cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors

This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Must have failed at least one established standard anti-cancer therapies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 12 weeks
* Adequate hematologic and end organ function
* Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
* Confirmed availability of representative tumor specimens
* Measurable disease according to RECIST Version 1.1

Exclusion Criteria:

* Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
* History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator
* History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* History of autoimmune disease
* Positive human immunodeficiency virus (HIV) test
* Severe infection within 2 weeks prior to the first dose of study treatment
* Significant cardiovascular disease
* History of allogeneic tissue/solid organ transplant or graft-versus-host disease
* Known clinically significant liver disease
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable Alzheimer's disease
* Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
* Able to attend outpatient clinic visits with primary caregiver

Exclusion Criteria:

* Unable to comply with study procedures
* Considered medically inappropriate for study participation
Sonographic Features of Normal Soft Tissues of the Feet

The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.

To study normal sonographic anatomy of soft tissues of the foot \[which include Extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones\] in asymptomatic individuals/volunteers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* no disease or abnormality of the feet

Exclusion Criteria:

* abnormality of the feet
Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to patients with "wet" age-related macular degeneration (AMD). AdGVPEDF.11D is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye, but whose levels are altered in diseases characterized by ocular neovascularization like AMD. The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the ability to inhibit growth of new blood vessels.

AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye will be the eye with the worst visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 50 years;
* Severe neovascular AMD in at least one eye responsible for a best corrected vision of 20/200 or worse in the study eye (if both eyes have neovascular AMD and equal visual acuity scores, the study eye will be determined by the investigator);
* Best corrected visual acuity in the fellow eye must be equal to or better than the study eye;
* Fluorescein angiography of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion. The subfoveal component must consist of CNV (choroidal neovascularization), blood or fibrosis. The total size of the lesion must be ≤12 MPS disc areas. The presence of a leaking subfoveal choroidal neovascular lesion will be evaluated by the investigator at the clinical site to determine patients' eligibility.
* Must not be candidates for (including patients who have had treatment with either modality in the past and are no longer candidates) or must have refused treatment with subfoveal laser photocoagulation or PDT (photodynamic therapy);
* Informed consent;
* Able to comply with protocol requirements including follow-up visits.

Exclusion Criteria:

* Liver enzymes \> 2 x ULN (ALT, AST, bilirubin);
* Clinical evidence of active infection of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus;
* Other treatment for AMD in the study eye within the last twelve weeks prior to Day 1;
* Other experimental medications within the last four weeks prior to Day 1;
* Significant retinal disease other than neovascular AMD, such as diabetic retinopathy or retinal vascular occlusion;
* Significant non-retinal disease such as ocular atrophy;
* Cataract or other significant media opacity that might compromise examination and photography of the posterior segment;
* Other causes of choroidal neovascularization such as pathologic myopia ( \> 8 diopters), ocular histoplasmosis or angioid streaks;
* Evidence of inflammation (grade 1 or higher) in the anterior and/or posterior chambers;
* Cataract surgery or submacular surgery within 3 months;
* Prior ocular treatment with radiation;
* Known allergy to fluorescein;
* Abnormal prothrombin or partial thromboplastin time ( \> 1.5 X ULN) or anticoagulant therapy that cannot be withheld for treatment.
Rollover Protocol for Prior SU011248 Protocols

The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol


Eligibility Criteria:
Inclusion Criteria:

* Prior SU011248 Protocol.
* Eligible to continue SU011248 treatment.

Exclusion Criteria:

* Uncontrolled CNS metastasis.
* Unfit to receive SU011248.
Application of Vascular Closure Device in Transvenous Cardiac Intervention

Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery

Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery.From the operation success rate, postoperative bleeding, immobilization time, the rate of revisiting the doctor due to wound problems within 1 month, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving lower extremity venous intervention with a diameter of 12F or more

Exclusion Criteria:

* None
Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia

Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to poor postoperative prognosis. As a novel ultra-short-acting benzodiazepines drugs, remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. Our study aimed to investigate the different effects of remimazolam and propofol on dynamic cerebral blood flow autoregulation function during general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years, gender not limited
2. Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia, with an expected operative length of approximately 1h\~2h
3. Good penetration of the temporal window.
4. ASA anesthesia classification grade I to II.
5. can communicate effectively with the physician.
6. Patients were aware of and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Relative contraindications to general anesthesia: patients with severe heart and lung function diseases.
2. History of syncope, and dizziness.
3. Patients with a history of psychiatric disorders, neurological disorders, drug abuse, or drug addiction
4. Patients with cerebrovascular or carotid artery lesions;
5. Those who are unable to cooperate in completing the test
6. Persons who have taken benzodiazepines intermittently in the last three months.
7. Those with known allergies or allergies to the test drug.
Diabetic Ketoacidosis and Its Impact on the Brain

About the Study: This research study is being conducted to see if diabetic ketoacidosis has any impact on learning, behavior and development in children with Type 1 diabetes mellitus. If there is an impact, is it transient or persistent? Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. The investigators will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by your doctor and bring their meter(s) for downloading to each visit. The children with Type 1 diabetes mellitus should also tell your doctor about the frequency of severe low and high blood glucose values.

Participant Schedule:

1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological testing and to become familiar with the MRI scanner.
2. Subjects who need to become more familiar with the MRI scanning process will view a video tape at home.
3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head completed.
4. Subjects between 10 and 17 years of age will also be asked to complete two additional abbreviated neuropsychological tests at one week and one month from enrollment.
5. Subjects may have the complete neuropsychological testing and MRI scan repeated 15 months from time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

To take part in the study, the participant must meet the following inclusion criteria:

1. Be between the ages of 4 to 17 years.
2. Either has been diagnosed with type 1 diabetes mellitus OR does not have type 1 diabetes mellitus

Exclusion Criteria:

If the interested participant has a history of head trauma with any loss of consciousness, prematurity (born less than 30 weeks of gestation), significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), neurologic disease independent of diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal appliances such as braces).
Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

This clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.

Objective: This randomized crossover pilot study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult patients with chronic intestinal failure on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes expression.

This study will include 20 adult patients with chronic intestinal failure. Patients will receive nocturnal parenteral nutrition for 2 weeks (period A) and will switch to daytime parenteral nutrition (period B) for 2 weeks (random assignment). During both study periods glucose variability and sleep / wake rhythm will be measured. After both study periods, patients will be admitted to the metabolic unit for 24 hours to measure bone turnover markers, nitrogen balance, glucoregulatory hormones, energy expenditure and substrate oxidation rates and clock gene expression in leukocytes.

Eligibility Criteria:
Inclusion Criteria:

* Home parenteral nutrition for at least 5 nights a week
* On home parenteral nutrition for more than 1 year
* No major changes in parenteral nutrition for 3 months prior to inclusion

Exclusion Criteria:

* Parenteral infusion for more than 16 h a day
* Use of bone modifying drugs in the last 2 years
* Bone fractures in the past year
* Renal insufficiency (eGFR \< 60 ml/min)
* HbA1c ≥48 mmol/ml
* Use of corticosteroids
* Shift work
* Performing intensive exercise (\> 2 hours a day and \> 3 times a week)
The Efavirenz (EFV) Central Nervous System Exposure Sub-study of Encore1

Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at risk of developing HIV-related brain disease. Important factors associated with the development of HIV-related brain disease include therapeutic concentrations of antiretroviral drugs in the CNS. Conflicting evidence regarding the CNS exposure of the antiretroviral drug used for the encore1 study, efavirenz (EFV) have been described in related studies. There were recent study of two small series assessment of EFV exposure in the cerebral spinal fluid (CSF); one group reported small detectable EFV concentrations, while another observed undetectable EFV exposure in the CSF. Also, in a larger reported series comprising of 80 subjects on EFV-containing antiretroviral therapy, a CSF to plasma concentration suggested that there is limited movement of EFV out of the CSF. In HIV-1 infected subjects at steady state, EFV plasma level parameters are dose proportional following 200mg, 400mg, and 600mg daily doses. The CNS exposure of EFV at different daily dosing has not been described.


Eligibility Criteria:
Inclusion Criteria:

* All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.

Exclusion Criteria:

* Existing neurological disease which in the opinion of the investigator would be a contra-indication to lumbar puncture examination
* CNS opportunistic infections in the past 12 weeks of randomisation
* Bacterial or viral meningitis in the past 12 weeks of randomisation
* Head injury requiring medical assessment in the past 12 weeks of randomisation
Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.

PCOS is the most common female endocrinopathy in reproductive age. This syndrome is a heterogeneous condition characterized by several symptoms and clinical signs related to reproductive, cardiometabolic and psychological disorders.We recently demonstrated that young PCOS women show an expansion of an unusual T-cell population with proinflammatory functions, identified by CD4+CD28null T lymphocytes . Of note, this T subpopulation has been found to be expanded in patients with unstable angina, type 2 diabetes (DM2), in absence of clinical evidence of CVD 12, and has been recently associated to recurrent coronary instability .Based on the above mentioned evidences, the aim of the present study is to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patientsTo evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) and NOMAC-valerate estardiol on some cardiovascular risk factors in PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with PCOS aged 18-35 years

Exclusion Criteria:

* chronic or acute inflammatory disease
* cancer
* autoimmune disease
* treatment with clomiphene citrate
* antiandrogens
* drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes)
BIS Monitoring of Patients With Hydrocephalus

We tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly. We also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage patients with hydrocephaly undergoing ventricular-peritoneal shunt placement

Context: Enlarged skull circumference in patients with hydrocephalus might alter bispectral index (BIS) values; as distorted skull contour distances sensors from a shifted cerebral mass as well as mental dysfunction as a result of disrupted Cerebrospinal fluid circulation.

Objectives: Investigators tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly. Investigators also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage patients with hydrocephaly undergoing ventricular-peritoneal shunt placement.

Methods: After ethics committee approval participants, or their next of kin, who gave written informed consent were recruited in the study. Investigators excluded potential participants suffering from hepatic disease. In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control patients at approximately the same age group were included in the study.

In the second study 15 post cerebral hemorrhage adult patients undergoing ventricular-peritoneal shunt placements and 15 adult control patients were included in the study.

2 BIS sensors were placed on patients' forehead and connected to BIS-Vista monitors. In a quiet anesthesia induction room investigators recorded BIS-Vista for 10 min before induction.

Remifentanil 4 ng ml-1 was started and propofol TCI was kept constant at 4 microg ml-1 with no adjustments for a 1 h anesthesia maintenance study-recording period when time of surgery allowed. Investigators also noted BIS values immediately before and after a patent ventricular-peritoneal shunt was successfully installed. After conclusion of surgical procedures, remifentanil and propofol infusions were terminated and this marked the beginning of the recovery phase of the study where we recorded BIS values for another 20 min emergence from anesthesia.

Eligibility Criteria:
Inclusion Criteria: . In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control patients at approximately the same age group will be included in the study.

In the second study 15 post cerebral hemorrhage adult patients undergoing ventriculo-peritoneal shunt placements and 15 adult control patients will be included in the study.

Exclusion Criteria: Patients with Liver disease
The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics

Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER stay.

* According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow.
* Get documented agreement from the caregiver if the patient meets the criteria.
* While the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (AP) and transverse (T) diameter(cm)
* If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient.
* If the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior \& posterior wall meet.
* If the AP X T was less than 2 X 2, excluded from the study enrollment.
* During the study, caregivers and the assigned nurse will be blinded

Eligibility Criteria:
Inclusion Criteria:

* Body temperature of patients ≥ 38℃ reported by guardians
* No definite focus of fever detected by physical examination
* Guardian agrees to use urine bag(kismo) collection technique

Exclusion Criteria:

* Previous history of urinary tract infections
* Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)
* ICU treatment indicated
* Newly diagnosed hydronephrosis on the day of visit
Shared Decision Making and How It Impacts the Patient Understanding

Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.

1. Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
2. Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
3. What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?


Eligibility Criteria:
Inclusion Criteria:

* - Aged 45 to 64 years
* Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician
* Self-identified as African American and/or Hispanic
* At least one of the following comorbidities:

  1. Obesity (BMI ≥ 30),
  2. Hypertension (ICD10 codes below)
  3. Diabetes (ICD10 codes below)

Exclusion Criteria:

* - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
* Prior total knee replacement
* Recommended total knee replacement
* Acute knee trauma