linjc16/ctgov huggingface dataset:
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.

Official Title
-----------------
Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Dietary Supplement: Oncoxin + Viusid
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment-naive subjects with recent onset rheumatoid arthritis Signed informed consent Exclusion Criteria: Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis

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: A<br>Oncoxin + Viusid | Dietary Supplement: Oncoxin + Viusid<br>* 50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.<br>|
| Placebo Comparator: B<br> | Dietary Supplement: Placebo<br>* 50 ml of Placebo (orally administered) twice a day, for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score (DAS 28 score) at week 12. | DAS 28=(0.56√NAD+ 0.28√NAT+0.7ln⁡VSG+0.14EGE) where NAD: number of joints with pain; NAT: number of joints with increased volume; VSG: sedimentation rate of erythrocytes; EGE: Global assessment of disease by the patient on a visual analog scale (1 to 100 mm) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events at week 12 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
Longitudinal Morphometric Changes Following SCI

Study Overview
=================
Brief Summary
-----------------
In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the level of the lesion provides evidence of neural degeneration; however, the spatial and temporal patterns of progression and their relation to clinical outcomes are uncertain. New interventions targeting acute spinal cord injury have entered clinical trials but neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim to use MRI to assess neuronal degeneration above and below the level of the lesion after acute spinal cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic spinal cord injury and healthy controls. We assess patients clinically and by MRI at baseline, 2 months, 6 months, 12 months, and if possible 24 months and 60 months follow-up, and controls by MRI at the same timepoints. We assess cervical atrophy in white and gray matter and use cross-sectional spinal cord area measurements to assess atrophy at cervical level (C2/C3) and in the lumbar enlargement. We use myelinsensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps in the brain to assess microstructural changes associated with myelin. We also use diffusion tensor imaging acquired in the spinal cord at C2/C3 and in the lumbar enlargement to identify axonal loss and demyelination in the spinal white matter. Finally, we assess associations between MRI parameters and clinical improvement.

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCI patients: acute injury to the spinal cord no medical or mental illness written informed consent over the age of 18 years Control subjects: over the age of 18 years written informed consent Exclusion Criteria: SCI patients: head or brain lesion associated with the trauma leading to the injury epileptic seizures MRI contraindications pregnant women or lactating women Control subjects: pregnant women or lactating women MRI contraindications neurological or psychiatric illness

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCI subjects<br> | |
| healthy control subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cord and brain volume (mm^3) changes |  | Patients will be recruited within the first months of injury and scanned 6 times during the first 5 years post injury. Healthy controls will follow the same time line. |
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Study Overview
=================
Brief Summary
-----------------
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.

Official Title
-----------------
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Conditions
-----------------
Chronic Total Occlusion

Intervention / Treatment
-----------------
* Device: CTO Crossing and Percutaneous transluminal angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suitable candidate for non-emergent, peripheral angioplasty documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply) limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery Exclusion Criteria: intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel appearance of thrombus or intraluminal filling defects peripheral intervention in the target limb within two weeks of the procedure renal insufficiency (serum creatinine of > 2.3 mg/dl) contraindication to a peripheral artery intervention participation in another investigational protocol

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 |
| --- |
|Device: CTO Crossing and Percutaneous transluminal angioplasty|Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Patients with a Major Adverse Events (MAE) | MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication. | 30 Day | 
| Incidence of Intraprocedural Technical Success | Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO | Intraprocedural (<24 hours) |
A Phase II Study of DMP 115 to Assess Focal Liver Lesions

Study Overview
=================
Brief Summary
-----------------
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.

Official Title
-----------------
An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: Peflutren Lipid Microsphere Injectable Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with 1 but <7 focal liver lesions Scheduled for liver biopsy within 30 days of study Scheduled for CT or MR within 30 days of study Exclusion Criteria: Critically ill subjects Subjects with right-to-left shunts

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peflutren Lipid Microsphere Injectable Suspension|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images. |  |  |
Endorectal Coil Magnetic Resonance Images (ERC-MRI)

Study Overview
=================
Brief Summary
-----------------
When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the rectum, we can see areas with tumour in the prostate gland, and well as details of the anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use this images to help target radiation therapy to the tumour better, we need to deform the images to the original shape of the prostate gland without the coil. In this study, we will develop a way to deform the images accurately.

Official Title
-----------------
Development of a Prostate Deformation Model to Enable Accurate Registration of Endorectal Coil Magnetic Resonance Images (ERC-MRI) to Reference Treatment Planning CT Images

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: Endorectal Coil Magnetic Resonance Images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenocarcinoma of the prostate patient undergoing dose escalated conformal EBRT low or intermediate risk prognostic factors: PSA < or equa to20, gleason score <8, T <T3, N category 0 or X, M category 0 or X > or equal to 18 years of age ECOG performance status 0 or 1 Exclusion Criteria: contraindications to MRI bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding insertion of fiducial markers IFB or collagen vascular disease previous colorectal surgery previous pelvic RT

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endorectal Coil Magnetic Resonance Images|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of this study is to develop a prostate deformation model using the finite element method from anatomic MR images of the prostate gland acquired with and without ERC. |  |  |
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Study Overview
=================
Brief Summary
-----------------
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.

Official Title
-----------------
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Conditions
-----------------
Pulmonary Arterial Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAH Treprostinil treatment for at least 3 months Severe infusion site pain Exclusion Criteria: Pregnancy/breastfeeding Decompensated heart failure Chronic liver disease Abnormal electrolytes Heart block (2/3 degree), sino-atrial block, idioventricular rhythm Systolic systemic BP <90mmHg Bradycardia HR <55 Adverse reaction to lidocaine or other amide local anesthestic Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br> | Drug: Lidocaine<br>* Lidocaine<br>|
| Placebo Comparator: Placebo<br>Remodulin only | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Questionnaire | Short Form McGill Pain Questionnaire - Change from baseline over one week | 1 week | 
| Daily Pain Diary | 10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proNT-BNP |  | 1 week | 
| 6 minute walk |  | 1 week | 
| Lidocaine level |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remodulin, Treprostinil
Modelling Weight Reference Centiles for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

Detailed Description
-----------------
It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at <34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

Official Title
-----------------
Modelling Predictive gender-and Gestation-specific Weight Reference Centiles for Preterm Infants Using a Population-based Cohort Study at Neonatology Unit of Assuit University Children Hospital

Conditions
-----------------
Pre-Term

Intervention / Treatment
-----------------
* Other: weight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data will be collected for all infants born at <34 weeks of gestation who were delivered by vaginal or caesarian section and born at Assuit University Hospital or referred to it. Exclusion Criteria: (1) Any neonate born at 34 weeks of gestation or more, (2) any neonate born at <34 weeks of gestation who died before a second weight could be recorded.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Month

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: weight|we can monitoring the growth of the infants by weight gain degree|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modelling predictive gender-and gestation-specific weight reference centiles for preterm infants using a population-based cohort study at neonatology unit of Assuit University Children Hospital | It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at <34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study. | one year |
Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia

Detailed Description
-----------------
80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.

Official Title
-----------------
Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: local anesthetic
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery ASA 1, II, AND III Exclusion Criteria: Patient refusal Infection at the entry site BMI > 3

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmethasone group<br>8 mg dexamethasone will be added to local anaesthetics | Drug: Dexamethasone<br>* dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery<br>|
| Sham Comparator: control group<br>isobaric bupivacaine will be given on each side | Drug: local anesthetic<br>* ultrasound guided superficial cervical block in thyroid surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesia duration | time of first analgesic requirement is the time of end of block analgesia | 24 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications related to the block | occurrence of complications secondary to the block well be recorded | 8 hours |
Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Study Overview
=================
Brief Summary
-----------------
Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique. This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART. The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .

Official Title
-----------------
Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: ganirelix
* Drug: suprefact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first cycle of ART age < 35 years basal FSH < 10 IU/L Exclusion Criteria: previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis only one ovary

Ages Eligible for Study
-----------------
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GnRH antagonist ganirelix 0.25 mg fromm 6th ovarian stimulation | Drug: ganirelix<br>* These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).<br>|
| Active Comparator: 2<br>GnRH agonist, suprefact, stimulation with a standard long protocol | Drug: suprefact<br>* GnRH agonist, standard protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | 2weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovarian stimulation |  | 10days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation