cyrilzakka/clinical-trials huggingface dataset:
Pegvisomant And Sandostatin LAR Combination Study

The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly
* Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
* Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment

Exclusion Criteria:

* Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
* Patients on current medical therapy other than Sandostatin LAR
* AST/ALT \>= 3xULN (upper limits of normal)
* Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
* Visual field defects (except post-surgical stable residual defects)
* Unable to self administer drug
* Radiotherapy within 12 months of entering the study
Intravitreal Bevacizumab for Diabetic Macular Edema

Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema.

This study designed to evaluate the effect of Intravitreal injection of a recombinant monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Clinically significant macular edema
* Possibility of performing macular OCT
* Consent of patient for inclusion in the study

Exclusion Criteria:

* History of macular photocoagulation in less than 6 months of inclusion in the study
* Necessity of surgical intervention
* Rejection of the remaining in the study by patient
Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial

The aim of this study is to establish PAtient-Centered Computerized Educating System for Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the intervention group will receive the PACCESS and the control groups will receive traditional health education to test the effects of PACCESS in increasing clinical decision-making, health behavior, activities of daily living and knowledge of stroke, and health care quality.

To prevent recurrent stroke and improve the health-related quality of life (HRQOL) in patients with stroke, education regarding the risk factors of recurrent stroke is a crucial part of effective care for patients with stroke. The aim of this study was to develop an application capable of providing health education for recurrent-stroke prevention. We also examined the effectiveness of this app for improving stroke-related knowledge and HRQOL in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* first time diagnosis of stroke (International Classification of Diseases, ninth revision, clinical modification \[ICD-9\] codes) of cerebral hemorrhage (ICD-9, 431) or cerebral infarction (ICD 9, 434)
* ability to follow instructions and complete the interviews
* having a designated caregiver who agrees to participate in the survey
* \>6 years of education
* have smartphone or the other mobile device can download the APP from internet.

Exclusion Criteria:

* cognitive impairment (Mini-Mental State Examination (MMSE scores\<24)
* having major mental diseases (i.e., depression, dementia, delirium, etc.)
* the inability to read/answer questionnaires
Interstitial Fluid in the Development of Cardiovascular Disease

At a given level of serum cholesterol, patients with T2D have an increased risk of developing atherosclerosis compared with nondiabetic subjects.

In a previous study we showed that the interstitial fluid-to-serum gradient of LDL and VLDL cholesterol is reduced in T2D patients compared with healthy controls. This was not found for HDL cholesterol. However, the cholesterol transporting function of HDL particles from interstitial fluid from patients with T2D were lower than in healthy controls. We hypothesize that that the apo B-containing particles in T2D patients are more susceptible to be retained or consumed in the extravascular space.

We are to study if skin biopsies from T2D patients contain more cholesterol than biopsies from healthy controls. We hypothesize that samples from T2D patients are richer in cholesterol, which could explain why VLDL and LDL cholesterol are lower in relation to their plasma levels in T2D.


Eligibility Criteria:
Inclusion criteria:

* Over 18 years.
* For the T2D study group: Diagnosed with type 2 diabetes.

Exclusion criteria:

For subjects with type 2 diabetes:

* Systemic inflammatory disease that requires active treatment
* Thyroid disease that requires active treatment
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Treatment with oral glucocorticoids
* Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range
* Pregnancy

For healthy controls:

* Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Blood pressure pronouncedly above 140/90
* Blood test results pronouncedly outside the reference range
* Pregnancy
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.

Eligibility Criteria:
Key Inclusion Criteria:

* Is able to understand and sign an approved information consent letter;
* Habitually wears daily disposable soft contact lenses in both eyes
* Uses rewetting drops on a regular basis;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Routinely sleeps in habitual contact lenses;
* Has any known active ocular disease and/or infection;
* Is pregnant or lactating;
* Other protocol specified exclusion criteria may apply.
Comparing 3 Imaging Systems

The purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. The study will determine whether diabetic retinopathy assessment is comparable between the cameras. The research is being done to see if a camera takes higher quality pictures over the other cameras.

60 participants will be enrolled into this study. Participants need to have diabetic eye disease. This is a one-time study visit that lasts approximately 1 hour.


Eligibility Criteria:
Inclusion Criteria:

* any race
* Established diagnosis of diabetes.
* Willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging.
* Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
* History of panretinal laser photocoagulation or vitrectomy (history of anti-vascular endothelial growth factor treatment is not an exclusion criteria).
* Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
SSP-002358 Drug Interaction Study With Omeprazole

This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.


Eligibility Criteria:
Inclusion criteria:

1. Age 18-55 years inclusive at the time of consent.
2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

   * Male, or
   * Non-pregnant, non-lactating female
   * Females must be at least 90 days post-partum or nulliparous.

Exclusion criteria:

1. Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
2. Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.
Risk Stratification of Nodal PTCL

This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma \[ALCL\], anaplastic lymphoma kinase \[ALK\]-negative)
* Patients diagnosed with between January 1, 2004 and April 30, 2016
* initially treated with curative intent
* Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment

Exclusion Criteria:

* Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas)
* Patients with ALCL-ALK+
* Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review
Video-oculography and Parkinson's Disease

This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015):

* the evolution of oculomotricity markers over time.
* the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
* the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography.
* the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.


Eligibility Criteria:
\*Inclusion Criteria:

1. Male or Female;
2. Clinically defined idiopathic Parkinson's Disease (PD);
3. Brain MRI performed in routine care in the 12 months preceding inclusion;
4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
5. Hoehn \& Yahr score: 1 to 3;
6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
7. Neuro-cognitive disorders: absent or minor (according to DSM5);
8. Sufficient written and oral expression in French;
9. Covered by a health insurance system;
10. Written informed consent signed by the patient;
11. Presence of a caregiver.

    \* Exclusion Criteria:
12. Psychiatric comorbidity (except anxiety or mild to moderate depression);
13. Neurological comorbidity, if significant;
14. Brain MRI showing:

    1. significant cerebrovascular pathology (Fazekas I admitted),
    2. another brain disease, including stroke.
15. Major cognitive impairment;
16. Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:

    * Cerebellar syndrome
    * Vertical oculomotricity disorders on clinical examination
    * Motor symptoms restricted to the lower limbs
    * Bilateral and perfectly symmetrical parkinsonism
    * Early dystonia
    * Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)
    * Progressive aphasia or apraxia
    * Moderate or severe postural instability and / or early falls
    * Early bulbar dysfunction (dysarthria, swallowing disorders)
    * Ventilatory dysfunction (inspiration)
    * Severe dysautonomia
    * DOPA-resistance
    * Neuroleptic treatment or related
17. Normal MIBG myocardial scintigraphy (if performed).
Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C

Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin for 24 Weeks. In many patients, there is no efficacy of this treatment on hepatitis C, and there is no treatment recommended for them. Interferon gamma has anti-infectious and anti-fibrosis activity. This study will evaluate the effect, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks, of the addition of interferon gamma in non responders patients. 65 patients will be included in order to include 27 patients who are non responders after 12 weeks of a second treatment and are eligible to receive interferon gamma. Patients will then receive peg-interferon alpha 2a (180 micro g once a week, by injection), ribavirin (1,000 to 1,200 mg per day, according to weight) and interferon gamma (100 micro g thrice a week, by injection) during 8 months

Eligibility Criteria:
Inclusion Criteria:

* Positive anti-HCV antibodies
* Positive HCV RNA (quantitative method)
* Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months
* Without lower dosage during previous treatment
* Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA
* Metavir over F2 on the most recent biopsy
* ALT increase over normal value twice during last 6 months

Exclusion Criteria:

* HIV infection
* Psychiatric pathology
* Alcool consummation
* Cirrhosis
* Pregnancy or plan of pregnancy
* Breastfeeding
Epidemiologic Patterns of Bacteremia After Trauma

Presence of pelvic and liver injury on arrival in ED, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. Scoring with the ISS, intra-abdominal and pelvic injury and presence of transfusion and shock at admission to ED appears a useful tool for identifying trauma patients at increased risk of bacteremia.

Purpose: Bacteremia is a major nosocomial infection problem in view of its high mortality. Bacteremia occurs in trauma patients frequently and increases a morbidity and mortality. The aim of this study was to identify risk factors and to describe epidemiological patterns for early onset (EOB) and late onset (LOB) bacteremia after trauma.

Methods: All trauma patients admitted to surgical intensive care unit (SICU) and general ward (GW) from January 2011 to December 2015 were retrospectively enrolled. The following information was collected for each patient and recorded in a computer database: demography, severity of trauma according to the Injury Severity Score (ISS) and each abbreviated injury score (AIS), severity of coma according to the Glasgow Coma Scale (GCS), presence of shock and transfusion. Early onset bacteremia was defined as EOB when onset occurred within 7 days after trauma, and late onset bacteremia was defined as LOB when appearing after 7 days from trauma.

Eligibility Criteria:
Inclusion Criteria:

* The patients who admitted to intensive care unit (ICU) or general ward (GW) through the emergency department after trauma were studied

Exclusion Criteria:

* Patients who arrived on dead-on arrival
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies.

This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface
2. Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
3. Positive skin or (radioallergosorbent) RAST tests by ImmunoCap to food or environmental allergens
4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

Exclusion Criteria:

1. Participants with intolerance or allergy to montelukast.
2. History of anaphylaxis requiring hospitalization.
3. No underlying renal or liver disease.
4. Participants with a diagnosis of severe asthma.
5. Participants diagnosed with primary immune deficiency.
6. Participants using sublingual immunotherapy.
7. Immunotherapy must be a maintenance dose for a minimum of 30 days.
8. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.
Comparison of Efficacy of Naproxen Versus Ibuprofen

Comparison between Naproxen and Ibuprofen in management of post operative endodontic pain was done.Total 116 patients were selected and divided in to two groups.One group was given Naproxen and other was given Ibuprofen.

This Randomized Controlled Trial was carried out in Outpatient Department of Operative Dentistry, Fatima Memorial Hospital, Lahore, Pakistan and was completed in six months from September 2nd,2019 to February 25th,2020. Sample size of 116 cases(58 in each group) of irreversible pulpitis was calculated with 80% power of test, 5% level of significance, P1(prevalence) for naproxen was 61.53% and P2 for ibuprofen is 38.46%. Estimation of P (prevalence) as 90% is based on pilot study carried in our Department. The patients were randomly allocated into two groups, A and B, by random number table. In both groups teeth were anaesthetized using 1.8ml of 2% lignocaine containing 1:100,000 epinephrine and isolated with rubber dam. An access cavity was prepared with round bur and pulpectomy was done using hand files. Working length was determined using an electronic apex locator and confirmed with periapical radiograph. Canals were prepared with step back technique. Canals were then dried with paper points and the access cavities were restored temporarily with cavit(Cavit3M ESPE).Visual analogue scale for pain score was measured for both groups before initial endodontic procedure . group A was given (naproxen 550 mg B.D), while group B was given (Ibuprofen 400mg B.D).Post-operative pain was measured subjectively after 24 hours with standard Visual Analogue Score (VAS) scored on a 10 cm scale, with markings at every 1 cm anchored by the end points of "no pain" on the left and "worst pain" on the right. Patient were asked to point the number most precisely describing the amount of pain he or she experienced after 24 hours. All this data was recorded in a specially designed proforma (attached).Efficacy was labelled as per operational definitions. Data was analyzed using SPSS version 20. For descriptive analysis, mean and standard deviation were reported for age, BMI and VAS score, whereas frequency and percentages were calculated for categorical variables like gender and educational status. A chi square was used to determine the significance of the difference between the efficacy of naproxen and ibuprofen. Data was stratified for age, gender, BMI and educational status .This comparison also included feelings of patients in terms of side effects. A p value 0.05 or less was taken as significant. Post stratification chi-square was applied with p value ≤0.05 considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* • Age range 20-40 years

  * Gender- either
  * Teeth with acute Irreversible pulpitis assessed by Electric pulp tester lasting more than 30 seconds
  * One tooth per arch with no opposing tooth involved

Exclusion Criteria:

* Patients who reported to have any systemic disease while taking history e.g. diabetes, hypertension
* During pregnancy
* History of taking analgesics 12 hours prior to treatment
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18-60 years of age

Exclusion Criteria:

* Any auto-immune disease or other serious acute, chronic or progressive disease
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy