cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis

Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. The cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. Individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle.

The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is limited. More recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. Although small numbers of subjects have been included in these trials, there have been encouraging preliminary data.

The aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. We also aim to assess whether this translates to better outcomes at 30 day follow up.

Prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis.

Our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing percutaneous coronary balloon angioplasty and stenting
* Ages 18 years and older
* TIMI III flow on the initial angiography
* Native coronary artery lesions

Exclusion Criteria:

* Patients unable to give consent
* Adenosine allergy
* Severe asthma with bronchial reactivity
* Cardiogenic or circulatory shock
* Acute or chronic total coronary artery occlusions
* Patients requiring Rotablator therapy
* In stent restenosis
* Second or third degree AV block without a permanent pacemaker
* ST-Elevation MI
* Elevated baseline CK/ CK-MB or troponin levels (Pre-existing Non-STemi)
* Current pregnancy
* Patients not already on statin therapy or intolerant of statins
Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients

The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.

The trial consists of 12 weeks of therapy that is divided into two sections. In the first 6-week section patients receive treatment with either TNI or BiPAP and in the second 6-week section treatment is changed. The starting therapy is allocated to the patients via randomisation and should be started directly after the baseline visit.

The treatment and the follow-up period end with the second visit after the second treatment section and the patient decides which device he/she wants to use further.

Eligibility Criteria:
Inclusion Criteria:

* presence of COPD with chronic respiratory global insufficiency
* chronic day-hypercapnia with pCO2 \>= 50 mmHg and typical symptoms of ventilatory insufficiency OR patients with exacerbation (after abate of acute symptomatology) with documented hypercapnia \>= 50 mmHG on preliminary findings
* age 18 or older
* the patient or caretaker must be able to operate the device after a specific training
* patient must be willing to use the nHF-/BiPAP-device for the whole trial period for at least 5 hours/day
* patient must be able to answer the questionnaires
* written informed consent is obtained

Exclusion Criteria:

* presence of acute respiratory insufficiency
* exacerbation of type I or II in the last 4 weeks
* conservative therapy including long-term oxygen therapy according to GOLD update 2011 is not exhausted
* previous treatment with NIV (non-invasive ventilation) in the last 14 days
* clinical instability or acute illness (e.g. acute myocardial infarction, tachycardial atrial fibrillation)
* signs of cardial decompensation (e.g. edema in the lower limbs, pleural effusion)
* other serious concomitant diseases, the assessment of eligibility is at the discretion of the investigator
* contraindications for NIV
* anamnestic suspicion or proven obstructive sleep apnea (OSA)
* relevant systemic infections, assessment of eligibility is at the discretion of the investigator
* BMI \> 30
* other additional pulmonary diseases of other genesis or diseases that affect breathing (e.g. mucoviscidosis, scoliosis, muscular diseases)
* lack of compliance
* participation in other interventional trials at the same time
* pregnant or nursing women
* fertile female patients without effective contraceptive measures during trial participation
Mallampati Classification vs Best Visible Mallampati for Prediction of Difficult Tracheal Intubation

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score.

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score.

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

This is a single center prospective observational study comparing the original Mallampati classification to the best visible Mallampati classification.

Data and variables concerning airway management during induction of general anesthesia are recorded on a specific record sheet.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled or unscheduled surgery
* Airway evaluation possible in both sitting and supine position

Exclusion Criteria:

* surgery of the neck, face, and upper airway
* lung and thoracic surgery
* pregnancy
* orotracheal intubation not indicated during surgery
* nasotracheal intubation required for surgery
* selective intubation required for surgery
* emergency surgery and procedure
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America guidelines recommend a clarithromycin-based combination therapy for treatment of Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient.

Objectives: To obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of MAC lung disease.

Methods: In accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment."

Eligibility Criteria:
Inclusion Criteria

* Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid

Exclusion Criteria

* Contraindications according to the package insert
* Patients with a history of hypersensitivity to any ingredient of Klaricid
* Patients who are receiving pimozide, ergot-containing products, or cisapride
* Patients who have AIDS (Acquired Immune Deficiency Syndrome)
Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position

This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction.

One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately.

This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.

It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.

Tunnel position will be recorded and confirmed with postoperative computer tomography.

Eligibility Criteria:
Inclusion Criteria:

* Physical activity classified by Tegner scale ≥ 5
* Absence of other associated ligament injuries in the operated knee
* No ACL rerupture or previous ACL reconstruction in the same or other knee
* Absence of untreated lesions of the opposite knee
* No obvious change in the alignment of the mechanical axis that required surgical correction
* Athletes of both gender with a minimum age of 18 years and maximum of 45 years
* Signature of the consent term (IRB)
* Not be pregnant.

Exclusion Criteria:

* Request to stop the study by patient at any time
* Fracture not associated with the surgical procedure
* Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.
Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression

The main aim of the project is the implementation and evaluation of a stepped care model (SCM) for patients with depression with 6 treatment options of varying intensity and setting, including innovative technologies (e-mental health, telephone-based psychotherapy). Within this complex intervention, patients are treated by a multiprofessional network of health care providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a control group receiving treatment as usual (cluster randomization on the level of participating general practitioners). It is expected that the SCM condition will show better results regarding reduction of mental symptoms, improvement of quality of life, more efficient access to care and better cost-benefit ratio.


Eligibility Criteria:
Inclusion Criteria:

* \>4 points on PHQ-D-9 depression scale
* sufficient knowledge of German language
* health situation that allows questionnaire completion

Exclusion Criteria:

* insufficient knowledge of German language
* health situation not allowing questionnaire completion
Machine Learning-based Anomaly Recognition System

MARS is an artificial intelligence-powered system that aims at detecting common fetal anomalies during real-time obstetrics ultrasound. The current study comprises 2 stages: (1) The stage of model creation which will include retrospective collection of images from fetal anatomy scans with known diagnoses to train these model and test their diagnostic accuracy. (2) The stage of model validation through prospective application of this model to collected videos with known normal and abnormal diagnoses

Routine second trimester anomaly scan has become a routine part of antenatal care. Early detection of fetal anomalies permits patient counselling, consideration of termination if detected anomalies are considerable, and arrangement of delivery and immediate neonatal care if indicated. Furthermore, with the expanding role of fetal interventions, early detection of fetal anomalies may expand management options, some of which may lead superior outcomes compared to postnatal interventions.

However, fetal anatomy scan necessitates a particular level of training and expertise, either by sonographers or obstetricians. Unfortunately, availability of experienced personals may be globally limited. Furthermore, first trimester anatomy scan has been evolving rapidly as ultrasound machine continues to develop and clinical research yields more information on first trimester normal standards and abnormal ranges. Accordingly, first trimester scan is anticipated to be a part of routine care in the near future. Although this tool should provide substantial benefits to obstetric patients, this would require more providers with specific training, which is unlikely to be readily available.

Artificial intelligence has been incorporated in the medical field for more than 20 years. With the advancement of deep learning algorithms, deep learning has yielded exceptional accuracy in image recognition. In the last decade, deep learning exhibits high quality performance that may exceed human performance at times. One of the earliest and most prevalent applications of deep learning in medicine are radiology-related.

In the current study, the investigators will create a series of deep learning models that appraise and identify common fetal anomalies in a series of frames including recorded videos or real time ultrasound. Deep learning algorithms will be fed by labelled images of known normal and abnormal findings representing common fetal anomalies for both training and validation. These images will be collected retrospectively through medical records of contributing centers. Their diagnostic performance will be tested on retrospectively collected videos including normal and abnormal findings. In the second stage of the study, These models will be applied to prospectively collected videos of fetal anatomy scan for further validation.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 18 and 45 years
* Available ultrasound image with clear findings
* postnatal confirmation of diagnosis

Exclusion Criteria:

* Absence of research authorization on medical records
Usage and Adverse Events of Physical Restraints in an Intensive Care Unit

The aim of this retrospective observational single-center cohort study is to (1) examine the frequency of physical restraint use in a Swiss intensive care unit, (2) identify related adverse events, and (3) determine risk factors associated with their use and complications in critically ill adult patients.

Physical restraints are widely used in intensive care units (ICU) worldwide to protect patients by preventing them from removing medical devices, accidentally taking out breathing tubes (self-extubation), or falling. However, while they are intended to keep patients safe, restraints can also have negative effects. Their use may increase agitation, self-extubation, infections, blood clots, longer hospital stays, and even a higher risk of death. Studies have also linked physical restraints to long-term problems, such as cognitive decline and post-traumatic stress disorder. However, most studies lack strong evidence and cannot exclude the influence of other factors.

This retrospective observational single-center cohort study aims to:

1. Determine the frequency with which physical restraints are used in a Swiss ICU
2. Identify the type and frequency of adverse events associated with physical restraint use
3. Identify other factors linked to physical restraints use and specific complications during intensive care of critically ill adult patients.

Furthermore, the study examines the use of chemical sedation with physical restraint use and the risk of delirium.

The results of this study will help improve patient care and contribute to better guidelines for physical restraint use in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e., patients ≥18 years of age)
* Being physically restrained in the intensive care unit at the University Hospital Basel between 2010 and 2023

Exclusion Criteria:

* Patients younger than 18 years.
* Patients with documented refusal to use data.
Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)

Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents.

Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at the pulmonary arteries level.

According to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in PAH treatment. In parallel, the investigators will focus on metformin mechanism of action.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 18 and 80
* Patients included will have pre-capillary PAH
* they have to be stable for more than 3 months
* Patient with a 6-minute walk test comparable over the last 3 months before inclusion
* Informed consent signed
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients

The purpose of this study is to evaluate and compare the changes by two modalities: Imaging by Strain by Speckle Tracking and Magnetic Resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 year-old patients
* With histologically confirmed thoracic cancer (breast, esophagus or lung)
* Recommendation of thoracic radiotherapy (RT) with curative intent
* With or without chemotherapy
* All patients must be able to read and understand Spanish
* All patients must sign informed consent form.

Exclusion Criteria:

* Patients with no medical records,
* Pregnant
* Previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency
* Patients with metastatic disease and indication of palliative RT
* Patients with significant comorbidities associated to a \<5 year life expectancy.
* Patients previously treated with thoracic RT
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.

The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and treatment compared to conventional standard care in patients with OA of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients,
* Age 40-70 years,
* Prediagnosed, confirmed and documented diagnosis of OA of the knee. Diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the American College of Rheumatology criteria,
* Documented radiologic changes of the knee-joint Kellgren-Lawrence criteria \> or = grade 2 in conventional X-ray or MRI-scan,
* Mean average pain intensity of 40 or more on two 100 mm visual analogue scales in the 7 days before baseline assessment,
* Written informed consent.

Exclusion Criteria:

* Pain in the knee caused by oCongenital dysplasia of the affected knee oRheumatoid arthritis oAutoimmune diseases oMalignancies oStatus post Knee surgery oStatus post Arthroscopy
* Administration of chondroprotective drugs in the preceding 3 months,
* Intra-articular injection into the affected knee-joint during the preceding 3 months,
* Beginning of a systemic medication with corticosteroids within the preceding three months,
* Beginning of any new treatment for OA during the previous 4 weeks (with the exception of analgesic treatment with Paracetamol or NSAIDs),
* Pregnancy or breastfeeding,
* Acute mental disorders,
* Serious acute organic diseases,
* Serious chronic co-morbidity,
* Obesity WHO-grade II/III
* Blood coagulation disorders,
* Coagulation-inhibiting medication other than Aspirin and Clopidogrel,
* Invasive measures performed at the affected joint during the previous 12 weeks or planned within the following 12 month,
* In the process of applying for pension or disability benefits,
* Simultaneous participation in any other clinical trial,
* Participation in a clinical trial during the 6 month before inclusion into this trial,
* Missing of the written informed consent form.
A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients

The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the study medication) of JNJ-40411813.

This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (effect of the study medication will be compared with the effect of placebo \[inactive substance\]), comparator-controlled (effect of the study medication will be compared with the effect of FDA approved and marketed active substance \[citalopram\]), and 3-way crossover (method used to switch participants from one treatment arm to another treatment arm) study. This study will be double-blinded for treatment with placebo and JNJ-40411813; however, it will be open label (all people know the identity of the intervention) for treatment with citalopram. This study will consist of screening phase (within 28 days prior to the start of study medication), treatment phase, and follow-up phase (approximately 14 days after the last administration of study medication). Participants will be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period 1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled in this study (3 participants in each sequence). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be evaluated throughout the study duration. The total duration of study participation for a participant will be approximately 10 Weeks.

Eligibility Criteria:
Inclusion Criteria:

- Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])

Exclusion Criteria:

* Significant history of or current significant medical illness including (but not limited to) liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers clinically significant
* History of a relevant sleep disorder and / or receiving treatment for sleep disorders
* Regular or periodic use of benzodiazepines
* Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
* Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication
* Use of any prescription medication or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of start of study medication