cyrilzakka/clinical-trials huggingface dataset:
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.

This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* systemic lupus erythematosus;
* histological diagnosis of lupus nephritis.

Exclusion Criteria:

* not in need of immunosuppressive treatment (in addition to corticosteroids);
* continuous dialysis starting \>2 weeks before randomization, with an anticipated duration of \>8 weeks;
* previous or planned kidney transplant.
Clinical Evaluation of Patient Preoperative Prep

The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of any race.
* Subjects in good health.
* Minimum skin flora baseline requirements on abdomen and groin.
* Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
* Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
* Subjects who are pregnant, attempting pregnancy, or nursing.
Neuro-ocular Baselines in a Sports Setting

Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. The proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. The project described herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain Injury) patients through the use of the developed device, which is called the Head and Intraocular Trauma Test (HITT) device.


Eligibility Criteria:
Inclusion Criteria:

* Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
* Engaged in sports
* Older or equal to 11 years of age, and less than 21 years of age.
* Provide informed consent; youths must have their parents sign the informed consent document. Children will be presented with a written assent statement and that they will be asked to sign the assent document.

Exclusion Criteria:

* Catastrophic polytrauma that would interfere with follow-up and outcome assessment
* Amblyopia/strabismus
* Pregnancy in female subjects
* Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
* History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
* Intoxication or chemical impairment at time of examination (upon initial presentation)
Perception of Fatigue Among Surgeons During Night Shifts

The aim of this study was to illustrate surgeons' own perception of fatigue and the impact they felt it had on their performance. This was accomplished through a focus group study, where 13 surgeons participated.


Eligibility Criteria:
Inclusion Criteria:

* Doctors working at department of surgical gastrointerology, who gave informed consent

Exclusion Criteria:

* Withdrawal of consent
68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years the time of radiotracer administration
* Provides written informed consent
* Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline
* Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Pregnant or nursing
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care

The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p\<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.


Eligibility Criteria:
Inclusion Criteria:

* Being over age 40
* Volunteer
* Computer and Internet literacy
* DM diagnosed or having at least one of diagnostic criteria.

These criteria;

* HbA1c ≥ 6.5
* FPG ≥ 126 mg / dl
* 2-hour postprandial glucose ≥ 200 mg / dl
* Any time postprandial glucose ≥ 200 mg / dl
* Diabetes symptoms

Exclusion Criteria:

* Having a communication problem
* Type 1 diabetes
* MODY type DM
* Level of psychiatric disorders in psychosis
* Dementia ones
Study With Fascigel

The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.


Eligibility Criteria:
Inclusion Criteria:

* Back pain (VAS above 4 cm)
* Limited range of motion
* Duration of pain for over 3 months
* Patient willing and able to provide the written consent
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

* State after back surgery
* BMI \> 35
* Age \< 18 years
* Pregnant or lactating woman
* Patient in terminal stage of living
* Patient with known hypersensitivity or allergy to any of substances contained in Medical Device
* Patient participating in the intervention clinical study
* Alcohol or drug abuse
* Patient undergoing chronic coagulation therapy
Role of Peanuts in Healthy Weight Gain in Athletic Individuals

Many athletes and military personnel desire weight gain primarily as lean mass to improve performance and effectiveness in military/sport endeavors. While much is known about the energy restriction required to reduce body weight, very little is understood about energy and macronutrients needed to promote healthy gains in body weight and lean mass. Typically, athletes are encouraged to increase calorie intake by \~500 kcal/day with an emphasis on adequate protein and carbohydrate, and judicious inclusion of healthy fat-containing calorically-dense foods, including peanuts and peanut butter. This study proposes to evaluate the effect of a 10-week diet and exercise regimen designed to promote healthy weight gain. This will include increasing energy intake by 500 additional kcal/day (above weight maintenance diet) through daily provision of either peanut-based whole foods/snacks (peanut group) or a similar, high-carbohydrate, peanut-free snack (control group) along with a supervised strength training regimen. Results will serve as an important first step in helping understand the gaps in knowledge related to healthy weight gain, designing better weight gain meal plans, not only in athletes and military personnel, but also in clinical populations where promotion of weight gain is advocated.


Eligibility Criteria:
Inclusion Criteria:

* Interested in gaining 5 pounds of body weight to enhance effectiveness in sport, fitness, or military training/competition.
* Willing to eat 500 kcal/d and weight train 3x/wk for 10 weeks
* Have weight trained in the past 12 months
* Not taking medications or dietary supplements that influence study results
* Non-smoker
* Without any major medical problems (including high blood pressure or coronary heart disease)

Exclusion Criteria:

* Nut, peanut, tree nut or legume allergy
* No weight training experience
* Orthopedic limitations that affect ability to weight train
* Currently taking dietary supplements or prescribed pharmacological agents that may affect lean tissue accretion
* Current or past anabolic steroid use
* Have a history of or current signs of disordered eating
* Pregnant
* Abnormal levels of thyroid stimulating hormone or hemoglobin, serum lipids (e.g., fasting triglycerides \>150 mg/dL and/or total cholesterol \>200 mg/dL)
tDCS to Decrease Opioid Relapse (UG3)

In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.

Investigators propose to use EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.

Eligibility Criteria:
Inclusion Criteria:

* current opioid dependence
* between 21-50 years of age
* recent initiation of buprenorphine or methadone (\<30 days)

Exclusion Criteria:

* current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
* current suicidality
* evidence of neurocognitive dysfunction
* contraindications for tDCS (e.g seizure disorder)
* probation/parole requirements or an upcoming move that might interfere with protocol participation
* planning to terminate buprenorphine in less than 3 months
* scalp lesions near the tDCS electrode sites
Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).


Eligibility Criteria:
Key Inclusion Criteria :

1. Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR.
2. Willing to comply with the required scheduling and assessments of the protocol.
3. Female subjects of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test, and must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.

Key Exclusion Criteria:

1. Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
2. Any prior history of seizure, epilepsy, or other convulsive disorder.
3. Any clinically significant abnormal laboratory values.
4. New history of moderate or severe renal impairment.
5. New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
6. Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
7. Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
8. Received an investigational drug, except fampridine-SR under the preceding study (MS-F202EXT, MS-F203EXT, or MS-F204EXT), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study.
9. A history of drug or alcohol abuse within the past year.
10. Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.

All patients who suffer from this disease are followed every 6 months during a 5 years period. FEV1 decline is the primary endpoint. Quality of life assessed using the Saint George's Respiratory Questionary is recorded too.

Eligibility Criteria:
Inclusion Criteria:

* Serum alpha one antitrypsin \< 0.8 g/l
* Emphysema diagnosed by CT scan
* Adult
* Obstructive disorder

Exclusion Criteria:

* Liver or lung transplantation
Factors Affecting Return to Work Among OEF/OIF Veterans With Polytrauma

The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans with polytrauma to live independently or do things "on their own" at home and in the community.

The Department of Veterans Affairs (VA) identifies employment as a priority issue for OEF/OIF veterans. However, OEF/OIF veterans with polytrauma represent a new and unique VA sub-population. Polytraumatic injuries are more complex than injuries sustained in any previous conflict. Returning to work, therefore, may prove especially challenging. Among individuals with severe disabilities, employment outcomes are closely tied to the individual's level of success with Independent Living (IL). IL refers to the ability to reside in the community and participate in activities of choice by managing available resources, negotiating barriers and exercising self-determination. IL often is viewed as a prerequisite to employment for severely disabled individuals, because barriers and facilitators to independence at home and in the community also influence success in the workplace. Thus, IL will be a critical first step to pursuing vocational/employment goals for OEF/OIF veterans with polytrauma. To date, no published studies have investigated IL among veterans with polytrauma. This pilot study will be the first project in a line of research to promote the independence and employability OEF/OIF veterans. The goals of the study are twofold. Goal 1 of the study is to investigate the barriers and facilitators to IL identified by community dwelling OEF/OIF veterans with polytrauma, caregivers, and IL service providers, and perceptions of how these factors may affect veterans' return to work. This goal will be accomplished by using qualitative methods for data collection and analyses. Qualitative interviewing will be used to elicit the perspectives of veterans with polytrauma and caregivers living in Florida, and Florida-based Vocational Rehabilitation and Employment IL service providers. Qualitative data will be coded, and then analyzed using the constant comparative method. Goal #2 of the study is to evaluate the feasibility of using the data collection tools and procedures for a future planned study. An efficacy evaluation will be used to test and refine the data collection tools (interview guides and demographic checklists). To evaluate data collection procedures, field notes will be recorded and analyzed to identify optimal organizational procedures and time parameters to minimize subject burden. Findings will be used to plan and design a large, national study of factors affecting return to work among OEF/OIF veterans with polytrauma living throughout the United States. Findings also will be used to develop future proposals to fund longitudinal research and implementation projects to improve employability outcomes among veterans with polytrauma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OEF/OIF related polytraumatic injuries

Exclusion Criteria:

* Polytraumatic injuries unrelated to OEF/OIF service
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol.

After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected.

Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment, a potential participant must meet all the following criteria:

1. Participant is \<21 years old on admission
2. Participant is admitted to the Pediatric Cardiac Intensive Care Unit
3. Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
4. Participant is receiving one or more of the study drugs of interest at the time of enrollment

Exclusion Criteria:

1. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery

Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.

The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.

The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Requiring cardiac or thoracic surgery under general anaesthesia
* Requiring a blood pressure catheter prior to GA induction

Exclusion Criteria:

* Hemodynamic instability on arrival in the operating room
* Hypotension on arrival in the operating theatre: Systolic blood pressure \< 100 mmHg or Mean arterial pressure \< 65 mmHg
* Hypertension on arrival at the operating theatre: Systolic blood pressure \> 160 mmHg or Mean arterial pressure \> 100 mmHg
* Adult under guardianship, curatorship or safeguard of justice
* Unable to give consent
* Pregnant or breastfeeding woman
* Emergency surgery (cannot be delayed by 24 hours)
* Current participation in an interventional protocol that interferes with the evaluation criteria of the study
* Not affiliated to or not benefiting from a social security scheme
* Lack of informed and written consent from the patient
* Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
* Patient with severe aortic insufficiency
* Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks