cyrilzakka/clinical-trials huggingface dataset:
Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.

OBJECTIVES:

Primary

* To estimate the proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC).
* To estimate the proportion of patients with Hodgkin lymphoma with clonal immunoglobulin (Ig) DNA detection in the plasma.

Secondary

* To estimate the agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue.
* To estimate the agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma.
* To estimate the detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma.
* To estimate the detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma.
* To analyze clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki-67 index.
* To estimate the detection rate of clonotypic B-cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma.

OUTLINE: This is a multicenter study.

Blood and tissue samples collected at the time of diagnosis are analyzed for serum free light chain and clonal immunoglobulin (Ig) DNA rearrangements and circulating clonotypic B-cells via PCR.

PROJECTED ACCRUAL: A total of 50 patients (25 with diffuse large B-cell/immunoblastic histologies, 15 with Burkitt lymphoma, and 10 with Hodgkin lymphoma) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of an untreated aggressive B-cell lymphoma, including:

  * Diffuse large B cell/immunoblastic lymphoma
  * Burkitt lymphoma
  * Hodgkin lymphoma
* Serological documentation of HIV infection by any of the FDA-approved tests
* Available diagnostic material from fresh frozen tissue or formalin-fixed paraffin embedded tissue OR willing to undergo a repeat biopsy (fine needle aspiration is acceptable)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation

There are limited data on how the guideline indications for ICD implantation are applied in clinical practice across Europe. Moreover, the impact of "time-dependence" of some indications to implantation on the guidelines adherence is still unknown.

Objective of the present observational study is the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to ICD/CRT-D implantation admitted to an in-hospital cardiac rehabilitation program.

Current guidelines recommend ICD implantation in patients at high risk of sudden cardiac death with either ischemic or non-ischemic heart disease. However, implantation rate of cardiac implantable electrical devices (CIED), especially ICD, CRT and CRT-D, is lower than expected and do not reflect guideline indications.

Several factors may justify the differences in ICD implantation rates across Europe and the gap between daily clinical practice and guidelines: economic restrictions, poor guidelines awareness, especially among referring cardiologists and general practitioners, and different guidelines adherence. The impact of "time-dependence" of some indications to CIED implantation on the guidelines adherence is still unknown.

Objective of the present observational study will be the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to ICD/CRT-D implantation admitted to an in-hospital cardiac rehabilitation program.

This is a prospective, multicenter, observational study performed in 6 cardiac rehabilitation facilities.

Eligibility Criteria:
Inclusion Criteria:

* Admission to an in-hospital cardiac rehabilitation program because of a recent index event;
* Provision of signed and dated informed consent form;
* Age ≥ 18 years.
* NYHA II-III class at the admittance in the cardiac rehabilitation facility;
* LVEF ≤ 40% at echocardiography at the admittance in the cardiac rehabilitation facility;
* Presence of a time-dependent indication to an ICD/CRT-D implantation:
* \<3 month of optimal medical therapy;
* \<40 days from the index myocardial infarction in patients with acute coronary syndrome;
* 3 months from the revascularization procedure in patients with surgery;
* \<3 months in patients with a de-novo heart failure episode of no ischemic etiology.
* Patients who have already received an ICD/CRT-D for primary prevention before the admittance in the cardiac rehabilitation facility, despite a time-dependent indication to an ICD/CRT-D implantation;
* Indication to ICD-CRT-D implantation for primary prevention.

Exclusion Criteria:

* Inability to give informed consent (diminished understanding or comprehension);
* Age \< 18 years;
* NYHA Class I or IV during the cardiac rehabilitation in-hospital stay;
* LVEF \> 40% at echocardiography performed at the admittance in the cardiac rehabilitation facility
* Absence of a time-dependent indication to an ICD/CRT-D implantation;
* Indication to ICD-CRT-D implantation for secondary prevention.
A Study of Mirikizumab (LY3074828) in Healthy Participants

The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination.
* Are first generation Japanese or are Caucasian.
* Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
* Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Exclusion Criteria:

* Have had symptomatic herpes zoster within 3 months of screening.
* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
* Have received live vaccine(s) within 1 month of screening or intend to during the study.
* Are immunocompromised.
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
* Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
* Presence of two (2) comparable target lesions
* Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
* Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* Significant confounding conditions as assessed by study doctor
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.


Eligibility Criteria:
Inclusion Criteria:

* mild or moderate to severe thyroid eye disease in one or both eyes
* age \> 18 years
* informed consent
* intraocular pressure \> 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
* not on current prostaglandin analog intraocular pressure lowering therapy

Exclusion Criteria:

* sight threatening thyroid eye disease
* children \< 18 years old
* patients that are not compliant with treatment or follow-up
* patients already on prostaglandin analog treatment
* patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
* patients that cannot tolerate prostaglandin analog treatment.
* patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial

Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection. Evidence showed that it is still difficult to get AEFI from passive reporting in Ethiopia. Vast novel method of enhanced AEFI surveillance has been practiced globally. However, those methods had serious limitations including the requirement of high resource and expertise. Hence, there is a need to find the most flexible low cost and integrated AEFI surveillance system. To the best of our knowledge, there has no published research in Ethiopia which compare Participant diary, SMS, and telephone interview for the purpose of active AEFI surveillance.

Objective: To assess participant centered active adverse event surveillance following measles immunization at Gedeo Zone health facilities, Ethiopia.

Method: An open randomized trial will be employed from October 1, 2022- December 1, 2023, at Gedio Zone health facilities. All parents, care givers/guardians whose child receive vaccine during the study period in the study site will be included in the study. A total of 391participants will be randomized to SMS, telephone interview or diary card group using random number generator on Excel. Every participant will be contacted on day seven to request them whether they experience any AEFI. Differences in proportions will compared using chi-square tests. A 0.05 level of significance will be used for all analyses. Independent sample t-tests will be used to compare the mean time (in days) required to collect complete AEFI data by SMS, telephone interview and diary card. Multinominal logistic regression analyses will be used assess the factors associated with effective use of tailored SMS, telephone interview and diary card for the AEFI active surveillance. To further investigate the association between the vaccine and the adverse events and factors associated with vaccine binary and multi variable logistic regression will be used.


Eligibility Criteria:
Inclusion Criteria:

* Parents, care givers/guardians, whose child receive vaccine.
* ≥18 years of age.
* Willing to adhere to study procedures, which will include a randomization.
* Willing to participate

Exclusion Criteria:

* Unable to give informed consent because of cognitive impairment.
* Those who are both illiterate and don't have mobile phone.
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children

This is a retrospective cohort study of children included in a large medical insurance claims database.

* To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:

  * Children younger than 24 months of age
  * Children 24-59 months of age with a claim associated with a diagnosis of asthma
  * Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
  * Children 24-59 months of age with immunosuppression
* To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
* To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations

Eligibility Criteria:
* Children less than 24 months of age during August through January/February.
* Children \<24 to 59 months of age during August through January/February, with:

  * two outpatient claims for asthma, or
  * one inpatient/emergency room claim for asthma, or
  * one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
* Children \<24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
* Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
Inflammatory Markers in Natural Orifice Hysterectomies

The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).

Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR), and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients.


Eligibility Criteria:
Inclusion Criteria:

* hysterectomy requirement with any conditions in gynecologic diseases

Exclusion Criteria:

* patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases)
* the presence of active infection
* using of corticosteroid, acetylsalicylic acid, or anticoagulant
* cystocele or rectocele repair with mesh
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.

The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m \^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).

Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Adolescent Scoliosis
* Risser sign \<3-4

Exclusion Criteria:

* Neuromuscular diseases
* metabolic disease
* Liver, lung, thyroid and parathyroid gland disorders.
Resting Metabolic Rate Testing in Bariatric Surgery Patients

This study evaluates if measuring resting metabolic rate (the number of calories the body burns at rest) before surgery can help predict successful weight loss after surgery.

This is a prospective study enrolling patients from the Baylor Weight Loss Surgery Center who have met all of the requirements to proceed with primary bariatric surgery. Patients will undergo pre-operative and post-operative metabolic testing (6 months, and 1 year after surgery) using a portable calorimeter with eventual follow up of medical record at 5 years. Data from up to 50 patients will be collected. The main objectives are to examine if the pre-operative resting metabolic rate can accurately predict successful weight loss after bariatric surgery and if it can be used to guide the selection of the type of bariatric surgery that would be most successful for the patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for a primary bariatric surgery
* 18 years of age to no upper limit
Observational Study of Blood Pressure Measurements and Continuous Dialysis

Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis.

We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* age \> 17 years old
* CVVHD renal replacement therapy
* indwelling arterial line

Exclusion Criteria:

* age \< 18 years old
* pregnancy
* temperature \< 34°C
* severe mechanical ventilator dyssynchrony
* cardiac arrhythmias precluding automated PPV measurement by ICU monitors
* non-pulsatile cardiac flow
* open thoracic cavity
Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

This is a large multicenter retrospective French cohort conducted in seven French centers that had performed at least five G-POEM procedures at the end of 2017. All patients treated by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France) in these seven centers were included in this study and followed until April 2019. The data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis.

Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe.

Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is \> 90% after 1 hour, \> 60% after 2 hours (H2), \> 30% after 3 hours (H3), and \> 10% after 4 hours (H4). All but one center performed the GES according to the US guidelines: that center performed a 3-hour GES with a local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A %H4 retention \> 30% was defined as severe delayed gastric emptying.


Eligibility Criteria:
Inclusion Criteria:

* treatment by G-POEM during the study period,
* at least a 1-year follow-up, and
* GCSI evaluation before and 1 year after G-POEM.

Exclusion Criteria:

* missing GCSI before and/or 12 months after G-POEM,
* non-pathological GES before G-POEM: delayed gastric emptying was defined as t ½ \> 113 min and %H4 retention \> 10%, and
* loss to follow-up or death before 12 months
Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis

Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

Methods: Twelve subjects diagnosed with chronic generalized periodontitis were selected and randomly divided into two groups: Test group which received scaling and root planning (SRP) followed by application of aloe vera gel as a local drug delivery agent in the deepest periodontal pocket and control group which received SRP alone. Clinical evaluation was undertaken using Plaque index (PI), Gingival index (GI), Probing pocket depth (PPD), Relative attachment level (RAL) and Gingival marginal level (GML) and microbiologic counts (total colony count/ml) were assessed at baseline, 6 weeks and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion in this study was based on the following criteria:

  1. Patients with age group between 30 - 60 years from both sexes.
  2. Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.

Exclusion Criteria:

* Exclusion criteria were:

  1. Subjects who have received antibiotic treatment in the preceding 6 months.
  2. Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.