cyrilzakka/clinical-trials huggingface dataset:
Single Ascending Dose Study of TRN-157 in Healthy Subjects

This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent
2. The subject is male or female 18 to 65 years of age
3. If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
4. Non-smoker
5. Good general health
6. Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
7. The subject is compliant and available throughout the entire study period

Exclusion Criteria:

1. Current diagnosis, as per subject or investigator or screening assessment, of:

   1. unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
   2. history of narrow angle glaucoma
   3. history of alcohol abuse within the past 5 years
   4. history of smoking within the past 6 months
   5. positive result for the alcohol and/or drugs of abuse
   6. weight \> 100 kg or \< 50 kg
   7. clinically significant abnormal ECG
   8. history of clinically significant (per the Investigator) disease or disorder
   9. any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
   10. Abnormal vital signs defined as any of the following:

       * Systolic blood pressure ≥ 140 mmHg
       * Diastolic blood pressure ≥ 90mmHg
2. Heart rate \< 40 or \> 85 beats per minute
3. Fever or other clinically significant physical exam findings
4. Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
5. History or current symptom(s) of respiratory tract inflammation
6. Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
7. Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC \< 80% of predicted or FEV1/FVC ratio \< 0.7)
8. FEV1 variability \> 10% between study visits
9. Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
10. Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
11. Inability to perform acceptable, quality serial spirometry or any other study procedures
12. Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody
The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease

Deficits in postural control are increasingly recognized among the important secondary impairments in patients with chronic obstructive pulmonary disease (COPD). There are conflicting results regarding the effect of inspiratory muscle training in improvement of inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of this study to enhance postural control of COPD patients with improving the stability of the trunk by using inspiratory muscle training.

The study is a randomized controlled trial in patients with stable COPD. The participants are divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle training. The members of the IMT group use the POWERbreathe Medic device. The control group perform the complex pulmonary rehabilitation program without IMT. The program is divided into 3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks period all subjects are measured. 60 patients are planned to take part in the investigation. The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by Arteriograph.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD
* Do not take part in other treatment
* Be able to learn the usage of inspiratory muscle trainer

Exclusion Criteria:

* Acute exacerbation
* Balance problems with neurological cause
* The patient unable to cooperate
* Participation in pulmonary rehabilitation 3 months before the study
* IMT use in the 3 months before the study
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine

The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment.

Studies have indicated that medication treatment for opioid use disorder (OUD) with buprenorphine, methadone, or extended-release naltrexone reduces the risk for overdose by 70%. However, treatment dropout rates remain unacceptably high, with approximately 50% of patients discontinuing treatment 6 months after initiation. There is a substantial body of research indicating that high rates of treatment discontinuation are due to the emergence of intense cravings to use illicit opioids in response to cues - which are reminders of the drug such as drug paraphernalia. Much of the research so far in improving treatment retention on medications for OUD have focused on helping patients learn how to avoid triggers and to manage their cravings if they do emerge, and psychosocial treatments as adjuncts to medications has similarly not been as helpful as hoped. As such, there is a critical need to identify novel strategies that will improve retention in medical treatment for OUD, and cannabidiol (CBD) has emerged as a possible adjunct to OUD treatment, as it appears to target brain regions that mediate cue-induced cravings. Two studies so far have shown that CBD reduces cue-induced cravings for abstinent individuals with OUD not taking any medications, but the impact of CBD on cue-induced cravings among individuals stabilized on buprenorphine is not known.

Given that long-term medication treatment remains the gold-standard approach, a critical question that remains unanswered is whether CBD can be used as an adjunct to buprenorphine treatment to reduce cue-induced cravings. As such, the purpose of this week-long open-label feasibility pilot is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Patients with OUD currently receiving treatment with sublingual buprenorphine will be eligible to enroll. The cue-induced cravings assessment will be conducted before and after the CBD administration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe
* Currently in treatment with methadone or buprenorphine

Exclusion Criteria:

* Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants
* Any current mood episode requiring level of care higher than outpatient treatment
* History of psychotic disorder or bipolar disorder
* Currently pregnant
* Hepatic liver enzymes greater than 3x upper normal limit
* Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame oil emulsion)
* Currently taking any medications with known significant pharmacokinetic interactions with CBD
Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees

The purpose of this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Specifically, the project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan.

This project directly addresses the Michigan Department of Health and Human Services (MDHHS) Mental Health and Wellness commission priority to provide "better access to high quality, coordinated and consistent service and care between agencies, service providers and across geographical boundaries."

The project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan. CHCs serve 680,000 Michigan residents across 260 delivery sites. Ninety-two percent of CHC patients have incomes below 200 percent of the federal poverty level. Approximately 16 percent of CHC patients are uninsured, and more than 53 percent rely on Medicaid for their insurance. Thus, providing PTSD treatment to CHC patients will improve care to Medicaid enrollees and promote Mental Health and Wellness commission priorities of developing a trauma informed system that includes implementation of evidence-based trauma-informed care.

To address the high burden of PTSD in Medicaid enrollees in Michigan CHCs, we plan to deliver PE-PC to patients in CHCs. This treatment consists of four 30-minute sessions of in-vivo and narrative exposure, with content drawn from the PE model. Recently published efficacy data from a randomized controlled trial showed that PE-PC significantly reduced PTSD and depression symptoms as compared to usual primary care treatment. These changes were maintained at 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. receive care at a Michigan CHC
2. have a PCL-5 score ≥33
3. have had psychotropic medication stability for at least 4 weeks

Exclusion Criteria:

1. substantially cognitively impaired (according to the Mini-Cog)
2. unable to agree to study procedures for any reason (including incompetency)
3. at high risk of suicide
4. currently engaged in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy)
5. unable to speak English
Treatment of Peri-implantitis Lesions by Using Biomaterial

The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.

Patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. At the day of the surgery the patients will be randomized into the 2 treatment groups.

The subjects will be then prescribed postoperative antibiotics (Azitromax 500 mg day one and 250 mg day 2-4).

Post-operative pain will be controlled with Ibuprofen (400mg x 3) for two days to all subjects. Subjects will rinse twice daily with Chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. Subjects will receive professional prophylaxis as required.

Subjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. Instructions on post-operative care will be repeated at each visit. In particular the following points have to be covered during the first month after surgery: Chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. In addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy.

Sutures will be removed after 14 days. Photos will be taken during the whole study to document the healing process.

Further follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* Presence of peri-implantitis
* A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
* Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.
* During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.
* The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.
* Implants included in the study must have been in function for more than 12 months.
* Ability to fully understand the nature of the proposed surgery and ability to sign an Ethics Committee-approved informed consent form

Exclusion Criteria:

* Subjects with diabetes mellitus (HbA1c \> 7.0)
* Subjects taking prednisone or other anti-inflammatory prescription drug
* Subjects taking medications known to have effects on gingival growth
* If the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study
* General contraindications for dental and/or surgical treatments
* Smokers (\> 10 cigarettes per day).
* Pregnant or lactating women
* Allergy to collagen
* Inability to consent for participation in the study and/or to accept the proposed
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.

Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation.

The study includes 4 groups of patients:

Group I (conventional CABG)

Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation.

Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode.

Group IV (CABG+ amiodarone). Conventional CABG with administration of amiodarone in postoperative periode.

Eligibility Criteria:
Inclusion Criteria:

* patients must have signed an informed consent.
* patients had indications for two or more coronary arteries to be bypassed
* no history of AF

Exclusion Criteria:

* acute coronary syndrome
* previous CABG.
* a significant decrease in the contractile function of the heart (EF \<40%)
* significant heart valve disease requiring surgical repair
* long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
* respiratory failure
* left ventricular aneurysm requiring surgical correction
* chronic renal failure (≤60 mL/min/1⋅73 m2)
* chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology)
* participation in other clinical trials
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.

The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation.

The study is an observational study of the first implementation in clinical routine in Austria.

Eligibility Criteria:
Inclusion Criteria:

* Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

Exclusion Criteria:

* Age under 18 years

  * Pregnant women
  * Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
  * Vulnerable or mentally retarded candidates
  * Invalid or withdrawn informed consent
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
* naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

Exclusion Criteria:

* patients on hormone replacement therapy (HRT) within the last 3 months;
* patients on other osteoporosis medication within the last 3 months;
* sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
* hypersensitivity to any component of ibandronate;
* contraindication for calcium or vitamin D therapy;
* history of major gastrointestinal upset;
* malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).
The Use of Impella RP Support System in Patients With Right Heart Failure

The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
2. Age ≥18 years old
3. Signed Informed consent

Exclusion Criteria

1. INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
2. Evidence of acute neurologic injury
3. RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
4. Intolerance to anticoagulant or antiplatelet therapies
5. Existing congenital heart disease that would preclude the insertion of the device.
6. Participation in any other clinical investigation that is likely to confound study results or affect study outcome
7. Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)
Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts

The participants will be subjected to:

* Personal, Obstetric and gynecological History taking.
* Clinical examination.
* B-mode ultrasonography was performed to characterize the adnexal masses morphologically.
* Color Doppler ultrasound.
* Grayscale and elastographic ultrasound examination, which will be done using acoustic radiation force impulse (ARFI) imaging with virtual touch quantification (VTQ). Five consecutive measurements were recorded for each lesion from the region identified as the region of interest (ROI) and the median of these measurements was recorded as the shear wave velocity (SWV) value of the lesion. In virtual touch quantification (VTQ) the shear wave speed is expressed in m/s. Only numerical results will be taken into consideration.

  . Realtime elastographic and B-mode images simultaneously will appear as a two-panel image. Elastogram appeared in the region of interest (ROI) box to determine the target ovarian lesion and surrounding tissue, then elasticity colour code will be classified in 5 patterns : pattern 1, an absent or a very small hard area; pattern 2, hard area 45 per cent; pattern 4, peripheral hard and central soft areas; pattern 5, hard area occupying entire solid component with or without soft rim. Strain index will be analyzed, which will be obtained by comparing the absolute strain value of solid component of ovarian cyst with that of surrounding soft tissue.
* The invistigator will reevaluate the lesions 4 weeks after the initial assessment to see the possible changes in the size and/or configuration of the lesions with B-mode and elastographic ultrasonography.
* Lesion will be evaluated as endometriomas and referred for surgery when shows no significant changes in size and configuration.
* Hemorrhagic cyst diagnosis will be made if the lesion had resolved on follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient suspected to have endometrioma or hemorrhagic ovarian cysts.

Exclusion Criteria:

* Simple cysts which were defined as a sonolucent thin-walled (\<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections \[12\].
* Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography
Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants with the diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Using medications that may interfere with the metabolism or serum levels of triglycerides;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Presence of concomitant cardiovascular disease, renal failure and hepatic failure;
* Decompensated diabetes;
* Current smoking;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.
Staccato Alprazolam Abuse Liability

Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.

The Phase 1 clinical study compared the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo in 14 subjects with a history of sedative abuse. Subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and matching placebo over 2 sessions. Those who demonstrated greater liking for alprazolam versus placebo were eligible to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 to 55 years, inclusive, who have a history of substance abuse or dependence on barbiturates and/or benzodiazepine receptor agonists for their intoxicating effects

Exclusion Criteria:

* Subjects with a significant current psychiatric illness or taking any psychotropic prescription medications for therapeutic uses.