cyrilzakka/clinical-trials huggingface dataset:
Severe Intraocular Infection

The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.

The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.


Eligibility Criteria:
Inclusion Criteria:

* Post-operative endophthalmitis
* Cataract

Exclusion Criteria:

* None
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients

This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 55 years of age;
* Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
* At least 4 unwanted/unexpected incontinent events/week

Exclusion Criteria:

* Known allergy to Oxymetazoline or silicone.
* Pregnancy or lactation.
* Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus;
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis C.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
* Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Hypertension (blood pressure over 150/105 mm Hg in screening visit)
* Unable to understand the use instruction, as judged by the investigator.
Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.

Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below:

  * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
  * High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement.
  * DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL.
  * Primary mediastinal (thymic) LBCL.
  * Primary cutaneous DLBCL, leg type.
  * Transformation of follicular lymphoma to DLBCL will also be included.
* Relapsed or refractory disease after 1 or more lines of therapy.
* Individuals must have received adequate prior therapy including:

  * Anti-CD20 monoclonal antibody AND
  * An anthracycline-containing chemotherapy regimen.
* At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements.

Key Exclusion Criteria:

* History of autologous or allogeneic stem cell transplant.
* Prior cluster of differentiation (CD)19 targeted therapy.
* Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
* Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease.
* In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.


Eligibility Criteria:
Inclusion Criteria:

* tinnitus for more than 6 months
* THI \> 38
* no central acting drugs in the last 6 months
* tympanogram type A-n

Exclusion Criteria:

* vascular and muscular tinnitus
* concomitant TMJ disorders
* abnormal otoscopy
* mixed and conductive hearing losses
Modafinil for Methamphetamine Dependence

Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.


Eligibility Criteria:
Inclusion Criteria:

18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).

* not currently enrolled in a treatment program
* subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
* subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
* women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.

Exclusion Criteria:

* current diagnosis of alcohol, opiate, or sedative physical dependence
* ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
* history of schizophrenia, or bipolar type I disorder
* present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
* medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine or desipramine)
* current suicidality or psychosis
* Liver function tests (i.e., liver enzymes) greater than three times normal levels
* pregnancy or breastfeeding
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo patients bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 Gray (Gy) (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the incidence of grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode indium phosphide, gallium and aluminum (InGaAlP), 660nm-100 milliwatts (mW)-4 Joules (J)/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx)
* Candidates for surgery or treatment for organ preservation
* Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
* Indication for radiotherapy and concurrent platinum-based chemotherapy
* Oral mucosa intact
* Agree to follow the protocol of oral hygiene
* Informed consent.

Exclusion Criteria:

* Patients using medication for treatment and or prevention of mucositis
* Patients incapable of treatment compliance or of performing the protocol of oral hygiene
SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME

Objective: The aim of the present study was to determine the effect of nursing interventions and sunlight exposure to reach optimum vitamin D levels by individuals living in nursing homes on vitamin D levels.

Material Method: In the first stage of this two-stage randomized-controlled experimental study with pretest-posttest design conducted in June - August 2018 period in the nursing home in Central Town of Tokat Province, the questionnaire prepared by the researcher, standardized mini mental test, Fitzpatrick skin typing questionnaire and Katz Index of activities of daily living were applied. Intervention (n=20) and control (n=20) groups were established with individuals using simple random method according to age, gender, skin type and vitamin D level. In the second stage, 30-35% of the body surface area of individuals in the intervention group was exposed to sunlight five days a week in July. For the participants in the control group, sunbathing was not offered. 25(OH)D, calcium, parathormone, phosphorus, alkaline phosphatase and albumin levels of all individuals were measured in blood samples taken at the beginning and end of the study. Two-way mixed ANOVA, Mann-Whitney U test, Wilcoxon signed rank test and Chi-square tests were used to evaluate the data.


Eligibility Criteria:
Inclusion Criteria:

* individuals (25 women and 41 men) who lived in nursing home during June 27, 2018 and August 01, 2018 period
* 60 years and older
* able to perform their daily life activities independently
* agreed to participate in the study

Exclusion Criteria:

* malignancies
* advanced liver and kidney failure
* history of gastric-bowel operation
* skin disease that could prevent sun exposure
* hyperparathyroidism
* malabsorption
* use of drugs that affect the levels of vitamin D, calcium, PTH and phosphorus and albumin
Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

The study will be a non-blinded two cohort design consisting only of symptomatic patients with CuTS or compressive peroneal neuropathy or in need of peroneal nerve decompression. The first cohort will be - patients with CuTS. Evaluation of each CuTS patient will include assessment by the treating surgeon and a certified hand therapist. Patients who have clinical examination and history consistent with a diagnosis of CuTS based on subjective and functional assessment outlined below will be consented to this study. The second cohort will be patients in need PND for compressive neuropathy of peroneal nerve. PND patients will be evaluated by clinical exam and have imaging with high resolution ultrasound or MRI negative for mass lesion.

Visit 1

* Exam and discussion with surgeon
* Exam and testing with Occupational Hand Therapist (Standard of Care) as described above. (CuTS cohort)
* Diagnostic studies (EMG/NCT) (Standard of Care)
* Questionnaires - PROMIS and ODI

Visit 2

* Standard of Care surgery
* During surgery, the surgeon will perform an MMG immediately pre-decompression and immediately post-decompression of the nerve. This will entail placing a sensor and probe on the nerve that will be decompressed.

Visit 3 and 4 (6 week and 3 month post-op)

* Clinical Exam by Surgeon
* Exam and testing with Occupational Therapist (Standard of Care) as described above. (CuTS cohort)
* Questionnaires - PROMIS and ODI

Visit 5 (6 months post-op)

* Clinical Exam by Surgeon
* Exam and testing with Occupational Therapist (Standard of Care) as described above. (CuTS cohort)
* Questionnaires - PROMIS and ODI
* Evaluation of MMG parameters

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.

Exclusion Criteria:

* Patients under 18 years of age
* Patients who are unable to return for follow-up evaluation.
Renal Denervation in Patients With Refractory Hypertension

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age.
* a systolic blood pressure of 160 mmHg or greater.
* receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
* agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
* competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* renal arterial abnormalities
* end stage renal disease requiring dialysis or renal transplant
* serum Cr \> 3, or calculated GFR \< 45 ml/min
* has experienced MI, unstable angina pectoris, or CVA with 6 months
* others
Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction

The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.


Eligibility Criteria:
Inclusion Criteria:

* inferior pedicle gynaecomastia surgery
* Age \> 16

Exclusion Criteria:

* Age \< 16
CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage

Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In 2006, the International Society for Cellular Therapy (ISCT) proposed the minimal criteria to define human MSCs. First, MSCs must be plastic-adherent when maintained in the standard culture conditions. Second MSCs must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules.


Eligibility Criteria:
Inclusion Criteria:

normal babies delivered by normal labor

Exclusion Criteria:

diseased or congenital anomalies
Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus Excretion.

Ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary organic acid that was developed at MRC Human Nutrition Research. We aim to determine if the ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate concentration, compared with the administration of placebo plus the same food on a different occasion. We hypothesise that ferric hydroxide adipate binds some phosphate ions in the gastrointestinal tract, which prevents part of the phosphate load in a meal from being absorbed. On another visit, calcium will be given with the same food, as a positive control, since this element is well known to restrict dietary phosphate absorption through the formation of insoluble calcium phosphates in the gut lumen. We will compare urinary phosphate concentrations after co-ingestion of the calcium salt and food versus urinary phosphate following ferric hydroxide adipate and the same food. Additionally, the calcium data will be compared with placebo data, since a significant reduction in urinary phosphate concentrations after calcium treatment will confirm the suitability of the study design.

Finally, iron absorption from the ferric hydroxide adipate treatment will be determined by labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.

The study design is: Three-way cross-over volunteer absorption study. Volunteers will not be told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental calcium). Researchers co-ordinating the study on a day to day basis will be aware of treatment allocation, but analysts will not be told which samples correspond to which treatments.


Eligibility Criteria:
Inclusion Criteria:

- Males and females, aged \>18 years, who are generally healthy.

Exclusion Criteria:

* Pregnancy and lactation
* iron deficiency and iron deficiency anaemia
* weight change of +/-2kg in the past month
* dysphagia
* surgery in the past three months
* cancer in the last ten years
* diabetes
* known medical and genetic conditions interfering with calcium and phosphate metabolism: e.g. hyper/hypo-parathyroidism, Fanconi syndrome, hyper/hypothyroidism (except individuals who are taking stable doses of thyroid hormones)
* chronic infection or chronic inflammation
* cardiovascular disease
* chronic respiratory disease
* abnormal renal function (based on glomerular filtration rate)
* known renal disease
* abnormal liver function/known liver disease
* hereditary haemochromatosis or haemoglobinopathies
* gastrointestinal disease
* bone disease
* hypertension
* current use of proton pump inhibitors
* use of other medication that affects mineral homeostasis (on a case by case basis, in consultation with HNR clinician)
* Extreme muscle hypertrophy (e.g. body building)
A Brief Intervention Programme on ASP

The brief intervention comprises a 4-page worksheet used in the classroom (main intervention) and subsequent weekly e-messages through WhatsApp (booster intervention). The worksheets for both groups will be printed in colour, and mainly contain pictures and simple texts. Students will be asked to provide smartphone numbers of themselves and their parents for receiving the booster interventions. After sending 4-6 e-messages in 4 weeks, students will complete a 1-month follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

* Parents and children should understand Chinese.
* Parents' consent to their children's participation.

Exclusion Criteria:

* N/A
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Patient age above 18 (men and woman)
* Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm
* Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm
* The abdominal aneurysm neck is longer than 1.5 cm
* Patient's physical condition allows performing general anesthesia
* Patient is willing to sign the informed consent and follow the study protocol.

Exclusion Criteria:

* Patient Age under 18 years
* Patient's physical condition dose not allows to perform general anesthesia
* Patient's with terminal disease and life expectancy of less than 3 months
* Patient objects to the treatment or study protocol
* Anesthesiologist or personal care physician object
* Patient suffer from Supra/infrarenal AAA
* The abdominal aneurysm neck is smaller than 1.5 cm
* Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/
Exercise and QUality Diet After Leukemia: The EQUAL Study

The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and exercise can help people lose weight and improve other health problems. This two year study will compare two methods of informing participants about ways to lose weight.


Eligibility Criteria:
Inclusion Criteria:

Eligibility will be confirmed via the CCSS-based medical record and by a series of questions on the EQUAL website, prior to consent.

* Participation in the CCSS cohort
* Diagnosed with acute lymphoblastic leukemia \< 18 years of age
* Cancer free at time of study enrollment
* Current age ≥ 18 years
* A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by self-reported height and weight on the most recent CCSS questionnaire
* Internet access and a personal email account
* Able to read and comprehend informed consent

Exclusion Criteria:

* Prior history of congestive heart failure, coronary artery disease, myocardial infarction, stroke, or unstable angina;
* Medical condition for which weight loss might be contraindicated or which would cause weight loss, such as pregnancy, anorexia or bulimia;
* Use of prescription weight loss medication within the previous 6 months
* History of total body irradiation (TBI)