cyrilzakka/clinical-trials huggingface dataset:
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex, (the sponsor on record at time of the study's initial registration) believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

This study will be a Phase 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5 days to COPD patients.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* \>/= 40 years of age
* History of COPD
* FEV1 \</= 65% of predicted and FEV1/FVC \</= 0.7 value at Screening
* Clinically stable with no changes in health status within the last 30 days
* Lifetime smoking history of at least 15 pack-years
* Willing and able to give informed consent

Exclusion Criteria (selected):

* Use of any systemic or inhaled antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* CrCl \< 50/ml/min, AST, ALT or total bilirubin \>/= 3 x ULN at Screening
* Significant or unstable medical conditions
Early Precut in Difficult Biliary Cannulation

This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.

Exclusion Criteria:

* active cholangitis or pancreatitis
* chronic pancreatitis,
* previous sphincterotomy,
* prior gastric surgery,
* coagulopathy,
* severe comorbidity (need for tracheal intubation)
* patients who refused or were unable to give informed consent.
* patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
* detection of ampulloma or peri-papillary diverticula during ERCP.
Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant

The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level


Eligibility Criteria:
Inclusion Criteria:

* Patients with single missing maxillary or mandibular premolar or molar
* The edentulous sites should be healed sites
* The opposing tooth will be a natural dentition

Exclusion Criteria:

* general contraindications to dental implant surgery
* Patient with irradiation in the head and neck region
* Immuno-suppressed or immuno-compromised patients
* Patients who took or are taking amino-bisphosphonates
* Patients with poor oral hygiene and motivation
* Patients with untreated periodontitis
* Uncontrolled diabetes
* Pregnancy or lactation
* Addiction to alcohol or other drugs
* patients with psychiatric problems
* Lack of occluding dentition/prosthesis
* Restricted mouth opening (less than 3.5cm inter-arch anteriorly)
* Patients with an acute or chronic infection/inflammation in the area intended for implant placement
* Patients unable to commit 5 years follow up
* Patients referred for implant placement only
Check Yourself v2.0

Health risk screening in adolescent primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, the study team has developed and optimized a web-based, electronic Personalized Motivational Feedback tool referred to as "Check Yourself v2.0" Based on motivational interviewing, a technique to mobilize personal change, Check Yourself is designed to promote healthy choices for the multiple behaviors relevant to adolescents.

The proposed study is a randomized controlled trial that compares the effectiveness of Check Yourself v2.0 to usual care. The purpose of this study is to determine the impact of Check Yourself on reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services relative to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Eligible adolescent participants will be13-18 years of age
* Able to understand English.
* Will have an appointment (or have a child with an appointment) with a participating medical practice.

Exclusion Criteria: Adolescents will be excluded from the study

* Participants do not meet age requirements
* Do not have an appointment with a participating provider at a PSPRN clinic,
* Lack the means to complete follow-up interviews (i.e., have neither telephone nor internet access)
* Have a sibling who has been/is being enrolled in the study or have previously participated in our previous trial comparing Check Yourself to usual care
* Not able to understand English.
Reducing Socioeconomic Disparities in Health at Pediatric Visits

This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.

This project builds upon the PI's prior studies including a recently completed cluster randomized controlled trial (RCT) at community health centers in Boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources.

This study will specifically test the effectiveness of a further strengthened intervention "WE CARE 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. Finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model.

The study will take place at six community health centers in the Greater Boston area. The centers will be randomized to either an intervention or control site. Data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (EMR) from birth to age 3. Focus groups will be used to gather implementation data from intervention health center personnel.

The WE CARE 2.0 intervention consists of: 1) WE CARE surveys which parents complete prior to their child's well-child visits; 2) information technology (IT) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff.

Families attending the control health centers will receive standard of care. Of note, since the health centers share a common EMR and for ethical reasons, control sites will have access to the IT generated referral mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Child is on Medicaid insurance
* Is attending routine newborn visit

Exclusion Criteria:

* Premature (less than or equal to 32 weeks GA)
* Has a chronic disease
* Has Neonatal Abstinence Syndrome
* Has a foster parent
Outpatient Cardiac Rehabilitation in Austria

The aim of this prospective trial is the manifestation of guidelines developed for outpatient cardiac rehabilitation in Austria.

The evaluation of prospective and retrospective data is supposed to give evidence on morbidity and/or mortality advantages compared to patients not participating in cardiac rehabilitation programs.

The database created in this context is supposed to pave the way as instrument to document and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria as a key for quality management.


Eligibility Criteria:
Inclusion Criteria:

* heart disease

Exclusion Criteria:

* participation in another study within the previous 6 months
* Medical conditions which prevent patients from complying with the exercise program
* Acute infections
* Hypertrophic cardiomyopathy
* Pulmonary artery embolism or phlebothrombosis within the previous 6 months
* Unstable angina pectoris
* Heart failure (NYHA IV)
* Hemodynamically unstable arrhythmia
A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics

The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent
* Healthy adult male or female volunteers, age 18-65 years，
* BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg .
* volunteers with normal renal function

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

Active stimulation will be compared with compared to SHAM stimulation in DNP patients.

20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).

Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, \& 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subjects between 40 to 80 years old.
3. Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
4. Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
5. Must have the ability to feel pain as self-reported.

Exclusion Criteria:

1. Subject is pregnant.
2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self-reported.
4. Use of carbamazepine within the past 6 months as self-reported.
5. Suffering from severe depression (with a PHQ 9 score of ≥ 10).
6. History of neurological disorders as self-reported.
7. History of unexplained fainting spells as self-reported.
8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
9. History of neurosurgery as self-reported.
10. Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).
Ghrelin and Diastolic Heart Function

In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2DM obese patients;
* T2DM obese patients under anti-diabetic full medical therapy and glycemic control.

Exclusion Criteria:

* clinical diagnosis of type 1 diabetes;
* T2DM patients in poor glycemic control (HbA1c values of \>7%);
* chronic neurological disorders;
* heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF \<55%);
* severe anemia;
* thyroid dysfunction;
* kidney failure;
* uncontrolled blood pressure (blood pressure \> 140/90 mmHg on two occasions 2 weeks apart);
* inflammatory chronic disease;
* neoplastic disease.
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB or IV NSCLC.
* Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy.
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
* ≥ 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Adequate organ and bone marrow function.
* Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤ 1.
* Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment.

Exclusion Criteria:

* Treatment with anticancer therapy within 3 weeks before study treatment.
* Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
* Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
* Current need for concomitant use of other TZDs during the study.
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
* History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
* Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
* Pregnant or breast feeding.
* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.
Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students

Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical student and is a determinant part of the national competition they have to undergo.

Medical studies, especially during examen period, are significantly associated with risk of developping depressions or anxious trouble, wich led to lesser performance, impaired memorization and impaired workload capacities.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback and meditation are procedures used to reduce the stress level.

There is currently no study on the effect of stress management procedures on the performance during OSCE for medical student.

This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical student. For examination purpose, the students will be divided in four groups that will undergo identical exam in the same time in four parallels circuits.

Before entering the circuit, all the students will received information for the study and sign consent.

All the students will be equipped with emWAve® devices that allows us to collect heart rate variability as physiological stress marker during the time of the intervention. Participants will undergo short questionnaires regarding perceived stress.

Then the groups of students will be randomized in four interventions groups for receiving a combination of intervention before and/or after the examination circuit. All the interventions last six minutes long. The randomisation groups are :

* Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
* Meditative stimulation audio tape before the circuit, no intervention after
* Standardised video as controlled group before the circuit and a relaxing breathing exercise coupled with biofeedback after
* Standardised video as controlled group before and not intervention after

At the end of the examination circuit, all the students will undergo short questionnaires regarding stress, participants will get equipped with emWAve ® devices again and participants will get the second intervention depending on the randomisation group.

Main objective is to show that relaxing breathing exercise coupled with biofeedback or meditative stimulation is better than an standardised video on performance during OSCE.

The main outcome is student grade at the exam, as determined by university evaluator who is blind to the intervention and with no links to the study.

Secondary objectives are to compare the effects of the interventions on measured physiological stress, psychological stress, and negative rumination.

Eligibility Criteria:
Inclusion Criteria:

* Adult person
* Registered as medical student at the university
* Participating at OSCE examination
* Have signed an informed consent form.

Exclusion Criteria:

* None
A Substance Use Adaptation of Fathering Through Change

This study is a randomized control trial of the Fathering Through Change intervention, delivered via text messaging, to fathers in recovery for substance use disorders.


Eligibility Criteria:
Inclusion Criteria:

* identify as being in recovery
* abstinent from illicit substances for at least 1 day and less than one year at time of enrollment
* parenting responsibilities for a child between the ages of 3-16
* spend at least 2 hours per week with child between ages of 3-16
* English speaking

Exclusion Criteria:

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Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.

Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.

Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done.

Discussion Results of the study will be discussed compared to other studies.

Eligibility Criteria:
Inclusion Criteria:Adult patients undergoing radical cystectomy. -

Exclusion Criteria: Patient refusal.

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