cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.


Eligibility Criteria:
Inclusion Criteria:

Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

Exclusion Criteria:

History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.

Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.

Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.

Pregnancy or intending to become pregnant.

Hypersensitivity to the product, history of alcohol or substance abuse.
Developing and Evaluating Product Messaging

Purpose: To assess the impact of taxes, warnings, and a combination of taxes and warnings on US adults' decisions to purchase products that contain red meat in an online grocery store.

Procedures (methods): Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be assigned to one of four trial arms: 1) Control (no warning and no tax), 2) Warnings (all products that contain red meat have a health warning and environmental warning), 3) Tax (30% tax on products that contain red meat), and 4) Combined warning and tax (all products that contain red meat will have the two warnings and a 30% tax). Then, participant will enter an online grocery store reflecting their assigned arm. The participant will be instructed to complete a shopping task in the online grocery store. After completing the shopping task, participants will be redirected to an online survey and answer a series of questions about the shopping task, labels (excluding tax and control groups), and taxes (excluding warning and control groups). Questions will also include standard demographic and health related variables.

Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be randomly assigned to one of four trial arms affecting the appearance of an online grocery store. Once in the online grocery store, participants will complete a shopping task. The participants will have 9 specified items to add to their shopping cart (1 pizza, 1 burrito, Burger patties \[meat or vegetarian\], Breakfast sausages \[meat or vegetarian\], 1 frozen individual meal, 1 loaf of bread, 1 sandwich filling \[for example, ham, turkey, or peanut butter\], 1 pack of tortillas, 1 taco filling \[for example, steak, chicken, or beans\]). Participants will be informed that they will not be spending any of their own money to complete the shopping task. After completing the shopping task, participants will be redirected to a survey. They will provide self-reported responses to survey questions (e.g. perceived healthfulness from eating red meat, perceived risk of cancer from eating red meat, thinking about the health/environmental harms of food products). Participants will also answer demographic and health related questions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Consumes red meat at least once per week.
* Responsible for at least 50% of grocery shopping for the household.
* Lives in the United States

Exclusion Criteria:

* Individuals who have participated in research studies from previous aims of this research.
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
* Non-childbearing potential female subjects
* Male subjects and female partners must agree to use at least 2 methods of contraception
* Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh \>50 kg at the Screening Visit.

Exclusion Criteria:

* Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
* Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
* Subjects with a positive urine screen for drugs of abuse
* Subjects with a history of regular alcohol consumption
* Subjects treated with an investigational drug within 30 days
* For Part A only: Subjects with 12-lead ECG QTcF \>450 msec (males) or QTcF \>470 msec (females) at the Screening Visit
* Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
* Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
* Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
* Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit
Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.

The study will include 100 participants with grass allergy and will look at the efficacy and usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind, placebo-controlled, crossover design.

Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal \> 3mm) within 12 months of study enrolment.
* Written informed consent
* Must be able to complete the study
* Reliable anticonception for fertile women
* FEV1 higher than 70 % of predicted value
* Positive grass IgE blood sample higher or equal to 0,7 kU/L

Exclusion Criteria:

* Improper fit of the Rhinix™ device
* Nasal septal deviation
* Retrospective TNSS for last summer \< 3
* Positive pregnancy test for fertile women
* Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)).
* Rhinitis medicamentosa
* Use of long acting anti-histamines.
* Documented evidence of acute or cronic sinusitis, as determined by the individual investigator.
* FEV1 lower than 70 % of predicted value
* Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septal perforations, nasal polyps, chronic nasal obstruction or other nasal diseases.
* Receipt of immunotherapy with grass pollen within the previous 10 years (at least two rounds of treatment).
* Women who are breastfeeding
NAC Effect on Infertile Women With Endometrioma

Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.

This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction.

Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 42 years
* Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV)
* Serum AMH levels between 0.7 and 4.5 ng/ml
* Standard long GnRH and antagonist ovulation stimulation cycle
* Body mass index (BMI) \<30 kg/m2

Exclusion Criteria:

* Non-inclusion criteria: Congenital uterine malformations
* Severe male infertility (TESE, PESA)
* Past medical history of asthma
Ibutilide Administration During Pulmonary Vein Ablation

To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients to be scheduled for atrial fibrillation radio frequency ablation
* paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment
* symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion
* patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone

Exclusion Criteria:

* patients with recent major hemorrhage (within 6 months)
* patients with a coagulopathy
* patients who are pregnant or breast feeding
* patients with acute congestive heart failure
* patients with hypokalemia or hyperkalemia
* patients with a prolonged QTc \> 440mms
* patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I
* patients with left ventricular dysfunction \< 40%
* patients with a history of recent MI (\< 1 month)
* patients with a history of an angioplasty of \< 1 month
* patients with a history of coronary artery bypass grafting surgery of \< 3 months.
* patients with a history of chronic renal failure or a creatinine clearance of \< 30ml/m
* patients with a history of stroke of \< 6 months
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation

The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF.


Eligibility Criteria:
Inclusion Criteria (Ivacaftor Arm):

1. Completed the last study visit of the treatment period of the previous study (NCT01705145)
2. Hematology, serum chemistry, and vital signs results on Day 1 with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator
3. As judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions and the parent or legal guardian should be able to ensure that the subject assents to participation in the study to the degree the subject can assent, and that the subject will comply with and is likely to complete the study as planned

Inclusion Criteria (Observational Arm):

1. Subjects who completed their assigned study drug treatment in the previous study (NCT01705145) and elected not to enroll in the ivacaftor arm and subjects who prematurely discontinued treatment in the previous study and received at least 1 dose of study drug treatment in the previous study will be eligible for enrollment in the observational arm.

Exclusion Criteria (Ivacaftor Arm):

1. Subjects who prematurely discontinued from the previous study
2. History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
3. Subjects with a history of study treatment intolerance as observed in their previous study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject
4. Subjects receiving commercially-available ivacaftor treatment
5. Subject was unable to complete an adequate slit-lamp examination at the last ophthalmologic examination in the previous study

Exclusion Criteria: (Observational Arm)

1. Subjects receiving ivacaftor treatment will not be eligible for enrollment in the observational arm.
Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning

The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

Lung ultrasound (LUS) has recently gained popularity among the imaging methods to perform bedside assessment of critically ill patients to guide clinical management. LUS is a non-invasive and easy-to-perform procedure that provides precise data on lung aeration, lung recruitment, lung morphology, and lung perfusion. Studies have shown that LUS is a useful tool in monitoring lung reaeration in intubated patients diagnosed with traditional ARDS undergoing prone positioning; however there are mixed findings in terms of the use of LUS in predicting potential prone positioning response. A recent study found that the non-intubated COVID-19 patients who responded to prone positioning had more pronounced disturbances of aeration in posterior regions, however, they only investigated patients' response to the first prone positioning and the information for the patients' outcome is lacking. In our previous study with intubated COVID-19 patients, we found that patients' response to the subsequent prone positioning had higher predictive value than the response to the first prone positioning. Therefore, the primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects 18 years and older,
2. Confirmed COVID-19 diagnosis
3. Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 \<300)
4. Ordered self-prone positioning per medical team

Exclusion Criteria:

1. Pregnant
2. Palliative care
Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.

Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Postmenopausal as confirmed in medical history
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB (Institutional Review Board)/Ethics Committee.
* Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
* Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32

Exclusion Criteria:

* Cachexia
* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Any NSAIDs aspirin or omega-3 free fatty acid supplementation within the last 14 days
* History of medical noncompliance
* Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
Hepatitis B Research Network Adult Cohort Study

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.

Aims

* Primary Aim:

  o To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
* Secondary Aims:

  * To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada
  * To evaluate changes in HBV infection status and quantitative hepatitis B surface antigen (HBsAg) levels and factors associated with those changes
  * To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal Alanine transaminase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months
  * To develop a bank of biospecimens (e.g., serum, plasma, DNA, lymphocytes, liver tissue) obtained from participants with HBV infection
  * To identify participants with HBV infection who are potential candidates in one of the treatment studies to be conducted by the Hepatitis B Research Network (HBRN)
  * To describe the natural history of hepatitis B infection in pregnancy including the frequency of, and clinical and virological characteristics associated with, hepatic flares during pregnancy and post-partum.

Eligibility Criteria:
The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.

Inclusion criteria

* Written informed consent
* At least 18 years of age
* Hepatitis B surface antigen (HBsAg) positive and either:

  * Pregnant
  * Anti-Hepatitis D positive
  * Diagnosed with acute Hepatitis B infection or experiencing a hepatitis flare
  * Immune tolerant or immune active phenotype
  * Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study (NCT01298037).

Exclusion Criteria:

* Hepatic decompensation
* Hepatocellular carcinoma (HCC)
* Liver transplantation
* Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
* Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV) or Hepatitis C (HCV) co-infection are not excluded).
* Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
* Unable or unwilling to return for follow-up visits
Randomized ActiveStep Clinical Evaluation

The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Referred for balance training

Exclusion Criteria:

* Age \< 65
Cutaneous Microcirculation and Diabetic Foot

15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Adult Men and Women
* Presence of diabetes
* Signed acknowledgement form

Exclusion Criteria:

* No signed acknowledgement form
* patients under 18 year-old
Occupational Therapy's Role in Promoting Community Wellness Utilizing Sit-Stand Workstations

The aim of this study is to combat the growing global health issue of sedentary behavior and the associated health consequences of prolonged sitting in the workplace. The population of desk-based workers makes up a relatively large population and are an important target for this health promoting initiative with a focus on improving posture, encouraging movement, and fostering a more active and healthy business community. It's important to recognize that occupational therapy practitioners can contribute to community health promotion/disease prevention programs by the skill-set of practitioners to understand habits and routines that influence the adoption and maintenance of healthy behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Participants must spend \> 50% of their work day seated at the computer
* Participants must be primarily English speaking
* Participants must work within the Health Sciences Center building at West Virginia University

Exclusion Criteria:

* Participants who are less than 18 years of age
* Participants who are not primarily English speaking
* Participants who spend \<50% of their work day seated at the computer
* Participants who do not work within the Health Sciences Center building at West Virginia University
* Participants who are pregnant