cyrilzakka/clinical-trials huggingface dataset:
iotaSOFT Pediatric Study

Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices
* Age 9 months to less than 12 years old at the time of CI surgery
* Willingness to participate in the study and able to comply with the follow-up visit requirements

Exclusion Criteria:

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion
* Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy.
* Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
* Absence of cochlear development
* Additional medical concerns that would prevent participation in evaluations as determined by the investigator
* Planned or current participation in a clinical study of an investigational device or drug
Hypoalbuminemia in Burn Patients

The purpose of this study is to determine whether 5% human albumin solution, given to correct hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).

Each year approximately 2 million people are burned in the USA, from which 80,000 are hospitalized and 6,500 die. It is a well known fact that the two most important factors for mortality in burn patients are age and percent total body surface area burn (TBSA), which are unmodifiable findings.

A predictable inflammatory response takes place after a burn injury leading to profound changes in patient homeostasis. As a result, hypoalbuminemia is one of the common finding in severe burn patients. 21% of hospitalized adult patients are hypoalbuminemic on admission. After admission, worsening of existing hypoalbuminemia and development of de novo one are frequently seen.

Moreover, hypoalbuminemia, a potentially modifiable variable, has been strongly associated with poor clinical outcomes in critically ill patients and in burn patients.

Dynamic organ dysfunction scores have been introduced in critically ill patients few years ago in order to describe the evolution of patients on a daily basis. The Sequential Organ Failure Assessment (SOFA) score is now one of the most accepted score in critically ill patients and has been validated in general medico-surgical unit, as well as in trauma and cardiac surgery patients. It encompasses components assessing six organ functions. This score has also been shown to predict mortality in critically ill patients and in burn patients when used in a dynamic way.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the BICU in the Centre hospitalier de l'Université de Montréal within 24 hours following their thermal burn injury.
2. Patients with second or third degree burns greater or equal than 20% of total body surface area.
3. Patients aged 18 years or older. -

Exclusion Criteria:

1. Patients with serum albumin greater than 30 g/dl at the time of randomization.
2. Patients with a do not resuscitate order.
3. Patients needing total parenteral nutrition.
4. Patients with the following chronic diseases that could affect baseline SOFA calculation or serum albumin levels: end-stage kidney disease, nephrotic syndrome, hepatitis, exudative enteropaty, chronic thrombocytopenia or hematological malignancy.
5. Patients with a known reaction to albumin.
6. Pregnant or lactating women.
7. Patients younger than 18 years old. -
Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate

A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect

Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:

Cohort 1:

• Ursolic Acid (150 mg) BID (twice a day)

Cohort 2:

• Curcumin (600 mg) BID

Cohort 3:

• Ursolic Acid (150 mg) and Curcumin (600 mg) BID

The study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3.

Eligibility Criteria:
Inclusion Criteria:

* Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy
* Be able to give informed consent
* Be age 18 or older
* Able to stop supplements

Exclusion Criteria:

* Unable to give informed consent
* Age \< 18
* High-risk prostate cancer or suspected metastasis
* Unable to swallow pills
* Unable to stop supplements
Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort

This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites.

Adrenocortical carcinoma is one of the rarest neoplasms in the world. In Brazil, especially in the South and Southeast regions, the incidence of adrenocortical tumors is around 15 times higher than in the rest of the world, largely attributed to the significant prevalence of the TP53-R337H germline mutation in this population. In view of this characteristic, the clinical and epidemiological characterization of this cohort, as well as the identification of prognostic factors, is of great importance. The starting point for this project was the cohort of 66 participants with adrenal carcinoma included in the final project of the medical residency in clinical oncology at the A.C. Camargo Cancer Center by student Rafael Haikal dos Santos Abduch. The aim is to include case studies from the main Brazilian site that have followed up and treated patients with adrenal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Participants over 18 years old;
* Diagnosis of adrenocortical carcinoma with at least one clinical evaluation at the reference institution;
* Initial diagnosis or recurrence from the year 2000 onwards.

Exclusion Criteria:

* Participants with insufficient clinical or pathological data in the medical records.
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
* Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
* No prior systemic therapy for RCC
* Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Exclusion Criteria:

* Any active central nervous system (CNS) metastases.
* Active, known, or suspected autoimmune disease.
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply
LACE+ and MRS Score Readmission Rate Assessment

A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.

The objective of this study is evaluate a program that provides transition of care services to a local Tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. The organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. The organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. The investigators look to assess LACE+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. The outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.

Eligibility Criteria:
Inclusion Criteria:

* Those referred to receive transition of care services between January 2018 to December 2019 and were discharged on 10 or more medications.

Exclusion Criteria:

* 89 years or older
A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans

The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body mass index (BMI) range of 18.5 - 30.0 kg/m2, inclusive. The subject weighs at least 50 kg. \[screening\]
* Female subject must be of non-childbearing potential:postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
* Male subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
* Subject agrees not to participate in another interventional study while in this clinical study.

Exclusion Criteria:

* Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Medical Investigator.
* Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or on admission to the clinical unit on day -1.
* Subject regularly uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit on day -1.
* Subject had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit on day -1.
* Subject participated in any interventional clinical study or has been treated with any investigational drugs within 90 days or 5 half-lives whichever is longer, prior to the initiation of screening
* Subject has a history of suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on day -1.
Behavioral Change Simulation Experiment Regarding Dentists' Repair Behavior

The aim of the present study is to determine the effect of two potential interventions on dentists' behavior regarding the repair of partially defective dental restorations.

Two potential interventions are delivered as written instructions to the participants. Dentists are asked to indicate their treatment preference for two given clinical scenarios (consisting of case vignettes, clinical photos, and radiographs) in two questionnaires prior (baseline data) and after receiving the intervention. Based on these data, the simulated behavior change (i.e. to repair or not to repair) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* General dentists, working in Germany and being listed in an address databse (www.adressdiscount.de)

Exclusion Criteria:

* Dentists who are not listed in the above-mentioned database
* Dentists who have previously declined to participate in future research from our department.
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Secondary Objectives To evaluate safety \& tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG).

To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide \& Bevacizumab for patients with recurrent malignant glioma.

If study demonstrates that combinatorial regimen of Etoposide + Bevacizumab is associated with encouraging anti-tumor activity among patients with RMG, further assessment of regimen in additional phase II \& possibly phase III studies, will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Pts have confirmed diagnosis of recurrent/progressive WHO gr III \& IV MG
* Age \>18 rs
* Interval of \>4 wks since prior surgery
* Interval of \>4 wks since prior XRT/chemo, unless there is unequivocal evidence of progressive disease \& pts have recovered from all anticipated toxicity of most recent therapy;
* Karnofsky performance status score \>60
* Hematocrit \>29 percent, ANC \>1,500 cells/microliter, platelets \>100,000 cells/microliter
* Serum creatinine \<1.5 mg/dl, BUN \<25 mg/dl, serum SGOT \& bilirubin \<1.5 x ULN
* For pts on corticosteroids, they have been on astable dose for 1wk prior to entry
* Signed informed consent approved by IRB prior to pt entry
* If sexually active, pts must agree to take contraceptive measures for duration of treatments.

Exclusion Criteria:

* Prior therapy w either bevacizumab/etoposide
* \>3 prior recurrences
* Pregnancy/breast feeding
* Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil
* Evidence of CNS hemorrhage on baseline MRI on CT scan
* Pts who require therapeutic anti-coagulation
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state
* Pts w another primary malignancy that has required treatment \<past year
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries

To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting and to compare the prevalence and severity of complications in patients \<60 and ≥60 years of age a retrospective medical records review is used.

Background: Colorectal cancer (CRC) is increasing in Low- and Middle-Income Countries (LMIC) as part of the ongoing epidemiological transition. Surgery is the main treatment and the global health agenda is increasingly putting focus on improving the safety and quality of surgical care in low-resource settings. The current systems for measuring surgical quality are mainly customized for high-income countries.

Aim: To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting. Additionally, to compare the prevalence and severity of complications in patients \<60 and ≥60 years of age.

Material and methods: Retrospective medical records review for postoperative complications and severity grading using the CDC.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has gone through colorectal cancer resection.
* Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka.

Exclusion Criteria:

* Reason for resection other than colorectal cancer.
Flat Foot and Coronal Spinopelvic Alignment

This study aimed to present the influence of unilateral and bilateral flat foot on coronal spinopelvic alignment in asymptomatic young healthy males. It will be carried out by examining the medical reports of individuals who apply to the National Health Board to work in positions requiring physical fitness between January 2018 and January 2019. Plain radiographies of the feet, pelvis, and spine will be analyzed. Calcaneal pitch angle (CPA) for flat foot, pelvic obliquity (PO), and Cobb angle (CA) for spinal asymmetry will be measured. After all analyzes were completed, participants will be divided into 2 groups as unilateral (UniFF) or bilateral (BiFF) flat foot, depending on the CPA measurements and will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ranging between 18.5-24.9 kg/m2 (accepted as normal weight by World Health Organisation (WHO))
* Age ranging between 18-25 years
* Male gender

Exclusion Criteria:

* Being older than 25 years
* BMI out of normal weight according to WHO
* Being female
* History of spinal trauma/ surgery
* Having/had spinal disorders like spondylolisthesis, spondylodiscitis, etc.
* Having/had chronic inflammatory arthritis especially spodiloarthrosis (i.e., ankylosing spondylitis, psoriatic arthritis, etc.)
* Having/had a vertebral fracture
* Having/had aseptic necrosis of the vertebra
* Radiographs with inappropriate image qualities.
BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder

To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.

To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.

To analyse the health status, quality of life and functioning/disability of patients.

Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
* Patients or their legal representatives have provided informed consent

Exclusion Criteria:

* Patients are unable to complete or to understand health questionnaires in Spanish language
* Patients enrolled in clinical trials or other studies
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers

The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.


Eligibility Criteria:
Inclusion Criteria:

* Patient (stem cell recipient) with hematological malignancies, age 3-18
* Healthy allogeneic stem cell donor (identical or non-identical related donor)

Exclusion Criteria:

* Patients \<3 years of age
* Patient who are unable to provide urine, stool or blood samples due to their medical condition
Energy Intake and Exercise Timing

The aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.

The present study will compare the nutritional response to the realisation of an acute exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 180 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* - BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia

The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
* Pneumonia of sufficient severity to require ICU admission and management

Exclusion Criteria:

* Pregnancy
* Weight over 150 kg
* Patients at increased risk of bleeding
* Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa
* Treatment with heparin or anticipated need for heparin
Evaluation of Meibomian Gland Dysfunction in Chinese Old Patients

The purpose of this study is to identify age-related changes in chinese meibomian glands that may be associated with meibomian gland dysfunction (MGD).


Eligibility Criteria:
Inclusion Criteria:

* have dry eye symptom
* have meibomian gland dysfunction

Exclusion Criteria:

* diabetes
* history of ocular surgery
* systemic disease or inflammation