cyrilzakka/clinical-trials huggingface dataset:
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in elderly subjects.

This is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of BEZ235 alone and in combination with RAD001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. The study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age ≥ 85 years
* Age ≥ 65 and \< 85 years with one or more of the following conditions:

  * Asthma
  * Chronic Obstructive Pulmonary Disease (COPD)
  * Chronic bronchitis
  * Type 2 Diabetes Mellitus (T2DM)
  * Congestive Heart Failure (CHF) New York Heart Association (NYHA) functional classification I-II
  * Current smoker
  * One or more emergency room visits or hospitalizations for a RTI during the previous 12 months

Exclusion Criteria:

* Subjects with medically significant cardiac conditions including NYHA functional classification III-IV
* Subjects with Type I diabetes mellitus.
* Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis
* History of malignancy in any organ system within the past 5 years except for the following:

  * Localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast.
* Subjects with any one of the following:

  * hemoglobin \< 10.0 g/dL for males and \< 9.0 for females
  * white blood cell (WBC) count \< 3,500/mm3,
  * neutrophil count \< 2,000/mm3
  * platelet count \< 125,000/mm3
* Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy
* Recent surgery other than minor skin surgery
* Liver disease or liver injury
* History or presence of impaired renal function
* History of immunodeficiency diseases
* Subjects with active infection
* Subjects with a Mini Mental Status Examination (MMSE) score \<24 at screening.
* Significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.
Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)

Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of the western population. It may cause symptoms such as irregular heartbeats, shortness of breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). In some cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of symptoms, there is an increased risk of stroke in some patients with this condition. Novel technologies are being developed to increase detection of silent atrial fibrillation, in order to find patients who might benefit from treatment with oral anticoagulants (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at home.

Hyperthyroidism (sometimes referred to as "toxic goiter") is defined as an excessive production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation in about 8% of cases.

Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating their hormonal disturbance, in order to find episodes of silent atrial fibrillation.

Design: Prospective observational study.

Hypotheses:

* Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial fibrillation in hyperthyroid patients.
* Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared to the normal population even after hyperthyroidism is treated.
* Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial fibrillation are at increased risk of stroke and should be considered for treatment with oral anticoagulants.


Eligibility Criteria:
Inclusion Criteria:

* Patient is deemed suitable for treatment with radioiodine or antithyroid drugs
* Patient has a thyreotropin (TSH) value below 0,1 mIU/L, measured less than 2 weeks before inclusion
* Patient has a CHADS-VASc-score of 1 point or higher (excluding if 1 point is for female sex only)
* Patient gives written consent to participate in study

Exclusion Criteria:

* Patient has a previously known diagnosis of atrial fibrillation
Eyedrop Instillation Technique

Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of glaucoma patients have problems instilling their eyedrops. These problems include not hitting the eye, spending many drops to get a single successful instillation and bottle contamination.

The present study will evaluate the effect of encouraging patients to put their eyedrops using one of 2 techniques, randomly assigned, to determine which is more successful at instilling the eye drop into the eye while spending the least amount of drug.

In one of the techniques the patient instills the eye drop with their eyes open in the inferior cul de sac. In the other technique the patient instills the eye drop with the eyes closed near the inner canthal region.

Patients will be randomized to encouragement to use the drops with either of the techniques. Encouragement will take place over a visit where they will be subjected to:

* Baseline evaluation of eye drop instillation using their usual technique.
* Short (2-5 minute) educational session session for the assigned technique.
* Followup evaluation immediately after the educational session.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma or glaucoma suspect
* Use of topical glaucoma medication in both eyes for at least 1 year prior to enrollment
* VA of 20/60 or better with habitual correction in at least one eye

Exclusion Criteria:

* Previous history of allergy to fluorescein
* Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
* Rejects participation
FlowTriever2 Pulmonary Embolectomy Clinical Study

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with acute PE
* PE symptom duration ≤ 14 days
* CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
* RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
* Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
* Stable heart rate \< 130 BPM prior to procedure
* Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.
* FlowTriever2 Catheter enters the vasculature

Exclusion Criteria:

* Thrombolytic use within 30 days of baseline CTA
* Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization
* Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
* FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
* Hematocrit \< 28% (NOTE: hematocrit required within 6 hours of index procedure)
* Platelets \< 100,000/μL
* Serum creatinine \> 1.8 mg/dL
* INR \> 3
* Major trauma Injury Severity Score (ISS) \> 15
* Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
* Cardiovascular or pulmonary surgery within last 7 days
* Actively progressing cancer
* Known bleeding diathesis or coagulation disorder
* Left bundle branch block
* History of severe or chronic pulmonary arterial hypertension
* History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
* History of uncompensated heart failure
* History of underlying lung disease that is oxygen dependent
* History of chest irradiation
* History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants
* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
* Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus)
* Life expectancy of \< 90 days, as determined by Investigator
* Female who is pregnant or nursing
* Current participation in another investigational drug or device treatment study
Adherence to Antiretroviral Therapy in HIV Infected Individuals in Assiut Governorate, Egypt

Egypt is a HIV low prevalence country but between 2010 and 2019 newly infected cases have more than quadrupled, and the rise continues at an alarming pace. Maintaining over 95% adherence level among the PLHIV in developing countries is a crucial issue to maintain viral suppression, to minimize HIV related morbidity and mortality. The present study aims to identify the level of adherence and the factors influencing adherence to ART in Assiut Governorate. To the best of our knowledge, no previous studies on adherence to antiretroviral therapy and its associated factors in HIV infected individuals were done in Egypt.

Egypt is a HIV low prevalence country but between 2010 and 2019 newly infected cases have more than quadrupled, and the rise continues at an alarming pace. According to the WHO country profile in 2021, 65% of people living with HIV (PLHIV) know their status, there is no statistic on viral load suppression, or the level of adherence to treatment among those who are under care.

To achieve optimal results from Antiretroviral therapy (at least 95%), high levels of patient adherence to ART is essential. Therefore, enhancing ART coverage is a principal strategy to end HIV/AIDS.

Medication adherence, which can be defined as the extent to which a patient's medicine-taking behavior corresponds with agreed instructions from a health care provider, is essential for realizing the potential benefits of most medication-based treatment. Many patients, especially those with chronic diseases, experience difficulties in adhering to a recommended treatment plan. Medication non-adherence, with average rates of those affected being between 30 and 50%, is a major challenge in the real-life treatment of these patients .

Despite several advances in ART for human immunodeficiency virus in the last decades, non-adherence continues to be a critical phenomenon in the treatment of these patients. Not only short-term virological response will be poor, but low drug concentrations also dramatically accelerate development of drug-resistance. So, maintaining over 95% adherence level among the PLHIV in developing countries is a crucial issue to maintain viral suppression, to minimize HIV related morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.

Aged 18 years old and more.

Exclusion Criteria:

* prisoners children patients aged less than 18 years old
Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension

Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. In patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. In this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of LAP acquisition than single arterial phase acquisition.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years
* Liver cirrhosis diagnosed with characteristic imaging feature or histology
* Presence of portal hypertension sign (splenomegaly and varices)
* Scheduled for liver CT
* And signed informed consent

Exclusion Criteria:

* Relative or absolute contra-indication of contrast-enhanced CT
Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia

The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.

In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.

Eligibility Criteria:
Inclusion Criteria:

* neurosurgical operation requiring invasive monitoring of arterial blood pressure

Exclusion Criteria:

* pacemaker, arrhythmia
* chronic medication with beta blocker
* possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
* anticholinergic drug administration before measures
* intracranial hypertension
* no social security coverage
* pregnancy
The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation

Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.

Because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction.

Many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (GBR). Surgical options vary depending on the severity of the bone deformity. GBR is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity.

Establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. Long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. According to a meta-analysis of 15 randomized-controlled trials, the estimated mean (SD) bone resorption for GBR in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. As a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss.

Traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (GBR) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology .

Specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (GBR) procedures in patients with lateral alveolar ridge defect and simultaneous implantation.

Hypothesis: patients with lateral alveolar ridge defect and simultaneous implantation subjected to a 3D printing surgical template with GBR are associated with radiographic evidence of more labial graft thickness and volume stability after six months post-surgical than patients with conventional GBR protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement.
2. In the anterior region, there is a labial bone defect.
3. Patients need the surgery in the first place to compensate for bone loss around implant.

Exclusion Criteria:

1. Systemic disorders that are out of control.
2. Heavy smokers (those who smoke more than 20 per day).
3. Women who are pregnant or nursing.
4. Thin gingival bio-type.
Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.

This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.

Eligibility Criteria:
Inclusion Criteria:

1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
2. age between 18 and 75 years;
3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
4. Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1/L1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).
5. Child-Pugh class A or B;
6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
8. Prothrombin time ≤18s or international normalized ratio \< 1.7.
9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. Cholangiocellular carcinoma (ICC).
2. Patients without image information should be excluded;
3. The survival or patients less than 3 months.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy.
6. Known history of HIV.
7. History of organ allograft.
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

BACKGROUND:

Patients with advanced cancer often suffer from fatigue and other symptoms and problems such as insomnia, appetite loss and pain. Problems that may have great consequences for their quality of life. Several studies suggest that a supplement of the hormone melatonin (MLT) may have a beneficial effect on these symptoms/problems. This needs further investigation.

AIM:

To investigate if a supplement of melatonin have an effect on a) fatigue (the primary outcome of the trial), b) the symptoms insomnia, appetite loss, depression and pain, and c) overall quality of life.

METHODS AND PATIENTS:

The trial takes place in the Department of Palliative Medicine, Bispebjerg Hospital, and 50 patients will participate. The participants have to be 18 years or above, have advanced cancer, and suffer from quite a bit or very much fatigue.

The study consists of two parts. In part I it is investigated if melatonin has a better effect than placebo on the outcomes mentioned above. This part is a consecutive, prospective, double blinded, randomized (MLT vs. placebo), cross-over study where the patients serve as their own control. In part II the effect of melatonin over time is investigated. Part II is a consecutive, prospective, open-label study.

The outcomes are assessed with weekly questionnaires (MFI-20 and EORTC QLQ-C15PAL) and a few daily diary questions.

Melatonin has been used in several studies, and the general conclusion is that it is a safe substance with few adverse drug reactions.

PERSPECTIVES:

If melatonin has the potential to alleviate fatigue and other symptoms in patients with advanced cancer and enhance the quality of life of these patients, this will be of benefit to many future patients. Trials such as this are important both nationally and internationally to develop an evidence-based palliative medicine.


Eligibility Criteria:
Inclusion Criteria:

* Answered "quite a bit" or "very much" to the question "were you tired?" (from EORTC QLQ-C15-PAL)
* Cancer in a palliative phase
* Written informed consent
* Age 18 years or above

Exclusion Criteria:

* Not capable of understanding or judging information, or fill out a questionnaire
* Untreated anemia (Hb \<= 6,0 mmol/L)
* Untreated hypocalcaemia
* Systolic blood pressure \< 100
* In treatment with coumadin
* Receiving unstable doses of methylphenidate, corticosteroids or sleeping medicine the past two weeks
* TSH \< 0.50 or \> 5.50 mcL/mL
* Pregnant or breast feeding
Genetic Determinants of Warfarin Anticoagulation Effect

The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments:

1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population.
2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom warfarin is about to be initiated
* Desired therapeutic range \>2 and \<3

Exclusion Criteria:

* Refusal to participate in the study