cyrilzakka/clinical-trials huggingface dataset:
Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury

Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).

Recent studies have found that acute intermittent hypoxia (AIH)-or repetitive exposure to brief episodes of low inspired oxygen--is a promising new strategy that can help restore motor function by promoting neuroplasticity throughout the central nervous system (CNS). Both rodent and human studies show that motor function is further enhanced when AIH is paired with task-specific training/rehabilitation (TST). Therefore, this study will investigate the therapeutic potential of combining AIH with a task-specific airway protection training. We propose that the combined use of AIH + TST will enhance the magnitude and duration of TST training alone in individuals with chronic traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 21-80 years
* A mild to moderate traumatic brain injury (TBI) confirmed by medical records
* A Glasgow Coma Scale score between 9-15
* Able to consent independently
* Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study

Exclusion Criteria:

* Other neurological diagnoses or a diagnosis of a severe psychiatric disorder
* Severe aphasia preventing a participant from understanding the protocol and consent form
* Pre-existing hypoxic pulmonary disease
* History of obstructive lung diseases such as chronic obstructive pulmonary disease (COPD) or significant asthma)
* Severe hypertension (\>160/100)
* History of head and neck cancer
* Allergy to barium sulfate
* Ischemic cardiac disease
Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration

The purpose of this study is to determine whether progesterone hormone levels differ following egg retrieval with a single lumen needle compared with a double lumen needle. These levels will be measured on several days before and after egg retrieval. The progesterone levels in each IVF group will also be compared to the group of women who are having IUI. In addition, these progesterone levels will be correlated with pregnancy outcomes.

This is a prospective randomized trial consisting of 3 groups of patients. Following a long lupron protocol IVF cycle there is a need for supplemental progesterone. The purpose of this study is to determine what range of serum levels should be observed when differing methods of egg aspiration have been administered and whether or not there is a correlation with outcomes or pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 21-37
* Cycle Day 3 FSH between 2-12
* History of regular menstrual cycles between 24-34 days

Exclusion Criteria:

* Previous IVF failure
* Severe male factor
* Severe obesity, BMI \> 40
* More than 20 follicles on ultrasound prior to retrieval
Electrophysiological Changes With Diet.

Dietary habits may affect our body by certain mechanisms, visual sense is one of the most vital human senses that needs special attention in our daily habits.

Retinal function directly related to our quality of vision, different drugs can affect our vision in certain ways, however, out unhealthy dietary habits can indirectly affect our quality of life and vision.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects with intermittent fasting.
* obese subjects with body mass index more than 30.

Exclusion Criteria:

* patients with any retinal diseases that may ter retinal functional test.
* patients on systemic drugs that may alter retinal function.
New Approaches to INOCA

Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control.

Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Coronary microvascular dysfunction, triggering structural remodeling and vasomotor disorders of coronary arterioles, is currently one of the leading hypotheses to explain INOCA pathophysiology. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control. Also, previous reports evidenced that metformin improves endothelial dysfunction. Nowadays, it is used in prediabetic patients too. In this scenario, we evaluated the role of metformin in reducing the risk of re-hospitalization in INOCA.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* diagnosis of INOCA;
* availability to participate in the study

Exclusion Criteria:

* cancer;
* atrial fibrillation or left bundle branch block;
* previous acute coronary syndrome (ACS) or cardiac revascularization; -pregnancy;
* severe heart valve disease
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 60 years old (less than 61 years old)
* With newly diagnosed with AML according to WHO classification:
* With 20% or more blasts in the bone marrow
* Patients with history of tumors other than myeloproliferative disorders or myelodysplastic syndromes, having received chemotherapy and/or radiotherapy without previous history of myelodysplastic syndromes are eligible for the present study
* High-risk cytogenetics defined as one the following abnormalities : 5/5q-, 7/7q-, t(6,9), 11q23 abnormality excluding t(9;11), 3q abnormality,complex karyotype (\>3 abnormalites)
* Left ventricular ejection fraction (LVEF) \> 50% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan.
* Adequate liver function (all of the following) except if secondary to the leukemia:

Total bilirubin below 1.5 x upper limit of normal (ULN), AST and ALT below 2.5 x ULN , gamma-GT below 2.5 x ULN,

* Adequate kidney function (all of the following): Serum creatinine below 1.5 x ULN, Creatinine clearance above 50 mL/min (Cockroft and Gault formula)
* ECOG performance status \< or = 2.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient.
* Affiliated to the French Social Security (Health Insurance).

Exclusion Criteria:

* Previous allogeneic stem cell transplantation.
* Pre-existing aplastic anemia
* Presence of favourable cytogenetics with t(8;21), t(15;17), or inv(16)
* Previous history of MDS or myeloproliferative neoplasm
* Uncontrolled active infection.
* History of arrythmia.
* Cardiac toxicity induced by another anthracycline administration
* Maximum cumulative dose reached for any anthracyclin
* Allergy to cytarabine, daunorubicin, fish or egg proteins10. Significant neurologic (grade \> 2) or psychiatric disorder, dementia or seizures.
* Clinical symptoms suggesting active central nervous system leukemia.
* Degenerative or toxic encephalopathy
* Severe complications of leukemia such as:Uncontrolled bleeding, Pneumonia with hypoxia or shock
* Prior total body irradiation \> 10 Gy.
* Known active HIV, Hepatitis B or C infection
* Pregnancy or breastfeeding
* Concomitant anti-amarile vaccination (yellow fever)
* Concurrent treatment with any other anti-cancer therapy except Hydroxyurea
Direct Acting Antiviral-Post Authorization Safety Study

This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.


Eligibility Criteria:
Screening Inclusion Criteria:

* Current participant in TARGET-HCC
* Adults, age ≥18 years
* First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological.
* BCLC Stage A
* Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded.
* HCV RNA positive

Screening Exclusion Criteria:

* Inability to provide informed consent
* HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details)
* Prior liver transplantation
* Hepatitis B Virus (HBV) surface antigen positive (HBsAg)
* Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed

Enrollment Inclusion Criteria:

* Continued participation in TARGET-HCC
* No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline
* HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained)
* Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed)

Enrollment Exclusion Criteria:

- Liver transplantation since Screening
Safe Play Areas for Ross County Kids Project

Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe.

Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play areas for children on farms.

Injury is the leading cause of mortality and morbidity among children in the United States. Because children spend much of their time playing, it is important that they have safe play environments where they can challenge themselves and develop physically, mentally, and socially. The SPARK Project will focus its intervention in Ross County, Ohio, an area with more than 930 farms. Prior to this project, relatively little has been done to promote the prevention of injuries to children who live and play on farms.

The specific aims of this project are as follows:

* In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe, Ohio.
* In collaboration with partners in Ross County, promote safe play areas for children on farms.

The SPARK Project will employ a multi-faceted approach to injury prevention, centered on community partnership and collaboration. Utilizing methodology that was successfully developed and implemented as part of the Community Action for Playground Safety (CAPS) Program in Columbus, the SPARK Project will combine both active and passive injury prevention strategies to reduce playground and play-related farm injuries to children in Ross County.

Eligibility Criteria:
Inclusion Criteria:

* For playgrounds

  * must be seen at Adena Medical Center or Pickaway Pediatrics
  * must be the parent of a child younger than 6 years of age
  * must live in Chillicothe (if recruited at Adena) or Circleville (if recruited at Pickaway Peds)
  * must be English speaking
  * must be at least 18 years old
* For farms

  * must self-identify as living on a farm
  * must have a child younger than 6 years of age
  * must live in Ross county or Pickaway county
  * must be English speaking
  * must be at least 18 years old

Exclusion Criteria:

* Participants can only enroll in one study at a time
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with CD for at least 3 months
* Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound

Exclusion Criteria:

* Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
* History of dysplasia or malignancy in the colon
* Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
* Body mass index (BMI) higher or equal to 38.0 kg/m\^2
The POSA Trial - Positional Therapy for Positional OSA

Vibro-tactile feedback may be beneficial for some patients, who have positional obstructive sleep apnoea (OSA).

Aim: to determine whether Positional Therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional OSA, in reducing the disease severity and associated symptoms, compared to Sham-Positional Therapy. The interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age.

Methods: A prospective randomised, parallel, double-blinded trial comparing Positional Therapy (Night Shift™; Advanced Brain Monitoring, USA) with Sham-Positional Therapy, performed in older (\>65 years) and younger patients with positional OSA (apnoea/hypopnea index (AHI)\>5 events/hour, 2:1 when supine). The primary endpoint, AHI at 3 months, will be measured by a repeat study with the device in situ, and compared between Positional Therapy and Sham-Positional Therapy. Patients' subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. Adherence to therapy will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18
* Ability and willingness to provide informed consent
* AHI \>5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep \>20, \<90% of total sleep; central apnoeas \<20% total apnoeas; recording of ≥4 hours of analysable signals
* Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation

Exclusion Criteria:

* Unstable cardiac disease
* Cardiac arrhythmia corrected with an artificial pacemaker
* Supplemental oxygen
* Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
* Concerns about sleepy driving or any other potentially dangerous symptom from physician
* BMI ≥40 Kilogram/m2
* Inability to sleep in a non-supine position
* Skin sensitivity or an open wound around neck
* Neck circumference \<12inches (30cm) or \> 22inches (55cm)
* Tics or tremors of the head
* Sleep with head in upright position
* A female of child-bearing potential that is pregnant or intends to become pregnant
Safer Food Allergy Management for Adolescents

Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. In a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.

Among the 15 million people with food allergies in the United States, adolescents experience the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. Despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis.

The objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. The primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies.

In a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest incentives on consistency of epinephrine carrying. Based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.

Eligibility Criteria:
Inclusion Criteria:

* Food allergy diagnosis by a physician and recorded in the medical chart
* Prior prescription of epinephrine auto-injector to treat anaphylaxis
* Access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone)
* Fluent in English
* Between ages 15-19 at baseline

Exclusion Criteria:

* Unable to obtain permission (consent) of a parent to participate in the study
* Will not or cannot give assent
* Currently participating in another clinical trial with related aims
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers

Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin superfamily of peptides. It is produced in different regions of the nervous system, including the brain, trigeminovascular system and several autonomic nerves. Once released from neurons, it acts on vasoactive intestinal peptide receptor 1 (VPAC1), vasoactive intestinal peptide receptor 2 (VPAC2) and pituitary adenylate cyclase-activating polypeptide type I receptor (PAC1), by mediating smooth muscle relaxation, vasodilation and water secretion. Along with other neuropeptides, such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP), it is released from the trigeminal afferents and exerts a strong vasodilating activity on the cranial vasculature, sharing the activation of adenylate cyclase. Especially, it shares 70% structure with PACAP and acts on the same receptors. But, unlike it, VIP cannot induce a long-lasting vasodilation and has a modest capability to induce migraine attacks. Whether a long-lasting infusion of VIP may induce a prolonged vasodilation in the cerebral vessels and migraine, as a twenty-minute infusion of PACAP, is unknown.


Eligibility Criteria:
Inclusion Criteria:

18-60 years. 50-90 kg. Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

Headache less than 48 hours before the tests start All primary headaches Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. A cardiovascular disease of any kind, including cerebrovascular diseases.
The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)

The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA

Multicentric, observational, single arm, prospective, study.

All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows:

* Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed
* At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed
* In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed.

Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.

Eligibility Criteria:
Inclusion Criteria:

- Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation.

Exclusion Criteria:

* no exclusion criteria
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation

Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.


Eligibility Criteria:
Inclusion Criteria:

* Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:

APACHE II score ≥9 (See Appendix 1) OR \>2 SIRS criteria with lactate ≥ 4 or BP \< 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

Exclusion Criteria:

* Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder

Eligibility Criteria:
Inclusion Criteria:

* Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
* Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption

Exclusion Criteria:

* Smoking in the previous 6 months
* History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
* Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
* PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 \< 70% of predicted, FVC \< 70% of predicted, DLCO \< 70% of predicted, TLC \< 80% of predicted.
* Allergy to insulin