cyrilzakka/clinical-trials huggingface dataset:
Signature Acetabular Posterior/Lateral Data Collection

The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.

Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with one of the following indication:
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

Additional inclusion criteria include:

* Subjects requiring primary total hip arthroplasty
* 20 to 75 years of age
* Subjects with a diagnosis of osteoarthritis or traumatic arthritis
* Subjects willing to return for follow-up evaluations.
* Subjects who can read, understand study information and give written consent without representation of a legally authorized representative.
* Bilateral patients are included if staged.
* Only Posterior Lateral Approach can be used for inclusion in this study

Exclusion Criteria:

- Exclusion criteria should be in accordance with Contraindications for the Biomet primary acetabular cup.

Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.

Additional contraindications include:

* Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia
* Subjects unable to cooperate with and complete the study
* Dementia and inability to understand and follow instructions
* Neurological conditions affecting movement
* Pregnancy

Additional exclusion criteria include:

* Surgical approach other than posterior lateral.
* Simultaneous bilateral procedures
The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY

To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

Recent studies have demonstrated substantial variation in the etiology of DFIs (Diabetic Foot Infections) in different regions of the world . In contrast to Western countries, studies from Asia and Africa have demonstrated that aerobic gram-negative organisms, particularly Pseudomonas aeruginosa, are far more common . The majority of current guidelines for the management of DFIs have been prepared in Western countries . Based on the results of more recent studies from the Asian continent, however, empiric antibiotic therapy for DFIs may need to be directed at organisms with substantially different antibiotic susceptibility patterns than those recommended in current guidelines. Thus, suggested antibiotic regimens for DFIs should be optimized for local clinical practice. The aim of the current trial is to provide an up-to-date view of the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Diabetes Mellitus
* Diabetic foot wound clinically diagnosed as infected

Exclusion Criteria:

-
Prevalence of Chronic Kidney Disease in Tunisian Diabetics

In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.

In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in diabetics. It is then relevant to assess the incidence of chronic kidney disease among the Tunisian diabetic population.

The study is an observational, multicentric, cross-sectional, and national project. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, or any healthcare providers in charge of diabetic patients.

A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Diabetes Type 1 or Type 2
* Follow-up at the consultation for at least more than 3 months
* Informed consent of the patient

Exclusion Criteria:

* Kidney transplant
* Chronic dialysis
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
* Patient is in good general health
* Blood pressure at time of randomization is 95-115 mm Hg

Exclusion Criteria:

* Secondary Hypertension or history of malignant hypertension
* History of stroke
* History of myocardial infarction
* Atrial flutter or atrial fibrillation
* History of congestive Heart failure
* Patient taking major psychotropic agent or anti-depressant
* Patient regularly uses NSAIDS or high dose aspirin
* Known positive test for HIV/AIDS or Hepatitis B
* Patient is being treated for acute ulcer disease
* Prior exposure to losartan
* Actively treated diabetes mellitus
* History of chronic liver disease
* Actively treated diabetes mellitus
* Any known bleeding or platelet disorder
* Absence of one kidney
* Women of childbearing potential
* Alcoholism or drug addiction
Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Complications after mastectomy include chronic pain and depression.

A mastectomy is surgery could be associated with complications include chronic pain and depression. In female breast cancer patients, the incidence of postoperative depression was 46.55%. Stellate ganglion block had been used for treating post-traumatic stress disorder (PTSD) and depression symptoms even in its prevention. Also, it used in treatment of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age ranging from 18 to 65 years
* American Society of Anesthesiologists (ASA) no more than II
* Had unilateral cancer breast
* Scheduled to do unilateral modified radical mastectomy

Exclusion Criteria:

* Pregnant female
* Existing Horner syndrome
* Had any neuromuscular disease
* Had allergy to local anesthetics
* History of use of analgesics
* Had any deformity or a previous surgery in the neck or ipsilateral arm or breast
* Had any contraindication to the procedure (coagulation disorders, local infection, sepsis)
* Had any contraindication to the sympathetic blockade (decompensate cardiopulmonary or hemodynamic disorders)
* History of psychotic disorder including depression, bipolar disorder or personality disorder
* Patient with Beck Depression Inventory (BDI) score more than 13
Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit

A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction. The standard treatment, including volume expansion and vasopressor/inotropic agents, often leads to water and sodium overload, increasing the risk of morbidity and mortality in the ICU. The combination of this overload and myocardial dysfunction lead to venous congestion, particularly affecting the lungs, kidneys and gastrointestinal system. Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload. Fluid tolerance, defined as a patient's ability to tolerate additional volumes of solutes without adverse effects, is assessed retrospectively by clinical signs (capillary refill time, oedema, hepatojugular reflux, etc.) and ultrasound scores (VExUS score, LUS score, etc.). However, these indicators do not fully reflect the complexity of venous congestion in patients with various conditions.

Assessing fluid tolerance remains a challenge in clinical practice. It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling. Despite their common use, there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance.

In conclusion, the main hypothesis is that changes in ultrasound congestion parameters (VExUS score, LUS score and others) during passive leg raising could predict a patient's subsequent tolerance to volume expander.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who has provided non-opposition (or health proxy or a close relative if unable to receive the information)
* Patient admitted to intensive care and requiring volume expander

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breast-feeding women
* Poor echogenicity assessed by the operator
* Chronic AC/FA
* Mechanical cardiac assistance
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis

The majority of individuals diagnosed with head and neck cancer, who undergo radiotherapy or concurrent Chemoradiotherapy, experience oral mucositis. Our research focuses on investigating the preventive and therapeutic impact of N-acetylcysteine and zinc in managing radiotherapy-induced oral mucositis.

almost all head and neck cancer patients who to receive radiotherapy or concurrent chemotherapy suffer from oral mucositis. Oral mucositis (OM) is associated with pain, difficulty in eating, dysphagia, and the need for enteral or parenteral nutrition, increased opioid consumption or even interruptions to cancer therapy. In immunosuppressed patients, OM is associated with bacteremia, increased inpatient hospitalization duration and higher 100-day mortality.

Treatments to manage cancer, such as radiotherapy, generates reactive oxygen species (ROS) that target neoplastic cell DNA resulting in cell damage and death. ROS from these therapies also indiscriminately target healthy non-neoplastic DNA.

Zinc carries out its antioxidant function in two ways: Reducing the concentration of oxidant agents and protecting structures and macromolecules suffer from oxidant agent.

N-acetylcysteine is an aminothiol and precursor to glutathione (GSH), glutathione in its reduced form is the most powerful intracellular antioxidant, thereby protecting against radiation-induced free radical damage.

our study is A randomized, controlled, parallel clinical trial that will be applied at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to investigate the prophylactic and therapeutic effect of N-acetylcysteine and zinc on radiotherapy induced oral mucositis in Head and Neck cancer patients.

Eligibility Criteria:
Eligibility Criteria

Inclusion Criteria:

* Patients aged 18 years or older.
* Patients diagnosed with head and neck cancer.
* Patients are recommended for treatment with radiotherapy with a minimum dose of 20 Gy.

Exclusion Criteria:

* Pregnancy and lactating women.
* Cigarette smoker patients.
* Patients with severe comorbid illnesses or immunocompromised status.
* Patients receiving induction chemotherapy or those with previous head and neck radiotherapy. Patients using Amifostine during radiotherapy.
Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors

This pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.

PRIMARY OBJECTIES:

I. To evaluate the feasibility of using the Carevive Survivor Care Planning System (SCPS) during the follow-up visit for breast oncology survivors treated in a university cancer center or a community medical center.

II. To evaluate survivors' perceptions of the usability of the Carevive technology.

III. To evaluate their perceptions of the acceptability (perception of benefit) of the treatment summary and survivor care plan.

SECONDARY OBJECTIVES:

I. Examine the psychometrics of surveys developed for this research. II. Compare participants' perceptions of the care received under the Carevive system with clinician documentation.

III. Compare clinician documentation of care received by this sample with documentation of care provided for historical controls at each site.

Eligibility Criteria:
Inclusion Criteria:

* Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
* Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
* Prospective study: Able to understand and read English
* Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
* Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)

Exclusion Criteria:

* Women who are pregnant
* Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts
The Female Microbiome in Patients Undergoing Bladder Instillation Therapy

The underlying pathophysiology for BPS/IC is currently an active area of research. There is speculation that there may be alteration in the bladder and vaginal microbiome that contributes to the symptomatology of BPS/IC, however existing literature is limited and contradictory. Nickel et al (2015) studied the bladder microbiota in women with IC/BPS during a flare versus nonflare. The study collected initial stream and midstream urine specimens and detected overall, there was no significant differences in the species composition. However, a greater prevalence of fungi (Candida and Saccharomyces) was seen in the flare group (15.7%) versus the non-flare group (3.9%) midstream urine specimens. Pearce et al (2015) sought to characterize the urinary microbiome via catheterized specimens from women with urgency urinary incontinence, a condition that can present similarly as IC/BPS. The study found that more than half of the patients were sequence positive, most commonly for Lactobacillus (45%) or Gardnerella (17%), with 25% made up of various other bacteria. In contrast, Abernethy et al (2017) showed via catheterized urine specimens from patients with IC/BPS that the urinary microbiome is less diverse and less likely to contain Lactobacillus species. There have been two recent studies investigating the female urinary microbiome in patients with IC/BPS. Nickel et al (2019) found no differences in species composition between urine from patients with IC/BPS versus controls. Meriwether et al (2019) reported similar findings, and additionally found no differences when comparing the vaginal bacterial microbiome in patients with IC/BPS versus controls. However, in evaluating the bladder microbiome, both studies utilized uncatheterized urine specimens. Wolfe et al (2012) showed microbiome differences between clean-catch and catheterized urine specimens, therefore vaginal contamination in both studies cannot be ruled out.

This study uses samples collected under an interventional study and consented for use in future research - this study is use of those samples under the future research provision, and this study was deemed to meet exempt category 4.

Eligibility Criteria:
Inclusion Criteria:

* Patients who previously or will be undergoing bladder instillation therapy for treatment of IC/BPS and whom had or will have urine/vaginal specimens collected at the beginning and between 4-6th instillations.

Exclusion Criteria:

* Patients not meeting inclusion criteria
Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.


Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for thoracotomy who presented with contraindications to TEA.

Contraindications to TEA are :

* Patient's refusal after informations about advantages and risks of the technique
* Anti platelets treatment that can't be discontinued
* Anticoagulants at a curative dosage
* haemostasis and/or coagulation disorders: thrombopenia \< 100.000/mm3, ACT \> 1,5 / control, PTT \< 75%
* Systemic or local infection of the puncture point
* 2 and 3 grade atrio-ventricular heart block without pacing
* Severe aortic valve stenosis
* Kyphoscoliosis
* certain neurological disorders

Exclusion Criteria:

* Patient's refusal to participate in the study
* Psychiatric disorder (impossibility to collect the informed consent)
* Patient under juridical protection
* On going an other study
* Pregnancy, breastfeeding
* Non balanced epilepsy
* 3 grade auriculo-ventricular heart block without pacing
* Severe hepatocellular insufficiency
* Anti arrhythmic treatment : class III of the Vaughan William's classification
* Skin infection of the puncture point
* Allergy to aminoamides local anaesthetic
* Surgical difficulties to insert paravertebral catheter
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B

The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg negative chronic Hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between 18 and 65 years of age at the time of randomization.
* Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to screening and at screening.
* Has HBV DNA \< 40 IU/mL for at least 1 year prior to screening and at screening
* Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at screening.
* Must be HBsAg positive at screening.
* Has been treated with NUCs for at least 2 years prior to screening.
* Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.
* For all females, must have a negative serum pregnancy test at screening. For female of childbearing potential, must have been using adequate contraception and must agree to continue to use it during all study period and for 6 months after completion of the study product administration.
* Has provided written informed consent.

Exclusion Criteria:

* Has elevated blood levels of alpha-fetoprotein (AFP) (\> 500 ng/mL).
* Has cirrhosis, defined as

  * platelet count \< 150,000/mm3, with esophageal varices on imaging and spleen size \> 12, or
  * liver stiffness of 11 kilopascal \[kPa\] as measured by elastography using FibroScan® or .an AST to Platelet Ratio Index (APRI) \> 2).
* Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).
* Has liver decompensation (albumin \< 3.5 g/dL and bilirubin ≥1.3 mg/dL).
* Is Hepatitis C virus (HCV) Ab positive at screening.
* Is Hepatitis delta virus (HDV) Ab positive at screening.
* Is Human Immunodeficiency Virus (HIV) Ab positive at screening.
* Has an immune suppressive disorder or treatment with immunosuppressive drugs.
* Has been treated with corticosteroids within 12 weeks prior to the first administration of study product, with the exception of topical or inhaled corticosteroids.
* Has been treated with rituximab.
* Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic hepatitis, Wilson disease, alcoholic or hemochromatosis).
* Has a history of allergic disease or reactions likely to be exacerbated by any component of the study products.
* Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.