cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment

The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.

Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.

The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
* signing of informed consent

Exclusion Criteria:

* Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.
Vitamin Metabolism in Kidney Disease

The purpose of this study is to evaluate the urinary excretion and renal metabolism of vitamins, in particular vitamin B12 and folate, in relation to various renal conditions involving loss of renal function and/or proteinuria.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Department of Nephrology, Aalborg Hospital
* Elevated serum creatinine
* Proteinuria
* Informed and written consent

Control subjects:

* Normal serum creatinine and creatinine clearance
* No proteinuria

Exclusion Criteria:

* Vitamin supplementation (exceeding predefined values)
* Renal replacement therapy (dialysis)
Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

The purpose of the study is to determine the effect of intranasal lidocaine on pain score in pediatric patients with migraine. Patients with significant pain after oral analgesics and plan for intravenous (IV) abortive therapy will be asked to participate. Half of patients will be given intranasal lidocaine and the other half will be given placebo. Pain scores and associated migraine symptoms (i.e. nausea, vomiting, photophobia, phonophobia, avoidance of activities, and aura) will be monitored and compared between the groups.

This will be a double-blinded, randomized-controlled trial using intranasal lidocaine to provide fast-acting pain relief in pediatric patients presenting with migraine to an urban pediatric emergency department (ED). Typically, abortive therapy for migraine in many emergency departments begins with oral analgesics such as ibuprofen and acetaminophen. However, many patients with inadequate pain relief after oral analgesics will require intravenous (IV) medications to abort their migraine symptoms. These medications can take up to thirty minutes or more for the onset of action to begin, potentially leaving patients in significant pain during that time. Also, obtaining IV access in children can be time-consuming and technically difficult, further delaying time to pain relief. Subjects will be given either intranasal lidocaine or placebo while awaiting IV placement and IV metoclopramide administration. Pain scales and associated migraine symptoms will be compared between the two arms before study medication administration and again at 5, 10, and 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be receiving IV metoclopramide because their migraine is refractory to oral analgesics, as determined by the treating physician.
* Moderate to severe headache with NRS score greater than or equal to 6
* Headache lasting between 2-72 hours
* Two of the following:

  1. non-occipital location of headache (frontal, frontotemporal, or unilateral)
  2. pulsating or throbbing quality
  3. aggravated by or causing avoidance of routine physical activity
  4. nausea, vomiting, or both
  5. photophobia and/or phonophobia (may be inferred from behavior)

Exclusion Criteria:

* unstable vital signs
* pregnancy
* lactating
* altered mental status
* developmental delay
* intractable vomiting
* first-time headache
* history of cardiac arrythmia
* previous adverse reaction or allergy to lidocaine
* non-English speaking
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.

RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted under the macular.

This first-in-human Phase 1/2a open-label dose-escalation interventional study plans to enroll a total of 18 subjects

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of dry AMD.
2. Ability to understand and give informed consent.
3. Adult male or female \>55 years of age.
4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale).
5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children.
6. If male, willing to use barrier and spermicidal contraception during the study.

Exclusion Criteria:

1. Allergy or hypersensitivity to dilation drops or fluorescein.
2. Active major medical conditions limiting ability to participate in the study.
3. Active malignancy or treatment with chemotherapy.
4. Systemic immunosuppressant therapy within past six months.
5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
6. Receipt of investigational product (IP) in a clinical trial within prior six months.
7. Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
8. Pregnant or nursing females.
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder

The purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.

This study is a smartphone-based, randomized, single-blind, controlled parallel-

design study with two intervention arms and one control arm. The two intervention arms

will receive in-app messages and phone-based support, which will be triggered by

participant's self-reported surveys and passive behavioral data gathered through a

smartphone app. The study will include a nationwide sample of adult (18 years or older)

smartphone users, who are currently experiencing depressive symptoms. The primary

outcome will be decrease in depression symptom severity, as measured by the 9-item

Patient Health Questionnaire, over 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Currently suffering from depression (as measured by a PHQ-9 score of 10 or more at the time of screening)
* Own an iPhone or Android smartphone with a mobile voice calling plan with a US carrier
* Fluency in English

Exclusion Criteria:

* Participants with visual or hearing impairment
* Recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening)
* Recent loss of a loved one (within the past two months at the time of screening)
* Unable or unwilling to accept End User License Agreement, or to provide information regarding their demographic characteristics and mental health history
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris

The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris
* Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive)
* Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive)
* No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled.
* Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to 4 to be enrolled.

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts)
* Subjects with active cystic acne or Polycystic Ovarian Syndrome
* Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s).
* Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
* Acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne, etc.)
* Use of antipruritics including antihistamine, within 24 hours prior to all study visits (Visit l/Baseline through Visit 4).
* Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion).
* Use within 6 months prior to baseline or during the study of oral retinoids (e.g. Accutane"') or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
* Use within 1 month prior to baseline or during the study of therapeutic vitamin D supplement (multivitamins are allowed).
* Use within 1 month prior to baseline or during the study of 1) systemic sterOids', 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents". (' Intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose. "Subjects may use Acetaminophen for pain relief, as needed, throughout the study)
* Use within 14 days prior to baseline or during the study of 1) topical sterOids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparation (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical anti-inflammatory agents, or 7) topical antibiotics.
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors

This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.

PRIMARY OBJECTIVES:

I. Administer and determine the feasibility of the personalized dietary intervention.

II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.

III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.

OUTLINE:

At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.

After completion of study, patients are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
* 6 months post-treatment completion
* Have a permanent ostomy or anastomosis
* English-speaking
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with stage IV disease will be excluded from the study
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Markers of Osteoporosis in Cystic Fibrosis

Main Study Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection.

Denosumab (Prolia) Sub study Approximately 10 adult subjects with CF who participated in the main study and have results indicating bone disease will receive treatment with Denosumab for up to 5 years. They will be asked to return annually for repeat DEXA scans, micro CT, and blood collection.


Eligibility Criteria:
Cystic Fibrosis Main Study Inclusion Criteria:

* Must have CF diagnosis confirmed by sweat test or genotype analysis
* Subjects (and parents/legal guardians as applicable) must have the ability to read and write in English

Sub-study Exclusion Criteria:

* No CF diagnosis
* Men or women without osteoporosis
* Less than 18 years of age
* Unwilling to return annually for study visits for up to 5 years
* Unwilling and/or medically unable to take denosumab
Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.

This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.


Eligibility Criteria:
Inclusion Criteria:

* women with story of infertility sine causa and mild-moderate male factor
* regular ovulatory menstrual cycles
* BMI ≤27 kg/m2
* normal day 3 hormonal pattern
* bilateral tubal patency

Exclusion Criteria:

* mono/bilateral tubal occlusion,
* severe male factor
* polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
* pelvic inflammatory disease
* endometriosis
* sexual organ malformations
* neoplasms or breast pathology incompatible with gonadotropin stimulation.
Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

This was a two arm parallel-group, randomised study. Subjects wearing single vision spectacles were recruited to participate in the study. Subjects were randomised to either continue to use their spectacles or to be fitted with the study daily disposable (DD) contact lens.

Eligibility Criteria:
Inclusion Criteria:

1. They are aged between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
5. They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
6. They have a cylindrical correction of -0.75DC or less in each eye based on the ocular refraction.
7. They own and habitually wear single vision spectacles.
8. They are willing to be fitted with contact lenses and understand they may be randomised to either group.
9. They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
10. They are able to wear the supplied surgical masks for the majority of time that they need to wear PFM and will wear the PFM for at least one hour a day for at least four days per week.
11. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses (if relevant) or spectacles.
12. They agree to not participate in other clinical research while enrolled on this study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens
2. wear.
3. They have a systemic disorder which would normally contra-indicate contact lens wear.
4. They are using any topical medication such as eye drops or ointment.
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
8. They are pregnant or breastfeeding.
9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
10. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
11. They require significant ocular/face personal protective equipment beyond a personal face mask.
12. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
13. They have spectacles which are not within ±0.50D of their refractive error.
A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.

Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections.
* Acyclovir for up to 14 days for acute herpes outbreaks.

Patients must have:

* Documented HIV infection.
* CD4 count 50 - 300 cells/mm3.
* No active opportunistic infections.
* No fever, diarrhea, or Herpes zoster.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
* Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).

Concurrent Medication:

Excluded:

* Antiretroviral agents, including ddI, ddC, AZT, and d4T.
* Immunosuppressive agents.
* Investigational HIV drugs/therapies including vaccines.
* Interferon or other immunomodulating agents.
* Corticosteroids (other than topical).
* Hematopoietins.
* Megestrol acetate.
* Agents known to cause neutropenia.
* Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
* Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior conditions are excluded:

* Prior history of cardiac disease.
* History of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.

Prior Medication:

Excluded:

* AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
* Prior cytotoxic chemotherapy.
* Acyclovir for herpes prophylaxis within 48 hours prior to study entry.

Prior Treatment:

Excluded within 30 days prior to study entry:

* Erythropoietin, transfusion, or blood product use.
* Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).
Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis

Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute (\< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio \> 0.9

Exclusion Criteria:

* age \> 80
* Recent thrombolytic therapy (with in 4 days)
* Active bleeding or know bleeding diathesis
* Known coagulopathy (including treatment with vitamin K antagonists) INR \> 3 and/or PTT \> 50
* Thrombocytopenia (PLT cound \< 100,000)
* History of any intracranial or intraspinal surgery, trauma or bleed
* Intracranial neoplasms, AVM, or aneurysm
* Recent (\< 1 month) GI bleed
* Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy
* Recent (\< 7 days) major surgery, trauma, or obstetrical delivery
* Renal insufficiency with eGFR \< 45 ml/min
* Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
* Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP \> 90 mm Hg for \> 15 min or need for pressor agents to maintain BP \> 90.
* Severe Hypertension (sustained systolic \> 180 mm Hg or diastolic \> 90 mm Hg.
* Pregnant patients
* known right to left shunt
* Large (\>10 mm)intracardiac thrombus
* Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
* Life expectancy \< 30 days
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Is 4 to 16 years 11 months of age at time of informed consent/assent obtained.
* Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
* Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
* Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \>18 μg/dL at the Screening visit.
* Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

* Has a history of adrenal disease.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device.
* Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
* Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
* Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.