cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects

This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria

  1. Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  2. Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight ≥ 50kg at screening.
  3. A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
  4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following condition applies:

     * Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 Contraceptive Guidance, OR
     * A WOCBP who agrees to follow the contraceptive guidance in Appendix 1 Contraceptive Guidance from screening through at least 90 days after the last dose of study drug; a WOCBP must have a negative beta-human chorionic gonadotropin (β-hCG) test at screening and baseline prior to administration of investigational product.

Exclusion Criteria:

1. Subject has a history of any clinically significant cardiac, respiratory (including asthma, bronchospasm), renal, hepatic,gastrointestinal, psychiatric, neurologic, hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or chronic infections, or other abnormality that may affect safety, or potentially influence the study results, judged by the investigator or designee.
2. Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
3. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 90 days or 5 half-lives (whichever is longer) prior to Day 1.
4. Receipt of any investigational product within 30 days or 5 halflives (whichever is longer) prior to Day 1.
5. Will have vaccination with live virus, attenuated live virus, or any live viral components within the 30 days prior to Day 1 or is to receive these vaccines at any time during study period or within 90 days after last dose.
6. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.
7. Male subject who is considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drug.
8. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to enroll this study.
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must give written informed consent before any study assessment is performed.
2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
4. Patients on optimized medical treatment for heart failure. -

Exclusion Criteria:

1. Patients not able to comply in the study.
2. Patients having contraindication for treatment with Entresto;

   1. Hypersensitivity to the active substances or to any of the excipients listed in section
   2. Hyperkalemia: \> 5.4 mmol/L
   3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.
   4. Hereditary or idiopathic angioedema.
   5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2)
   6. End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis).
   7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
   8. Pregnancy Breast-feeding-
Bimatoprost/Timolol Versus Travoprost/Timolol

The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.

PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.

METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma

Exclusion Criteria:

* No other ocular diseases
AuraGain Performance in Lateral Position

To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.

Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a limited number of studies have been conducted on the performance of AuraGain in pediatric patients.

Changes in the position of the head and neck alter the shape of the pharynx leading to changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in both the adult and pediatric population. Having a large occiput and a relatively cephalically placed glottis, the ventilation in children is more compromised due to poor alignment of the pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal inlet both decreasing the delivered tidal volume. Different changes occur during extension and lateral rotation

Although the clinical performance of the AuraGain would be expected to be high, or at least non-inferior, to that of the widely used currently available SGAs, clinical trials are required to verify its performance in head and neck positions other than the neutral position (i.e flexion, extension and lateral rotation).

Eligibility Criteria:
Inclusion Criteria:

* Weight: 15-30 kg.
* Age: 2-9 years.
* Sex: both males and females.
* ASA physical status: 1-3.
* Operation: elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

Exclusion Criteria:

* Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
* Potentially difficult airway.
* Patients with history of neck, respiratory, or digestive tract pathology.
* Patients with gastroesophageal reflux, gastrointestinal stenosis, or stricture.
Infections of the Central Nervous System

This study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection.

The specific aims of the study include:

1. To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME.
2. To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME.
3. To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME.
4. To identify a specific group of patients that benefit from cranial CT prior to LP.
5. To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, ...) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT.
6. To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≥18 years admitted to the University Hospital Basel with confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from January 2006 to December 2021 with or without cranial CT prior to LP
* All patients aged ≥18 years admitted to the University Hospital Basel over the same time period with suspected infectious meningitis and/or encephalitis as principal and/or secondary diagnosis with or without cranial CT

Exclusion Criteria:

* Patients without suspected infectious meningitis and/or encephalitis.
* Patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission
* Patients who have refused "General Consent" (i.e., written agreement of patients which allows the further use of their collected medical data for research purposes in encoded form).
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)

Single ascending dose of HM15211 in healthy obese subjects.

A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Participation in an investigational study within 30 days prior to dosing
The Effect of Paliperidone Palmitate in Schizophrenia

The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.

In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* PANSSS total score \<120
* each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests \< 16
* three different groups ( other antipsychotics refractory schizophrenia patitents : CGI\> 4 chronic akathisia : DIEPSS overall severity \>1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS \<3)
* Competent patient who is manage to answer the questionnaires.
* In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

* No history of antipsychotics prescription
* History of NMS(Neuroleptic malignant syndrome)
* Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
* clozapine medication within 1 month before screening
* SSRI, MAOI, TCA medication within 2 months
* Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
* patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
* current or previous history of drug depedence according to DSM-IV
* Pregnant or breast-feeding female patient
* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
* history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
* History of participating to other investigational drug trial within 1month prior to screening
* Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers

In this study we, the investigators at the Centre for Addiction and Mental Health, intend to explore whether bupropion is able to reduce smokers' responses to cigarette-related environmental cues, and craving. Previous studies have indicated that bupropion may be able to achieve these outcomes. Therefore, we predict that smokers treated with bupropion for several weeks will show reduced reactivity to cigarette cues and craving.

Current smoking cessation pharmacotherapy paradigms ignore the over-learned behaviour associated with smoking, thus contributing to the relatively poor absolute efficacy of pharmacotherapy. Chronic nicotine use causes adaptive changes in the brain that differ from the acute effects leading to craving when smoking is stopped. This is a key element of relapse. Thus, the development of more effective treatments involves a better understanding of craving and relapse by exploring the interaction between the psychology and neurobiology of nicotine addiction. Bupropion, an amphetamine derivative, has demonstrated efficacy in smoking cessation in motivated smokers. Its' mechanism of action is unclear but may be mediated by extinction processes. We hypothesize that bupropion will reduce cue-responsiveness and subsequent cravings in current smokers who are not consciously attempting to quit or cut down on smoking. Fifty smokers (\>10 cigarettes/day) of either sex will be recruited to take either oral placebo or bupropion 150 mg twice daily for a total of 42 days. Subjects will attend bi-weekly experimental sessions where cue-responsiveness will be measured using physiological and subjective responses to a variety of neutral and smoking-related cues. Subjective effects will be measured using the Questionnaire of Smoking Urges, the Tobacco Craving Questionnaire and Visual Analog Scales. Subjects will record smoking behaviour and subjective experiences daily in a smoking diary. Outcome variables include cue responsiveness, daily diary ratings, exhaled end tidal CO levels, plasma cotinine levels, and subjective effects. Gender effects will be assessed by using sex as a covariate in the analysis. This study will provide preliminary data on pharmacotherapy-assisted extinction as a novel approach to smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* At least 19 years of age
* Smoking at least 10 cigarettes per day for at least 2 years
* Never treated with bupropion/Zyban

Exclusion Criteria:

* Co-morbid psychiatric disorder
* History of psychotic disorder or eating disorder
* Current alcohol or substance abuse/dependence (excluding nicotine, caffeine)
* Brain injury
* Seizure disorder
* Pregnancy, lactation, or at risk of becoming pregnant
* Current regular use of psychotropic drugs
* Known allergy or sensitivity to bupropion
To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial related activities
* Healthy Chinese male subjects
* Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
* Fasting plasma glucose less than 6.0 mmol/L
* Non-smoker

Exclusion Criteria:

* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
* Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation

This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 and \< 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or
* Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory \[e.g. Holter\] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
* Patients with a Congestive heart failure, Hypertension, Age ( \> 65 = 1 point, \> 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated

Exclusion Criteria:

* History of stroke, transient ischemic attack or systemic embolism
* History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
* History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
* Known bleeding diathesis or any known active bleeding site at screening or baseline
* Family history of bleeding disorder
* Known active GI lesions predisposing to bleeding events
* Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
* Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area \<1.5 cm2)
* Patients with a prosthetic heart valve

Other protocol defined Inclusion/Exclusion criteria may apply
Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:

* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy

Participants will undergo FPF imaging using the OcuMet Beacon system.

The goal of this clinical trial is to learn if areas of mitochondrial functional distress in the macula (as imaged using fundus flavoprotein fluorescence) correlate with areas of anatomic disease identified on standard fundus autofluorescence (FAF) imaging.

The study aims to evaluate patterns of anomalous fundus flavoprotein fluorescence (FPF) in patients with advanced geographic atrophy (GA) due to dry age-related macular degeneration.

Participants will undergo FPF imaging using the OcuMet Beacon system and FAF imaging using Heidelberg Spectralis.

Eligibility Criteria:
Inclusion Criteria:

* 50 years or older and may be either male or female of any race
* Established diagnosis of GA due to AMD
* GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm2 to 17.5 mm2. GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation
* Willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging
* Presence of neovascular AMD on OCT as confirmed by an ophthalmologist
* Presence of significant media opacity preventing adequate retinal imaging
* Presence of concurrent retinal disease which may confound assessment
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Must have clinically concerning symptoms of Post-traumatic Stress Disorder and/or it's dissociative sub-type, as indicated by either a score of 3+ on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the Dissociative Subtype of PTSD Scale (DSPS).
* Must be between 3-24 months postpartum
* Must be receiving regular, primarily in-person psychotherapy from a therapist at a clinic in the Greater Detroit area.

Exclusion Criteria:

* Are currently pregnant
* Have a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder
* Have a documented history of epilepsy
* Have ever experienced previous head injury with loss of consciousness
* Are currently experiencing domestic or intimate partner violence or otherwise state that their current living conditions are unsafe
* Are currently experiencing psychosis or have been suicidal within the last six months
* Are currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis
* Have engaged in self-harming behaviors in the last 3 months requiring medical attention
* Do not have competence to understand or consent to the study procedures
* Do not have fluency in written and spoken English