linjc16/ctgov huggingface dataset:
Autoimmunity in the Pathogenesis of AF

Study Overview
=================
Brief Summary
-----------------
This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

Detailed Description
-----------------
The study sets out to identify an explanation for the pathogenesis of AF, potentially forming the basis for designing novel targeted therapies to prevent or reverse this prevalent human disease. The overall objectives are to determine whether autoimmune diseases are associated with AF development and to identify specific diagnostic and prognostic biomarkers that will improve the ability to accurately predict risk of AF development. The study will prospectively enroll patients with and without AF and determine their serum cytokine levels and assess the functional responses of T cells on the basis of cytokine production after in vitro T-cell specific stimulation, using Luminex bead-based multiplex technology.

Official Title
-----------------
The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Peripheral Blood Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: AF (Persistent, paroxysmal AF) Controls 1: (No prior history of AF or inflammatory or autoimmune diseases) Controls 2: (biopsy proven Psoriasis) Exclusion Criteria: Clinically apparent acute infections over the past 4 weeks Chronic infections Recent malignancies Recent Radiation or chemotherapy Chronic kidney disease (≥ stage 2) Organ transplantation History of chronic liver disease Major surgery or invasive procedure in the past 6 months Internal prosthesis Receiving immunosuppressive therapy Known rheumatologic diseases (except for the participants with psoriasis) Females who are known to be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Persistent AF<br> | Other: Peripheral Blood Sample<br>* 30mL peripheral whole blood sample<br>|
| Paroxysmal AF<br> | Other: Peripheral Blood Sample<br>* 30mL peripheral whole blood sample<br>|
| Psoriasis<br> | Other: Peripheral Blood Sample<br>* 30mL peripheral whole blood sample<br>|
| Healthy Controls<br> | Other: Peripheral Blood Sample<br>* 30mL peripheral whole blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines Levels | Cytokine Profiles | through study completion, approximately 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autoimmune Diseases
Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes

Study Overview
=================
Brief Summary
-----------------
Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® in order to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Detailed Description
-----------------
Autologous cell therapy remains the standard treatment in lymphomas (Hodgkin or non Hodgkin) and myelomas in the first line if they have bad prognostic factors or second-line cases of relapsed or relapsed patients. The essential condition for performing an autograft is the existence of a graft sufficient for this procedure. The European Society of Marrow Transplantation (EBMT) recommends to inject a minimum of 2 × 10 6 CD34 + cells / kg. Although in terms of conventional products (Neupogen® and Granocyte®), the literature is very rich, there is no data on the use of biosimilars in this indication. A PUBMED search using the terms peripheral blood stem cell harvest, OR Zarzio® biosimilars did not produce any results. Zarzio® has a tolerance and efficacy profile equivalent to classical products when used in post-chemotherapy, primary or secondary prophylaxis. It therefore seems important to compare its efficacy and tolerance in mobilization situations for peripheral stem cell sampling.The Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Conditions
-----------------
Hematology, Graft, Mobilization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age supérieur to 8 year Recommandation of ABSCT Exclusion Criteria: - No indication of ABSCT Age inférieur to 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF) | Utilisation of bio similairs of GCSF for stimulation in view of obtaining an autologous graft | Two days |
The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

Study Overview
=================
Brief Summary
-----------------
To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture

Official Title
-----------------
A Six Month Double-Blind, Placebo-Controlled Trial Followed by Six Month Open-Label Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Alendronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female aged > 55 Low trauma hip fracture up to 90 days Be willing to submit to periodic bone mineral density radiographic studies of the spine & 24 hr urine collection Written informed consent - Exclusion Criteria: Disorders known to affect bone metabolism Not taking bisphosphonates within last 6 months Drugs known to interfere with calcium metabolism within the lats 6 months prior to hip fracture serum calcium> 2.65 mmol/L Treatment with any investigational drug within the last 30 days

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.

Detailed Description
-----------------
The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.

Official Title
-----------------
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis, Ocular Myasthenia Gravis

Intervention / Treatment
-----------------
* Drug: Apraclonidine Hcl 0.5% Oph Soln


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement. Exclusion Criteria: Patients receiving mono-amino-oxidase inhibitors. Patients with history of hypertension, cardiac, or cerebrovascular disease. Women with confirmed pregnancy.

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

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

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

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: Patients<br>Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis. | Drug: Apraclonidine Hcl 0.5% Oph Soln<br>* Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye<br>* Other names: Iopidine 0.5%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in palpebral fissure height (PF) | Change in PF measurements | Before administration, at 1, 5, 30, and 60 minutes after administration | 
| Change in marginal reflex distance-1 (MRD1) | Change in MRD1 measurements | Before administration, at 1, 5, 30, and 60 minutes after administration | 
| Change in marginal reflex distance-2 (MRD2) | Change in MRD2 measurements | Before administration, at 1, 5, 30, and 60 minutes after administration | 
| Change in levator function (LF) | Change in LF measurements | Before administration, at 1, 5, 30, and 60 minutes after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myasthenia gravis, ocular myasthenia, apraclonidine
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation

Official Title
-----------------
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: CT ASPHINA 409


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; Patients of any gender Assured follow-up examinations Biometry measurement preferably compatible with the IOLMaster evaluation; IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract) Exclusion Criteria: BCVA not available preoperatively or better than 0.3 logMAR pre-op Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial Patients whose freedom is impaired by administrative or legal order Concurrent participation in another drug or device investigation -
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: 409M<br>CT ASPHINA 409M IOL | Device: CT ASPHINA 409<br>* intraocular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Monocular best corrected distance visual acuity | 12 to 18 months after surgery |
L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

Detailed Description
-----------------
This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension

Official Title
-----------------
Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Conditions
-----------------
Thalassemia

Intervention / Treatment
-----------------
* Drug: L-arginine
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with thalassemia and pulmonary hypertension. Exclusion Criteria: Rheumatic heart diseases. Other comorbid disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Active Comparator: L-arginine<br>l-arginine for pulmonary hypertension in patients with thalassemia. | Drug: L-arginine<br>* l-arginine for thalassemia with pulmonary hypertension<br>|
| Active Comparator: Sildenafil<br>Sildenafil for pulmonary hypertension in patients with thalassemia. | Drug: Sildenafil<br>* Sildenafil for thalassemia with pulmonary hypertension<br>* Other names: Viagra;|
| No Intervention: Control<br>No pulmonary hypertension | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement of pulmonary hypertension | patients with improvement of pulmonary hypertension | 6 months |
Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
There is no standard treatment for the patient population being asked to participate in this study. Although one current regimen, used by some investigators, has a high rate of response compared to other therapies, it is associated with moderate to severe toxicity. As gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to determine how active and safe they are against patients with this type of cancer.The objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine in patients with this condition.

Official Title
-----------------
Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Conditions
-----------------
Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Pemetrexed
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma No obvious primary on routine history, physical examination, and investigations Patients greater than or equal to 18 years of age ECOG Performance Status 0-1 Patients requiring opioids for pain control must be on a fixed analgesic regimen aimed to provide adequate pain control with no more than 3 breakthrough (supplemental) doses of analgesics per day to control pain; Additional inclusion criteria due apply, but not are not listed here. Exclusion Criteria: Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Unable to stabilize pain and analgesics for a period of 7 days prior to starting study treatment Prior treatment with chemotherapy Bilirubin greater than or equal to 40 mol/L AST or ALT greater than or equal to 5 times the upper limit of normal (ULN); Additional exclusion criteria due apply, but not are not listed here.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary purpose of this study is to determine the objective response rate (ORR) for pemetrexed and gemcitabine when administered every two weeks to patients with adenocarcinoma of unknown origin who present with predominant liver metastases. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives include measures of disease control including overall survival and to describe the toxicities of therapy in this patient population. |  |  |
Evaluation of the PediGuard™ for Pedicle Screw Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine. Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle. Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.

Official Title
-----------------
Evaluation of the PediGuard™ for Pedicle Screw Insertion

Conditions
-----------------
Posterior Spinal Fusion

Intervention / Treatment
-----------------
* Device: Pediguard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1 Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs Written informed consent and assent (assent for adolescents) Exclusion Criteria: Pedicle screw insertion by image guided techniques, including Fluoronav Tumor Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis Severe senile osteoporosis (> 2 standard deviations below the norm) Women who are pregnant Children with open growth plates Previously fused spinal levels Unwillingness to sign written informed consent and assent.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pediguard|PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). |  | Post-op CT prior to discharge |
Study of Applying Acupressure in Low-birth Weight Premature

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.

Detailed Description
-----------------
A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.

Official Title
-----------------
Study of Appling Acupressure in Low-birth Weight Premature

Conditions
-----------------
Premature

Intervention / Treatment
-----------------
* Behavioral: acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center. Exclusion Criteria: Exclusion criteria of very low birth weight (>1500gm) from a sick baby room in a medical center.

Ages Eligible for Study
-----------------
Maximum Age: 37 Weeks

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge. | Behavioral: acupressure<br>* The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.<br>|
| No Intervention: control group<br>The control group only receive routine care in sick baby room unite. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge. | 15 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupressure, very-low- birth-weight premature, body weight, behavioral state, developmental status