cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Oral Immunotherapy with Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Patient with allergic rhinitis to birch pollen.
* Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.
* Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.
* Subject affiliated to a social health insurance scheme
* Subject able to understand the aims and risks of the research and to give dated and signed informed consent
* For women of childbearing age: negative urine pregnancy test at inclusion visit

Exclusion Criteria:

* Severe or uncontrolled asthma
* Severe obstructive syndrome
* Active neoplastic disease
* Active autoimmune disease
* Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
* History of bariatric surgery
* History of anaphylaxis to apples
* Allergy to cooked apples
* Contraindication to anti-histamines, corticoids, salbutamol, adrenaline
* Other contraindication to an oral challenge test
* Allergy to placebo ingredients
* Presence of oral syndrome during consumption of placebo in the first oral challenge test
* Allergenic immunotherapy to birch pollen in progress or completed less than 5 years ago
* Current treatment with anti-IgE, anti-IL4/13, anti-IL5 or anti-TSLP biotherapy.
* Impossibility of giving the subject informed information
* Subject under court protection
* Subject under guardianship or curatorship
* Pregnancy
Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia

Check the sedation conditions during topic cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Topic cataract surgery

Exclusion Criteria:

* NA
PET Imaging in Patients With Suspected Cardiac Sarcoidosis

Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be ≥ 18 years of age
2. History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation
3. Clinical suspicion of cardiac involvement defined as the presence of any of the following:

   1. High degree A-V nodal block
   2. Complete bundle branch block
   3. Reduced left or right ventricular systolic fusion
   4. Any cardiac arrhythmia
   5. Chest pain, dyspnea or syncope without clear etiology
4. FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
2. History of neuroendocrine tumors
3. Currently taking the medication Octreotide
4. Currently on total parenteral nutrition (TPN)
5. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
6. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.

PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

OBJECTIVES:

* Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.

OUTLINE: This is a multicenter study.

Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 months for 1 year and then every 6 months for 9 years.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of T-cell large granular lymphocytic leukemia

  * Increased numbers of large granular lymphocytes in peripheral blood smears
  * CD3+CD8+CD57+ immunophenotype by flow cytometry AND
  * CD3+CD57+ cell count at least 2,000/mm\^3 OR
  * CD3+CD57+ cell count at least 500/mm\^3 with clonal T-cell receptor beta gene rearrangement
* Patients must have at least 1 of the following:

  * Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm\^3)
  * Neutropenia (ANC less than 1,000/mm\^3) and recurrent infections
  * Anemia (hemoglobin less than 9 g/dL)
  * Thrombocytopenia (platelet count less than 50,000/mm\^3)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* NCI CTC 0-3

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 2 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

* No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
* No concurrent dexamethasone or other steroidal antiemetics

Other:

* No prior cyclosporine therapy for this leukemia
Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial

Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for inclusion in this study only if they meet all of the following criteria

1. 18-70 years old, gender unlimited ；
2. Previous history of gout ；
3. According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
4. fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)

Exclusion Criteria:

If the subjects meet any of the following criteria, they will not be selected ：

1. Gout in the past two weeks ；
2. Secondary hyperuricemia ；
3. Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
4. WBC \< 4.0 × 109 / L, PLT \< 100 × 109 / L, HGB \< 90g / L, or other hematological diseases ；
5. bad blood pressure control (BP\>160mmHg/100 mmHg)
6. Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
7. Patients with active peptic ulcer ；
8. Patients with gastrointestinal cancer ；
9. Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
10. Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ；
11. Those who need continuous prednisone treatment ；
12. Those who need antibiotic treatment for infectious diseases ；
13. Those with body mass index (BMI) greater than 30 ；
14. people with alcoholism ；
15. People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ；
16. Researchers who have received other drugs within 3 months before screening ；
17. The people who are researchers thinks it is not suitable to participate in the study.
Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Age of patient \<40 years
* Irregular astigmatism
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD suspicious eyes (determined by OCT)
A National Survey on the Prevalence and Impact of Multiple Pharmacy Use in Specialty Pharmacy

Specialty medications often have dispensing restrictions which can be dictated by manufacturer limited distribution strategies, narrow insurance networks, or a combination of both. Unfortunately, this may result in patients being required to use 2 or more pharmacies to fill their prescription medications; this is referred to as multiple pharmacy use (MPU). The investigators' plan is to administer a survey to patients who have been prescribed one or more specialty medications to evaluate the prevalence of MPU in this population as well as to investigate patients' attitudes about MPU and potential factors increasing the likelihood of MPU

The investigators will identify patients from participating member sites via a review of prescribing records for specific specialty medications. Patients will be contacted via telephone to explain the purpose and risk of the study. Consented patients will then be asked a series of 11 questions about their attitudes and experience with taking and obtaining their specialty medication(s). Additional demographic and clinical information about patients will be collected via chart review.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older
* English-speakers
* An active patient of a performance institution and ability to provide informed consent to participate with the survey
* Electronically prescribed at least one specialty medication by a performance site provider, which can be either a new or renewed order, within the last 3 months

Exclusion Criteria:

* Subjects less than 18 years of age
* Non-English speakers
* Patients that cannot or are unwilling to provide consent
* Patients who have not had a new or renewed specialty medication prescription order placed electronically within the last 3 months
Effect of Nebulized Bronchodilators on Heart Rate

The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions

Exclusion Criteria:

* Known allergy or sensitivity to study medications
* Baseline heart rate was greater than 110 beats per minute
Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation

To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.

To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. All enrolled children will undergo standard preoperative and postoperative MRI imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. This imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. This study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosis with Intractable Epilepsy

Exclusion Criteria:

* No Intractable Epilepsy
Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.

In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self identify as lesbian, gay, bisexual, or transgender
* Age 18-65
* Current cigarette smoker
* Desire to quit smoking (self-report rating of interest in quitting)
* Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
* Agree to attend behavioral counseling sessions, be randomized, and be followed-up
* Agrees to use nicotine patch and has no prior adverse reactions to patch
* Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend for contact and follow-up.
Forced Fluid Removal in High Risk Acute Kidney Injury

The objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid overload. The intervention will use furosemide infusion and/or continuous renal replacement therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (KDIGO) guidelines.

Acute kidney injury (AKI) is a common and serious complication in patients admitted to ICU. A core element of critical care is resuscitation with crystalloid solutions. In many cases fluid accumulates and patients become fluid overloaded (positive fluid balance \> 10% of bodyweight). This is especially true in patients with AKI, since they often have impaired ability to excrete salt and water. Most observational suggests harm with increased positive fluid balance.

Objectives: To assess feasibility of forced fluid removal with diuretics and/or CRRT in ICU patients with AKI and severe fluid overload, compared to current clinical practice.

Design: Multicentre, parallel group, randomized, assessor blinded pilot-trial with adequate generation of allocation sequence, and allocation concealment.

Trial Size: The pilot study is planned to include 50 patients. Inclusion is expected to start in August 2015.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Acute Kidney Injury defined according to the KDIGO criteria
* Renal Recovery Score ≤ 60%. (Calculated using www.renal-recovery-score.com)
* Fluid overload defined as a positive fluid balance ≥ 10% of ideal body weight.
* Able to undergo randomization within 12 hours of fulfilling other inclusion criteria

Exclusion Criteria:

* Known pre-hospitalization advanced chronic kidney disease. (eGFR \< 30 mL/minute/1.73 m2 or chronic RRT.)
* Severe hypoxic respiratory failure (use of invasive ventilation and FiO2 \> 80% and PEEP \> 10 cm H2O)
* Severe burn injury (≥ 10% TBSA)
* Severe hypo- or hyper- natremia (\< 120 or \> 155 mmol/l)
* Hepatic coma
* Mentally disabled undergoing forced treatment
* Pregnancy/breast feeding
* Lack of commitment for on-going life support including RRT
* Lack of informed consent