cyrilzakka/clinical-trials huggingface dataset:
The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye

The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.

One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.

Eligibility Criteria:
Inclusion Criteria:

* patients recently diagnosed with primary open angle glaucoma or ocular hypertension
* Caucasian and African American ethnicities
* Male and Female
* Age 30 and above

Exclusion Criteria:

* A history of ocular medication use within the last 12 months
* Inflammatory/ allergic skin diseases or dermatitis
* presence of periocular hyperpigmented skin lesions
* Systemic pigmentation disorders
* Use of systemic drugs that can affect skin pigmentation
* Visitation of tanning salons, or use of self tanning products
* Pregnancy or patients planning to become pregnant in the near future
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.

This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).

There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).


Eligibility Criteria:
Inclusion Criteria:

* Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
* Stable body weight, defined as \<5 kg change (per participant report) for 90 days before visit 1

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
* Any malignancy not considered cured
* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
* History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
* Symptomatic gallbladder disease
* Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
* History of major depressive disorder or other severe psychiatric disorders within the last 2 years
* Any lifetime history of a suicide attempt
* Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
* Known history of HIV
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug screen
* Participation in a formal weight reduction program within 90 days prior to visit 1
Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB

The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (\<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80).

The pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.

Eligibility Criteria:
Inclusion Criteria:

* Medicaid eligible
* Enrolls in the CHW Hub
* Able to read and understand English

Exclusion Criteria:

-
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)


Eligibility Criteria:
Inclusion Criteria:

* Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly
* Body weight \> 40 and ≤ 160 kg at screening
* Male or female subject ≥ 20 years of age at screening
* At least one kidney
* Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
* Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and \< 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
* Ferritin ≥ 50 ng/mL at screening

Exclusion Criteria:

* New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
* Sustained and poorly controlled arterial hypertension (defined as systolic BP≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \< 90mmHg) at randomization
* Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
Advanced Imaging for Pulmonary Fibrosis

The purpose of this study is to determine if measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.

60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined \[68Ga\]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline. The investigators will compare the ability of PET and MRI measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. The investigators will also test whether combining the PET and MRI measurements results in more accurate prediction of progression than either modality alone.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
2. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, and/or rituximab) for at least 3 months.
3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
4. FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.

Exclusion Criteria:

1. Current or prior exposure to FDA approved anti-fibrotic therapy.
2. Extent of emphysema greater than extent of fibrosis.
3. Pregnancy or plans to become pregnant at baseline or during follow-up.
4. Contraindications to MRI.
5. Contraindications to receiving gadolinium-based contrast agents.
6. Research-related radiation exposure exceeds 50 mSv in the prior year.
7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
8. Clinically significant PH defined by use of pulmonary vasodilatory therapy.
9. Respiratory infection within the prior 6 weeks.
10. Smoking of any kind within the prior 6 months.
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection

It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.

Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.

Patients will be randomized to one of the treatment groups:

* SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
* PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more.
* Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
* Signature of Patient's Consent or Verbal Consent of Legal Representative

Exclusion Criteria:

* Intracranial hypertension
* Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
* Current volume \< 250ml
* History of malignant hyperthermia
* Liver failure
* Neutropenia (\<0.5x109)
* Pregnant or lactating women
* Have received chemotherapy in the last month since their inclusion in the study
A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation

Study population will consist of HRD+ (BRCAm +/- positive genomic instability score according to used test system) OC with available medical history. It is estimated that approximately 400 patients will be enrolled in approximately 25 sites. Demographic and clinical characteristics, treatment approaches and outcomes in HRD+ patients with high-grade epithelial ovarian, primary peritoneal, and/or fallopian tube cancer will be collected at baseline and on prospective visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age;
* Willing and ability to provide written informed consent for participation in the study;
* Known status HRD+ (positive BRCAm test and/or positive Genomic Instability test);
* Patients with histologically confirmed diagnosis of high-grade IC-IV FIGO stages epithelial ovarian, primary peritoneal, and/or fallopian tube cancer;
* Completed primary treatment (surgery and/or 1st line CT +/- bevacizumab) no more than 3 months after completion of primary treatment.

Exclusion Criteria:

* Patients participating in other clinical studies
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.


Eligibility Criteria:
Inclusion criteria:

* Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1
* Fasting C-peptide value of \< 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
* Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:

  * Multiple Daily Injections (MDI) of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR
  * Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at least 5 months experience of using CSII prior to Visit 1
* HbA1c \>/= 7.5% and \</= 10.0% at Visit 5 measured by the central laboratory
* Age \>/= 18 years at Visit 1

Additional inclusion criteria may apply

Exclusion criteria:

* History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
* Pancreas, pancreatic islet cells or renal transplant recipient
* T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues, Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1
* Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation
* Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until randomisation

Additional exclusion criteria may apply
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

Influenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection. Consequently, influenza vaccine has been recommended for children 6-59 months of age. Influenza vaccine is not approved for use in children under 6 month of age who are at highest risk. Therefore, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices has recommended vaccination of household contacts of children under 6 month of age - a cocooning strategy.

The current study is a hospital-based study to assess the effectiveness of a program to vaccinate birth mothers and household contacts of newborns with influenza vaccine. We propose to study both birth mothers and household contacts of newborns delivered at Durham Regional Hospital and Duke University Medical Center, birthing hospitals serving Durham and surrounding counties in central North Carolina. We will implement several strategies to increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will be assessed utilizing a survey method (maternal interview at the birthing hospital and a follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage rates for new mothers and household contacts of newborns delivered at the intervention hospital will be higher when compared to coverage rates in the comparison hospital. Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Mother of a newborn delivered at either Durham Regional Hospital or Duke University Hospital between October 2007 and February 2008

Exclusion Criteria:

* Fetal demise or stillbirth
* Maternal rights relinquished
* Language barrier
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Eligibility Criteria:
Inclusion Criteria:

Children must meet all of the following criteria:

* Previously healthy
* Age less or equal to 12 months at the time of randomization
* Gestational age more or equal to 36 weeks
* Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
* Documented positive RSV test within 48 hours prior to randomization
* Randomization within 12 hours of the decision to hospitalize a child for RSV illness
* Written informed consent obtained from the participant's parent(s)/legal guardian

Exclusion Criteria:

Children must have none of the following:

* Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
* Any use of systemic or inhaled steroids within the past 30 days prior to randomization
* Intubation for ventilatory support at randomization
* Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
* Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
* Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
* Mechanical ventilation at any time prior to the onset of the current RSV infection
* Congenital heart disease \[children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\]
* Previous reaction to IVIG, blood products, or other foreign proteins
* Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
* Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
* Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV