cyrilzakka/clinical-trials huggingface dataset:
Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0

To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary function, fractional exhaled nitric oxide and quality of life of the patients.

Patient safety will be monitored by assessing changes in these parameters, as well as changes in standard of care measurements (e.g., laboratory values and x-ray images).

Eligibility Criteria:
Inclusion Criteria:

1. \>6 months post-bilateral lung transplant
2. Any patient with a stable FEV1 or a decline that is \< 20% from baseline.
3. No current signs of infection
4. No current signs of rejection
5. \>21 years old
6. Routinely followed at the enrolling site
7. Capable of giving informed consent

Exclusion Criteria:

1. Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
2. Evidence of active congestive heart failure or symptomatic coronary artery disease, in the opinion of the site investigator
3. CLAD grade 1 or higher
4. Currently on any ICS therapy
5. Initiation of chronic azithromycin within 1 month of study enrollment (chronic azithromycin use defined as azithromycin 250mg or 500mg daily or every Monday, Wednesday, Friday)
6. Positive pregnancy test at screening, if female and of child bearing potential
Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated after treatment has ended. Both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.

Eligibility Criteria:
Inclusion Criteria:

1. History of low back pain for a minimum of 6 months with radiation to leg or buttocks
2. Over 18 years of age and under 70
3. Must have a visual analogue scale (VAS) pain score \>50mm
4. Must be in generally stable health
5. Must be willing to abstain from alcohol during the course of the study
6. If female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study
7. Must be able to read and understand instructions and the questionnaires
8. Must be willing to participate in daily data collection requirements via telephone (IVRS)
9. Must understand all aspects of the study, and willing to sign an informed consent form in that regard.

Exclusion Criteria:

1. Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
3. Involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain.
4. Neurological disorder including history of seizures
5. Major psychiatric disorder during the past six months
6. Active suicidal ideation or recent suicidal behavior
7. Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
8. Significant renal disease or severe renal insufficiency
9. History of, or current, substance abuse/dependence
10. Significantly abnormal laboratory values
11. Pregnant or lactating any time during the course of the study
12. Known sensitivity to Savella or other SNRI
13. Glaucoma
14. Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
15. Beck Depression Inventory Score \>30
16. Current Sleep Disorder
Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 45 years old,
* SF levels \<30 μg/L,
* Body weight \< 70 kg
* Normal Body Mass Index (18.5-25 kg/m2),
* Signed informed consent.

Exclusion Criteria:

* Anemia (Hb \< 12 g/dL)
* Elevated CRP \> 5 mg/L,
* Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
* Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
* Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
* Difficulties with blood sampling,
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
* Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
* Pregnancy, breastfeeding
* Women who intend to become pregnant during the course of the study,
* Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
* Smokers (\> 1 cigarette per week),
* Participant is likely to be absent on one the study appointments,
* Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients

This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.

A total of up to 4 cohorts were planned to be enrolled, with an additional lower or intermediate cohort of participants. First to third generation Japanese participants could be enrolled in all cohorts but were not required to be enrolled. The screening period for this study will be up to 60 days. A single dose of MHU650 intravitreal injection will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the EOS visit.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), or retinal vein occlusion (RVO). In the opinion of the investigator, the decrease in vision in the study eye must be due to macular edema.
* Early Treatment Diabetic Retinopathy (ETDRS) letter score in the study eye must equal to or worse than 60 letters (approximately Snellen equivalent of 20/63) but better than 14 letters (20/500) at screening and baseline. The ETDRS score in the non-study eye should be ≥ 60 letters at screening and baseline.
* Sufficiently clear ocular media and adequate pupil dilation to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins
* Vital signs as specified in the protocol

Key Exclusion Criteria:

* Concomitant conditions or ocular disorders in the study eye which may, in the opinion of the investigator, confound the interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period
* High risk and/or/ active proliferative diabetic retinopathy in the study eye, as per investigator assessment at both screening and baseline.
* Participants with the following conditions in the study eye at screening or baseline must be excluded: structural damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal arterial occlusion, neovascularization of iris of any cause.
* Laser photocoagulation (macular or panretinal) in the study eye during the 6-month period prior to baseline.
* Patients with type 1or type 2 diabetes who have hemoglobin A1C of ≥ 12 at screening
* Other ocular conditions as specified in the protocol
* Systemic conditions as specified in the protocol
The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia


Eligibility Criteria:
Inclusion Criteria:

* Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study
A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food

Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.


Eligibility Criteria:
Inclusion Criteria: - Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria: - Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
Skin Test Study of BM32

The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients

BM32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum hydroxide-adsorbed equimolar mix of four active ingredients, BM321, BM322, BM325 and BM326. The four active ingredients are purified recombinant proteins containing non-allergenic peptides from the four major timothy grass pollen allergens, Phl p 1 (BM321), Phl p 2 (BM322), Phl p 5 (BM325) and Phl p 6 (BM326) which are fused to the PreS domain of hepatitis B virus, a protein used in childhood vaccines. BM32 holds promise not to induce IgE mediated immediate type (e.g. anaphylactic reactions) or T-cell mediated late phase side effects during immunotherapy.

The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins due to their low/absent IgE- and T cell-reactivity exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). This study will therefore provide important information for immunotherapy studies based on BM32.

Eligibility Criteria:
Inclusion Criteria:

* Positive history of grass pollen allergy and positive skin prick test reaction to grass pollen extract
* Age between 18 and 60 years
* Subjects must have a standard health care insurance
* Subject must appear capable to understand and comply with all relevant aspects of the study protocol

Exclusion Criteria:

* pregnancy or breast feeding
* autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
* contra-indication for adrenaline
* severe general maladies, malignant diseases
* patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs
* contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia, unstable or uncontrolled bronchial asthma (30)
* use of beta-blockers
* participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation without other interventions will be acceptable
* risk of non-compliance with the study procedure and restrictions
* use of oral H1 antihistamines within the previous 3 days, oral Ketotifen within the previous 5 days and topical corticosteroids in the test area within the previous 14 days.
* systemic (short-term) corticosteroids within the previous 14 days
eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that \<20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.

This study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre/post-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speak and understand English
* Male or Female
* No prior germline genetic testing
* Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing

Exclusion Criteria:

-Communication difficulties such as:

* Uncorrected or uncompensated hearing and/or vision impairment
* Uncorrected or uncompensated speech defects
* Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety

SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety commonly occurs, it is conceivable that a combination of an established antidepressant agent such as SJW and an established anxiolytic agent such as kava may effectively treat MDD presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid anxiety, than by the individual substances alone. Determination of this is not addressed in this study due to limitations of time and resources. The determination of the strength of the SJW-kava combination will be ascertained by comparing similar trials using SJW and kava mono-therapy in addressing MDD and GAD.

The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid anxiety more than placebo.


Eligibility Criteria:
Inclusion criteria:

* Any person male or female aged 18-65 presenting with a diagnosis of unipolar depression confirmed by CIDI auto (quantified by BDI) and an anxiety score on the DASS of 8 or above i.e. the mean (quantified also by BAI)

Exclusion criteria:

* Psychotic/ Bipolar illness
* Current or \< 6 month significant suicidal ideation
* Diagnosed hepato-biliary disease/inflammation
* Current or \< 6 month substance abuse disorder including alcohol
* Current or \< 12 month use of kava, St. John's wort,
* Current or \< 1 month of synthetic antidepressants or benzodiazepines
* Previous reaction to kava or St. John's wort
* Medications that maybe pharmacokinetically altered via St. John's wort including:

  * Amitriptyline anti-coagulants e.g. phenprocoumon, warfarin,
  * Anti-fugals e.g. voriconazole,
  * Anti-histamines e.g. fexofenadine,
  * Benzodiazepines e.g. alprazolam,
  * Chemotherapeutics e.g. irinotecan, digoxin, HIV medication (anti-retrovirals), \* Immunosuppressants e.g. cyclosporine, methadone, OCP,
  * Statins e.g. simvastatin, warfarin (Henderson 2002; Izzo 2004).
  * However this interactions are based on case studies and theoretical interactions and are regarded to be induced by hyperforin (a constituent of St. John's wort); low or non-standardised hyperforin preparations are regarded to not induce drug interactions as little induction of P-glycoprotein and CYP P450 enzymes occurs (Madabushi et al. 2006). Although in vitro studies have confirmed that kava and the isolated kavalactones modulate certain CYP 450 enzymes, no documented evidence of human kava-drug pharmacokinetic interactions exists (Mathews, Etheridge \& Black 2002; Singh 2005)
* Seeing a psychologist or counsellor currently or in the previous month.
* Non-English speakers.
* Pregnancy
Effects of Acute Pain on Cognitive Performance in Young Adults

The effects of pain on cognitive performance have not been thoroughly investigated. Broadly, the purpose of this research is to investigate the effects of acute pain on performance of a variety of cognitive performance measures. The investigators hypothesize that acute pain impairs cognitive performance, particularly cognitive measures of working memory, attention, and processing speed.


Eligibility Criteria:
Abbreviations: HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9.

Inclusion Criteria:

1. 18-35 years old
2. Self-identifying as generally medically healthy
3. Able to read, write and speak English
4. Able to provide informed consent
5. Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

Exclusion Criteria:

1. Resting HR \< 50 or \> 100 bpm
2. Resting BP \< 90/60 or \> 140/95 mmHg
3. Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
4. Score on the MoCA \<23
5. Score on the GAD-7 ≥ 10
6. Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
7. Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis
8. Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
9. Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
10. History of serious concussion or head injury, defined as a loss of consciousness for \> 5 minutes and/or requiring medical treatment, or \> 2 concussions over the lifespan
11. Any history of acute or chronic problems with balance, any dizziness, or \> 1 fall in the last 12 months
12. Taking 4 or more medications
13. Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
14. Any current or chronic pain condition during the last year, located anywhere in the body
15. Allergy to capsaicin or hot peppers
16. Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
17. Skin sensitivity to soaps/creams/perfumes or to heat
18. Poor circulation in the area targeted for the painful stimulus
19. Prior participation in a locomotor learning study in this lab within the last 2 years