cyrilzakka/clinical-trials huggingface dataset:
Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol (ie, willing to wear only the study lenses and not use habitual lenses during the study).
  3. Females between 18 and 29 (inclusive) years of age at the time of screening
  4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye.
  5. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
  6. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye.
  7. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
  8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.
  9. The subject must be willing to be photographed and/or video-taped

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating
  2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
  3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
  4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)
  5. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
  6. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
  7. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion).
  8. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

The study's aim is to enhance current immunization activities in community pharmacies through targeting the two most commonly available non-seasonal vaccines in community pharmacies, namely pneumococcal and herpes zoster vaccination services. The study will compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies.

Community pharmacies are in a unique position and have potential to help increase immunization rates, especially among those who do not visit their primary care provider regularly. This study seeks to increase the level of pharmacy-based immunization delivery.

The study intervention is designed to increase the current level of pharmacy-based immunization delivery and foster practice change to sustain the intervention effect. Our intervention combines evidence-based strategies for improving immunization coverage and strategies to overcome system barriers to increase sustainability of the intervention over time. The study will focus on pneumococcal and herpes zoster vaccination services.

Specific aims include:

1. To compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies. The pre-intervention period will correspond to the intervention period.
2. To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies.
3. To compare the level of sustainability of immunization services over the period of 6 months after the intervention period ends between the intervention group and the control group.
4. To explore facilitators and barriers to implementing immunization services.
5. To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.

Eligibility Criteria:
Inclusion Criteria:

* Alabama and California community pharmacies
* Must provide in-store prescription-dispensing service
* Must provide pneumococcal vaccine and/or herpes zoster

Exclusion Criteria:

* Must have no plan to close or change the ownership in the next 12 months
Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.

Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done.

Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen.

20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.

Eligibility Criteria:
Inclusion Criteria:

* Patient is admitted to the intensive care unit
* Patient has a central (venous) infusion line
* Patient is at least 18 years old
* Patient receives treatment with anidulafungin

  * that is initiated on the ICU or
  * that is continued on the ICU and the patient has had no more than 2 days of treatment with anidulafungin

Exclusion Criteria:

* Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
* Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin
* A woman that is pregnant, wanting to become pregnant or nursing an infant
* \< 48 hours (expected) treatment with anidulafungin on the ICU ward
* Has previously participated in this trial.
Treatment of Vitiligo With Low-energy Visible Light Laser

The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.

Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
* Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
* Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
* Agree to follow and undergo all study-related procedures

Exclusion Criteria:

* Women who are lactating, pregnant, or planning to become pregnant
* Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* Patients with a known history of photosensitivity disorders
* Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
* Patients with a known history of melanoma or non-melanoma skin cancers
* Concomitant use of tanning beds
* Any reason the investigator feels the patient should not participate in the study
Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).

Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65
* known hypertension on ≧ 3 anti-hypertensive drugs
* Apnea-hypopnea index ≧15
* able to give informed written consent

Exclusion Criteria:

* moderate renal impairment (glomerular filtration rate \<30 mL/min/m2 )
* endocrine/renal/cardiac causes of secondary HT
* congestive heart failure and clinically fluid overloaded
* On drugs that elevates BP e.g. NSAID, steroid
* Non-compliance to anti-hypertensive medications
* Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
* Active inflammatory/infective conditions e.g. rheumatoid arthritis
* Excessive sleepiness that can be risky e.g. occupational driver, machine operator
* Modification/changes of anti-hypertensive regimen within 8 weeks
Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer

This is a prospective observational study aimed to validate biomarkers that predict response.

This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Histologically-confirmed triple negative invasive breast carcinoma
* Any type of ductal or lobular invasive carcinoma
* Patients with or without BRCA-1 and BRCA-2 mutations are eligible to participate
* Life expectancy \> 6 months
* Pre-, Peri- or Postmenopausal
* Clinical Stage T2-4, N0-3, M0 (Stage II-III)
* Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
* Adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. However, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.

Exclusion Criteria:

* Prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
* Only ductal/lobular carcinoma in situ but not invasive component
* Any sort of confirmed metastatic disease (AJCC Stage IV at diagnosis)
* Any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
* Pregnant or lactating, in case this precludes the subject to receive chemotherapy.
* Impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. This will be exclusively decided by the treating oncologists.
Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil

There is increasing evidence that psychosocial factors may affect health by means of biological effects and changes in behavioral health. Observational studies suggest an association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid), after pregnancy and the occurrence of postpartum depression (PPD). This is an observational cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in the city of Rio de Janeiro. The general objective is to describe the magnitude and identify factors associated to common mental disorders (CMD) during pregnancy and postpartum giving emphasis to maternal nutritional status.

Main specific objectives:

1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low birthweight, small for gestational weight and prematurity), considering the effect of other determinant factors, and
2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.

The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy and once in postpartum. Women are interviewed in four time points:

1. First trimester: 8th and 13th (baseline),
2. Second trimester: 22nd-24th gestational weeks,
3. Third trimester: 34th-36th gestational weeks,
4. Postpartum: 30-45 days

The following information will be gathered:

1. Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)
2. Dietary intake (food frequency questionnaire)
3. Anthropometric measure (stature and body weight) and physical activity
4. Biochemicals: fasting glucose, lipid profile (total cholesterol, HDL-c, LDL-c), serum fatty acid composition, inflammatory markers (C-reactive protein, interleukin-6), hormones (adiponectin, insulin, leptin).

All women are followed throughout pregnancy constituting the observational cohort. In the second trimester, those women identified as being in risk for PPD \[past history of depression (DSM-IV) or presenting a score of depression (Edinburgh scale) \>= 9 at the baseline interview\] are invited to participate in the clinical trial. These women will be randomly allocated in two groups:

Intervention 1: Fish oil: \[1,8 g/dia n-3 (1,08 g EPA e 0,72 g DHA)+ vit E (0,2 mg/g) Intervention 2: Placebo comparator: soybean oil + 1% fish oil + vit E (0,2 mg/g)

The supplementation occurs from the 22nd-24th week of pregnancy for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged 20 to 40
* up to 13 weeks of pregnancy
* free from chronic or infectious diseases (except obesity)
* residing in the study catchment area

Exclusion Criteria:

- twin pregnancies
The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

The participants will be randomly assigned to two groups: One group received machine-based resistance training (MRT) at the hospital, while the other group received usual care (US). The outcomes will be measured in the participants after 8 weeks including handgrip strength, gait speed, performance on the five-times sit-to-stand test.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 60 years old
* Meet the diagnostic criteria of 2019 AWGS2 sarcopenia, can be diagnosed once meeting (1) + (2) or (1) + (3) or (1) + (2) + (3): (1) Appendicular skeletal muscle mass (ASM): dual-energy X-ray absorptiometry (DXA) (male \<7.0 kg/m², female \<5.7 kg/m²). (2) Muscle strength: handgrip strength (male \<28.0 kg, female \<18.0 kg). (3) Physical performance: 6-meter walking speed \<1.0 m/s.
* Meet the diagnostic criteria of heart failure following ESC 2021.
* Clearly understand the content and purpose of the study and sign the informed consent form.

Exclusion Criteria: There are contraindications for Exercise Testing in patients with stable heart failure according to ACSM 2022:

* Early stage after acute coronary syndrome (within the first 2 days)
* Unstable coronary artery disease
* Decompensated heart failure
* Acute venous thrombosis or recent arterial embolism (pulmonary or systemic)
* Acute myocarditis, pericarditis, endocarditis
* Aortic dissection of the valve
* Severe symptomatic aortic stenosis
* Acute systemic disease or fever
* Uncontrolled or life-threatening atrial or ventricular arrhythmias (including new-onset atrial fibrillation or flutter)
* Uncontrolled tachycardia (resting heart rate \> 120 beats per minute)
* Third-degree AV block
* Uncontrolled diabetes
* Symptomatic orthostatic hypotension (\> 20 mmHg)
* Gradually increasing fatigue during exercise or dyspnea at rest or with exertion within the past 3-5 days
* Significant myocardial ischemia at low workloads \< 2 METs or 50W
* Relative contraindications according to ACSM 2022:
* Weight gain ≥ 1.8 kg in the past 1-3 days
* Simultaneous use of continuous or intermittent Dobutamine
* Decrease in blood pressure with exercise
* NYHA IV heart failure
* Complex ventricular arrhythmias at rest or with exertion
* Resting heart rate ≥ 100 bpm when lying down
* Comorbidities that limit exercise
* Severe obstructive hypertrophic cardiomyopathy
* Have participated in a cardiovascular rehabilitation program within the last 6 months
* Do not agree to participate in the study
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
* Aged 18-75 years.

Exclusion Criteria:

* Known allergy to afamelanotide or the polymer contained in the implant;
* Presence of severe hepatic disease or hepatic impairment;
* Renal impairment;
* Any other medical condition which may interfere with the study protocol;
* Existing melanoma;
* Female who is pregnant or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
* Use of any other prior and concomitant therapy which may interfere with the objective of the study;
* Participation in a clinical trial for an investigational agent.
Thiamine as a Metabolic Resuscitator in Septic Shock

The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Suspected or confirmed source of infection
* Hypotension (systolic pressure \<90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence.
* Lactic Acidosis \> 3 mmol/dl

Exclusion Criteria:

* Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders
* Liver dysfunction specifically defined as AST or ALT elevation greater than 240
* Current Thiamine supplements or usage
* Competing indication for thiamine administration
* Cardiac Arrest
* DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)