cyrilzakka/clinical-trials huggingface dataset:
EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now.

FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.

Hydrocephalus is caused by excess cerebrospinal fluid in the brain that can lead to lethargy, seizures, and comas. There is no cure for it nor is there any way to prevent it from happening. Affecting 1M Americans today, treatment costs the healthcare system \>$2B per year. Neurosurgically implanted shunts, the standard treatment, often fail. Patients with failed shunts show nonspecific symptoms, including headaches, dizziness and nausea. CTs and MRIs are used for diagnosis, but are inconclusive, expensive, and often lead to unnecessary admissions.

Rhaeos, Inc. is a VC backed, clinical stage medical device company developing FlowSense, a patent protected platform technology and a noninvasive wireless, wearable skin patch that can assess and monitor fluid flow subdermally throughout the body. The company is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now.

FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient¿s neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more existing external ventricular drains (EVDs).

Exclusion Criteria:

* Patients with no external ventricular drains (EVDs).
A Pilot Study of RISE for Nurse Managers

The purpose of this study is to determine whether RISE for Nurse Managers has a significant impact on nurse managers' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years old
2. Licensed as an RN
3. Nurse manager employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Carrollwood, Celebration, Connerton, Dade City, Daytona Beach, DeLand, East Orlando, Fish Memorial, Heart of Florida, Kissimmee, Lake Placid, Lake Wales, New Smyrna Beach, North Pinellas, Ocala, Orlando, Palm Coast, Sebring, Tampa, Waterman, Wauchula, Wesley Chapel, Winter Garden, Winter Park, or Zephyrhills campus
4. Able to speak, read, and understand English fluently
5. Able to provide informed consent
6. Willing and able to comply with all study procedures and requirements for the duration of the study

Exclusion Criteria:

1. Employed as a direct care nurse or in another level of nursing leadership (i.e., assistant nurse manager, director of nursing, executive leader)
Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Prostate cancer with metastases
* Prostate cancer should be castration resistant
* Progression during hormonal therapy

Exclusion Criteria:

* Visceral metastases (eg liver, lung or brain metastases)
* Prior treatment with any immunotherapy for prostate cancer
* Prior or ongoing cytotoxic therapy for prostate cancer
* Autoimmune disease
* Inadequate hematologic, renal, or hepatic function
Analgesia in ÖAMTC Helicopter Emergency Service in Austria

A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.


Eligibility Criteria:
Inclusion Criteria:

* Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016

Exclusion Criteria:

* No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
* Anemia with low erythropoeitin (EPO) levels

Exclusion Criteria:

* Poorly controlled hypertension
* Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
* Treatment with EPO within the last 6 weeks
* Pregnant or breastfeeding females
Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China

Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.

This was a multi-centre prospective study. All infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland China in 2019. A total of 20839 transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. The primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. The effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.

Eligibility Criteria:
Inclusion Criteria:

gestational age more than 35 weeks(≥35) -

Exclusion Criteria:

all kinds of congenital diseases, infants with pathologic jaundice

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Relation of Consummatory and Anticipatory Food Reward to Obesity

Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body weight on average and most patients regain this weight within a few years. Further, most obesity prevention programs do not reduce risk for future weight gain. The limited success of treatment and prevention interventions may be due to an incomplete understanding of the processes that increase risk for obesity. Recent data suggest that obese adults show abnormalities in reward from food intake and anticipated food intake relative to lean adults, but the precise nature of these abnormalities is unclear and it has not been established whether these abnormalities predate obesity onset or are a consequence. It is vital to elucidate risk factors for obesity onset to advance understanding of etiological processes and determine the content of prevention and treatment programs.

The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by virtue of having two obese parents, show abnormalities in reward from food intake (consummatory food reward) and anticipated reward from food intake (anticipatory food reward) compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities in consummatory and anticipatory food reward increase risk for weight gain and obesity onset, (3) examine moderators that may amplify the relations of consummatory and anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory food reward in those participants who show obesity onset relative to those not showing obesity onset. Each of these goals is described in more detail below.


Eligibility Criteria:
Inclusion Criteria:

* We will require that adolescents have age- and sex- adjusted standardized body mass index (BMI) scores between the 25th and 75th percentile at baseline for inclusion.
* Low risk youth: Lean parents will have a BMI between 18 and 25.
* High risk youth: Obese parents will have a BMI value of greater than 30.

Exclusion Criteria:

* Students who report contraindicators of fMRI (e.g., metal implants, braces, or pregnancy).
* Current major psychiatric disorders (including substance use disorders, conduct disorder, oppositional defiant disorder, ADHD, major depression, bipolar disorder, panic disorder, agoraphobia, or generalized anxiety disorder)
* Current use of analgesics and other psychoactive drugs (e.g., cocaine)
* Serious medical complications (e.g., diabetes)
* Relevant food allergies
* Current smoking
* Current weight loss dieting
Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore.

This study is a prospective ranzomized analysis including 372 human oocytes from 44 women. Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 A23187 (GM508 CultActive Gynemed) will be applied. Non treated oocytes will serve as control. Oocyte fertilization rates, embryo development and embryo quality will be analyzed. Obstetrics variables of offspring will be also followed and compared.

Background: Oocyte non-activation (OAD) is the main cause of fertilization failure in intracytoplasmic sperm injection (ICSI) cycles. Oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization, triggered by the action of sperm-specific phospholipase C zeta (PLCz) that causes an increase in the amount of free Ca2+. This increase, as well as its transient elevations in space and time, is species-specific. Defects in this pattern of Ca2+ release and oscillation are attributed to most cases of OAD. Several strategies have been described and applied to achieve artificial oocyte activation (AOA), which use mechanical, electrical, or chemical stimuli, among which the use of calcium ionophores such as ionomycin and A23187 (calcimycin) predominates. Documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using ICSI-AOA compared to conventional ICSI. However, the lack of well-designed studies, the heterogeneity of the population undergoing AOA, and the scarcity of results comparing different AOA protocols make it difficult to assess the clinical efficacy and safety of the technique.

Study question: In patients with prior fertilization failure or low fertilization rates (30% or less), does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure? and if it does, which protocol is more efficient?

Eligibility Criteria:
Inclusion Criteria:

* Own oocyte patients who have had previous fertilization failure in previous cycles.
* Own oocyte patients with fertilization rate in previous cycles less than or equal to 30% of the microinjected oocytes.

Exclusion Criteria:

* Oocyte Recipient Patients
* Sperm bank sperm recipient patients
* Patients who after oocyte decumulation have less than 2 mature oocytes.
A Study of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy

This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002.

Multiple-dose levels of IMC-002 will be tested in subjects with advanced cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Signed ICF
2. Histologically or cytologically proven metastatic or locally advanced solid tumors
3. Subject must have at least 1 measurable lesion by RECIST 1.1.
4. Availability of tumor archival material or fresh biopsies
5. Adequate hematologic function, hepatic function, and renal function
6. Agree to use effective contraception
7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

1. Treatment with nonpermitted drugs
2. Prior treatment with a CD47 or SIRPα targeting agent
3. Concurrent anticancer treatments
4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period
5. Previous malignant disease other than the target malignancy for this study
6. Active infection requiring systemic therapy before Day 1
7. Any active autoimmune disease, or history of autoimmune disease
8. Any psychiatric or cognitive condition
9. Known severe hypersensitivity reaction
10. Pregnant or lactating
11. Currently enrolled in another clinical study
Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning

Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Collecting CEUS and clinical data of HCC from different institutions retrospectively.

Developing a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients.

Then, validating the deep learning model in the prospective data.

Eligibility Criteria:
Inclusion Criteria:

* patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation
* without macro-vascular invasion
* Child-Pugh A/B grade
* HCC is proved by pathological examination or two enhanced imaging
* CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation
* Invasive biomarker or prognosis of HCC available
* CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)

Exclusion Criteria:

* postop follow-up loss or expired less than 3 months
* patients with co-malignancy
* poor images quality for analyzing
Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.

Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients' capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT's support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.

After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant's home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* If entering the study as an inpatient, hospitalization was recent
* Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended
* Assumes primary responsibility for taking medication
* Currently living in a stable environment

Exclusion Criteria:

* History of significant head trauma, seizure disorder, or mental retardation
* History of alcohol or drug abuse or dependence within 1 month prior to study entry
* History of violence within 6 months prior to study entry
HIV, Buprenorphine, and the Criminal Justice System

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Age ≥18 yrs
* Meets DSM-IV criteria for opioid dependence
* Has medical entitlements in DC
* Able to provide informed consent
* Able to communicate in English or Spanish

Exclusion Criteria:

* Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
* Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
* AST and ALT \>5x the upper limit of normal (AST≥175, ALT≥195)
* Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
* Breastfeeding or unwilling to stop breastfeeding
* Subject is part of another pharmacological research study
* Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
* Suicidal ideation
* Hypersensitivity to buprenorphine
Association of Implant Position and Crown Contour With Tissue Health

Emergence profile and crown contour of implant supported rehabilitation, which is influenced by implant position, is associated with peri-implant health and esthetic outcomes. However, there is no study prospectively explore the association between implant position, emergence profile/crown contour, and dental implant outcomes. Thus, the present study aims to (1) assess the multivariate association between local factors and peri-implant soft-tissue health, inflammation, and microbiome; and (2) to identify patterns/clusters of implant characteristics significantly associated with health or inflammation.

This will be a prospective study aimed at associating the development of peri-implant mucosal inflammation (mucositis) and deeper inflammation (peri-implantitis with marginal bone loss) with features associated with implant position (three-dimensional position of the implant platform) and the consequent shape of the crown contour and emergence profile. The hypothesis is that implant position determines the shape of the crown, which in turn determines the persistence of a local microbial biofilm as unfavourable crown contours hamper oral hygiene efforts aimed at biofilm control/removal. The persistence of a biofilm will cause soft tissue inflammation, which may lead to microbial dysbiosis and disease.

Eligibility Criteria:
Inclusion Criteria:

Patients with a single implant-supported restoration in anterior jaws (premolars to premolars), with adjacent natural teeth, with pre-surgery CBCT and intra-oral scans, and willing to comply with research appointments/schedule.

Exclusion Criteria:

* Pregnancy or intention to become pregnant at any point during the study duration;
* With any systematic diseases/conditions that are contradictions to dental implant treatment;
* Inability or unwillingness of individual to give written informed consent.
* Inability of follow-up according to the protocol.