cyrilzakka/clinical-trials huggingface dataset:
FiO2 and Outcomes After OPCAB (the CARROT Trial)

Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery including off-pump coronary artery bypass grafting (OPCAB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.

A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective off-pump coronary artery bypass grafting

Exclusion Criteria:

* emergency
* robot-assisted surgery
* minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia
* preoperative pulmonary morbidity requiring oxygen therapy
* preoperative use of ECMO or IABP
* preoperative tracheal intubation or mechanical ventilation
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

  1. Smoking history of at least 20 pack years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

     Exclusion Criteria:
* Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
* Patients who had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with a history of asthma.
* Patients with diabetes type I or uncontrolled diabetes type II.
* Any patient with lung cancer or a history of lung cancer.
* Patients with a history of certain cardiovascular co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Regional Anesthesia Block in Fibula Free Flap Reconstruction

Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
* Subjects undergoing primary or secondary reconstruction

Exclusion Criteria:

* Subjects needing elevation of care to the intensive care unit due to remaining intubated for extended period of time or other complications during the peri or post operative period
* Subjects with surgical complications requiring significant alteration of the treatment plan

  o Subjects requiring a return to the operating room during admission will be excluded, unless it is for a procedure not related to the original surgery occurring after post op day 3, such as a gastrostomy tube or long term IV access.
* Subjects with true allergies to the study drugs
* Subjects undergoing reconstruction with more than 1 free flap, or with the use of any additional regional flaps
* History of substance dependence or enrollment in a pain management program
* Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin.
* Subjects who do not stay in the hospital for at least 4 days post operatively
* Subjects requiring anticoagulation will not require modifications prior to receiving regional anesthesia.
* Inability to properly place catheter or administer the regional anesthesia
Bupropion for the Treatment of Methamphetamine Dependence - 1

The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis
* Subject must be willing to comply with study procedures.
* Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures
* Be able to comply with protocol requirements

Exclusion Criteria:

* Please contact site for more information.
Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

HIV-exposed infants (HEI)

* All HEI who access maternity/post-natal services within 48 hours of life
* Tested for HIV at birth using the POC NAT platform
* Caregiver provides informed consent for participation

Caregivers

* Mother/caregiver of an HEI who was offered POC EID at birth
* Able to provide informed consent to participate in the study

Health workers

* All health workers working in maternity services in the study sites
* Provides informed consent to be interviewed

Key informants (laboratory managers and program leads/focal persons)

* Health managers working in the field of pediatric HIV services or PMTCT
* Provides informed consent to be interviewed

Exclusion Criteria:

HIV-exposed infants (HEI)

* HEI tested for HIV using conventional EID at project sites
* HEI whose caregivers refuse birth testing
* HEI where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia)

Caregivers

* Caregivers of HEI who cannot legally provide consent to participate in the study

Health workers

* Healthcare workers who do not make use of EID or results of EID

Key informants

* Key informants who cannot legally provide consent to participate in the study
ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved patient informed consent form prior to administration of any study-related procedures.
* Patient must have stable HS.
* Total abscesses and/or nodule (AN) count of ≥5 at Baseline visit.
* HS lesions present in at least 2 distinct anatomical areas at Screening and Baseline.

Exclusion Criteria:

* Patient has a history of active skin disease other than HS that could interfere with the assessment of HS.
* Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism.
* Patient has experience with \>2 biologics, \>1 Janus kinase (JAK) inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
* Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the Screening visit.
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
* Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
* Aged between 65 and 85 years.
* Willingness to provide written, informed consent.
* Ability to adhere to study protocol.

Exclusion Criteria:

* Secondary hypertension.
* Diabetes mellitus.
* Atrial flutter/atrial fibrillation.
* Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF \< 40%.
* Recent (\< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
* Recent (\< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft).
* Severe valvular heart disease.
* History of hypersensitivity to indapamide, thiazides or to any of the components of the products.
* Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
* Participation to another investigational study in the last 3 months.
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Japanese men or women at least 20 years of age
* Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
* Karnofsky Performance Status ≥70;
* Life expectancy of ≥12 weeks

Exclusion Criteria:

* Any available standard line of therapy known to be life-prolonging or life-saving
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
* Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
Influence of Diuresis Timing (F+0 Vs F-15) on 99m Tc DTPA Renography for the Diagnosis of Suspected Obstructive Uropathy

Evaluation of the influence of the diuretic injection timing (F+0 Vs F-15) on the dynamic 99mTc- DTPA renal scintigraphy for the diagnosis of suspected obstructive uropathy in adult hydronephrotic patients.

Obstructive uropathy can be defined as any blockage of urine drainage from the kidney (renal calyces or renal pelvis), ureter, or bladder. As a result of the blockage, urine backs up into the kidneys, causing dilatation of the ureter, renal pelvis, and renal calyces, which can damage the kidney if it is not treated. The appearance of dilated or enlarged renal pelvis and calyces is referred to as hydronephrosis and is a symptom of obstructive uropathy.

Diuresis renography(renal scan with using of diuretic drug such as furosemide) is non-invasive test which is based on a high endogenous rate of urine flow stimulated by the administration of furosemide. Interpretation of the test is based on the rate of washout of the radiopharmaceutical from the collecting system in the upper urinary tract.

A number of different protocols exist in terms of the timing of furosemide injection, (F+0) protocol in which furosemide is injected at the same time of radiotracer administration \&( F - 15)protocol in which furosemide is administered 15 min before tracer administration.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years.
* Patients with hydronephrosis (unilateral or bilateral) referred for renal scan.
* Patients able to sleep in a fixed position for 20 minutes.

Exclusion Criteria:

* Severely impaired renal function.
* Advanced hydronephrosis
* Pregnancy.
Alcohol in the Treatment of Obesity

This pilot study looks at the relationship of moderate alcohol consumption on weight loss.

We hypothesize that individuals who consume a moderate amount of alcohol, such as a glass or two of wine daily, will lose more during a weight-reduction program than will those who do not, if equal calories are administered to both groups. The purpose of this pilot study is to look at the relationship of alcohol in weight loss. The current standard in weight loss programs is to eliminate alcohol from the diet. We propose to enroll 50 females enrolled at the Structure House residential diet program in Durham, North Carolina. Half or the subjects will receive 150 calories in the form of white wine, 3.5 ounce with lunch and 3.5 ounces with dinner. The other half of the subjects wil receive their 150 calories in their regular diet. All participants are asked not to consume any additional alcohol. Participants will be weighed daily. The study lasts four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21, female, BMI ≥ 30, no history of substance abuse, prior alcohol use of at least one drink/week; Exclusion:
* pregnancy, breast feeding, previous history of alcohol abuse, liver disease.
Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling

The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary disorders.

The study has three main objects:

1. to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14)
2. to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders)
3. evaluating specificity and sensitivity

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy following preimplantation genetic testing

Exclusion Criteria:

* None
Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease

This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.

Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Probable Alzheimer's disease
* Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
* Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
* Female subjects are ≥1 year post-menopausal or are surgically sterile
* Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
* Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
* General health status acceptable for participation in a 24 week clinical trial be administered

Exclusion Criteria:

General

* Participation in another therapeutic clinical trial within 30 days before Baseline
* Prior participation in an amyloid vaccination clinical study
* Inability to swallow capsules
* Likely inability to complete 24 week study
* Inability to be ≥75% compliant with single-blind placebo run-in medication
* Inability to adequately perform cognitive tests
* History of significant cardiovascular disease
* Major depression
* Psychosis
* History of stroke within 18 months of screening
* Head trauma
* Inability to perform any screening or baseline evaluations
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential

Exclusion criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
18349-Human Photoallergy Test

To evaluate the potential of a test material to produce a photoallergic response.


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee
Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders

The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

The investigators will recruit participants with symptoms suggestive of a neurodegenerative and/or related disease. Participants could be evaluated on a yearly basis, undergoing a baseline visit and possible follow-up evaluations with an interval of one year. At each visit, participants could undergo any combination of the following based on their symptoms and complaints: a neurological assessment, a speech/language assessment, a neuropsychometric assessment, an MRI, an FDG PET/CT scan, a PiB PET/CT scan, a Tau PET/CT scan and/or a C-11 ER176 PET/CT scan. All participants will be asked to provide a blood sample to allow for future genetic studies.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be over the age of 21
* Have symptoms suggestive of a neurodegenerative and/or related disorder

Exclusion Criteria:

* Participants will be excluded if they have any concurrent illnesses that could account for all of their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes
* Women that are pregnant or post-partum and breast-feeding will be excluded
* Participants will be excluded if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, Hypogammaglobulinemia, Wiskott-Aldrich syndrome and Down's syndrome
* Participants will be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts)
* Participants will be excluded if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)