cyrilzakka/clinical-trials huggingface dataset:
A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants

The purpose of this study is to assess the effects of aticaprant on QT/ QT interval corrected for heart rate (HR) (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the study center on Day -1 of the first treatment period. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
* Body mass index (BMI; weight \[kilograms {kg}/ height square \[meter square {m\^2}\]) between 18 and 30.0 kg/m\^2 (inclusive), and body weight not less than 50 kg at screening
* All female participants must have a negative serum pregnancy test (Beta-human chorionic gonadotropin \[Beta-hCG\]) at screening and a negative urine pregnancy test at admission to the study site on Day -1 of the first treatment period
* A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of at least 90 days after receiving the last dose of study intervention
* Non-smoker (not smoked for 3 months prior to screening)

Exclusion Criteria:

* History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the investigator considers should exclude the participant
* History of additional risk factors for Torsade de Pointes or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (less than/equal to 40 years), drowning or sudden infant death syndrome in a first degree relative (that is, biological parent, sibling, or child)
* Any skin condition likely to interfere with electrocardiographic electrode placement or adhesion
* Breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA). Advances in cardiac surgery have improved HS mortality such that there is increasing attention to IRA and their management. The objective of this research project is to prospectively observe a cohort of infants with HS and IRA and evaluate their long term outcomes. Specifically, the investigators would like to determine what is the natural history of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators plan a prospective, multi-center, observational study to follow this complicated group of patients. This will be a web-based database collected from major cardiac tertiary care centers in both Canada and the United States. Patients with HS will be recruited by their primary site and clinical data will be collected by their primary site prospectively throughout childhood until they are at least five years of age. This patient population will be followed by their own clinical care givers; this is not an interventional study. No additional clinic visits will be required and the patients will not have to be contacted. Patient medical records will be accessed by a member of the study team at the primary site at least once per year or more frequently if interventions are required or complications develop.


Eligibility Criteria:
Inclusion Criteria:

* All infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome

Exclusion Criteria:
Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia

The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.

Despite significant advances in the prevention and treatment of cerebrovascular disease in the last few decades, stroke remains the third leading cause of death and the leading cause of adult disability in the United States. For the population that has experienced a cerebrovascular event, the risk of future stroke is greatly increased. The initiation of effective secondary prevention strategies is most effective when implemented early (before disabling stroke occurs), monitored frequently, and maintained long-term after a cerebrovascular event.

The Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention uses stroke navigators to help people who have suffered a stroke implement secondary prevention strategies. Stroke navigators are lay persons trained to provide education on secondary prevention behavior, and trained to navigate the health and human service system. The goals are to help individuals who have had a stroke obtain the necessary services and programs to engage in secondary prevention behaviors and, ultimately, to prevent the recurrence of stroke.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized due to ischemic stroke\* or intercurrent ischemic stroke\* event within the past 30 days OR Transient ischemic attack, confirmed by stroke neurologist.
* Atherogenic etiology(large vessel, small vessel, cryptogenic with at least one stroke risk factor, or embolic stroke due to atherogenic cardiac disease) as defined by TOAST criteria.
* Community dwelling prior to stroke
* Resides within the District of Columbia or closely nearby (preferably within 10 miles of the DC border)
* Expected to reside within the District of Columbia or closely nearby (preferably within 10 miles of DC border)
* Caregiver or interested party available, if moderately or severely disabled (not required to actually reside with participant)
* Sufficient number of collateral contacts to assure follow-up. Defined as: Preferred: at least 6 contacts; and No fewer than 3 contacts (unless approved by study PI/co-PI/co-I)
* Judged likely to return to community setting at completion of post-acute care.

Exclusion Criteria:

* Non-atherogenic cause of stroke
* NIHSS \> 20
* Any medical condition that would limit participation in follow up assessments
* Baseline dementia per informant report (AD8) or screening assessment (Short Blessed Memory Orientation Concentration Test)
A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants

The primary purpose of this study is to evaluate the effect of multiple-dose administration of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult participants; and to evaluate the effect of time-separated, multiple-dose administration of famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).


Eligibility Criteria:
Inclusion Criteria:

* Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters \[kg/m\^2\]), extremes included, and body weight not less than 50.0 kilograms (kg) at screening
* Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening
* Must have a normal 12-lead Electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than or equal to (\<=) 450 milliseconds (ms) for male participants and \<= 470 ms for female participants; QRS interval less than (\<) 120 ms; PR interval \<= 200 ms. If the results of the ECG are outside the normal ranges, the participant may be included only if the investigator judges the deviations from normal ECG to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must sign an informed consent form (ICF) indicating he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

* History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) \<60 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease \[MDRD\] formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* Past history of clinically significant cardiac arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
* Any evidence of clinically significant heart block or bundle branch block at screening
* Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by hepatitis C virus \[HCV\] antibody) at screening
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate the long-term safety of efgartigimod in participants with pSS who have completed the treatment period of the qualifying efgartigimod studies (including ARGX-113-2106).

ARGX-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pSS-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients with pSS. Participants will be enrolled from both active and placebo arms of qualifying efgartigimod studies and receive efgartigimod 10 mg/kg over 48 weeks in the extension study without knowledge of their treatment assignment in the qualifying study. Eligible participants must have completed the treatment period of the qualifying study and must not have permanently discontinued the IMP in that study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least the legal age of consent for clinical trials when signing the ICF
* Is capable of providing signed informed consent and complying with protocol requirements
* Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP
* Has completed the qualifying efgartigimod pSS studies and agrees to continue study drug treatment without interruption in the extension study

Exclusion Criteria:

* Clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Pregnant or intention to become pregnant during the study
* Any severe systemic pSS manifestation that may put the participant at undue risk based on the investigator's opinion
Effect of the Height of the Operating Table During Spinal Anesthesia

The purpose of this study is to analyze the accuracy of needle insertion and the discomfort during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In particular,the investigators intend to compare the angles between the patients' back and the inserted spinal needle in the coronal plane at different operating table heights.

Sixty patients will be recruited undergoing elective surgery under spinal anesthesia. The patients will be randomly allocated to one of four groups: Group U, L, X, and N. These acronyms indicate the heights of the operating table which set at the needle insertion point of anesthetists, namely the level of umbilicus, lowest rib margin, xiphoid process, and nipple in a standing posture. The angle between the patient's skin and the spinal needle will be measured by the protractor in the coronal and sagittal plane. The anesthesiologists will be asked to record the subjective general discomfort graded by Numeric Rating Scale. And the degree of neck, lower back, knee, and elbow flexion of the anesthesiologists will be measured by taking pictures during procedure.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* body mass index (BMI)\>30
* history of spine operation or severe anatomical abnormalities of spine
Does Lowering Eye Pressure Affect the Results Obtained From Objective Visual Field Testing?

A study to determine whether a patient's range of vision test results improve after their eye pressure is lowered by 30% or more by testing on a new machine called the Accumap and how to learn how much the Accumap's results change from one test to another within the same person.

The investigators believe that Multifocal VEP readings (Accumap)(and therefore visual function and ganglion cell function) improve after acutely lowering intraocular pressure.

Accumap testing will be performed before and two to three hours after treatment is initiated to lower IOP. In eye that have bilateral treatment, one eye will be assigned randomly to the study. The mean multifocal objective perimetry amplitude will be compared before and after IOP reduction. Also, the mean amplitudes of five circumferential zones will be compared before and after IOP lowering. Visual field testing and HRT testing will be performed before and after treatment as well if possible. Paired t-tests will be performed no pre-and post-treatment mean MOP amplitude values and circumferential zones to determine statistical significance. A second group of patients whose pressures will not be lowered will also be tested with Accumap at baseline and two hours afterwards, in order to examine reproducibility of mean MOP amplitude and mean circumferential amplitude. HVF and HRT testing will also be obtained on thes patients when possible.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours.

Exclusion Criteria:

* Recent (within 6 weeks) intraocular surgery
* Visual acuity worse than 20/40
* Pathology unrelated to glaucoma (retinal disease, stroke, brain tumor, etc) associated with visual field defect
* Prior corneal transplant, corneal edema, or corneal diseases such as keratoconus or dense scarring
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Japanese ancestry
* Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
* Having active UC confirmed by endoscopy
* Moderately to severely active UC

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients

This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the main symptoms

The study has planned 4 visits during 2 weeks period (1 week of screening period, 1 week of treatment period). All subjects who agree to participate in the study and voluntarily give written informed consent are assessed by inclusion and exclusion criteria at the screening visit. After the screening period, the final eligibility of the subjects will be assessed at the randomization visit. Subjects who are determined to be appropriate for this study will be allocated to experimental group(YMC026) or control group(placebo) randomly in a 1:1 ratio. Subject will be administered the investigational product daily for 6 days. The safety for the subjects will be assessed at Day 3 and Day 6 visit, and the efficacy evaluation will be assessed at Day 6 visit.

Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 15 years ≤ age \< 75 years
2. Patients with BSS(Bronchitis Severity Score) ≥ 5point at screening visit and randomization visit
3. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with severe respiratory disease
2. Patients with severe pulmonary disease
3. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
4. Patients with pregnant and/or have breast feeding
5. Patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product
6. Patients who were treated with β2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product
7. Patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product
8. Patients who are participating in another trial within 30 days prior to screening visit
9. Patients who investigators determines not appropriate to take part in this clinical study
Ultrasound Lung Fluid Responsiveness During Hysterectomy

Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.

A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive ﬂuid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Female patients scheduled for an elective laparoscopic hysterectomy.
* American society of anesthesiologists status I-II.

Exclusion Criteria:

* Patient refusal.
* Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
* Valvular heart diseases.
* Renal insufficiency (GFR\<60 ml/kg/1.73m2).
* Hepatic insufficiency (Albumin less than 3).
* Patient with previous or current history of pulmonary disease.
* History of allergy to anesthetic drugs.
* Obese patients (BMI\>30).
Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.

Eligibility Criteria:
Inclusion:

- Generally healthy of at least 18 years of age with active rheumatoid arthritis.

Exclusion:

- A history or presence of clinically important medical disease.
A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors

This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic cancer not amenable to standard therapy;
* any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
* measurable and/or evaluable disease (Part 1); \>=1 measurable lesion (Part 2);
* ECOG performance status 0-2.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
* active CNS lesions;
* acute or chronic infection.