cyrilzakka/clinical-trials huggingface dataset:
Fluvastatin After Heart Transplantation

Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.


Eligibility Criteria:
Inclusion Criteria:

* De novo heart transplantation

Exclusion Criteria:

* Known allergy/intolerance to fluvastatin;
* Preexisting neuromuscular disorders;
* Significant liver disease and/or elevation of transaminase exceeding 3 times the ULN
* Severe renal impairment : creatinine \> 3 mg/dL
* Intellectual/cognitive impairment likely to compromise informed consent or adherence to protocol or age \<18 years.
* Patients refusal
* Pregnancy
The Effect of Low Level Laser Therapy on Neck and Shoulder Pain

This study is to see if applying red and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

It is the goal of the current study to demonstrate non-inferiority in efficacy of the Erchonia® EVRL when used in simultaneous dual diode mode (both the red (640 nano-meter (nm)) and violet (405 nm) diodes activated simultaneously) compared to its use with the red diode only activated, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Eligibility Criteria:
Inclusion Criteria:

* Subject presents with one or more of chronic neck or shoulder pain.
* Subject is diagnosed with of one or more of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain.
* Pain is chronic, having persisted for longer than the past 30 days
* Self-reported Pain rating on the 0-100 Visual Analog Scale (VAS) of 50 or greater.
* Willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation.
* Willing and able to refrain from engaging in any non-study procedure therapies throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture
* 18 years of age or older

Exclusion Criteria:

* Current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia
* Use of analgesics or muscle relaxants within 7 days prior to study procedure administration.
* Use of systemic corticosteroid therapy (inhaled and topical corticosteroids permitted), narcotics or Botulinum toxin (Botox®) injection in the neck/shoulder region within 30 days prior to study procedure administration.
* Active cancer or treatment for cancer within the last 6 months.
* Unstable cardiac disease, such as recent cardiac arrhythmia, congestive heart failure or myocardial infarction.
* Prior surgery to the neck/shoulder region.
* Known herniated disc injury.
* Active infection, would or other external trauma to the areas to be treated with the laser Medical, physical or other contraindications for or sensitivity to light therapy.
* Serious known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
* Pregnant or breast feeding.
* Participation in a research study within the past 30 days.
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of COPD or asthma
* a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
* postbronchodilator FEV1 \> or = 50% predicted

Exclusion Criteria:

* Exacerbation
* systemic corticosteroids
* DM, HIV and autoimmune disease
* immunosuppressive therapy
Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide

Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors are increased and Octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung function in patients with IPF. In this proof of concept study, patients with IPF will receive an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* confident diagnosis of IPF according to ATS/ERS criteria

Exclusion Criteria:

* known intolerance to somatostatin or octreotide
* another disease with predicted survival \< 12 months
* pregnancy or lactation
* previous treatment with somatostatin or somatostatin analogs
* patient on a waiting list for transplantation
* antifibrotic treatment or prednisone \> 10 mg/day within the last 6 weeks
* symptomatic biliary lithiasis
* blood coagulation disorders that prevent intra-muscular injections
* HIV infection
* hepatitis B or C active infection
Treatment Phenotypes for Adolescents With Asthma

This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.

This study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. Participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. The study team will collect data on medication use patterns in a real world setting for 12 months per participant. Additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.

Eligibility Criteria:
For adolescent participants:

Inclusion Criteria:

* Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available

Exclusion Criteria:

* Other significant chronic lung disease (from problem list)

  * Cystic fibrosis
  * Chronic respiratory failure
  * Tracheostomy status
  * Intersititial lung disease
* Significant developmental delay
* Taking more than 3 asthma related medications
* Primary language other than English, Spanish, Catalan, Dutch, French, German or Italian

Healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.
Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis

The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.

This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design.

Therefore, each nail out of two from a single patient will be randomized into the following study arms:

Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months.

Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months.

At the end of 6 months the data from both groups, A and B, regarding \*clinical cure, \*mycological cure and \*extent of damage to the nail plates will be analyzed using specific tests.

Eligibility Criteria:
Inclusion Criteria:

* 19-60 year-old
* preserved cognitive status
* direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds

Exclusion Criteria:

* diabetes type 1 or 2; peripheral vascular disease
* having undergone any treatment in the last 6 months
* peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc)
* willing to paint nail during the study
* high blood pressure
* use of any immunosuppressive drugs; congenital or acquired immunodeficiency
Efficacy of Moderate Sedation for Dental Treatment of Young Children

There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.

There is a lack of clinical trials on pediatric dental sedation in children 3 years old and under. We investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation. Healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective stabilization without sedative (PS). One observer scored children's behavior using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analyzed using non-parametric bivariate tests.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (ASA PS 1)
* Children under 36 months old
* Children presenting early childhood caries
* Children with no history of dental treatment

Exclusion criteria:

* Lost to follow-up
Study of CT001 in Healthy Volunteers

A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.

A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 up to 55 years
* Non-smokers
* Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)
* Physical Status Class 1 or 2
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.

Exclusion Criteria:

* Mental illness
* Opioid Risk Tool score of \>3
* Pain Catastrophizing Scale score, total points \>30
* Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression
* Daily intake of analgesics
* History of alcohol or drug abuse or use of illicit drugs.
* Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication.
* Participant showing abnormal nasal cavity/airway
* History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.
* Positive tests for HIV, hepatitis B and hepatitis C
* Positive COVID-19 test or clinical symptoms of COVID-19
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial
* Blood donation within 4 weeks prior to the first dosing visit
Physical Activity Choices Everyday

This study aims to test two strategies for weight loss maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and weekly personalized feedback on diet, activity, and weight loss goals. Individuals who lose at least 5% of their initial body weight during this program, will be invited to participate in Phase II. During Phase II, two 4-month treatments for weight loss maintenance will be tested. At the beginning of Phase II, participants will be randomly assigned to one of the two maintenance programs: (1) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70
* Body Mass Index between 30-50
* English Speaking
* Have a smartphone that can be used for study activities

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 1 year
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Have no Internet access or unwilling to use personal smartphone for study.
Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers

This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
* Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
* Participants with history of smoking or use of tobacco products in the last 3 months.
* Pregnant or nursing (lactating) women.
Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure

The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 22-65 years of age at time of enrollment
* Subjects must already be consented to 17-007934 or 19-001254
* Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
* If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline
* Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits

Exclusion Criteria:

* Persons presently or soon to be incarcerated
* Females who are pregnant or suspect they may be pregnant
* Persons with nicotine and/or alcohol dependence
* Patients with cognitive impairment that limits their ability to make autonomous decisions
* Known allergies or sensitivities to study materials (eggs and spirulina)
* Assessed, by the physician or delegate, that enrollment would not be appropriate
Protamine Sulfate During Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care in inoperable and high-risk patients with severe, symptomatic aortic stenosis. Information regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate access site closure is scarce and based on expert consensus. Clinical practice varies between centers. Protamine sulphate may decrease the amount of bleeding complications related to the access-site. The impact on possible thromboembolic complications is unknown. Both bleeding and thromboembolic complications increase mortality after TAVI. A randomized trial is required in order to assess impact of protamine sulfate on prevalence and extent of bleeding and thromboembolic complications.

Information regarding reversal of unfractionated heparin (UFH) with protamine sulfate (PS) is based on expert consensus from 2012, which recommends use of UFH in order to achieve activated clotting time (ACT) \> 300 seconds as well as UFH reversal with PS in case of TAVI via transapical access as well as transfemoral access with the exception of cases with minimal bleeding risk. However, the clinical practice varies between centers - some use PS routinely, others - only in selected cases. The actual impact of PS on bleeding complications reduction is unknown. Furthermore, a pro-thromboembolic effect of the PS cannot be excluded. Both bleeding (major and life-threatening according to Valve Academic Research Consortium \[VARC\] criteria) and thromboembolic complications increase mortality after TAVI. The occurrence of these complications in international TAVI registries in 30-day observation ranges from 9.7% in case of major bleeding, 4.7% in case of life-threatening bleeds and 5% in case of strokes. There are no randomized studies assessing impact of PS on frequency of bleeding and thromboembolic complications after TAVI, its side-effects and influence on mortality. Randomized trial is required in order to assess impact of protamine sulfate on prevalence of bleeding and thromboembolic complications.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent successful TAVI
* with any approved TAVI device
* via transfemoral access
* with use of any of the approved vascular closure devices
* provided written informed consent

Exclusion Criteria:

* no consent
* periprocedural complications requiring continuation of heparin or administration of protamine sulfate
* alergy to fish, protamine, protamine derivates, history of Humulin N, Novolin N, Novolin NPH, Gensulin N, SciLin N, NPH Iletin II and isophane insulin intake
A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease

The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.

This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing elective and urgent (i.e., non-emergent) PCI
* Age \>18 years
* eGFR \<60 ml/min/1.73 m2
* Angina or equivalent and/or documentation of inducible myocardial ischemia
* Presence of =1 coronary stenosis, evaluated \>70% by visual estimation (on a previously performed coronary angiography) or with an FFR =0.80
* ability to provide written informed consent

Exclusion Criteria:

* Emergent PCI due to either hemodynamic instability, ST-elevation myocardial infarction or sudden cardiac death
* PCI on chronic total occlusion
* Prior PCI within 3 weeks
* Age \>90 years
* Left ventricular ejection fraction \<20%
* Need for mechanical circulatory support
* Pregnancy
* Prisoners
* Non-English speaking patients
* Inability to provide written informed consent