cyrilzakka/clinical-trials huggingface dataset:
A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Have persistent post cataract extraction macular edema whose condition is stable
* Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
* Have at least one eligible eye to be treated in the study
* Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
* Have macular edema confirmed by fluorescein angiography

Exclusion Criteria:

* Have proliferative vitreoretinopathy greater than grade B in either eye
* Have ocular disorders in the study eye that may confound interpretation of study results
* Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
* Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
* Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
* Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
* Have had any ocular implant device for the delivery of therapeutic agents
* Be taking any excluded medications that could obscure or confound study results
Measuring Quality of Decisions About Treatment of Menopausal Symptoms

The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of menopause. In particular, we will examine whether the decision aid increases knowledge about menopause/managing menopause symptoms and concordance between goals and treatment choices.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 40-60
* Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year

Exclusion Criteria:

* Prior diagnosis of breast cancer
* Surgical or medically induced menopause (ovaries removed)
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants

The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening
* Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
* Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kg at screening
* Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
* Male participants must agree to use an adequate contraception method

Exclusion Criteria:

* History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
* Participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or to itraconazole and rifampin
* Participant has contraindications to the use itraconazole and rifampin per local prescribing information
* Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics.

The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.


Eligibility Criteria:
Inclusion Criteria:

-diagnosis of moderate-to-severe psoriasis

Exclusion Criteria:

-
Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN)

The main purpose for holding this survey is epidemiological surveillance, it must provide the indicators that contribute to the evaluation of the plan "improvement of the quality of life in chronic diseases" and monitoring the goal of 81 health law public in August 2004. This survey is intended to be renewed during the implementation period of the public health law to provide plan monitoring indicators.

The main objective is : To describe the quality of life of patients with major end-stage renal disease treated with dialysis method for at least one year.

The seconds objectives are :

* To contribute to the knowledge of the key determinants of the quality of life among chronic renal failure patients.
* To study the influence on way of giving a questionnaire about assessment of level of quality of life

The proposed scheme is that of a repeated cross-sectional survey, with prevalent patients dialysis for at least 1 year, by self-administered questionnaires using standardized instruments and passed among a representative sample of subjects included in the nine participating regions kidney system. The first study in 2005, it is required to be repeated during the plan period (theoretically in 2007, 2009 and 2011).

Three studies will be carried out between 2005 and 2010. The progress of each study is the same.

The random draw of eligible patients, according to a stratification by region and age group is carried out by the Biostatistics and Medical Informatics Service of the Necker Hospital in Paris, responsible for basic SIMS-REIN, for data center in the regions Champagne-Ardenne, Languedoc-Roussillon, Limousin and Provence-Alpes-Côte d'Azur. For Auvergne, Bretagne, Lorraine and Rhône-Alpes, which operate independently for the collection of data REIN, the random draw of patients is done by each epidemiological center responsible for this collection.

The Biostatistics and Medical Informatics Service of the Necker Hospital, and epidemiological centers of Auvergne, Bretagne, Lorraine and Rhône Alpes must submit the list of selected patients Clinical Research Associate (CRA) national.

Eligibility Criteria:
Inclusion Criteria:

* Patient prevalent dialysis for at least 1 year
* Age at least 18 years old at the time of dialysis at
* Treaty within one of the nine aforementioned regions
Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette

This study is being conducted to assess the abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography will be evaluated and compared with subjects' usual brand combustible cigarette.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
* Subjects have urine cotinine \>200 ng/mL and exhaled carbon monoxide \> 10 ppm at Screening
* Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure

  ≤95 mmHg, and heart rate ≤100 bpm
* Females of childbearing potential who are practicing a reliable method of contraception

Exclusion Criteria:

* Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1
* Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1
* Subjects with clinically significant and relevant abnormalities of medical history.
* Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1
* Pregnant or breastfeading female subjects
The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep and Stress

The purpose of this study is to explore the effects of extremely low frequency electromagnetic waves on improving stress and sleep quality. Experimental studies, pre- and post-test double-blind crossover tests are adopted. The selected subjects include: patients in the sleep center of the Taipei Medical University Hospital and the Department of Nursing and Bachelor of Taipei Medical University There are about 100 students in the post-nursing department. They are randomly assigned to groups A and B using a computer. The experiment period is two weeks. The two groups will take a pre-questionnaire test in the afternoon of the first day of the experiment and wear wearable bracelets. Group A first After getting the device with low-frequency electromagnetic field, group B first got the device without low-frequency electromagnetic field. The appearance of the two is the same. The bracelet is worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in the device half an hour before going to bed every day, and put it on the bedside table about 20cm away from the head, and then turn off the device after getting up. The research tools are basic attribute questionnaires, sleep quality scales, sleep diaries, smart care VIP bracelets, and EEG. Among them, the wearable bracelet can monitor the stress index, fatigue index, calories burned, and walking steps. Then SPSS 22.0 software is used for data file building and statistical analysis. The data is analyzed by descriptive statistics and inferential statistics. The expected result is that the experimental group and the control group have significant differences in reducing stress and improving sleep quality, which can relieve stress and improve sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* under 20 years old,great mental health,BMI is between 18.5\~24(normal range).

Exclusion Criteria:

* Cognitive disturbance, confusion, pregnancy, alcohol and caffeine addiction.
Energetics and Function in Older Humans

The investigators have previously reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves concentrations of red-cell GSH. The investigators also found that when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an increase in intracellular GSH concentrations. The current proposal will investigate if cysteine and glycine supplementation for a duration of 24 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after completing supplementation, measurement of GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be done to determine the effects of washout.

Data not available at present

Eligibility Criteria:
Inclusion Criteria:

Older subjects:

* age 70-80 years;

Younger subjects:

* age 21-30 years

Exclusion Criteria:

1. No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer;
2. Any limitations in ability to walk;
3. Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped);
4. BMI less than 20.
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis that qualifies them for a DUCBT
* Absence of recent active mold infection
* Adequate organ function
* Availability of eligible donor material

Exclusion Criteria:

* Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
* Human immunodeficiency virus (HIV) infection
* Active infection
* Extensive prior chemotherapy
* Prior myeloablative allotransplantation or autologous transplant.
Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

The primary objective is to assess the efficacy of ZD6474 when given orally to patients with relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be entered on study


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma.
* Patients must have a minimum serum M-protein level \>=10g/L on serum protein electrophoresis or for patients with light chain only disease, a minimum Bence-Jones protein of 1g/24 hr.
* Patients must have received prior treatment for multiple myeloma: patients may have received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have relapsed following treatment (\>= 3 months) OR patients may have relapsed following high dose chemotherapy and SCT as first line treatment provided they have not had any other treatment.
* Lab at inclusion of AGC \>= 1.0 x10_9/L and platelets \>= 50 x10_9/L Bilirubin, AST and/or ALT \<= 1.5 x UNL; creatinine \< 2 x UNL, Potassium \>= 4.0 mmol/L; calcium and magnesium within normal limits·
* Patients may not have had \> 2 prior regimens of chemotherapy and/or prior thalidomide treatment.
* Patients may not have had any non-alkylating based chemotherapy.

Exclusion Criteria:

* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \>= 5 years.
* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study.
* Patients who have relapsed during treatment with oral alkylating chemotherapy.
* Patients who have received more than 2 prior regimens of chemotherapy.
* Patients who have received excluded medication or have excluded medical conditions.
* Patients who have received any non-alkylating based chemotherapy regimens as initial therapy, or as therapy for recurrent disease.
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions

The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.


Eligibility Criteria:
Inclusion Criteria:

* Currently undergoing mental health treatment;
* Have a history of trauma;
* HIV negative;
* Sexually active with an opposite sex partner within the past 6 months;
* Not using PrEP for HIV prevention at the time of screening;
* Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
* Fluent in English;
* Own or have regular access to a smart phone.

Exclusion Criteria:

* HIV positive;
* Concurrently participating in another HIV prevention program;
* Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
* Have psychological distress that would prohibit them from participating in the study;
* Be unable or unwilling to meet study requirements.
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple dose inhaler for use in the COPD Phase III program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Age 40-75 years
* Smoking history

Exclusion Criteria:

* Other serious disease
* Allergy to QAB149
* Respiratory tract infection
Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial

This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).

II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

After completion of study intervention, participants are followed up at 12 weeks and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* 50-77 years of age
* Current or former smoker with 20-pack year smoking history and within the last 15 years
* Fewer than 60 minutes of participation in moderate intensity physical activity each week
* All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease \[COPD\]), or systemic disease that would make moderate intensity exercise participation unsafe
* Willing to sign an informed consent

Exclusion Criteria:

* Person is on a regimen of the following medications: immunosuppressants, bisphosphonates, steroids, anticoagulants, warfarin, apixaban, probiotics
* Person undergoing treatment for cancer in any form
* Person plans to enter smoking cessation or change status
Observational Study of the Clinical Use of the OCS™ Heart

Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)

This is an observational study at two centers that will enroll minimum of 60 heart transplant recipients transplanted with donor heart preserved using the OCS™ Heart System. All consented subjects who receive OCS™-preserved heart transplants will be approached for participation. The study will evaluate short and long-term effectiveness of the OCS™ Heart System for heart transplantation.

Eligibility Criteria:
Inclusion Criteria:

All recipients of heart transplantation with Use of the OCS™ Heart

Exclusion Criteria:

Donor Hearts

* Presence of coronary heart diseases
* acute myocardial infarction
* Presence of heart valve disease (Stenosis or Insufficiency \> first degree)
* Presence of left ventricular hypertrophy (septum and posterior wall thickness \>1.7 cm)
* State of shock of donor (MAP \<60 mmHg, CVP \>15, PCWP \>15 mmHg) with use of Dobutamine \>10 ug/kg/min and/or Norepinephrine \> 0.5 ug/kg/min or Epinephrine \> 0.2 ug/kg/min
* irreversible persistant pulmonary hypertrophy, defined as transpulmonary gradient \>15 mmHg of the recipient