cyrilzakka/clinical-trials huggingface dataset:
Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants

The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER. The total study duration will be approximately of 24 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks). Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are compliant with self-medication or can receive consistent help or support
* Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)

Exclusion Criteria:

* Participants with the past history of neuroleptic malignant syndrome (NMS)
* Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
* Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
* Female participants who are pregnant or are breast feeding
* Participants who have participated in any investigational drug trial within 1 month prior to the screening visit
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214

(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.

Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written, and dated informed consent prior to any study specific procedures.
* Healthy male and nonpregnant, nonlactating female 18 to 55 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
* Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
* Be willing to eat the high-calorie, high-fat breakfast or fast accordingly
* Be able to understand and comply with the requirements of the study as judged by the Investigator

Exclusion Criteria:

* History of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results
* History of gastrointestinal surgery (except for appendectomy) or unintentional rapid weight loss
* History of seizure activity, including febrile seizures
* Past diagnosis of more than 1 episode of major depression
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Assessing Intellectual and Motor Outcomes in High-risk Infants

Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.

In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Science Foundation Ireland (SFI) and the Cerebral Palsy Foundation, USA.


Eligibility Criteria:
Inclusion Criteria:

- (High Risk Group)

Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:

All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight

All encephalopathic infants

Neurological risk factors (e.g., cerebral birth defect, injury/malformation on neuroimaging, persistently abnormal neurological exam)

(Control Group)

All full term infants will be eligible if:

Term infants born \> 37 weeks gestational age

Not admitted to the NICU

No neurological impairments at birth (no identified congenital or genetic abnormalities)

Exclusion Criteria:

- (High Risk \& Control Groups)

Death prior to discharge from the neonatal unit (High-Risk Infants only)

No parental consent (High-Risk and Control Infants)
Night Owl Metabolism

The proposed study uses a novel and rigorous randomized cross-over study design in youth (17-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.


Eligibility Criteria:
Inclusion Criteria:

* Overweight similar to (BMI ≥ 85th percentile but \<95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and \<95th percentile equivalents for a 20-year-old will be used))
* Post-pubertal
* Normal sleep duration (avg. \>7 hours of sleep per night)
* Social jetlag (difference between weekend and weekday sleep) of \< 2 hours.

Exclusion Criteria:

* Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome
* Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm
* Screening high risk for obstructive sleep apnea
* Night shift work.
Trial of the Impact of the Electronic Frailty Integrated With Social Needs

Participants in Electronic Frailty Integrated with Social Needs (eFRIEND) will randomize to receive regularly scheduled in-person and telehealth contacts with a community health worker (CHW) or continue to receive standard of care. The purpose of this research is to use CHW to help older adults because there may be some resources that could benefit them that they are not aware of or for which they need help applying.

The study team will conduct a pragmatic randomized pilot trial of a CHW-led hybrid in-person/telehealth program pathway (eFRIEND) for frail older adults. Using Zelen's effectiveness design, the study team will identify eligible frail older adults via the Electronic Health Record (EHR). Eligible participants will be randomized to the eFRIEND pathway or usual care. The study team will randomize 2050 older adults (1050 to eFRIEND, 1000 to usual care), with the randomization stratified by primary care clinic. Eligible participants randomized to the eFRIEND pathway will be contacted by phone to discuss study procedures and obtain verbal informed consent. eFRIEND comprises a 6-month intervention. All CHW will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training. CHW are trusted members of the community and are utilized as part of routine care to assist patients. At the first visit, the CHW will assess if the participants have any unmet social and/or functional needs (baseline survey). The frequency and amount of time of each point of contact will be at the discretion of the CHW.

Eligibility Criteria:
Inclusion Criteria:

* Frail based on the electronic Frailty Index (eFI\>0.21)
* Live in Forsyth County, NC
* Linked to any Accountable Care Organizations (ACO) registry
* Have a Primary Care Provider (PCP) in Atrium Health Wake Forest Baptist (AHWFB) system, and have seen their PCP or someone else in the clinic of their PCP within the last 12 months

Exclusion Criteria:

* Diagnosis code for dementia in the past 2 years
* Does not speak English
Validation of VascuQol-6 Spanish Version

VascuQol (VQ) is a specific questionnaire to assess the quality of life of patients with critical limb ischemia which is also used as an index in vascular registries. The original version has 25 items (VQ-25), divided into 5 subscales or domains: pain, symptoms, activity, social and emotional. The shortened version, VascuQol-6 (VQ-6) is made up of 6 questions and 4 possible answers, which score from 1 (worst quality of life perceived by the patient) to 4 (best quality of life perceived by the patient). The total score is between 6 and 24, and a higher value is related to better health.

While the VQ-25 questionnaire has been translated and validated in 21 languages, the shortened version VQ-6 has been translated and validated in some languages, not including Spanish. As it is a fast and easy-to-use tool iwhich has demonstrated statistical validation to measure PAD in other versions of the same questionnaire (other languages), a cross-cultural adaptation and statistical validation of the questionnaire from English to Spanish will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* With a diagnosis of Peripheral Arterial Disease (intermittent claudication and critical lower limb ischemia)
* Whose first language is Spanish
* Who sign the informed consent.

Exclusion Criteria:

* Patients with cognitive impairment that difficults understanding of the questionnaire
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)

The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adult patients (\>= 18 years old)
* Patients who can understand all study information and literature to provide fully informed consent
* Atrial fibrillation (AF) as the primary diagnosis
* Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
* Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

* Pregnant women
* Patients with active cancer
* Patients unable to consent for themselves
* Patient on concomitant antiplatelet therapy
Threat-Avoidance Learning in Anxiety Patients

Anxiety disorders are characterized by exaggerated levels of fear that are not proportional to the actual level of threat. More specifically, anxiety patients have marked deficits in the downregulation of fear reactions during situations of objective safety. Pre-clinical research on Pavlovian fear conditioning and extinction has discovered that fear downregulation stems from areas in the prefrontal cortex (the ventro-medial prefrontal cortex, vmPFC) that recruit intercalated cells in the amygdala to inhibit its central nucleus, which is responsible for a variety of behavioral expressions of fear (Milad \& Quirk, 2012). Accordingly, functional magnetic resonance imaging studies (fMRI) revealed reduced vmPFC activity coupled with increased fear reactions during situations of objective safety in anxiety patients (Milad et al., 2009). Another core symptom of anxiety disorders, though much less investigated, is the excessive avoidance of situations that trigger the fears. These 'safety behaviors' often interfere with daily life activities and valued goals in life, and they are thought to perpetuate the exaggerated levels of fear by precluding opportunities to learn that the feared situations are actually not dangerous. Surprisingly, experimental research on avoidance behaviors in anxiety patients is virtually non-existent. This experiment modifies the Pavlovian fear conditioning procedure to include avoidance, and explores the behavioral and neural processes of this type of fear regulation in anxiety patients (trans-diagnostically) and healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age. Proficient in English. Right-handed Free of medication that affect cerebral metabolism. Able to give informed consent. High stress level (defined as a score of \>= 3 on the 4-item Perceived Stress Scale).

Exclusion Criteria:

History of neurologic or psychiatric disease (other than the specified anxiety disorder), substance abuse or dependence that is current or within the last year.

Major/chronic medical conditions. History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae. History of seizures. History of stroke Prior neurosurgical procedure. Metal in the body, metal injury to the eyes. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt. Pregnancy; breastfeeding or nursing Claustrophobia Weight \> 350 lbs.
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study

The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.

Healthy controls (HC) will be studied as outpatients and undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks. Individuals with Cocaine Use Disorder (CUD) will complete the study as inpatients on our unit and undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks. Participants will complete sleep studies (to evaluate sleep architecture); the first two nights after admission and the last two nights before discharge. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-60 years
* Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
* For females, a negative serum pregnancy test
* For CUD: DSM-5 criteria for Cocaine Use Disorder and positive urine toxicology showing recent use
* For HC: Negative urine toxicology

Exclusion Criteria:

* DSM-5 criteria for other substance use disorders (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
* A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5)
* A history of significant and/or uncontrolled medical or neurological illness
* Current use of psychotropic and/or potentially psychoactive prescription medications
* Medical contraindications to MRI procedure
Cognitive Correlates of Substance Abuse - 11

The purpose of this study is to characterize the cognitive performance of methamphetamine abusers by comparing them with cocaine abusers and normal controls.


Eligibility Criteria:
Inclusion Criteria:

M/F . Meet DSM-IV criteria for cocaine or methamphetamine dependence. Agree to conditions of the study and sign informed consent.
Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor
* tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
* disease that can be evaluated by RECIST v1.1 and measurable disease

Exclusion Criteria:

* central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease
* history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
* clinically significant cardiac dysfunction
* inadequate end organ function as defined by specified laboratory values
* use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
* use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment
* clinically significant, uncontrolled impaired gastrointestinal function or GI disease
* prior treatment with a HSP90 inhibitor
* radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
* pregnant or nursing women
* history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.

The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old.
2. Subjects must have a plan of extraction of impacted tooth.
3. Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
4. weight at least 45kg,and no more than 100kg.
5. If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
6. Willingness to comply with the study procedures and requirements.
7. willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
2. a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
3. any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
4. Oral surgical site combined with infection.
5. Severe cardiovascular and cerebrovascular diseases.
6. Severe gastrointestinal disease.
7. had a history of seizures or drug or alcohol abuse.
8. uncontrolled hypertension.
9. significant abnormal electrocardiogram
10. significant abnormal laboratory value.
11. Allergic to the study drug and ingredients.
12. Pregnancy, lactation or recent Pregnant plan;
13. Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
14. other conditions unsuitable for participation in the study.