cyrilzakka/clinical-trials huggingface dataset:
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis

The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.

The study consisted of 2 treatment periods: a double-blind, placebo-controlled period from Baseline to Week 8 (Treatment Period 1) and a double-blind secukinumab treatment period from Week 8 to Week 24 (Treatment Period 2).

At Baseline (Treatment Period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (Group A) or placebo (Group B). At Week 8 (Treatment Period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg.

Patients assigned to secukinumab 150 mg (Group A) at Baseline who were responders (i.e. spinal pain score \< 4) at Week 8 continued on the same dose until Week 24 under 1 treatment arm (Arm A1). Patients assigned to secukinumab 150 mg at Baseline who were non-responders at Week 8 were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm A2) or secukinumab 300 mg (Arm A3) from Week 8 to Week 24.

Similarly, patients assigned to placebo (Group B) at Baseline were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm B1) or secukinumab 300 mg (Arm B2) from Week 8 until Week 24.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
* patients with back pain for at least 3 months and age of onset less than 45 years
* Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
* Spinal pain numeric rating scale score of more than 4 at Baseline.
* inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization

Key Exclusion Criteria:

* Chest X-ray or MRI with evidence of ongoing infectious or malignant process
* Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
* Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
* Active ongoing inflammatory diseases other than axial spondyloarthritis
* Other ongoing mechanical diseases affecting the spine.
Effect of Fiber Supplementation on the Need for Medication with Gestational Diabetes

The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.

The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Known or new diagnosis of gestational diabetes without reason for medication
* Age \>=18 to \<=50

Exclusion Criteria:

* - Non-English as primary language.
* Known or suspected fetal anomaly or aneuploidy.
* Known lower bowel disorder
* Known phenylketonuria
* Prisoners.
* Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of type 2 diabetes mellitus (T2DM)
* Random C-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/mL) (\>0.2 nanomole/liter \[nmol\]/L\])
* HbA1c of greater than or equal to (\>=)6.5 percent (%) to less than or equal to (\<=)11.0% and meets 1 of the inclusion criteria below:

  1. On diet and exercise only for at least 4 weeks prior to screening
  2. On diet and exercise and a stable dose of metformin monotherapy \>=1,000 mg per day or MTD per day for at least 8 weeks prior to screening
  3. On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen \[that is, type{s} of insulin\] and \<=15% change in the total daily dose of insulin \[averaged over 1 week to account for day to day variability\])
  4. On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening

Exclusion Criteria:

* History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
* Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)
* Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements \>270 milligram/deciliter (mg/dL) (\>15 millimole/liter \[mmol/L\]) during the pretreatment phase, despite reinforcement of diet and exercise counseling
* Severe hypoglycemia within 6 months prior to Day 1
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Alanine aminotransferase level \>5.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the subject may participate)
Gastric Cancer RAD001 Study

The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the stomach. Patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction.
* Metastatic or Loco-regionally advanced disease
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT /MRI scan. See section 11.2 for the evaluation of measurable disease.
* Age \>= 18 years.
* Life expectancy of greater than 12 weeks.
* ECOG performance status \<= 2 (Karnofsky \>= 60%).

Exclusion Criteria:

* Patients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment \[except alopecia\].
* Patients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
* Patients who are on CYP3A4 modifiers are excluded from the study
* Patients with known brain metastases.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001.

Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.

* Patients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of RAD001.
* Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Poorly controlled diabetes mellitus
* High LDL cholesterol or triglyceride level
* Pre-existing neuropathy of \>= grade 2
* Patients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. Par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin
* Pregnancy or lactation.
Changes of NLF in Serum of Long COVID Patients

The study investigates the blood NFL levels in Long-COVID patients.

The study investigates the blood NFL levels in Long-COVID patients.

Eligibility Criteria:
Long-COVID Syndrom
Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic

The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.

All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history
* 50% or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM\&R, Pain Anesthesia, or Neuroradiology Spine Intervention).
* Baseline pain must be \>/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).

Exclusion Criteria:

* SIJ steroid treatment within the prior 6 months.
* Patients with a history of infection currently on antibiotic therapy
* Usage of systemic immunosuppressants
* Pregnancy
Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

This observational and experimental study seeks to establish a Smart Device System (SDS) to monitor high-resolution handtremor-based data using Smartphones, SmartWatches and Tablets. By doing this, movement data will be analyzed in depth with advanced statistical and Deep-Learning algorithms to identify new clinical phenotypical characteristics Parkinson's Disease and Essential Tremor.

Current smart devices as smartphones and smartwatches have reached a level of technical sophistication that enables high-resolution monitoring of movements not only for everyday sports activities but also for movement disorders. Tremor-related diseases as Parkinson's Disease (PD) and Essential Tremor (ET) are two of the most common movement disorders. Disease classification is primarily based on clinical criteria and remains challenging. The primary goal of this study is to identify new phenotypical characteristics based on the captured movement data by the tremor-capturing smartwatches and tablets and smartphone-based questionnaires.

The system will be applied and analyzed within an experimental and observational setting and only captures from patients, which have received informed consent. Within the study period, the SDS is not intended as clinical diagnostic support for physicians and will be not be used as medical device.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's Disease (ICD-10-GM G20.-) or Essential Tremor (G25.0)
* Comparison group: Other movement disorders including atypical Parkinsonian disorders and healthy participants

Exclusion Criteria:

* Unable to obtain informed consent
* Skin-related conditions at one of the wrists or any other medical conditions that could harm the participant's health by wearing the smartwatch at both wrists.
Effect of Improved Indoor Lighting on Residents of Residential Care Homes with Dementia

Elderly with dementia living in residential care homes often have limited access to adequate lighting (daylight). Light can however positively impact the individual on a number of factors, including sleep quality and mental health. The proposed non-invasive study seeks to evaluate the impact of an improved lighting environment in the living areas of residential care home residents with dementia on both the physical and mental well-being of these individuals. To assess sleep quality, an actigraphy device will be used from which a number of parameters corresponding to sleep quality can be obtained. Mental health/behaviour of the participants will be assessed by validated questionnaires. These questionnaires will be filled for each participant independently by 2 members of the nursing staff.

Two groups of residential care home residents will be observed during this study: an intervention group and a control group. In the intervention group, innovative lighting designs are already implemented in the living area. The control group will experience no significant modifications to their lighting conditions. Extra luminaires (floor lamp/table lamp) will be employed without significantly improving the light exposure during the day.

It is hypothesized that the introduction of enhanced lighting during the day in the living area of the intervention group will result in improved sleep quality and enhanced mental well-being.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with dementia
2. Residing in the selected living area

Exclusion Criteria:

1. Blind individuals
2. Not residing in the selected living area
3. Not diagnosed with dementia
Transforming the Cascade Of Hepatitis C Care

Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a small minority of those in need of treatment receive it; 3) Members of minorities and older patients are even less likely to receive needed care; and 4) Until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings.

Community Health Centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. Therefore, these can be ideal places to deliver complex HCV care if they possess the needed expertise. However, most community-based primary care and community health centers lack access to Hepatitis C evaluation and treatment services, leading to a major public health problem.

Thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation rates at each of these sites is estimated as less than 10%. The investigators hypothesize that our project will increase the rate of participation in all the steps of the HCV care cascade and ultimately lead to more than doubled rates of treatment uptake

Primary Objective:

Determine uptake, effectiveness and safety of IFN-free, DAAs among "real world" patients, including those with multiple comorbidities, in the primary care setting.

Secondary Objective(s):

1. Demonstrate the transformation of the cascade of Hepatitis C Care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to HCV care including HCV screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate.
2. Advance understanding of hepatitis C related decision-making in the era of Interferon (IFN)-free Direct acting agents (DAAs) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis C treatment at primary care clinics

Eligibility Criteria:
Inclusion Criteria:

* All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers

Exclusion Criteria:

* Criteria for automatic specialty referral (exclusion from treatment at community health centers) Child Turcotte Pugh Class B or C Any history of decompensated liver disease or hepatocellular carcinoma Evidence of renal disease (GFR \<50) or coexisting autoimmune condition HIV of hepatitis B co-infection
ROLE OF URINARY BIOMARKER NEUTROPHIL GELATINASE ASSOCIATED LIPOCALCIN (NGAL) IN EARLY PREDICTION OF AKI IN CIRRHOSIS OF LIVER

Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis , with prevalence rates estimated around 68%, 25%, and 33%, respectively.

The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis has contributed to an increased awareness and earlier detection of AKI. However, some important problems remain. One of the main issues is the differential diagnosis of AKI, particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is important because treatment is different; renal replacement therapy (RRT) is used for the former, and vasoconstrictors and albumin are used for the latter.

Aim of the study:

To determine utility of NGAL in chronic liver disease patients with acute kidney injury.

Objective:

1. To compare urine NGAL values in HRS and Non-HRS group.
2. To determine optimal cutoff of urine NGAL for early determination of HRS.

Plan of investigation:

All the following investigations will be done at admission for the patients who satisfy the inclusion criteria

Routine blood investigations :

CBP, LFT, PT- INR, RFT urine sodium on day 1 urine spot urine protein creatinine ratio CUE Urine c/s Urine NGAL Serum creatinine will be repeated on Day 3.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosis by combination of clinical, laboratorial, endoscopic and imaging
* Age over 18 years old
* Acute kidney injury (defined by ICA-AKI criteria)
* Agreement to participate in the study

Exclusion Criteria:

* Shock/CCF
* Age less than 18yrs •
* Underwent renal replacement therapy within the last 6 week prior to evaluation
* Prior kidney or liver transplantation
* Confirmed pregnancy
* Established CKD
* Congestive cardiac failure
* Patients who have taken diuretics in the last 48 hours
Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up

Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* adults
* with glycosylated ferritin dosage for suspected adult onset still disease
* with at least 18 month of follow-up

Exclusion Criteria:

* known infectious disease
* known cancer
* known active connective tissue disease or vasculitis
Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.

Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.

The salience of early life experiences during the transition to parenthood underscores the risk of perinatal depression for those with childhood adversity. Mitigation of the adverse effects of childhood adversity via prevention of perinatal depression is an essential component of a reproductive justice-focused public health strategy. Whether and how the collaborative care model can be most effectively leveraged to prevent perinatal depression among pregnant people with a history of ACEs is unknown. To answer these questions, investigators propose a randomized clinical trial of trauma-informed interpersonal therapy modeled after the ROSE intervention and embedded within a perinatal collaborative care program utilizing a type 2 hybrid effectiveness-implementation design.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* At least one prenatal visit at Northwestern Medicine
* Less than 24 weeks gestation
* Non-anomalous pregnancy
* English- or Spanish- speaking
* ACE score ≥ 2
* Singleton gestation

Exclusion Criteria:

* Intent to delivery outside of Prentice Women's Hospital
* Active major depressive episode
* Active substance use disorder
* Participation in a study with a competing intervention or outcome