cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial

The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This will be the first study, internationally, to evaluate the clinical and cost effectiveness of Comprehensive Geriatric Assessment (CGA), a highly promising intervention for improving patient-important health outcomes in frail older people with Chronic Kidney Disease (CKD).

There is an increasing number of frail patients with CKD, and multiple morbidities. Many of them face rapid deterioration of health, referral to residential aged care facilities and loss of independence. This substantively impairs their quality of life and has societal ramifications, including very high costs of care. Patients and carers are often overwhelmed by the multitude of decisions they have to make and may follow a care path that is in contrast to their goals.

The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers.

The primary objective is to test the hypothesis that in frail older people with stages 3-5 CKD, Comprehensive Geriatric Assessment (compared with usual care) will increase attainment of patient-identified goals at 3 months follow up. The secondary objectives are to test the hypotheses that the Comprehensive Geriatric Assessment will increase attainment of patient-identified goals at 6 and 12 months follow up, improve their quality of life and reduce frailty, hospital and residential aged care facility admissions while being safe and cost-effective.

In this multicentre cluster randomised controlled trial, a total of 500 adult CKD stage 3-5 patients will be recruited. Sites will be randomly allocated to either provide a Comprehensive Geriatric Assessment to participants or usual care. The primary outcome measure is goal attainment scaling at 3 months follow up. The secondary outcome measures will be goal attainment scaling at 6 and 12 months, quality of life EQ-5D-5L, frailty index, mortality, hospital and residential aged care facility admissions and cost-utility analysis.

Eligibility Criteria:
Inclusion Criteria for screening:

* Moderate to severe CKD as determined by the treating nephrologist:
* Stage 3 = eGFR 30 - 59 ml/min/1.73 m2
* Stage 4 = eGFR 15 - 29 ml/min/1.73 m2
* Stage 5/5D = eGFR below 15 ml/min/1.73m2, including patients receiving dialysis
* Aged ≥65 years, or ≥ 55 years if Aboriginal or Torres Strait Islander

For inclusion in enrolment:

* Frailty Index \>0.25 (FI-CKD tool)

Exclusion Criteria:

* Estimated life expectancy of less than 12 months.
* Unable to provide informed consent and/or participate in the Goal Attainment Scaling process due to cognitive impairment or another reason.
Observation of Gas Exchange in the Middle Ear

Observation of fluid behavior over a perforated eardrum.

A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.

Fluid present in middle ears is observed during the regular treatment of patients.

The observation in made during the treatment and not as an additional activity. The fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation \[considered as the normal ears\] compared to otitis media ears.

The observation is made on bubble formation over the perforation. The time length of the inspection is about 1 minute, under the microscope, during the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients having perforated eardrum.

Exclusion Criteria:

* Non cooperative patients.
The EVICEL® Gastrointestinal Study

The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.

This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing primary elective GI surgery
* Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures

Exclusion Criteria:

* Avastin use within 30 days prior to surgery;
* Known hypersensitivity to the human blood products or the components of the investigational product;
* Female subjects who are pregnant or nursing;
* Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
The South-East Asian Transgender Health Cohort

This is a prospective observational cohort study that will enroll 300 HIV-negative transgender people and 150 transgender people living with HIV from 4 community health centers in Thailand, Vietnam, and the Philippines. Each participant will be followed-up until the completion of 24 months.

This prospective observational cohort study will longitudinally track physical (e.g. HIV/STI, sexual risk behavior, gender affirmation, clinical information, cardiovascular health, medical history) and mental health (e.g. stigma and discrimination, gender-based violence, anxiety, depression); identify biomedical, structural, and psychosocial factors impacting physical and mental health among transgender people; describe the structural barriers to healthcare experienced by transgender people as well as develop the guidance on holistic healthcare policies for transgender people.

Eligibility Criteria:
Inclusion Criteria:

* Thai/Vietnamese/Filipino nationality
* Aged ≥ 18 years old
* Self-identify as a transgender woman or transgender man
* Have signed consent form

Exclusion Criteria:

* None
Using mHealth to Optimize Pharmacotherapy Regimens

This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.

Comprehensive early treatment of individuals experiencing schizophrenia has the potential to alter the course of illness and improve long-term outcomes. Psychotropic medications are a critical component of early treatment strategies. First-episode psychosis (FEP) is a critical time to optimize prescribing but evidence suggests that prescribing for this population is suboptimal.

A contributing factor to these difficulties is thought to be the lack of accurate information about the effects of medications on symptoms, their side effects, as well as their behavioral, cognitive, and emotional correlates. At medication management appointments, prescribers typically rely on patients' recollection of how they were doing over periods of weeks. Such retrospective assessments are problematic as they are vulnerable to the influence of memory difficulties, cognitive biases including recency effects and frequency illusions, and reframing. Recent advances in smartphone technologies (mobile Health; mHealth) may help to overcome many of the limitations of retrospective assessments.

This pilot study will be a collaboration with OnTrackNY, an innovative coordinated specialty care (CSC) program for individuals aged 16-30 who are experiencing FEP. OnTrackNY originated as part of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Implementation and Evaluatoin Study. The initial phase of this project will use input from stakeholders including patients, front-line providers, clinical leaders, and members of the research team to adapt and refine the mHealth intervention to improve feasibility and clinical utility. A pilot study at 3 OnTrackNY sites will then examine its feasibility and effectiveness by comparing the management and outcomes of 60 patients randomly assigned to the mHealth application or usual care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
* Able and willing to give informed consent and participate in the intervention
* Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.

Exclusion Criteria:

* Suicidal at baseline with C-SSRS score 4 or 5.
* PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)
Evaluation of Predictive Markers for Toxicity and Efficacy in Patients With mccRCC Treated by Anti-VEGF Therapy

The purpose of this study is to assess whether certain metabonomics and/or lipidomics features in correlation with pharmacokinetics before, during and after treatment with sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or pazopanib in metastatic clear cell renal cell carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man ≥ 18 Years old, histologically proven metastatic clear cell (or al least clear cell predominant) RCC,
* Good or intermediate risk according to MSKCC-criteria, Subjects falling into conditions for reimbursement of sunitinib or pazopanib in the context of mRCC,
* Measurable disease based on RECIST criteria (version 1.1) , Subject has given voluntary written informed consent,
* Subject is in the investigator's opinion, willing and able to comply with the protocol requirements, Subject has an ECOG ≤ 2,
* Subject with a life expectancy ≥ 3 months,
* Concurrent treatment with bisphosphonates and denosumab is allowed however it should have been started before screening of the study. If possible starting new medications between the baseline metabolo- and lipidomotype- and the first metabolo- and lipidomotypeanalysis should be avoided,
* Subjects having recovered from side effects from previous therapies to a grade 1 CTC vs 4.0 criteria

Exclusion Criteria:

* Patients with non-clear cell RCC and/or with sarcomatoid differentiation,
* Patients presenting any other type of cancer disease within 5 years from inclusion into this study; in the absence of cervical cancer or basocellular carcinoma, Patients with uncontrolled arterial hypertension,
* Patients with uncontrolled hypo- or hyperthyroidism,
* Patient had major surgery within 4 weeks before enrolment,
* Patient with myocardial infarction within 6 months prior enrolment or with NHYA class III otr IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities,
* Patient has another serious medical condition that could potentially interfere with the completion of study,
* Sero-positive for HIV, Subject known to be hepatitis B surface antigen positive or who has an active hepatitis C infection,
* Subject has an active systemic infection requiring treatment,
* Female subject is pregnant or breast feeding, Subject enrolled in another clinical trial and/or receiving an investigational agent.
Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio

Neuromuscular Blocking Agents (NMBAs) are routinely administered to patients in a multiplicity o anaesthetic settings in order to paralyze and impede (re)active muscular contraction. The availability of monitoring devices allowing an accurate measurement fo the degree of neuromuscular block during anesthesia has raised the standards for a proper evidence-based use of NMBAs.

For this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0.2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the adduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio - a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-ratio of \>0.9, with some authors advocating a ratio of 1 as the only acceptable and complications avoiding result.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.
* Administration of General Anesthesia by means of Total Intravenous Anesthesia technique.
* Use of Rocuronium as a neuromuscular blocking agent.

Exclusion Criteria:

* Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure
* Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.
Clopidogrel Response in Acute Ischemic Stroke

The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke
* admittance to stroke unit
* clopidogrel medication

Exclusion Criteria:

* no consent
* prior bleeding disorders
* severe liver disorders
* current gastrointestinal disorders
* congestive heart failure
* life-threatening malignancies
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis three times a week for at least 12 weeks
* Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
* Mean worst itching VAS is 50 mm or more in both the first and second observation periods

Exclusion Criteria:

* Complications that may affect the assessment of uremic pruritus
* Started or changed pruritus treatment within 13 days prior to starting observations
* Received ultraviolet treatment within 27 days prior to starting observations
* Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
* Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
* Pregnancy, or breastfeeding
Laser Therapy on Orthodontic Tooth Movement

The aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1) enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Facial convexity
* Protrusion or biprotrusion of the incisors
* Dental crowding
* Healthy periodontal condition
* Satisfactory oral hygiene

Exclusion Criteria:

* Patients under medications that may interfere with bone metabolism, such as anti-inflammatory, antibiotics and hormonal supplements in the previous three months
* Skeletal crossbite
* Parafunctional habits
* Occlusal interference
Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of using capnography in detecting the correct placement of nasogastric tubes using the reference standards of radiography and measurement of aspirates for pH value.

A prospective observational diagnostic study will be conducted. Patients ≥ 18-year-old and requiring the insertion of an nasogastric tube will be recruited using a convenience sampling method from general medical and geriatric wards, intensive care units (ICUs), accident and emergency departments (AEDs), and subacute/rehabilitation/infirmary wards in 21 acute or subacute/convalescent/extended care hospitals. End-tidal carbon dioxide (ETCO2) detection by sidestream capnography, which indicates airway intubation of an nasogastric tube when a capnogram waveform or an ETCO2 level \> 10 mmHg, will serve as the index test. The reference standards will be the pH value of gastric content aspiration (pH ≤ 5.5 indicates gastric placement) and X-ray performed after the index test. Each participant will be included only once. Sensitivity, specificity, positive predictive value, and negative predictive value, and the area under the receiver operating characteristic curve of capnography will be calculated to assess the diagnostic performance of capnography. The variability in diagnostic accuracy in participants with different characteristics will be compared. The time spent and the cost of the index test and the reference test will be compared.

This study will provide evidence on the diagnostic accuracy of capnography in verifying nasogastric tube placement and inform the update of clinical practice guidelines and stakeholders' decisions regarding the adoption of ETCO2 detection as a routine method for verifying nasogastric tube placement.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above;
* Admitted to the general medical and geriatric wards, ICUs, or subacute/rehabilitation/infirmary wards in subacute/convalescent/extended care hospitals or visiting AEDs in acute hospitals;
* Requiring the insertion of an nasogastric tube into the stomach for assessment, nutritional support and medication administration during the study period.

Exclusion Criteria:

* Participants receiving life-saving intervention at the time of recruitment.
Establishing an Inflammatory Breast Cancer Registry

Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer that disproportionately impacts young women. IBC often affects the skin of the breast, as well as the breast itself, making it appear inflamed. The purpose of this study is to collect data and information on IBC patients so that researchers can study factors associated with IBC. The data and information collected will be used to establish the IBC Registry, a private cancer registry.

Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will participate in this study. Participants will provide researchers with access to their medical and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute telephone interview concerning general information about themselves and the initial manifestation of IBC and to a 30-minute interview about their medical history.

Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast carcinoma that disproportionately affects young women. Clinical features of IBC include warmth, redness, edema, skin dimpling and rapid enlargement; the hallmark pathologically is dermal lymphatic invasion. Minimal criteria necessary for a clinical diagnosis of IBC have been debated and relatively little is known about the epidemiology, pathogenesis and molecular characteristics of these very lethal tumors. This project, funded by a grant from the Department of Defense awarded to PHL, would develop a national registry of approximately 300 volunteers (aged 18 years or older) with IBC. Subjects will provide access to medical records, pathology records, slides, blocks and tissue (fixed and frozen) and x-rays and consent to an interview. Recruitment will be performed at collaborating institutions and through an IBC research foundation (Owen Johnson) that maintains a website and e-mail contact lists. The registry resources would be made available collaboratively to anyone in the breast cancer research community, based on merit as determined by a designated committee. Central aims of the study include determining whether clinically or pathologically defined IBC differs in clinical behavior or biologically, identifying markers in IBC that may provide useful information about the aggressive potential of breast cancers generally, and evaluation of tissue for mouse mammary tumor virus (MMTV) related sequences. The purpose of this IRB submission is to review the role of MES as a collaborating pathologist on this study. Enrollment is closed as of this time.

Eligibility Criteria:
* Patients will be recruited from collaborating institutions throughout the US and through the IBC research foundation (established by patient advocate, Mr. Owen Johnson), which maintains a website and a research e-mail list. The goal is to recruit approximately 300 volunteers, at least 18 years of age or older.
Naltrexone Treatment for Prolonged Grief Disorder (PGD)

This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Lives within a reasonable distance from NYPH for convenient clinic visits.
3. Can speak, read, and write English proficiently.
4. Meet diagnostic criteria for PGD based on the DSM guidelines
5. If a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. Female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit.
6. If a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug.

Exclusion Criteria:

1. Having recently started taking/prescribed medications for any psychiatric illness (e.g. SSRIs for MDD) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included.
2. Having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included.
3. Prior history of recently active (e.g. within the past 3 months) opioid dependence.
4. Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide).
5. Possible future use of opioids during the study (e.g. for surgery).
6. Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone.
7. Currently pregnant, lactating, or planning to become pregnant during the study.
8. Active hepatitis or liver disease.
9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal on initial laboratory examination.
10. Screen positive for active suicidal thoughts or behaviors.