cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.

This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label, first--in--human study to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A \[Dose Escalation\] and Part B \[Dose Expansion\]) and Phase II. Additionally, all subjects (Phase I and Phase II) will be eligible to participate in 1 of 2 sub-studies. Patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
* Must not have received prior oral endocrine therapy \< 2 weeks prior to first dose
* Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
* Adequate hepatic function
* Adequate renal function
* Normal coagulation panel
* Willingness to use effective contraception

Exclusion Criteria:

* Gastrointestinal disease
* Significant renal disease
* Significant cardiovascular disease
* Significant ECG abnormalities
* Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
* Pregnancy or breastfeeding
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

The objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.

The subjects were to be enrolled sequentially to three dose groups, starting with the lowest dose level. Subjects could participate in only one Group. Progression to an increased dose of lucerastat was permitted only after review of all data from the previous cohort suggested that it was safe to do so.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Male subjects aged from 18 to 45 years at screening.
* Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
* Serious adverse reaction or hypersensitivity to any drug.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Physiological Complexity of Gait Over the First Six Months Post Stroke

Physiological complexity of gait, a measure of the interaction of multiple control mechanisms for walking within a biological system, is decreased in persons with chronic stroke compared to those without disability. Thus, it is assumed that the quantification of gait complexity represents the adaptability and health of the individual. However, it is unknown if the level of gait-related complexity improves over time with recovery from stroke. Therefore, the primary purpose of this study is to determine if the physiological complexity of gait changes over the first six months post stroke within the contemporary healthcare environment. Secondary aims include 1) determining if there is a difference between the amount of physiological complexity of gait and lateralization of hemispheric damage after stroke and 2) exploring the relationship of complexity to lower extremity motor impairment, walking speed and balance. Sixty individuals within one month post stroke from the greater Indianapolis area will be recruited for this prospective, longitudinal outcomes study. Testing sessions will occur at intervals across the first six months post stroke: within 1 month, at 3 months, and at 6 months post stroke. During each testing session, participants will complete a 2-minute walking task during which accelerometer signals from wireless inertial measurement units will be collected and converted to sample entropy to quantify the physiological complexity of gait. Additionally, measures to quantify lower extremity motor impairment, walking speed and balance will be collected and analyzed. Changes in complexity of gait from early to later stages of stroke recovery may serve as a foundation for prognosticating outcomes, such as predicting capacity for community mobility and/or risk of fall. The proposed study will meet a critical need to develop methods that differentiate among capacities for adapting movement patterns in individuals with neurological dysfunction. This work will ultimately build upon evidence that will assist therapists in tailoring interventions in such a way to optimize function.


Eligibility Criteria:
Inclusion Criteria:

* within 1-month post unilateral, cortical, ischemic stroke
* has only experienced one stroke
* between the ages of 21-80
* able to walk a short distance (at least 14 meters) on level surfaces without physical assistance, with or without the use of an assistive device and/or orthosis
* able to follow at least two-step verbal instructions
* available for the entire period of the study (5-6 months)

Exclusion Criteria:

* hemorrhagic stroke
* bilateral hemispheric stroke
* stroke in the brainstem or cerebellum
* pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke
* complications from other health conditions that could influence walking
Establishment of Airway Database for Surgical Patients

Difficult airway is a major reason of anesthesia related injuries with latent life threatening complications. Foresee difficult airway in the preoperative period is vital for the patient's safety. The aim of this study is to develop a computer algorithm that can detect whether the patient is a difficult airway based on photographs form six aspects. This method will be decreased potential complication related to difficult airway and increased patient safety.

Introduction:

The primary purpose of the study is to develop a computer algorithm that can detect whether the patient is a difficult airway based on photographs from six different aspects.

Methods:

This study is divided into two parts. In the first part, we collected the patients' airway assessment score who underwent general anesthesia with endotracheal intubation assessed by an experienced attending anesthesiologists before and after intubation. Evaluation of airway score after tracheal intubation as the gold standard for airway assessment. Digital photographs of the face of each patient in frontal neutral view and in profile neutrals were obtained. Details of the photographs, each corresponding to a facial motion: (1) Frontal, neutral. (2) Frontal, mouth open. (3)Frontal, extreme mouth open and tongue out. (4)Frontal, extreme upper lip bite (5)Profile, neutral. (6) Profile, neutral, maximum head back. The patient's photographs and the airway evaluation score after intubation were input to the computer to train the computer. In the second part, the trained computer was used to evaluate the airway score of the new patient compared with that of the patient after intubation, and calculated the sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* General anesthesia-induced tracheal intubation in patients who undergoing elective surgical patients

Exclusion Criteria:

* Patients with multiple facial injuries Patients who had undergone head or neck surgery Patients who need emergency operation
The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation

Renal dysfunction is a major risk factor for poorer outcome after liver transplantation. Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly understood. Calcineurin inhibitors are generally perceived as the most important cause; however the liver transplant procedure itself represents a major surgical / hemodynamic / inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and creatinine clearance are late markers of acute kidney injury and changes in these parameters occur only after substantial injury has already occurred. Even a stable creatinine does not exclude structural kidney damage.

A series of new markers of tissue injury have been identified and have the potential to identify acute kidney injury better and earlier than creatinine and creatinine clearance. The aim of this study is to determine whether and how liver transplantation affects these urinary and plasma biomarkers and to study whether the changes in these biomarkers may predict later changes in standard functional parameters (creatinine and creatinine clearance). For this purpose, the urinary and plasma biomarkers, together with creatinine, will be determined serially during the different phases of the liver transplant process and daily until day 5 after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years

Exclusion Criteria:

* Younger than 18 years old
* Combined organ transplants
* Dialysis dependent prior to liver transplantation
Immune Response in Peripheral Blood of Patients With Colon Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells.

PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

OBJECTIVES:

* Quantify T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) from the peripheral blood of patients with colon cancer.

OUTLINE: This is an open-label study.

Patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). Blood is analyzed for tumor peptides (carcinoembryonic antigen and MUC1), circulating cytokines, and lymphocyte response by ELISA, ELISPOT, or intracellular flow.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Study of Pain Following Removal of Wisdom Teeth With Acute Pulpitis

The purpose of this study is to determine whether pulp chamber opening and drainage on wisdom teeth with acute pulpitis before the extraction could reduce postoperative pain so beneficial to patient.


Eligibility Criteria:
Inclusion Criteria:

* inclusion criteria of upper wisdom teeth for the two groups were: vertical eruption; being worthless to be restored; deep caries in the occlusion surface with acute pain; without caries or acute pulpitis in the adjacent second molar

Exclusion Criteria:

* systemic diseases, smokers, inflammation in oral cavity,with history of psychiatric illness,pregnant or lactating females
Long-term Follow-up of Fingolimod Phase II Study Patients

This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Randomized in study FTY720D2201 and received at least one dose of study drug.

Exclusion Criteria:

* None
Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)

The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving BioMatrix stents
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients with cardiogenic shock
Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

The aim of this prospective randomized controlled trial is to assess the efficacy of cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy for trainees.

Colorectal cancer is one of the major malignancies in western countries and also in Japan. Therefore , the demand for total colonoscopy (TCS) has risen remarkably. However, failure to reach the cecum occurs in up to 10 % of cases.

A difficult colonoscopy procedure will often be associated with more complications, and require heavier sedation to alleviate patient's discomfort.

Auxiliary devices that could facilitate the examination would be needed. A cap is a simple device that can be attached to the tip of a colonoscope. The advantage of the cap in getting a good view might be helpful in cecal intubation by depressing the folds and also by keeping an appropriate distance between the colonoscope lens and colonic mucosa. We speculated that inexperienced colonoscopists would obtain greater benefit from cap-attached colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo colonoscopy examination

Exclusion Criteria:

* Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
* Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding ・Patients who diagnosed as inflammatory bowel disease
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy

The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.


Eligibility Criteria:
Inclusion Criteria:

* Male patients undergoing an elective robotic assisted radical prostatectomy
* Written informed consent
* Age ≥ 18years

Exclusion Criteria:

* Emergency surgery
* History of chronic steroid use
* Previous prostatic surgery
* Previous radiotherapy or brachytherapy
* Patients with hypersensitivity or allergy to the suture material.
* Participation in another study
* Non-compliant patient (dementia etc)
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g

Vitamin A is essential for optimal growth, and development. In the newborn, especially if preterm, it is necessary for the cellular differentiation, for the health of the anterior eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis. Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very low (\<1500g birth weight) and extremely low (\<1000g birth weight) preterm infants are born with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless, optimal vitamin A supplementation for these infants is not clearly defined, despite evidence of benefit of an early supplementation.

Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease marked by respiratory compromise associated with high mortality and severe long-term morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that may be related to less rhodopsin quantity which seem dependent on vitamin A concentration. Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral administration as drops is available resulting particularly convenient avoiding the pain associated with repetitive intramuscular injections, or the discomfort of parenteral administration. Studies of vitamin A in the infant population suggest that plasma retinol concentrations \>0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have lower concentration and concentration \< 0.35 µM/L are very dangerous. Vitamin A deficiency at this level may constitute a problem for preterm newborn, resulting for example, in histological alterations in the respiratory epithelium leading to chronic lung disease, retinopathy of prematurity, patency of the ductus arteriosis, and immune competence deficiency.

The aim of the present study is to verify efficacy and tolerability of a new oral administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants \< 1500g weight at birth, verifying the competence of the supplementation reaching ideal blood concentration (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the controlarm.


Eligibility Criteria:
Inclusion Criteria:

* parents signed informed consent
* very low birth weight infants undergoing ventilation for at least 24 hours
* Infants able to receive adequate breast or formula milk

Exclusion Criteria:

* parents denied informed consent
* congenital malformations
* infants not able to receive breast or formula milk
Riluzole in Huntington's Disease

Primary objective:

* The primary objective of the study is to establish that riluzole slows down (1) the decrease in total functional capacity (TFC), (2) the increase of the motor score of the Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a combined score of these.

Secondary objectives:

Secondary objectives are to assess

* changes in the other UHDRS subscales
* the number of patients who need antichoreic treatment and the time until this treatment has to be initiated
* the safety/tolerability of riluzole in Huntington patients


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more
* UHDRS Motor score of at least 5 points
* UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care
* Females require a negative blood pregnancy test at inclusion

Exclusion Criteria:

* Any forms of chorea other than Huntington's disease
* Patients on antichoreic treatment within one month prior to entry or foreseen to require such treatment within the first 3 months after randomization (antichoreic medication is prohibited during entire study)
* Other unacceptable prior/concomitant medications
* Uncontrolled major psychiatric disorders, in particular uncontrolled major depression (DSM IV definition)
* Drug or alcohol dependence and/or abuse (DSM IV definition) within the past 6 months
* Any other concomitant disease with a reasonable possibility to interfere with the study
* Females who are breast-feeding, not sterilized, at least one year postmenopausal or don't use an adequate contraceptive method for at least one month prior to and during study participation
* Participation in another clinical study with any investigational drug within 30 days prior to study screening
* Prior exposure to riluzole
* ALT and/or AST and/or Total Bilirubin levels greater than 1.5 times the upper limits of normal range, or hepatic disease other than Gilbert's disease
* Creatinine serum concentrations above 200 µmol/l (resp. 2,3 mg/dl) or hematology parameters as follows: Hemoglobin smaller 11 g/dl for males resp. smaller 10 g/dl for females, or White Blood Cell smaller 3,5 x 10000000000/l