device: PneumRx Coil System<br> <br> * Other names: LVRC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of Life (QOL) measures |  | 6 months and yearly up to three years post treatment 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pulmonary Function and Exercise Capacity test results |  | 6 months and yearly up to three years post treatment 1 | 
| Safety including any device malfunction or failure(s) |  | 6 months and yearly up to three years post treatment 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coil, RePneu, PneumRx, LVRC
Correlation of Visual and Motor Deficits in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of patients with stroke with accompanying motor and visual deficits. There will be patients' evaluations at 2 time points at the acute and subacute period after the stroke. Statistical correlation of the improvement of their deficits will be conducted

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: Physiotherapy and speech therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute phase stroke patients with motor and visual deficits Exclusion Criteria: previous stroke, neurologic disease or visual deficit

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stroke patients<br> | Procedure: Physiotherapy and speech therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemispheric stroke scale |  | participants will be followed for the duration of hospital stay, an expected average of 6 weeks from the time of stroke | 
| visual fields exam |  | participants will be followed for the duration of hospital stay, an expected average of 6 weeks from the time of stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
course of motor and visual rehabilitation, improvement of deficits, stroke patients
Rhizomelic Chondrodysplasia Punctata Registry

Study Overview
=================
Brief Summary
-----------------
The goal of this registry is to collect medical information on individuals with rhizomelic chondrodysplasia punctata and closely related conditions. 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 rhizomelic chondrodysplasia punctata (also called RCDP). This registry will enable detailed natural history studies of RCDP, with the 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 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
-----------------
Rhizomelic Chondrodysplasia Punctata Registry at A.I. duPont Hospital for Children

Conditions
-----------------
RCDP - Rhizomelic Chondrodysplasia Punctata, RCDP1, RCDP2, RCDP3, RCDP4, RCDP5

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with RCDP or closely related conditions by metabolic and/or genetic testing Exclusion Criteria: Not meeting diagnosis of RCDP or closely related conditions by study team physician review of prior metabolic and/or genetic testing
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 |
| --- | --- | --- |
| Characterizations of the natural history of rhizomelic chondrodysplasia punctata | Data will be collected at enrollment, and over time, to allow for analysis of associated features throughout the lifespan | 5 years | 
| Identification of clinical features that are predictive of poor outcomes | Identifying risk factors will allow for preventative treatments and thus a better quality of life for individuals with RCDP. | 5 years |
Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Study Overview
=================
Brief Summary
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate

Official Title
-----------------
Study of the Human Anti-TNF-Antibody Adalimumab

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: adalimumab
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints. Exclusion Criteria: A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40 mg<br> | Biological: adalimumab<br>* 40 mg adalimumab sc, every other week<br>* Other names: Humira;|
| Placebo Comparator: Placebo<br> | Biological: placebo<br>* placebo sc, every other week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 |  | Week 12 | 
| ACR70 |  | Week 12 |