cyrilzakka/clinical-trials huggingface dataset:
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects

A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.

This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.

Eligibility Criteria:
Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
* Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
* Subject is Caucasian.
* Female subject must be of non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or post-menopausal ≥ 1 year with follicle stimulating hormone \[FSH\] \> 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
* Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
* Subject has a body weight \> 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
* Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
* Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

* Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
* Subject has clinically significant abnormalities on a 12 lead ECG done at screening
* Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
* Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
* Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years
* Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention within plus/minus 4 weeks of gadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get a CTA for the purpose of exclusion of CAD within plus/minus 6 weeks of gadobutrol-enhanced CMRI
* Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at stress/rest and gated single photon emission computed tomography (GSPECT, if GSPECT will be a study procedure)
* Women of childbearing potential (e.g. age \< 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test
* Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as a study procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI

Exclusion Criteria:

* Suspected clinical instability or unpredictability of the clinical course during the study period
* Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
* History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator's assessment / judgment
* Estimated glomerular filtration rate (eGFR) value \<30 mL/min/1.73 m\^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment.
* Acute renal insufficiency
* Coronary artery bypass grafting (CABG)
* Acute myocardial infarction (\< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure
* Irregular heart rhythm
* Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease
SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coronavirus disease (COVID-19 virus). Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus.

Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel COVID-19 virus. Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus. The purpose of this trial is to provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 and up
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures.
* Must have laboratory confirmed COVID-19 positive test
* Must have severe or immediately life-threatening COVID-19

Severe disease is defined as:

1. dyspnea
2. respiratory frequency ≥ 30/min
3. blood oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
5. lung infiltrates \> 50% within 24 to 48 hours

   Life-threatening disease is defined as:
6. respiratory failure
7. septic shock, and/or
8. multiple organ dysfunction or failure

Exclusion Criteria:

* Known contraindication to transfusion or history of prior reactions to transfusion of blood products
Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.

Sampling Method: Probability Sample (consecutive patient sampling)

Eligibility Criteria:
Inclusion Criteria:

* Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
* Written informed consent

Exclusion Criteria:

* All relevant conditions according to Summary of product characteristics (SmPC)
* Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
* Patients currently included in any investigational trial on CHB
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 with Recurrent Genital Herpes

This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A.


Eligibility Criteria:
Part A: Inclusion Criteria:

* Subject has a body mass index (BMI) between ≥ 18.0 and \< 32.0 kg/m2
* In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1 or Day 1 (predose)
* Agreement to comply with protocol-specified contraceptive requirements

Part B: Inclusion Criteria:

* Subject has a body mass index (BMI) between ≥ 18.0 and \< 32.0 kg/m2
* Other than HSV infection, is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 (predose)
* Agreement to comply with protocol-specified contraceptive requirements

Part A and B: Exclusion Criteria:

* Current infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV).
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/distribution/elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before Screening, whichever is longer.
Prospective Registry on Vascular Access in Interventions in Lazio Region

Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.

We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria:

* Patients already enrolled in other clinical trials
Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Overall good health
* Elective Cesarean section ASA class 1 or 2

Exclusion Criteria:

* Allergy to synthetic suture materials
* Diabetes whether gestational or pregestational
* use of steroid or immunosuppresive medication within last 6 month of procedure
* Skin sepsis or systemic fever
* BMI \> 35
* History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4
Effects of Food Form on Cephalic Phase Responses

This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite hormone responses.

Beverage consumption has been implicated in the problem of obesity. However, the exact relationship between beverages, lower appetitive response and lower compensatory dietary responses remains unclear. This study aims to address this gap in the research. For aim 1, the null hypothesis is that the energy in beverage and solid forms will not affect appetite hormonal responses differently. The alternative hypothesis is that exposure to the energy-yielding beverage will elicit a lower appetitive hormone response compared to oral exposure to the solid food form. For aim 2, the null hypothesis is that learning will not change appetite hormone responses. The alternative hypothesis is that learning will decrease appetite hormone responses in the non-energy-yielding beverage more than in the energy-yielding beverage.

The main aims will be studied in 3 phases. In phase 1,the unconditioned cephalic phase responses of participants to nutritive and non-nutritive beverage and solid food forms will be determined. In phase 2, participants will consume a randomly allocated solid food or beverage (either nutritive or non-nutritive) consecutively for 2 weeks. In phase 3, (which will occur immediately after the end of Phase 2), participants will be retested for their cephalic phase responses to determine if there is an effect of learning on appetite hormone response.

Eligibility Criteria:
Inclusion Criteria:

* Body fat percentage \> 25% for men and \> 32% for women. BMI of 24 kg/m2- 37kg/m2
* No purposeful use of foods or beverages that are sweetened with non-nutritive sweetener \> 3 times a week
* No purposeful addition of non-nutritive sweetener to foods and beverages \>3 times a week
* No Phenylketonuria (PKU)
* Rate palatability of test load and food sample as greater than 5 on a 9 point category scale.
* Be willing to eat at least 100 grams of carbohydrates for three days prior to each test day
* Self-reported consumer of breakfast and lunch
* Be willing to eat macaroni and cheese during breakfast-lunch hours
* Not taking medications known to influence appetite
* Non-smoker \>1 year or more
* Habitual activity pattern over the last 3 months and no plan to change this over the course of the study
* Not on any extreme diet (e.g. Atkins Diet)
* Weight stable (≤ 5 kg change over the last 3 months)
* Not a restrained eater (have a dietary restraint score of \<9 on the Three Factor Eating Questionnaire-Restraint section)
* Not a disordered eater (Have a score of \<20 in the Eating Attitudes Test-26)
* Have not donated blood for at least 3 months prior to participating in the study
* Indicate no plan to donate blood during, and for three months after the study
Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

The term "acute abdomen" is often used to describe the manifestations of any serious intraperitoneal disease, which may indicates surgical intervention. Acute abdomen in pregnancy accounts for approximately 7-10% of all abdominal emergencies.

Several pathologies could contribute acute abdominal pain during pregnancy. They include obstetric and non-obstetric causes. As for the non-obstetric causes , any gastrointestinal or urological disorders could be presented by an acute abdominal pain.

In pregnancy, several factors overlap and making the diagnosis challenging. These factors include the distorted anatomy by the growing uterus that displaces intraperitoneal structures. Additionally, nausea, vomiting, and abdominal pain are considered the normal course during pregnancy especially at the first trimester. Moreover, sure diagnosis must be achieved to operate in a pregnant woman with more possible morbidity and mortality for the mother and\\or fetus.

Laparoscopy can be safely performed during any trimester of pregnancy. Historical recommendations were to limit surgery to the second trimester only, but these recommendations were based on experience with open surgical procedures during pregnancy. These recommendations were thought to minimize the spontaneous abortion rate of surgical intervention during the first trimester, which was reported to be as high as 12%, and to avoid preterm labor, reported in up to 40%, when surgery occurred during the third trimester. However, studies limited to laparoscopy have shown improved outcomes and demonstrated that pregnant patients may undergo laparoscopic surgery safely during any trimester without any appreciated increase in risk to the mother or fetus.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women having acute abdomen and underwent surgical intervention will be included in this study.

Exclusion Criteria:

* Non-pregnant women with acute abdomen are excluded.
ExoDx Prostate Evaluation in Active Surveillance Patient Population

The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

Eligibility Criteria:
Inclusion Criteria:

* Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Exclusion Criteria:

* Clinical symptoms of urinary tract infection at time of enrollment.
* History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
* Known hepatitis or HIV
* History of concurrent renal/bladder tumors
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen

The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.

The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.

Eligibility Criteria:
Major Inclusion Criteria for participants:

1. Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
2. Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
3. Couples electing single embryo transfer (SET)

Major Exclusion Criteria for participants:

1. All patients who do not voluntarily give their written consent for participation
2. Under 18 years old, above 42 years old
3. BMI \> 35
4. Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
5. Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
6. Total basal antral follicle count less than 6 follicles
7. Failed more than one previous FET cycle
8. Use of oocyte donation
9. Use of gestational carrier
10. Presence of hydrosalpinges that communicate with endometrial cavity
11. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
12. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
13. Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
14. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
15. Use of surgical procedures to obtain sperm
16. Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
17. Sex selection
18. Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Transcranial Brain Stimulation in Vegetative State Patients

The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29.
* Age between 18 and 65 years.
* Time from the lesion: more than 4 months.
* Stable clinical condition.
* written consent fron the legal administrator of the patient.

Exclusion Criteria:

* Presence of epileptiform activity on EEG.
* Previous history of epilepsy.
* Extensive hemorrhage or ischemia.
* Metallic clips or intracranial implants.
* Pacemaker e Baclofen infusion.
* Presence of drugs influencing arousal or awareness.