cyrilzakka/clinical-trials huggingface dataset:
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

* be between 18 and 70 years old with a diagnosis of HeFH;
* be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
* have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
* be male or nonpregnant, nonlactating female;
* give informed consent; and
* meet body weight requirements.

Exclusion Criteria:

In order to participate in this study, patients must not meet any of the following exclusion criteria:

* recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
* uncontrolled hypothyroidism or other uncontrolled endocrine disease;
* known, clinically significant eye abnormalities (e.g., cataracts);
* appropriate serum creatinine phosphokinase levels;
* history of liver disease or liver enzyme levels above appropriate levels;
* alkaline phosphatase above appropriate levels;
* serum creatinine above appropriate levels;
* liver cirrhosis and severe liver steatosis;
* clinically significant infection, malignancy, or psychosis;
* use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
* participation in any other investigational study, including device or observational studies, within 30 days;
* lactating or have a positive serum pregnancy test;
* current drug or alcohol abuse; or
* unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator
Effects of Nicotine in Tobacco Smokers

This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Daily smoking at least 2 years

Exclusion Criteria:

* Currently pregnant or breastfeeding.
A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers

This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or cobicistat on the pharmacokinetics (PK) of PBI-200.

This is an open-label, single-sequence, three-period drug-drug interaction study in healthy male and female volunteers to evaluate the effect of a potent CYP3A inhibitor, ritonavir or cobicistat, on the single dose PK of orally administered PBI-200. It is expected that co-administration of ritonavir or cobicistat with PBI-200 will increase the exposure of PBI 200.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age (inclusive).
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).
* Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
* History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
* Intolerance to repeated venipuncture.
* Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
* Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
* Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.
Post-Traumatic Stress Disorder (PTSD) and Seroquel

This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.

An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Fluency in English
* A diagnosis of PTSD
* No pregnancy
* Right-handedness

Exclusion Criteria:

* Pregnancy or lactation
* Any cognitive impairment that precludes informed consent
* Known intolerance or lack of response to Seroquel
* Previous enrollment or randomization of treatment in the present study
* Participation in another drug trial within 4 weeks prior enrollment into this study
* Patients with Diabetes Mellitus
* History of allergic reaction or hypersensitivity to Seroquel
* Contraindications to magnetic resonance imaging
* Treatment with an effective medication for PTSD
Seven-year Outcomes Following Intensive Anti-VEGF Therapy in Wet AMD

The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

This study was conducted at two clinical sites in Budapest, Hungary after the "Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2)" phase-3 multicenter, prospective, randomized, double blind clinical trial (ClinicalTrials.gov ID: NCT00637377).

Patients were treated with intravitreal anti-VEGF injections between 2008 and 2017. During the first 2 years in the framework of the VIEW 2 study, participants were randomized per protocol to intravitreal aflibercept or ranibizumab treatment arms and received injections according to the VIEW 2 study protocol.

This study focused on long-term outcomes that happened after the VIEW 2 study. After finishing the VIEW 2 study, patients returned to daily routine medical care and were followed under regular clinical care in real-life conditions and were treated with predominantly ranibizumab anti-VEGF injections (participants received interventions as part of routine medical care). Treatment was administered as needed according to the judgement of the physician. Retreatment criteria were based on visual acuity, signs of activity on optical coherence tomography (OCT) or indirect slit lamp biomicroscopy. Results at the end of the follow-up (year 7) were retrospectively analyzed.

Eligibility Criteria:
* Same as the original VIEW2 study (NCT00637377)
* Finished VIEW 2 study
Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology Patients

To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.

The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are between 50 and 75 years of age;
* Have not had known or suspected infection with SARS-CoV-2 at any time;
* Subjects must fall into one of the following subsets of cancer patients:

  * Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months
  * Prostate cancer on androgen-deprivation therapy for biochemical recurrence
  * Colon cancer on adjuvant chemotherapy for stage III disease
  * CLL on a BTK inhibitor as a first-line single agent for at least 3 months
  * Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months
* Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
* Have at least a one-year life expectancy;
* Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination

Exclusion Criteria:

* Subjects have a known hypersensitivity to a vaccine component;
* Have had known or suspected infection with SARS-CoV-2 at any time;
* Are organ transplant recipient on immunosuppression;
* Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
* Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
* Received high-dose corticosteroids at any time after receiving the vaccine;
* Are unable to give informed consent;
* Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor
Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.

This is prospective, randomized clinical trial in subjects undergoing elective surgery requiring general anesthesia.

Opto-electronic plethysmography (OEP) has been developed as a non-invasive method for the analysis of chest wall motion, allowing highly accurate measurements of chest wall volume changes of different respiratory compartments in various conditions.

The investigators set out to use this technology to study chest wall volume changes during recovery from total intravenous anesthesia (from discontinuing the anesthetic agent till extubation) and early postoperative period.

The study protocol compares two different approaches:

1. The group receiving recruitment maneuver (RM) immediately after intubation and positive end expiratory pressure (PEEP) 7 cm H20 until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.
2. The group not receiving RM, PEEP 0 cm H2O and inspiratory oxygen concentration 100% during recovery from anesthesia.

The volume changes of the chest wall is monitored continuously by OEP, functional residual capacity (FRC) and arterial oxygenation are measured at the defined points in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ASA classification I-II, scheduled for elective surgery requiring general anesthesia
* signed informed consent

Exclusion Criteria:

* BMI \> 35
* co-existing respiratory disease (COPD, asthma )
* patient refusal
* pregnancy
* deformities of the thorax
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence


Eligibility Criteria:
Inclusion Criteria:

* Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

* Any eye disease or abnormality
* Any permanent eyeliner or eyelash implants of any kind
* Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
* Any use of prescription eyelash growth products
* Any use of over the counter eyelash growth products during the 6 months prior to baseline
* Any use of treatments that may affect hair growth during the 6 months prior to baseline
Coronary Thromboaspiration and Infarct Size

Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.

Eligibility Criteria:
Inclusion Criteria:

* acute phase of myocardial infarction (\>48 hours from the onset of chest pain)
* stable hemodynamic conditions
* completely occluded infarct related artery

Exclusion Criteria:

* heart failure signs in the acute phase
* contra indication for MRI or SPECT IMAGING
Early Exposure to Lead and Adolescent Development

This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.


Eligibility Criteria:
Subjects for the Cincinnati Lead Study were recruited prenatally if their mothers resided in areas within Cincinnati, Ohio where there has historically been a high incidence of lead poisoning. Infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.
Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.

OBJECTIVES:

Primary

* Determine if folic acid supplementation lowers the adenoma recurrence rate.

Secondary

* Determine the number of adenomas per patient and the size and histology of the adenoma.
* Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.
* Assess the interaction between folic acid and pretrial and midtrial folate levels.
* Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral folic acid once daily.
* Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum
* Plan on having an endoscopy within 4 years after initiation of the trial
* Must release medical records regarding past and any future endoscopies

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L

Exclusion criteria:

* Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer
* Diagnosis of homocystinemia
* Diagnosis of pernicious anemia
* Any gastrointestinal disorder that could lead to a vitamin B12 deficiency
* Diagnosis of cirrhosis or pancreatitis
* Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

* No prior gastrectomy, total colectomy, or pancreatectomy
* Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins)
* No concurrent methotrexate or anticonvulsant
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older
* Scheduled for cataract surgery by phacoemulsification
* Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

* Any subject that has a history of uveitis or active iritis
* Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
* No ocular use of prostaglandins within 2 weeks of surgery
* Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
* Active ocular infection
Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28\[CRP\]) at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
* Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity
* Individual fulfills all of the following minimum disease activity criteria:

  * ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[SJC66\]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints \[SJC28\]) at screening and Day 1, and
  * ≥ 6 tender joints (from a tender joint count based on 68 joints \[TJC68\]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints \[TJC28\]) at screening and Day 1, and
  * hsCRP \> upper limit of normal at screening
* Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.

Key Exclusion Criteria:

* Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
* Prior exposure to any Janus kinase inhibitor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* If a woman, must be not of childbearing potential: postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 12 months and a serum follicle stimulating hormone \[FSH\] \>40 International Units Per Liter \[IU/L\]); or surgically sterile
* If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of Period 1 and Period 2
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last study drug administration
* Body mass index (BMI; weight \[kg\]/height\^2 \[m\]\^2) between 18 and 32 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than 50 kg
* Non-smoker for at least 6 months before first study drug administration

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
* Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at screening as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled until completion of the study