cyrilzakka/clinical-trials huggingface dataset:
Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo

This is a randomized, single-blinded placebo-controlled trial.

Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at the end of the operation, (2) injection of standard bupivacaine at the end of the operation, or (3) no injection of local anesthetic. All patients will be able to receive IV and oral narcotic medications in the postoperative period on an as-needed basis.

If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement.

Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm.

Patients who are in the placebo arm will have a similar volume of saline injected into the operative site.

Postoperatively, all patients will be kept in the hospital for at least one night. Total length of stay will be documented. They will all have the option of receiving IV morphine injections as well as oral acetaminophen-hydrocodone as needed for additional pain control. The administration of these additional medications will be recorded for each patient.

On postoperative day 1, each patient will be administered the American Pain Society Outcome Questionnaire while in the hospital. After discharge from the hospital, we will call the patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the same questions each time. For any patients staying in the hospital longer than 1 day, the questionnaire will be administered in the hospital on the same postoperative days. Subject participation only lasts for these 7 days of follow up.


Eligibility Criteria:
Inclusion Criteria:

1. All female patients over 18
2. Subjects must be scheduled to undergo bilateral therapeutic or prophylactic skin or nipple-sparing mastectomy at Medstar Georgetown University Hospital
3. Subjects must have immediate reconstruction consisting of either tissue expander placement or direct implant placement at the time of mastectomy
4. subjects are capable of giving informed consent

Exclusion Criteria:

1. Subjects cannot be homeless persons
2. Subjects cannot have active drug/alcohol dependence or abuse history.
3. Subjects cannot be pregnant
4. Subjects cannot have documented chronic or recent opioid use as well as chronic pain syndromes
5. We will exclude any patients who will plan to undergo postoperative whole breast radiation
6. Subjects cannot have bupivacaine (and all related analog) allergies
Impact of Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial

The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. Exploratory analysis was conducted to observe the differences in perioperative levels of blood glucose, serum insulin, inflammatory factors (IL-6, IL-1β, TNF-α), neuroinjury markers (S-100β protein, neuron-specific enolase) between the two groups. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* Elective surgery (with an expected duration of 2 hours or more)
* ASA grade Ⅰ-Ⅲ
* Voluntary participation and informed consent obtained
* Diabetes mellitus

Exclusion Criteria:

* Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)
* Severe visual or auditory impairments, language barriers, or patients who cannot cooperate
* Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse
* Neurosurgical patients
* Patients who are expected to require hepatic portal blockage during surgery
* Patients who are expected to be transferred to ICU after surgery
* Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome
Pulmonary Aspergillosis in Tuberculosis Patients

Pulmonary tuberculosis (PTB) is the most common cause of lung destruction, contributing to coinfections development, and Aspergillosis spp. is one of the most important. Diagnosis of chronic pulmonary aspergillosis (CPA) in PTB patients is difficult due to similarity of clinical and radiological data, especially in resource-constrained settings. Differentiation of PTB patients with singling out a group with a higher Aspergillus IgG level during the initial examination will help physicians to orient to further examination of CPA.

Objectives: to determine the prevalence of aspergillosis in Koch's bacillus-positive and Koch's bacillus-negative PTB patients and antifungal resistance of Aspergillus species isolates in Central Asia countries.

Chronic pulmonary aspergillosis (CPA) complicates treated pulmonary tuberculosis (PTB), with high 5-year mortality. PTB affected an estimated 10.4 million people in 2016. Just 57% of PTB cases reported to the World Health Organization (WHO) were bacteriologically confirmed. CPA both complicates and mimics treated PTB. The prevalence of CPA in patients with treated TB and the contribution of misdiagnosed CPA to PTB prevalence estimates are unclear.

Mycological analysis of sputum for Aspergillus is often negative in CPA. Detection of Aspergillus IgG is one of the main analysis in CPA diagnosis, but until recently had been inadequately validated for use in this context. Both tests are infrequently available in areas of high PTB prevalence.

Antifungal therapy improves survival. But, survival rates vary significantly among published studies. Reported survival rates are 58%-93% at 1 year of follow-up, 17.5%-85% at 5 years of follow-up, and 30%-50% at 10 years of follow-up. In a selected group of patients with CPA, weekly subcutaneous injections of IFNγ has been shown to improve disease control and also helps with bacterial clearance. Several factors have been reported to affect mortality, including by underlying pulmonary disease, advanced age, NTM infection, quality of life scores, and serum albumin levels. No data on the prevalence of CPA among patients with PTB and resistance of Aspergillus spp. to antifungal drugs in Uzbekistan and neighboring countries.

The aim of the study is to determine the prevalence of aspergillosis in Koch's bacillus-positive and Koch's bacillus-negative PTB patients and antifungal resistance of Aspergillus species isolates in Central Asia countries.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary tuberculosis patients (smear-positive)
* Pulmonary tuberculosis patients (smear - negative)

Exclusion Criteria:

* neutropenia
* severe immunosuppression caused by cancer chemotherapy
* hematopoietic stem cell or solid organ transplantation
* HIV infected individuals
Equity and Efficacy of Allocation Priority for Liver Transplantation Patients With MELD≥30 in Italy

In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Another objective of this allocation strategy is to reduce the waiting time, thus performing the LT in better clinical conditions. This multicentre retrospective national study aims to evaluate several parameters of efficacy and equity, such as waiting time in the list, dropout rate, and graft survival, in two eras of enlisted patients, before and after the introduction of the macroarea sharing policy in Italy. With the intent to minimize the presence of possible selection biases, the two groups were matched trough Propensity Score Matching (PSM).

A retrospective multi-centre study involving six Italian transplant centres was performed using prospectively collected databases from each participating centre, registering MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.

Study population was divided in two groups according to the time of waiting list before or after the introduction of MELD ≥ 30 allocation scheme: ERA-1 Group (August 2010 - July 2014), and ERA-2 Group (August 2014 - July 2018).

Primary endpoint was waiting list time across different eras in patients above and below MELD ≥ 30 cutoff. Secondary endpoints were dropout rate as well as patient and graft survival.

Eligibility Criteria:
Inclusion Criteria:

- LT patients registered from August 2010 to July 2018

Exclusion Criteria:

* LT patients registered before August 2010 and after July 2018
* Data not available for analysis
Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)

This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, 25-50 years of age
* Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
* Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
* Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
* Written informed consent signed

Exclusion Criteria:

* ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
* Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
* Undiagnosed vaginal bleeding
* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
* With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN)
* Pregnancy or nursing
* Previous physical therapy of LSIL/CIN1 after pathologic diagnosis
* Participation in any clinical studies within the last 30 days
* Subjects that the investigators judged to be not suitable to participate the study besides above
WREX Outcome Study

This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for children who are using the WREX, or have used it in the past. The survey consists of a set of questions a) performed online and b) performed over the phone.

The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for Children alone has provided a WREX for about 80 children in the last 3 years. This is being done through the orthopedic and muscle clinics in the hospital. We would like to perform a retrospective study to see how well the children are doing with the WREX. We propose getting this feedback through a survey administered to families using the WREX. The survey will be performed in two parts. 1) A phone survey will use the Canadian Occupational Performance Measure (COPM). 2) an online survey with additional questions. The parents are asked to submit answers on behalf of the children if they are unable to.

Eligibility Criteria:
Inclusion Criteria:

* Neuromuscular disease
* Use the Wilmington Robotic Exoskeleton

Exclusion Criteria:

* people who do not use the Wilmington Robotic Exoskeleton
Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury

The main objective of this study is to evaluate the effects of tRNS while undergoing computerized cognitive rehabilitation therapy to conclude if this combination of therapies would be effective for the cognitive rehabilitation of patients with acquired brain damage, such as traumatic brain injury. We want to study the therapeutic potential of tRNS to enhance the therapeutic outcome of cognitive training, studying its global effect over the rehabilitation of attention, memory and executive functions, compared to sham tRNS.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* documented history of severe or moderate TBI (severe TBI: Glasgow Coma Scale 3-8; moderate TBI: Glasgow Coma Scale 9-13)
* out of post-traumatic amnesia
* less than 6 months after TBI
* cognitive impairment objectified by neuropsychological exploration.

Exclusion Criteria:

* impairment of language, affecting the production and/or comprehension of speech and the ability to read and/or write
* severe alteration of the visual field or visual perception problems that limits the use of technological devices
* sever motor impairment of both upper extremities that prevent the use of technological devices
* previous or current history of psychiatric, neurological or systemic alterations that affect the central nervous system
* history of substance abuse
* dermatological diseases in the skull
* presence of metal implants or holes in the skull
* epilepsy.
Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial

A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The goals of this project are to adapt the AWAKE platform into an intervention acceptable for use in adolescent cancer survivors and their guardians in order to improve survivors' hope, quality of life, and health-promoting behaviors, and to generate the preliminary data needed for a randomized control trial to test the efficacy of the AWAKE platform in this population.

A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. Adaptation of this intervention to incorporate messaging for adolescents and their guardians has the potential to have a long-term impact on adolescent cancer survivors. The goals of this project are to adapt the AWAKE platform into an intervention acceptable for use in adolescent cancer survivors and their guardians in order to improve survivors' hope, quality of life, and health-promoting behaviors, and to generate the preliminary data needed for a randomized control trial to test the efficacy of the AWAKE platform in this population.

Eligibility Criteria:
Inclusion Criteria:

Adolescent survivors:

* Early survivor: 3 months to 2 years after therapy completion
* Long-term survivor: ≥2 years after therapy completion
* 13-17 years of age
* Access to tablet or smartphone and internet

One designated guardian per survivor

Exclusion Criteria:

* Cognitive delay that would preclude participation
* Participant or designated guardian unable to read English
* Active disease relapse
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 70 mg/dL (1.8 mmol/L) or non-HDL-C \>/= 100 mg /dL (2.6 mmol/L).

The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.

Eligibility Criteria:
Inclusion Criteria:

* Must be on background lipid lowering treatment.
* Must be at high risk of a CV event.
* Must have an LDL C \>/=70 mg/dL (1.8 mmol/L) or non-HDL-C \>/= 100 mg/dL (2.6 mmol/L).

Exclusion Criteria:

* Planned coronary (PCI or CABG) or other arterial revascularization.
* New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction \< 25% by cardiac imaging.
* Chronic renal insufficiency with creatinine clearance of \<30 ml/min/1.73m\^2 by MDRD formula or with end state renal disease on dialysis.
* History of hemorrhagic stroke.
* Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle

The purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle

The predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic RVOT arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for RVOT-VT initiation indicated that women have RVOT-A initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with RVOT arrhythmia ,20 healthy volunteers) will be screened, the Participants will undergo ECG monitoring and their blood samples will be collected at various times throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Must be female
* Aged 20 to 45 years, with regular menstrual cycles.
* With normal BMI
* Without organic heart disease
* Healthy volunteers and women with RVOT arrhythmia are both being recruited.

Exclusion Criteria:

* Pregnancy
* Use of hormonal therapy including birth control pills or other drugs
Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology

Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension


Eligibility Criteria:
Inclusion Criteria:

* patients who are 18 years old or more
* patients with pulmonary hypertension diagnosed with echocardiography

Exclusion Criteria:

* patient who are less than 18 years old
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant patients using tacrolimus and/or mycophenolic acid
* Age between 0 and 18 years
* Indication for an AUC measurement - judgement of clinician

Exclusion Criteria:

* Incapacitated patients
* No informed consent
* Not proficient in the Dutch language
A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.

The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. All patients undergoing either an open, laparoscopic or robotic-assisted
3. Incisional or Inguinal Hernia repair procedure
4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion Criteria:

1. Emergent Cases for both Incisional and Inguinal Hernia
2. Incisional Hernia related to ostomy formation
3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Evaluation of the PlasmaJet Neutral Argon Plasma System to Treat Skin Ageing

The purpose of this study is to determine the comparative effects of the PlasmaJet neutral argon plasma system and the Rhytec Portrait PRS nitrogen plasma system in the treatment of aging facial skin


Eligibility Criteria:
Inclusion Criteria:

* request for treatment to improve facial skin

Exclusion Criteria:

* pregnancy
* history of HIV infection
* autoimmune or connective tissue disorder