cyrilzakka/clinical-trials huggingface dataset:
Randomized MINIMA Stem with DELTA TT or DELTA ST-C

This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.

This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Any race
* A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
* patien willingness to partecipate and signature of informed consent form

Exclusion Criteria:

* local or systemic infection
* septicaemia
* persistent acute or chronic osteomyelitis
* confirmed nerve or muscle lesion compromising hip joint function
* vascular or nerve disease affecting the concerned limb
* poor bone stock (for example due to osteoporosis) compromising the stability of the implant
* metabolic disorders which may impair fixation and stability of the implant
* any concomitant disease and dependence that might affect the implanted prosthsis
* metal hypersensitivity to implant materials
* required revision of previous standard femoral stem
* women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
* life expectancy less than 5 years
Acute PAncreatitis and Home Care vs. Hospital Admission Study

Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.

With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.

Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

This is prospective, randomized, controlled, multicentre trial.

OBJECTIVES

Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.

METHODS

Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.

The primary and several secondary endpoints will be obtained:

1. Treatment failure rate (the primary endpoint).
2. Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.
3. Relapse pain.
4. Diet intolerance.
5. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
6. Pain and Analgesic requirement.
7. Local complications including pancreatic necrosis, abscess, pseudocyst.
8. Health costs
9. Patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
2. age \> 18 years, sign consent form.

Exclusion Criteria:

1. pregnant o breastfeeding women.
2. abdominal pain lasting \>96 horas before admission.
3. the possibility of poor oral intake for reasons other than AP.
4. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
5. Chronic pancreatitis.
6. ASA ≥3.
7. Randomization lesser the 24 hours after randomization.
Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period
* Informed consent form signed and dated by legal guardian and investigator
* Informed assent form signed by the patient if appropriate

Exclusion Criteria:

* Refusal of the patient or guardian to participate in the research project
MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \< 15 mL/min) who receive a kidney transplant from a living donor.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stage KDIGO 4 or 5
* First kidney transplant from a living donor
* Age ≥ 18 years
* ABO compatible
* CDC-PRA \< 20%
* No donor-specific antibodies
* Negative CDC and ELISA crossmatch
* Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone
* Informed consent
* Adequate contraception (women with child bearing potential)

Exclusion Criteria:

* Psychiatric disorder
* Heart failure (NYHA III or IV)
* Severe liver disease
* Active hepatitis B or C or HIV infection
* Active bacterial, fungal or viral disease
* Malignancy or malignancy in the last 5 years before screening
* Preexisting immunosuppression
* Vaccination with a live vaccine in the last 3 months before screening
* S/p splenectomy
* Substance abuse
* Pregnancy or lactation
* Women: Child/pregnancy with the intended donor
* Allergy against the investigational drug or part of it
* Other diseases that prohibit participation in the study (in the opinion of the investigator)
* Participation in an other interventional study
Improved Understanding of Ongoing Transmission of Leprosy in the Hyperendemic Comoros (ComLep)

Despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, Grande Comore, presents few cases. The high proportion (31% in 2015) of disease in children indicates that recent transmission is a major driver of the persistent endemicity, and that present control measures are not sufficient. The low proportion (2.6% average in last 10 years) of grade II disabilities in newly diagnosed cases indicates that case detection is early.

The main objective of the present proposal is to identify which persons would most benefit from prophylactic treatment. The secondary objective is to unravel human, bacterial and environmental risk factors for transmission of and progression to leprosy disease, with the ultimate goal to reduce the leprosy incidence.. The program has remaining expertise to re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate molecular genotyping techniques to complement conventional epidemiological investigations in a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify transmission links. A third objective is to document diagnostic delays in more detail

As the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in four villages on Anjouan in 2015, a prospective cohort study will permit measuring the leprosy incidence in close contacts as well as those in neighboring houses, who did or did not receive rifampicin prophylaxis.

The expected outcome of this project will be to identify risk factors for leprosy transmission. Specifically, we expect to identify those contacts at highest risk of developing leprosy disease, who would most benefit from rifampicin prophylaxis or other preventive measures.


Eligibility Criteria:
Inclusion Criteria:

* in the prospective cohort study: All newly diagnosed leprosy patients (any age) on the island of Anjouan who provide written informed consent.
* In the in-depth interviews: Patients who are part of a cluster and provide written informed consent. Additional written informed consent will be asked for questions in which the identity of other member(s) of a cluster needs to be revealed.

Exclusion Criteria:

* in the prospective cohort study: None.
* In the in-depth interviews: Patients belonging to clusters not extending beyond the same first or second circle
Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Cognitive impairment is a common residual symptom after a depressive episode and expose patients to a risk of relapsing or therapeutic resistance.

Neurofeedback (using ElectroEncephaloGraphy - EEG or functional Magnetic Resonance Imaging - fMRI) allows patients to self-regulate their cerebral activity, which is supposedly provided through an intelligible and motivating feedback.

Recent results exhibited clinical improvement in depressed patients who underwent a fMRI neurofeedback protocol targeting the amygdala. Furthermore, prefrontal alpha activity was temporally correlated to variations of the BOLD signal in the amygdala. Simultaneous fMRI/EEG neurofeedback is hypothesized to potentialize its antidepressant effect.

Our objective will be to test this assumption by conducting a double-blind randomized trial, and to prove the superiority of bimodal fMRI/EEG neurofeedback over fMRI neurofeedback alone in depressed patients.

An original visual feedback will be provided and validated beforehand by a pilot study.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 65 years old
2. Signature of an informed consent after being given clear and loyal oral and written information

Exclusion Criteria:

Related to the volunteer

1. Prior experience of a neurofeedback task

   Related to the MRI
2. Implanted cardiac pacemaker of defibrillator
3. Brain aneurysm clip
4. Cochlear implant
5. Ocular on encephalic metallic foreign body
6. Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for less than 6 weeks.
7. Claustrophobia

   Other criteria
8. Unstable hemodynamic status
9. Acute respiratory failure
10. Alteration of general state or continuous monitoring requirement
11. Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse...
12. Neurological condition or diagnosis of dementia in medical history
13. Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a month prior to inclusion
14. Undergoing treatment influencing the blood flow prescribed less than three weeks prior to inclusion
15. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
Approaches to Foot Complication Prevention: A Survey of Diabetes Educators

The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.

Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?

To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.

Eligibility Criteria:
Inclusion Criteria:

* American Association of Diabetes Educators (AADE) member with accurate email address on file with the AADE.

Exclusion Criteria:

* AADE member with an inability to read English.
Comprehensive Triaged HIV Prevention in Tanzania

This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV testing and counseling, (b) Educational activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime provision of a small amount of food or health products for sex partners of persons testing positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An income generation training program for people testing positive for HIV, (g) Transportation assistance in visiting the HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h) Counseling and transportation support for those on medical treatment for HIV to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. The study will take place within two communities located in Kisarawe district, Tanzania. The intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (STIs) than those in the control community.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18-55 years of age
* Lives in the household regularly
* Able to provide informed consent
* Plans on living in the study area for the duration of the study (2 years)

Exclusion Criteria:

* Younger than 18 years of age or older than 55 years of age
* Does not reside in the household regularly
* Is not able to provide informed consent
* Does not plan on living in the study area for study duration (2 years)
Adult-onset Generalized Morphea

This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.


Eligibility Criteria:
Inclusion Criteria:

* Age of onset ≥ 18 years
* Patients with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites)
* Availability of good-quality clinical photographs
* Patient who, after being informed, has not expressed his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion Criteria:

* Patients with linear morphea who met criteria for generalized morphea
* Patient's opposition to participate
Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)

This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic colorectal cancer (CRC) compared to cetuximab and irinotecan alone.

The primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype improves Overall Survival OR Progression-free Survival compared to participants treated with cetuximab and irinotecan alone.

Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the insulin-like growth factor type 1 receptor-1 (IGF-1R). Dalotuzumab may act through inhibition of insulin-like growth factor-1 (IGF-1)-mediated cell signaling to cause reductions in tumor growth and spread antibody dependent cell-mediated cytotoxicity.

In preclinical studies, dalotuzumab improved the activity of an anti-epidermal growth factor receptor (EGFR) mAb and the activity of erlotinib, a small molecule inhibitor of EGFR.

All eligible participants will receive cetuximab 400 mg/m\^2 infusion over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 over 60-120 minutes along with irinotecan infusion over 30-90 minutes. Dosage of irinotecan will be the same as most recent pre-study therapy. Participants will then be assigned to one of three treatment double-blind arms.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have confirmed wtKRAS CRC.
* Participant must have previously failed both irinotecan and oxaliplatin containing regimens, and should have progressed on or within 3 months of completing their last line of therapy with objective evidence of progression as verified by previous radiologic scans.

Exclusion Criteria:

* Participant has had cancer treatment within 2 weeks before the first dose of study drug(s) or if the side effects from the drugs have not gone down to a certain level 2 weeks before the first dose of study drugs.
* Participant has had a bad side effect to irinotecan therapy.
* Participant has human immunodeficiency virus (HIV).
* Participant has Hepatitis B or C.
* Participant is pregnant or breast feeding or planning to have a child while on this study.
Morphine Versus Ketorolac in Low Back Pain

The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in low back pain.

The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in low back pain.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : acetaminophen 1 g, sodic metamizole 1g both diluted in 500 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of musculoskeletal low back pain
* grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

* contraindications of ketorolac or opioids
* pregnancy
* known allergies to ketorolac or opioids
* post-traumatic low back pain
* refusal of participation
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.

The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
* Age \>18, Age \<80
* Capable of giving informed consent

Exclusion Criteria:

* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* Active skin infections at site of TDC insertion
* Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
* Neutropenia defined as absolute neutrophil count less then 1,700/microliter
* Known central venous stenosis
* Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
* Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
* Inability to provide informed consent
* Pregnant or nursing women
* In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate
Comparison of Low and High Ligation in the Rectal Cancer

The purpose of this study is to evaluate the defecatory function when nerve fibers around the inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.

Fecal incontinence after anterior resection are often observed. Whether or not postoperative bowel function is influenced by the preservation of nerve fibers around the root of IMA and LCA (low ligation) is still unknown. So in this randomized controlled trial, we evaluate the efficacy of low ligation in terms of the bowel function.

Eligibility Criteria:
Inclusion Criteria:

* On the basis of whether anterior resection was anticipated at WMUH for rectosigmoid and rectal cancer, and appropriate informed consent was obtained.

Exclusion Criteria:

* Patients who could not respond to medical interview for own bowel function
* Patients without an informed consent
High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury

Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.


Eligibility Criteria:
Inclusion Criteria:

* severe head injury (GCS \< 9) Next of kin informed consent

Exclusion Criteria:

* Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2\< 300 mmHg) Blood loss \> 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion