cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD followed by a MAD study of Inzomelid. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC) comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical Monitor.


Eligibility Criteria:
Inclusion Criteria- Healthy Volunteers:

* Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
* Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug;
* Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Inclusion Criteria- CAPS Patients:

\* Patients with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 70 years (inclusive at the time of informed consent);

Exclusion Criteria- Healthy Volunteers:

* Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;

Exclusion Criteria- CAPS Patients:

* Live vaccinations within 3 months prior to Screening, for the duration of the study and for up to 3 months following the last dose of study drug;
* Positive QuantiFERON test at the Screening visit or within 2 months prior to Screening.

Participants who have a positive QuantiFERON test with documentation of BCG vaccination, who are at low environmental risk for TB infection or reactivation, and have a negative chest X-ray can be included;

\* Pregnant or lactating at Screening or planning to becomepregnant (self or partner) at any time during the study, including the follow-up period;
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.
* Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.
* Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Heart rate\>100 bpm, QRS Interval\>120 msec, QTc Interval \>430 msec, PR Interval\>220 msec, or any other abnormalities observed on the Electrocardiogram.
* Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.
* Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.
Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)

This study utilizes implementation science principles to culturally adapt a pre-existing web-based application (WebApp) for use with college students. The ADAPT-ITT process will be utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college population with a focus on life skills and holistic self-care as reinforcement to currently available primary prevention programming available to incoming students. The study hypothesis is that the adapted WebApp will be usable, acceptable, and students will be willing to use it as a reinforcement to current university primary prevention programming. The study team will also monitor retention of participants over the academic year. This is a repeat pilot test to evaluate changes implemented to the WebApp after the initial pilot during the 2017-2018 academic year.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled as a student at the participating university (University of Michigan)
* Age 18 or older
* Willing to participate in the study
* Able to speak and read English
* Participated in Relationship Remix at the University of Michigan at residence halls during the Fall of 2018.
* Enroll with your University of Michigan email.

Exclusion Criteria:

* Did not complete the Relationship Remix session.
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-squamous NSCLC.
* Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
* Other inclusion criteria may apply.

Exclusion Criteria:

* Small cell lung cancer (SCLC) or mixed SCLC and NSCLC.
* Central nervous system (CNS) metastases.
* Malignancy other than NSCLC.
* Palliative radiotherapy for bone lesions inside the thorax.
* Prior radiotherapy of bone marrow.
* Active hepatitis B.
* Active hepatitis C.
* Tested positive for human immunodeficiency virus (HIV).
* Life expectancy \< 6 months.
* Woman of childbearing potential who is pregnant or is breast feeding.
* Woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
* Other exclusion criteria may apply.
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19

Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission.

This genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be adult and of greater than or equal to (\>=) 18 years of age or older at the time of consent
* Participants must be immunocompromised (IC) population eligible to receive sotrovimab
* A positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 through clinical testing or routine screening undertaken as part of clinical management
* Prescribed treatment with sotrovimab as standard of clinical care
* Able to provide informed consent and willing to adhere to study-related procedures

Exclusion Criteria:

* Participants who require hospitalization (related or not to COVID-19) at baseline
* Participants who initiated sotrovimab therapy in inpatient settings
* Participants unable to perform nasal/oropharyngeal sample collection
* Blinded participants from other COVID-19 related trials
Quality-of-Life Management for COPD Patients

The investigators aim to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" (CAir) on health-related quality-of-life in patients with COPD.

The disease management programme "Living well with COPD" was developed to relieve symptoms and prevent exacerbations. It covers a disease self-management approach, educational topics, lifestyle coaching and physical activity advice.

Future implications should aim to make the intervention easily accessible for a broad spectrum of patients at scalable costs. Patients need an engaging communication platform which can inform, coach and even listen in between medical visits. The inclusion of a chatbot agent may provide this tailored feedback. The investogator's aim is to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" on health-related quality-of-life in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosed COPD according to GOLD-guidelines

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 3 months
* Pregnant patients
Home-Based Cardiac Rehabilitation for Patients With Heart Failure

The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.


Eligibility Criteria:
Inclusion Criteria:

Roll-in Phase

1. Stage C HF (NYHA Class I-III) AND

   1. Discharged from a HF hospitalization (all LVEFs) OR
   2. Scheduled for appointment in HF clinic with a prior HF hospitalization within the past 12 months with LVEF \>35%
2. Receives longitudinal HF care at VUMC main campus, including at least one visit prior to the roll-in phase

Randomized Controlled Trial (beyond roll-in phase)

1. Willingness to continue and participate in the study visits and other study activities required for the RCT

Exclusion Criteria:

Roll-in Phase

1. Unwilling or unable to provide informed consent for participation in the RCT
2. Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable)
3. Age \< 18 years
4. Stage D HF (advanced HF under evaluation for LVAD or transplant)
5. NYHA class IV symptoms
6. Congenital heart disease
7. Pregnant
8. Group 1 pulmonary hypertension
9. Moderate-severe or severe (3+ or greater) valvular heart disease
10. Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
11. Planned surgery within 3 months
12. Pacemaker or internal cardioverter defibrillator placement or revision performed within past 1 month or planned within 3 months
13. Prior Cardiomems placement or planned in next 3 months
14. Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
15. Treating provider or study team physician indicates that participation in the RCT would be unsafe
16. Participation in any ongoing randomized trial that has not completed follow-up

Randomized Controlled Trial (beyond roll-in phase)

1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn at least 10 hours/day).
2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Current or previous treatment with benralizumab for SEA
2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
4. Able to provide signed informed consent (if required based on local guidelines)

Exclusion Criteria:

1. Patient on any other biologic during the 12 months prior to treatment with benralizumab
2. Previously or currently receiving any biologics for the treatment of asthma or NP in a clinical trial. This exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).
Atrial Fibrillation and Diabetes Mellitus

Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

A total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. The relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation
* Diabetes mellitus
* Able to understand and willing to sign the Informed Consent Form.
* Age ≥18 years.

Exclusion Criteria:

* Contraindication for DE-MRI with a full dose of gadolinium-based contrast agent.
* Previous left atrial ablation or surgical procedure
* Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
* Mental or physical inability to take part in the study
* Morbid obesity (BMI \> 35), or inability to be placed in MRI due to body mass.
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)

This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
3. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion Criteria:

1. History of significant sensitivity or allergy to androgens, or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
9. History of stroke or myocardial infarction within the past 5 years.
10. History of or current or suspected prostate or breast cancer.
11. History of untreated and severe obstructive sleep apnea.
12. History of long QT syndrome (QTc \> 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)

This study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future.

The overarching goals of this research are to investigate: (1) neural substrates of approach/avoidance behaviors in remitted MDDs; (2) stress-induced signaling in remitted individuals with past MDD; (3) neural markers that prospectively predict disease course.

This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task.

Eligibility Criteria:
Inclusion Criteria for all participants:

* All genders, races, and ethnic origins, aged between 18 and 45
* Capable of providing written informed consent, and fluent in English
* Right-handed
* Absence of any psychotropic medications for at least 2 weeks
* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)

Inclusion Criteria for "Remitted MDD" group:

* Meets inclusion criteria for all subjects, plus:
* History of MDD as defined by DSM-5
* Absence of anxiety disorder for the past two months

Exclusion Criteria for all participants:

* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy)
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* History of seizure disorder
* History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups
* History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance/alcohol use disorder only if it ended as least 12 months ago
* History of cocaine or stimulant use or dopaminergic drugs
* History or current diagnosis of dementia, or a score of \< 26 on the Mini Mental State Examination at the screening visit;
* Patients with mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs
* Clinical or laboratory evidence of hypothyroidism
* Patients with a lifetime history of electroconvulsive therapy (ECT)
* Failure to meet standard MRI safety requirements
* Abnormal ECG and lab results
* History of seizure disorder
Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.

This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
* Patients who received this drug for the first time at the medical institution after the day of launch of this drug.
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described.

Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Having been seen at least once in consultation in the Internal Medicine, Endocrinology and Nutrition department of Hautepierre Hospital
* Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021
* In whom biological confirmation of recurrence has been demonstrated
* Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Treatment pre and / or post surgery by radiotherapy
* No recurrence
* No treatment with a somatostatin analogue for recurrence
* Subject under guardianship, curatorship or safeguard of justice