cyrilzakka/clinical-trials huggingface dataset:
A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant

A study of patient adherence and convenience to immunosuppressive agents in newly liver transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial for comparison between once-daily early conversion and twice-daily tacrolimus formulation.

This is prospective, multi-center, open-labeled, randomized study to investigate adherence of administration of once-daily tacrolimus formulation (Advagraf®) in newly Taiwanese (Chinese) liver transplant patients. The procedure of liver transplantation will follow the site-specific procedure. Each subject will be randomized on postoperative day 15 (POD15; defined Day 14 +/- 1)

Eligibility Criteria:
Inclusion Criteria:

* Patient has been fully informed and has signed an IRB approved informed consent form within 7 days (Day 7-13) prior to POD 15 and is willing and able to follow study procedure
* Patient is a primary liver transplant recipient
* Patient is 20 to 70 years of age
* Patient should be clearly conscious, fully understand and able to answer questionnaire

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a liver.
* Patient currently requires dialysis
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has received a liver transplant from a non-heart beating donor
* Patient who is HCV negative has received an HCV positive (HCV RNA by PCR or HCV antibody) donor liver
* Patient who is HbsAg negative has received an HbsAg positive (HBV DNA by PCR or HBV antibody) donor liver
* Patient has received a liver transplant from a decrease donor \> 70 years of age
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully.
* Patient is hemodynamically unstable on POD 15
A Study of LY2940680 in Healthy Participants

This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the safety and side effects of LY2940680 in healthy participants. Part A will involve two groups of participants, each taking up to two single doses of LY2940680 at different dose levels. There is a minimum 14 day washout period between each of the participant's doses. The purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets into the bloodstream and how long the body takes to get rid of it. In addition, the effect of food and a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a minimum 7 day washout period between doses. Participants may only enroll in one part. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination
* Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m\^2)
* Have clinical laboratory test results within normal reference range
* Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
* Prepared to eat an entire high fat breakfast

Exclusion Criteria:

* Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
* Have known allergies to LY2940680, related compounds or any components of the formulation, or known allergies to lansoprazole (Part B only)
* Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product. Participants in Part A are not allowed to participate in Part B
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data (cholecystectomy or appendectomy are allowed if surgery at least 6 months prior to screening)
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Have used or intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study. Exception: participants may continue hormone replacement therapy (HRT; estrogen)
* Use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or Starfruit within 7 days prior to dosing or during the study
An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty

Orthostatic hypotension following total hip arthroplasty is known to limit the ability of patients to perform physical therapy (PT) and increase the length of hospital stay and costs. Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to patients with suspected low SVV, and an intravenous fluid bolus will be administered to patients with low CO. 120 patients will be consented with a view to studying 30 patients who meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4 hrs post-intervention. All patients will undergo measurements for blood pressure, arterial augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is that midodrine or fluid therapy will significantly raise the mean arterial blood pressure (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension Questionnaire (characterized by a two-point improvement in symptom score).


Eligibility Criteria:
Inclusion Criteria:

* Patients of participating surgeons undergoing unilateral primary total hip arthroplasty
* Ages 18-90
* English-speaking
* If the patients are diagnosed with orthostatic hypotension (fall in SBP of at least 20 mmHg or DBP of at least 10 mmHg within 3 min of assuming a sitting/standing position)

Exclusion Criteria:

* Body mass index \> 40
* Low ejection fraction (\<50%)
* Clinical diagnosis of congestive heart failure
* Aortic insufficiency characterized as greater than moderate
* Severe uncontrolled hypertension
* Symptomatic bradycardia (HR \< 50 bpm and symptoms)
* Creatinine \> 1.2 mg/dl
* Hepatic insufficiency
* Severe respiratory disease in which supplemental oxygen is required
* History of severe urinary retention
* Use of MAO inhibitors
* Severe supine hypertension (SBP \>= 150 mmHg or DBP \>= 90 mmHg)
* History of visual problems and using fludrocortisone acetate
* Contraindication for repeated BP measurements
* Revision THA and additional procedures
* Clonidine use
A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis.

This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).

The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.

This study includes a 35-day screening period; a 16-week randomized, placebo-controlled treatment period (Period 1); a 36-week long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).

Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to four treatment groups:

Group 1: LNK01001 12 mg BID (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 2: LNK01001 24 mg BID (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Group 3: Placebo (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 4: Placebo (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter)

Starting at Week 4, rescue therapy is allowed if medically necessary and the following parameters are met:

At Week 4 through Week 24: subjects with \< 50% reduction in EASI response at any two consecutive scheduled visits, compared to the Baseline EASI score.

After Week 24: subjects with \< 50% reduction in EASI at any scheduled or unscheduled visit, compared to the Baseline EASI score.

Starting at Week 16, the use of any concomitant topical medication for atopic dermatitis can be administered per the investigator's discretion and will no longer be considered as rescue therapy for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least ≥18 and ≤75 years of age.
* The subject has a diagnosis of atopic dermatitis for at least 1 year.
* Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4.
* Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.

Exclusion Criteria:

* Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study.
* Requirement of prohibited medications during the study.
* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
* History of malignancy or current diagnosis of malignancy before screening visit.

In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.
New Markers for Treatment Response to Radiotherapy in Prostate Cancer

The actual follow-up of patients undergoing definite radiotherapy for prostate cancer includes regular measurements of prostate specific antigen (PSA). Successful radiotherapy is critically dependent on local control of cancer; however, PSA takes 2-3 years to reach a nadir after therapy. We aim at collecting blood/urine after prostate massage before, and after radiotherapy in order to define new markers predicting local control earlier and more precisely than PSA.

Patients will be closely followed for 5 years (weeks 0, 2, 4, 6, and months 2, 3, 6, 9, 12, 18, 24, and then yearly). Each assessment includes PSA measurement, urine collection after prostatic massage, and blood collection.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing radiotherapy of biopsy confirmed clinically localised adenocarcinoma of the prostate

Exclusion Criteria:

* patients with inflammatory processes of the rectum
* patients with no rectum due to previous surgery
Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)

This is a single-blinded RCT evaluating the effect of robotic-assisted (RM) or conventional laparoscopic surgery (LM) in the management of uterine leiomyomas.

Uterine fibroids are the most common benign tumors of the uterus and may be presented 20%-40% of women at reproductive age.The uterine fibroids can be asymptomatic without intervention. However, they often are the cause of abnormal uterine bleeding, pelvic pain, infertility, and even miscarriage. Myomectomy, rather than hysterectomy can be one option for symptomatic women who wish to preserve their childbearing capabilities or for reasons other than for fertilit. Nowadays, patients pursue cosmetic benefit and early recovery and prompted the search for more conservative and minimally invasive surgical methods when surgical intervention is inescapable and surgical devices are improved.

The feasibility, safety and advantage of cosmetics of laparoscopic myomectomy (LM) has been confirmed after the improvement of techniques and instruments. However, it is very "unfriendly" for our surgeons because of many disadvantages such as keeping stand for long time, unable to relying on, or swaying visual field by first-assistant, etc. Since the approval by the US Food and Drug Administration (FDA) in April 2005, robotic surgeries using the da Vinci Surgical System (Intuitive surgical Inc., Sunnyvale, CA, USA) have been applied widely in many surgical fields including gynecology, urology, orthopedics, general surgery and cardiothoracic surgery. The three-dimensional vision system and the wrist-like structure of EndoWrist instruments (Intuitive surgical Inc., Sunnyvale, CA, USA) recapitulating the motion of the surgeon's hand make precise procedures easier than in conventional laparoscopy, which allows robotic surgery to overcome some of the shortcomings and limitations of traditional laparoscopy. Dr. Lai and colleagues had also successfully undergone robotic surgery in many complicated gynecologic diseases in Taiwan.

However, how to choose or apply robotic-assisted (RM) or conventional laparoscopic surgery (LM) in the management of uterine leiomyomas is still an important issue for our surgeon. We still lack clear definitions about which one kind of myoma may be smoothly performed in RM or LM. The current study is aimed to compare the clinical outcome and efficacy of these 2 minimally invasive procedure in myomectomy, RM and LM, for women with symptomatic uterine fibroids, in this prospective randomised control trial.

Eligibility Criteria:
Inclusion Criteria:

* All women who has symptomatic benign myoma.

Exclusion Criteria:

* Patient is unwilling the scheduled operation after randomization.
Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination

Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

* Correlation memory / Immunity;
* Prevalence of VZV immunity in pregnant women;
* Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
* Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women \>18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged over 18
* Affiliated to a social protection scheme or women benefiting from such a regime
* Women who gived a writing consent

Exclusion Criteria:

* Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
* HIV-positive women
* Garfted women whatever organ
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Covered by national health insurance
* Admitted to ICU after surgery for intra-abdominal infection :

  * With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3(1)
  * Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively.
* With written and signed informed consent

Exclusion Criteria:

* Allergy to caspofungin
* Life expectancy ≤ 48h
* Expected withdrawal of treatment
* Radiological drainage without surgery
* Severe hepatic impairment (Child-Pugh C score)
* Pregnant or lactating women
* Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)
* Infected acute pancreatitis
* Ascites fluid infection
Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function

Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.

Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.

At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Received living or deceased donor kidney transplant during study period
* Documented DGF

Exclusion Criteria:

* Multiple organ transplant
* Recipients with acute rejection present on first biopsy evaluation before first belatacept dose
* Recipients with a first dose of belatacept after index discharge or tacrolimus initiation
Connectivity and Neural Signatures of Consciousness in Unresponsive States

The CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness.

Individuals with severe brain injury often require extensive treatment in intensive care units (ICU) and hospitalization wards while uncertainty prevails about the recovery of consciousness and cognitive abilities. Especially in the acute phase after injury, treatment decisions have a tremendous impact on outcome, but rely on assessments of behavioral responsiveness which are known to be unreliable and subject to many confounders. Objective, quantifiable diagnostic and prognostic measures that can be deployed at the bedside during the ICU stay are lacking. Development of new metrics are hampered by our lack of a fundamental understanding of (i) thalamocortical network mechanisms underlying consciousness and (ii) brain-injury induced neural dynamics impacting both consciousness and outcome. Continuous EEG monitoring has been used to aid in this respect to (i) predict recovery of consciousness and outcome, and (ii) diagnose nonconvulsive seizures in unresponsive patients. Although promising, it lacks sensitivity, spatial resolution, and causal power. There is an urgent need for techniques allowing high-precision detection of pathological dynamics, patient stratification and prediction of a capacity for consciousness recovery in acute unresponsive patients with brain injury. Intracranial electrodes as part of multimodal monitoring in subjects with impaired consciousness and severe brain injury allow continuous bedside recordings of high spatiotemporal resolution in different network nodes and allows inducing brain perturbations, transcending correlational evidence of network analysis. This technique could increase the detection and treatment of nonconvulsive seizures contributing to brain injury and unresponsiveness and simultaneously allows to study networks supporting consciousness. This can lead to new diagnostic and prognostic biomarkers for recovery based on thalamocortical profiles of activity, reactivity (complexity) and connectivity, ultimately paving to way for the development of biomarker-driven treatments to support early recovery such as deep brain stimulation. Eventually this can contribute to clinical decision making: abstaining from aggressive treatment in patients with no potential for recovery, and more importantly, continuing treatment in subjects with a responsive brain but without clear behavioural correlate.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Brain injury of any kind, with impaired consciousness or suspected seizures

Exclusion Criteria:

* \< 18 years old
* Known pregnancy
* Any condition that, in the judgement of the investigator, makes participation in the study unsafe or unfeasible (e.g., irreversible coagulopathy, large intracranial tumors, surgical technical problems...)