cyrilzakka/clinical-trials huggingface dataset:
KJ-TFC-004 Drug-drug Interaction Study

To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.

Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged between 19 and 50 during screening period
* BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
Comorbidities in Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (DM) has adopted a top priority as it is a disease with an increasing prevalence. The number of people living with DM has increased more than fourfold over the past 40 years to more than 460 million people today

All-cause mortality rates have declined substantially in several high-income countries, including England.

A diversification in non-fatal conditions in people with DM has also been reported. This is attributable to broader, non-vascular conditions. Due to increasing longevity among people with type 2 DM with increasing and diversifying multimorbidity in them, the health needs of people with Type 2 DM are therefore likely to be broad, and complex.

Finding multimorbidity (two or more chronic conditions) is common in people with Type 2 DM and increasing, but the comorbidity profiles of people with T2DM vary substantially.

Many studies have primarily focused on identifying multimorbidity patterns in the general population.

The understanding of multimorbidity patterns and composition of specific comorbidities in people with DM, and how this varies across patient groups and during the course of the disease, is limited. Further knowledge of this could provide insight into providing more holistic and more personal approaches to clinical guideline development, care pathways, and secondary prevention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes.

Exclusion Criteria:

1. Patients with type 1 diabetes.
2. Patients with secondary diabetes.
Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barrett's Esophagus

Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus. Chromoendoscopy after local acetic acid application enables recognition of the mucosal surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-Scan or acetic acid to diagnose Barrett's esophagus. The primary endpoint of the current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.

Patients with visible columnar lined lower esophagus (CLE) are included. After standardized PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies are taken.

Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus and can be recognized by new endoscopic techniques. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-scan (newly developed post processing digital filter) or chromoendoscopy (acetic acid) to diagnose Barrett's esophagus.

Patients with visible columnar lined lower esophagus (CLE) or known Barrett's esophagus are included. After standardized PPI therapy (14 days; standard dosage) patients are randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application (10-15ml; 1.5%) or HD+ endoscopy in conjunction with i-scan. Mucosal surface structure within CLE is graduated according to Guelrud's classification (type 1-2: endoscopic prediction: gastric epithelium; type 3-4: Barrett's epithelium). Biopsies are taken in a targeted fashion (type 1-4) in both groups and subsequently 4-quadrant biopsies were taken. Primary outcome analysis's to investigate the diagnostic yield of the different biopsy protocols.

Eligibility Criteria:
Inclusion Criteria:

* patients with CLE
* patients with known Barrett's esophagus

Exclusion Criteria:

* pregnancy
* severe coagulopathy
* known malignancies
To Assess Rotation for Femoral Version and Tibial Torsion

Determining the investigators ability to accurately assess rotational malalignment clinically compared to imaging.

The objectives of this study are 1) to assess the inter/intra-observer reliability of rotational measurements on axial MRI images and 2) determine the correlation between clinical and MRI measures of femoral version and tibial torsion.

The investigators will use previously obtained MRI images to retrospectively calculate the inter-observer and intra-observer reliability of our measurements. Participating physicians will undergo training to standardize measurement technique. Five orthopaedic surgeons and one radiologist will perform the measurement to calculate inter-observer reliability. To asses intra-observer reliability, repeat measurements will be performed by the same physicians at a later date (at least 2 weeks). The physicians will be blinded to previous results when performing the second set of measurements. A standardized rotational profile will be performed on all patients presenting to the investigators with patellofemoral complaints or rotational abnormalities warranting intervention. Internal and external hip rotation will be measured in the prone and supine positions. Tibial torsion will be assessed with the thigh-foot axis in the prone and sitting positions. Investigators will participate in a formal training session prior to data collection to normalize measurements. Each study participant will undergo MRI imaging of the femur and tibia.

Eligibility Criteria:
Inclusion Criteria: Retrospective:

* Prior study MRI images available in the University PACS system
* Prior study MRI images obtained at PCMC and uploaded into the OsiriX software (OsiriX is a software program compatible with multiple imaging formats that has easily adaptable measurement tools)
* We will search our imaging database from 2009 to current. Included will be all gun site MRI studies obtained at PCMC or the UOC for evaluation of rotational profile. We will exclude any study in which images are not sufficient to obtain all of the required measurements needed for our study. A preliminary review of the imaging database has identified 42 potential studies. Our power analysis calls for 15 patients to be included to obtain a 95% confidence interval.

Inclusion Criteria: Prospective:

* All patients of the investigating physicians, male and female, between the ages of 8 and 30 presenting with complaints of patellofemoral pain/instability or rotational abnormality
* All patients with neuromuscular disease, including cerebral palsy

Exclusion Criteria: Retrospective:

* Any patients with imaging studies insufficient to provide all of the required measurements and any patient previously surgically treated for rotational malalignment

Exclusion Criteria: Prospective:

* Any patient that has undergone previous surgical treatments for rotational malalignment.
* Any patients with implantable devices not compatible with MRI
Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

The aim of this study is to assess Uterine artery color doppler parameters after bilateral uterine artery ligation (BUAL) for Postpartum Hemorrhage.

Obstetric haemorrhage is the main reason of maternal death in both countries with high and poor incomes. Most of these deaths occurred within the first 24 hours following birth. Placenta accrete, retained placenta, genital tract lacerations, uterine rupture, and coagulation abnormalities are established risk factors for postpartum hemorrhage. The management of Idiopathic pulmonary hemosiderosis (IPH) and postpartum hemorrhage relies on numerous considerations: type of delivery (vaginal or caesarean delivery), bleeding etiology (uterine atony, trauma, retained placenta) and hemodynamic stability.

In the first stage, early identification, and treatment with uterotonics, suturing the lacerations, and fundal massage are crucial. When bleeding persist, even in the aggressive medical treatment, suitable surgical intervention should be performed.

Surgical therapy relies on the patient's desire to maintain fertility, the severity of the bleeding, and the surgeon's experience.

Historically, peripartum hysterectomy was the only available management to prevent postpartum hemorrhage but, in some instances, hysterectomy alone is insufficient to control the bleeding.

Also, the desire to preserve fertility have resulted in the development of other techniques, such as pelvic embolization and internal iliac artery ligation (IIAL)and bilateral uterine artery ligation (BUAL).

Bilateral uterine artery ligation (BUAL) is the most popular surgical procedure for quick management of postpartum hemorrhage. It may be performed alone or with conjugation with other postpartum hemorrhage methods in with success rate exceeds 90 %. Recanalization is a natural process that may occur following vascular structure closure with a suture or radiological embolization.

Eligibility Criteria:
Inclusion Criteria:

* 70 women aged between 20 and 35 years old.
* Undergoing Bilateral Uterine Artery Ligation after Postpartum Hemorrhageafter cesarean section
* resistant to medical treatment, and did not need to hysterectomy.

Exclusion Criteria:

* Patients with male factor, tubal factor, and absence of lactation.
* Diabetes mellitus, hypertension, morbid obesity, autoimmune disease, or vascular disease in the history, smoking.
* Intrauterine growth restriction in previous pregnancies history, detection of a uterine anomaly or a medical condition, as well as administration of a hormonal treatment during the study.
* Uncontrolled bleeding is needed for a hysterectomy.
EndoACAB vs PCI for LAD Revascularization

The purpose of this study is to determine which treatment option is better for patients who have isolated coronary artery disease (blockages of one vessel supplying blood to the heart muscle). The treatment options compared in this study are:

1. Endoscopic coronary arterial bypass
2. Percutaneous Coronary Intervention. This study is aimed to determine the best treatment for patients with coronary artery disease.

Coronary artery disease (CAD), also known as coronary heart disease (CHD) involves the progressive narrowing of the arteries that nourish the heart muscle. CAD is the main cause of death in Russia.

Patients with LAD disease have worse coronary flow outcomes Currently established types of myocardial revascularization are coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI). High effectiveness of CABG was proved by multiple studies. PCI is a first line therapy in the treatment of one vessel disease due to the less invasive approach and current technological possibilities of this revascularization method.

However, the established gold standard of multivessel coronary blockage treatment is CABG. It was reflected in the latest ESC/EACTS Guidelines on Myocardial Revascularization, due to the better early and late outcomes associated with the graft specifics.

On the other hand, standard CABD operation has a high injury and morbidity rate, which were factors for development of less invasive techniques of CABG.

According to the latest ESC/EACTS guidelines there are no advantages between PCI and CABG in the LAD disease treatment, both methods are Class I; level of evidence A.

The choice between myocardial revascularization methods in patients with LAD disease is the critical task.

Eligibility Criteria:
Inclusion Criteria:

* The presence of isolated lesions of LAD are available for revascularization PCI and EndoCAB
* Suitable candidate for both PCI and EndoCAB as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
* Age ≥ 18 years

Exclusion Criteria:

* Previous cardiac surgery of any kind, including CABG
* Previous thoracic surgery involving the left pleural space
* Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
* Indication for chronic oral anticoagulation therapy at the time of randomization
* Extra-cardiac illness that is expected to limit survival to less than 5 years
* Allergy or hypersensitivity to any of the study drugs or devices used in the trial
* Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
* Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
* Ejection fraction of 40% or less Left ventricular dysfunction
Conservative Surgery with Modified Widman Flap Vs Papilla Preservation Technique for the Treatment of Residual Pockets

The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III/IV periodontitis.
* Completed steps I-II periodontal therapy at least 6 weeks before.
* Full mouth plaque score of less than 15% at re-evaluation.
* Full mouth bleeding score of less than 15% at re-evaluation.
* Sextant with residual probing pocket depth (PPD) ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
* Signed informed consent.

Exclusion Criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Pregnant or nursing women.
* Presence of tooth mobility ≥ class 2.
Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients

The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:

Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?

Participants will:

Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance.

The study is a randomized controlled trial that aims to evaluate the effects of aerobic interval training (AIT) on fatigue level and functional performance in post-angioplasty patients.

The study involves 47 participants who have undergone percutaneous coronary intervention (PCI) for coronary artery disease (CAD) and have completed phase 1 of cardiac rehabilitation.

The participants are divided into two groups: Group A receives medication only, and Group B receives medication plus AIT. The AIT consists of four sessions per week for four weeks, with each session lasting 40 minutes and alternating between high and low-intensity intervals.

The study hypothesizes that AIT will have a positive effect on fatigue level and functional performance in post-angioplasty patients, compared to medication alone.

The study uses descriptive statistics, paired t-tests, and independent t-tests to analyze the data and test the hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* Patient with post angioplasty (having 1 or 2 stents)
* Patient who completed phase 1 cardiac rehabilitation
* Post coronary angioplasty patients 2 weeks of hospital discharge.

Exclusion Criteria:

* Patients with neurological disorders
* Patients with valvular and obstructive airway diseases.
* Patients with acute infections, malignancy
* Angioplasty complications such as arrhythmias, blood clots in-stent, and atrial fibrillations
* Patients with uncontrolled hypertension.
* Patients with uncontrolled diabetes.
* Presence of fracture.
Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study

The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.

Nearly 5 million people in the United States have congestive heart failure (CHF). Although medical therapy such as beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains worse than the majority of cancers in this country. Accordingly, significant opportunities exist for the improvement in outcomes of patients with CHF, both from a morbidity and mortality standpoint. Such opportunities may lie in the outpatient medical management of patients with CHF.

In this study, the primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years of age
2. Left ventricular ejection fraction ≤ 50% (at any time in the past)
3. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
4. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria:

1. Severe renal insufficiency defined as serum creatinine \> 2.5 mg/dl
2. United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)
3. Inoperable aortic valvular heart disease
4. Life expectancy \<1 year due to causes other than HF such as advanced cancer
5. Cardiac transplantation or revascularization indicated or expected within 6 months
6. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 L (when diagnosed as standard of care)
7. Subject unable or unwilling to provide written informed consent
8. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
Cognitive Screening in Lung Cancer Patients

This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Small-cell and non-small-cell lung cancer (stage I, II, III, IV)
* Age ≥ 18 years
* Patients able to speak and read the local language(s) fluently
* Acceptance and signature of informed consent

Exclusion Criteria:

* Age ≥ 70
* Presence of brain metastases
* Patients with concomitant neurological or psychiatric disorders.
* Patients undergoing brain radiotherapy
* Previous diagnosis of lung cancer
Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.


Eligibility Criteria:
Inclusion Criteria:

* patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
* Written informed consent
* Availability of a partner/caregiver
* Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
* Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria:

* Pregnant women.
* Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
* Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
* Contraindication for MRI imaging
* Presence and/or history of immunodeficiency (e.g., HIV infection).
* Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
* Prior and/or current treatment with immunosuppressive drugs.
* Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
* Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.