cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

OBJECTIVES:

Primary

* Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer.

Secondary

* Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients.
* Determine relapse-free survival of patients treated with this regimen.
* Determine overall and specific survival of patients treated with this regimen.
* Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients.
* Determine the direct and indirect costs of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of invasive breast cancer

  * Stage I or II disease

    * Tumor size ≤ 30 mm

      * Located in any breast quadrant
    * No nodal involvement
* No inflammatory breast cancer
* No positive margins after surgical resection (performed on study)
* No microcalcifications
* Hormone receptor status

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Over 70

Sex

* Female

Menopausal status

* Not specified

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Sustainable Healthcenter Implementation PrEP Pilot Study

A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.


Eligibility Criteria:
Inclusion Criteria:

* adult
* documented without HIV infection (acute or established)
* report sexual behaviors that indicate substantial risk of HIV acquisition
* report injection-related behaviors that indicate substantial risk of HIV acquisition

Exclusion Criteria:

* \<18 years of age
* documented HIV infection (acute or established)
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Eligibility Criteria:
Inclusion Criteria:

* A current diagnosis of social anxiety disorder as defined in the DSM-5.
* A Liebowitz Social Anxiety Scale total score of ≥60.
* Suitable contraception use in line with protocol requirements.
* Ability to swallow tablets.

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
* Hamilton Rating Scale for Depression score of ≥18.
* Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months.
* Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.
Examining the Efficacy of a Novel Moisturizer Across Eight Weeks

Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture, skin is unlikely to have the properties most commonly associated with healthy skin. Recent research has recently highlighted that rambutan extract, niacinamide, and glycoin can all help promote skin moisture and health. To help people experience better skin health, Thu Brulé has developed a serum designed to be used twice daily. Specifically, the test product in this trial was designed to help moisturize the skin and help lock in that moisture. The purpose of this trial is to examine the efficacy of the test product across an eight-week hybrid trial. The outcomes of interest include participants' perceptions of skin health and photographs/images taken of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 30-80.
* Frequently experience dry skin.
* Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication or over-the-counter products (e.g., Adapalene/Differin)
* Must be in good health with no unstable, uncontrolled health conditions.
* Must follow a stable, consistent dietary regimen.
* May experience hyperpigmentation and dark spots.
* Must be willing to maintain the following daily skincare routine: Daily cleansing, test product, and sunscreen that is at least SPF 30
* Must discontinue retinoids four weeks before the study start date and not use retinoids during the trial.
* Must be willing to communicate in English.
* Must be willing to use the test product as directed (twice daily)
* Must be willing to come to the Citruslabs office in Santa Monica, California at the beginning and end of the study.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Currently participating in another research study.
* Currently using oral retinoids.
* Individuals with self-reported very oily skin.
* Individuals with cystic acne or otherwise very acne-prone skin.
* Anyone using oral acne treatments (e.g., accutane).
* Anyone prone to experiencing strong bouts of hormonal acne.
* Anyone using prescription medication relevant to the skin.
* Undergoing any cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
* Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (e.g., retinoids)
* Anyone with learning and/or cognitive difficulties that prevent him/her from reading and understanding questionnaires and surveys (e.g., dementia)
* Severe chronic conditions, including oncological conditions or psychiatric disorders.
Multi-channel aEEG in Cardiac Arrest Patients With Targeted Temperature Management

This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Relation of aEEG in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (ROSC) will be evaluated.

Normal trace was defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.

Eligibility Criteria:
Inclusion Criteria:

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion Criteria:

Cerebral origin cardiac arrest Known epilepsy
mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health

The present study aims to evaluate the effectiveness of a pharmacological nursing educational intervention (EFE) with "Myplan Aplication" about the patient's experience, adherence to pharmacological treatment, and positive mental health of patients with femur fracture.

Once the informed consent has been obtained, the investigators will explain to the patient the pharmacological treatment with the support of an aplication (what it is for, how the medication should be taken, possible adverse effects), also the investigators will share time with the patient during the 4 face-to-face training sessions. The investigators will accompany during their hospital stay, offering to pacients telematic support upon discharge with the treatment and until the end of the study. This is a quasi-experimental non-randomized study with 3 phases of data collection. Possible adverse reactions, if any, will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of femur fracture
* knowledge of the Spanish language
* 24-hour admission to the traumatology unit
* level of consciousness on the Glasgow scale of 15
* have access to a mobile device
* ability to participate in the pilot study
* be able to provide written informed consent or obtain consent from a legal representative.

Exclusion Criteria:

* presence of psychological pathologies or cognitive impairment
* isolation in hospital admission
Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine

A randomized controlled trial to:

1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

Original outcomes were edited and Implementation outcomes were added November 2023.

Eligibility Criteria:
Inclusion Criteria:

* PWID
* Interested in MMT
* Meets DSM-V criteria for Opioid Dependence

Exclusion Criteria:

* Not willing to consent
Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.


Eligibility Criteria:
Inclusion Criteria:

* Double lung transplantation
* Age of 18 or older at the time of the procedure

Exclusion Criteria:

* Single lung transplantation
* Re-transplantation
* Previous major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)
* ECMO bridge to transplantation
* Coronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indication
* Pre-operative anti-coagulation/anti-platelet treatment
* Paediatric transplantation
* Multi-organ transplantation
* Active pregnancy or breastfeeding.
Interactions Between Intravenous (IV) Cocaine and Lofexidine

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.

To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
* Be between 18 and 50 years of age, inclusive.
* Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
* Be able to verbalize understanding of the consent form and provide written informed consent.
* Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:

  * diaphragm and condom by partner
  * intrauterine device (that does not contain progesterone) and condom by partner
  * sponge and condom by partner
  * complete abstinence from sexual intercourse

Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.

Exclusion Criteria:

* Please contact site for more information
Effect of Different Sperm Processing Methods in ICSI Outcome.

A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up, sperm gradient centrifugation and Zeta methods. SDF and ICSI outcomes are monitored after semen processing.

A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up (G1/ n=40), sperm gradient centrifugation (G2/ n=40) and Zeta (G3/ n=40) methods. SDF test was assessed by Halosperm kit, whereas sperm morphology was assessed by spermac stain according to strict criteria. Fertilization, division, blastulation, implantation and pregnancy rates will be tabulated and statistically tested.

Eligibility Criteria:
Inclusion Criteria:

* unexplained infertile couples for 2 years
* age from 20 years old to 37 years old

Exclusion Criteria:

* endometriosis cases
* uterine factors
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers

Many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions. The investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. This study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. The investigators will also compare the effect of different fats (olive oil and soybean) in the TPN solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years

Exclusion Criteria:

* The patient is pregnant or breast feeding
* Subjects have or with history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dL, liver disease (ALT 2.5x \> upper limit of normal), serum creatinine ≥1.5 mg/dL
* Smokers or ex-smoker \< 3 months of cessation, drug or alcohol abuse
* Mental condition rendering the subject unable to understand the scope and possible consequences of the study.
Fatty Acid Regulation of Platelet Function in Diabetes

This study investigates the potential protective effects of altering fatty acid in the platelet as a method for prevention of platelet activation and thrombosis in type 2 diabetes mellitus. Fatty acids (omega-3 and omega-6) and their oxidized lipids will be evaluated for protection from agonist-mediated platelet activation in platelets from type 2 diabetics and healthy controls.

12-lipoxygenase and essential fatty acids such as omega-3 and omega-6 have been shown to play important roles in regulating platelet activation, but the underlying mechanisms have not been fully elucidated as well as their true protection from thrombosis.

12-lipoxygenase inhibition prevents platelet activation in part by inhibiting 12-lipoxygenase oxidation of free fatty acids in the platelet. These oxidized fatty acids are known to play both a pro- and anti-thrombotic effect on platelets depending on the fatty acid. oxidation of arachidonic acid by 12-lipoxygenase results in a pro-thrombotic bioactive lipid whereas oxidation of the omega-6 fatty acid DGLA found in plant oil results in formation of a potent anti-thrombotic bioactive lipid. Determining the extent of protection from this and other bioactive lipids produced through 12-lipoxygenase will allow for a better understanding of which fatty acid supplementation may best protect from thrombosis.

Essential fatty acids such as omega-3 (DHA/EPA) and omega-6 (DGLA) appear to be protective. However the underlying mechanism for this potential protection is not well understood. Identifying the mechanism by which these supplements protect from platelet activation may identify new approaches to preventing thrombotic events in this high risk population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects and T2DM patients
* African American and Caucasian
* T2DM patients on controlled medication (taking metformin)

Exclusion Criteria:

* Dietary supplement within 2 weeks of enrollment
* Fish and plant oil supplements 2 months prior to enrollment
* NSAIDS and aspirin 1 week prior to enrollment
* Smoking
* Cardiovascular event within 6 months prior to enrollment
* Other anti-platelet treatment including phosphodiesterase (PDE) and P2Y12R inhibitors
* Estimated Glomerular Filtration Rate (eGFR) below 30 (severe renal insufficiency)
* eGFR above 90
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1

This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
* Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
* Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
* Females must be surgically sterile or menopausal
* Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Women with reproductive potential
* Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
* For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease
Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.

Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.


Eligibility Criteria:
Inclusion Criteria:

* Must be the biological mother of a child (approximately age 8-10 years) enrolled in the study
* All subjects are to have normal healthy skin and no presence of pre-existing or dormant dermatologic skin conditions;
* Willing to use only the provided cleansing product during the washout time period;
* Willing to refrain from topical product use on the skin for the duration of the study. Topical products that should not be used include moisturizers, lotions, sunscreens, oils, tanners;
* Willing to refrain from swimming, using hot tubs, excessive sun exposure or tanning beds during the course of this study;

Exclusion Criteria:

* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer) a