cyrilzakka/clinical-trials huggingface dataset:
RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.

Eligibility Criteria:
Inclusion Criteria:

PATIENT:

* Age between 20 and 85 years
* Signed informed consent
* Acceptance of late angiographic control (6-9 months)
* Angina and / or objective evidence of ischemia

LESION:

* In-Stent restenosis (\> 50% visual) any bare metal stent
* Knowledge of prior stent location

Exclusion Criteria:

PATIENT:

* Inclusion in another clinical research protocol
* Women of childbearing age
* Severe associated systemic disease (including renal or liver failure)
* Severe depression of left ventricular ejection fraction (LVEF \<25%)
* Disease that affects life expectancy
* Recent myocardial infarction ( \<7 days)
* Time of implantation of the previous BMS \<1 month
* Severe difficulties expected for late angiographic study

LESION:

* Angiographic failure during implementation of initial stent(residual stenosis\> 50%)
* Image of large thrombus in-stent (\> vessel diameter)
* Tortuosity or Ca + + with very severe difficulties during prior stent deployment
* Vessel diameter \<2 mm (visual estimate)
* Restenosis only "outside" the stent (The edge of the stent is not affected)
* Completely occlusive restenosis (100%, TIMI 0)
* Very diffuse restenosis (\> 30 mm length)
Trial of a Treatment Algorithm for the Management of Crohn's Disease

Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity.

Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids. Although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified Optimizing outcomes in CD requires rapid control of inflammation. Intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. Conventional therapy is frequently ineffective in moderate to severe CD, and is often continued for a prolonged time. Consequently, many patients are under-treated. An alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (TNF) antagonists may be optimal. However it is unknown whether this approach is superior to usual care

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Crohn's disease
* Able to speak and understand English, French or Flemish
* Access to a telephone or email/internet service
* Written informed consent must be obtained and documented

Exclusion Criteria:

* Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
* Participating in other investigational studies
Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.

There are controlled group who receives standard medical theraphy (radiotherapy or chemoradiation), one group who receives standard medical theraphy (radiotherapy or chemoradiation) and Auto-dendritic adjuvant therapy, and other group who receives standard medical theraphy (radiotherapy or chemoradiation) and Allo-dendritic-secretomes adjuvant therapy and continued with auto-dendritic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
* Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST
* Did not take traditional medicine in the last 2 months.
* Patients can understand the nature of the study and willing to sign informed consent
* Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.

Exclusion Criteria:

* Patients who are pregnant, planning to pregnant, or breastfeeding
* Patients assessed to require chemoradiation during this study
* Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST
* Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
* Patients who have creatinin clearance result \<40 ml/min, bilirubin serum \>1.5x above normal, SGPT-SGOT \>5x above normal
* Patients on immunosuppressive medications, such as corticosteroids
* Patients who undergo Major thoracic or abdominal operation
* Patients on high medical risk condition due to uncontrolled infection
* Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)
* Patients who have concurrent congestive heart failure history and other heart disease
* Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial
* Patients who refuse or did not participate in part or all of the research process
Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

Considering that respiratory physiotherapy lack scientific evidence to support its application in the treatment of several obstructive diseases, this investigation was designed to evaluate the hypothesis that Flutter Valve can improve the airway clearance of hypersecretive bronchiectasis patients.

The application of airway clearance techniques is considered an important component in the treatment of bronchiectasis patients (Van der Shans, 1997). For this purpose, a number of techniques has been introduced in the last decades. The Flutter Valve was initially proposed for the treatment of children with cystic fibrosis (CF) (Lindemann, 1992), but there is not enough evidence about its utilization in patients with bronchiectasis (Van der Shans \& cols, 1999).

The effects of the Flutter Valve on respiratory mechanics of patients with bronchiectasis have been evaluated by forced spirometry (Pryor e cols, 1994; Gondor e cols, 1999; Thompson e cols, 2002). This approach however, does not allow the characterization of mucus transportation along the airways (Williams, 1994). The forced oscillation technique (FOT), a non-invasive alternative to characterize respiratory mechanics, allows the evaluation of respiratory mechanics at different frequencies without special maneuvers (Dubois e cols., 1956). According to eligibility criteria and in a randomized order, the patients were submitted to two protocols (control and Flutter Valve intervention), with one-week interval between them (washout). Respiratory mechanics and expectorated sputum volume were assessed before and after each intervention, in order to assess the Flutter Valve effect on tracheobronchial sputum removal.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical and high-resolution computerized tomography diagnosis.

Exclusion Criteria:

* chest pain,
* acute hemoptysis,
* recent history of rib fracture or pneumothorax (less than 1 year),
* respiratory infection in the four weeks before measurements,
* asthma,
* cystic fibrosis,
* daily sputum production lower than 25 mL/day
A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion

The purpose of this study is to evaluate the safety and efficacy of BMS-986504 monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
* Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
* At least 1 measurable lesion as per RECIST v1.1.
* Documented radiographic disease progression on or after the most recent line of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
* Capability to swallow tablets intact (without chewing or crushing).

Exclusion Criteria:

* Active brain metastases or carcinomatous meningitis.
* History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Prior treatment with a PRMT5 or MAT2A inhibitor.
* Known severe hypersensitivity to study treatment and/or any of its excipients.
* Other protocol-defined inclusion/exclusion criteria apply.
Inhalation Flow Rate-study

Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.

The aim of the study is to measure inspiratory profiles of patients with non-Cystic fibrosis bronchiectasis using the breath activated T-326 Inhaler.

The following parameters will be derived from the inspiratory profiles:

* Peak Inspiratory Flow (PIF, in L/min)
* Inspiratory Volume (V, in L)
* Inspiratory Time (t, in s).

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (HRCT) or magnetic resonance tomography (MRT)
* Ability to reproducibly perform spirometry according to American Thoracic Society/European Respiratory Society criteria
* Clinically stable in the opinion of the investigator at the time of the study visit.
* Male and female patients ≥ 18 years of age.

Exclusion Criteria:

* Pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in Forced expiratory volume in the first second (FEV1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks.
* History of lung transplant.
* Recent significant hemoptysis (≥ 300 mL or requiring blood transfusion) in the preceding six (6) weeks before screening.
* Established diagnosis of bronchial asthma.
* Established diagnosis of cystic fibrosis.
* Proof of any relevant medical finding or disease in the last three (3) months which might interfere with participation in the study or patient safety (e.g. pneumothorax, uncontrolled hypertension, uncontrolled cardiac arrhythmia, myocardial infarction, cerebral vascular accident).
* A relevant disease that is considered to interfere with the study results is any disease that, except for the impairment of lung function, interferes with the patient's ability to inhale from the device. For example, COPD per se is usually not considered as a reason for patient exclusion, unless coughing or obliteration of the upper airways with sputum interferes with the patient's ability to inhale from the device.
* Relevant surgical history in the last 3 months (e.g., but not limited to abdominal, thoracic, ocular or brain surgery).
* History or evidence of lung resection, thoracotomy, known aneurysm and severe scoliosis.
* Pregnancy.
Optetrak Knee System Post Market Clinical Follow-Up

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
* Patient is skeletally mature
* Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary

Exclusion Criteria:

* Patient has a local or systemic infection
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant
* Patient has a mental or physical condition that may invalidate evaluation of the data - ---
* Patient is a prisoner
* Surgery is contraindicated according to the applicable product package insert
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age at enrollment
* Confirmed diagnosed with RA
* Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site

Exclusion Criteria:

* Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
* Was followed at the site for less than 1 year since biologic treatment initiation
* Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula

Other protocol defined inclusion/exclusion criteria could apply
Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS

Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome

Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-60 years
2. had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
3. Eastern Cooperative Oncology Group performance status of 0-2.
4. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.

Exclusion Criteria:

1. younger than 18 years old, or older than 60 years old.
2. Diagnosed as acute promyelocytic leukaemia.
3. Pretreated with anthracycline.
4. CNS involvement.
5. Positive for HIV, hepatitis B virus, or hepatitis C virus.
6. New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome
7. Uncontrollable systemic infection (viral, bacterial, or fungal),
8. Inability to sign the informed consent form.
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients

The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).


Eligibility Criteria:
Inclusion Criteria:

* An adult between 18 and 85 years of age.
* Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
* Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
* Able to speak and read English.
* Willing to comply with study specific instructions, and complete all study procedures according to protocol.
* Able to understand study rationale and sign informed consent.

Exclusion Criteria:

* Diagnosed with glaucoma
* History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
* Currently taking warfarin and dabigatran (Pradaxa).
* History of having arrhythmias - can interfere with EECP triggering.
* Subject has bleeding diathesis.
* Subject has active thrombophlebitis.
* Subject has severe lower extremity vaso-occlusive disease.
* Subject has a documented aortic aneurysm requiring surgical repair.
* Subject is pregnant.
* Subject with blood pressure higher than 180/110 mmHg.
* Subject with a heart rate more than 120 bpm.
* Subject with high risk of complications from increased venous return.
* Subject with clinically significant valvular disease.
* Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
* Subjects with pacemakers and other metallic implantable devices.
Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.

Exclusion Criteria:

* The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.
Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit

Previous studies have demonstrated the direct associations between malnutrition and hospital mortality as well as the length of stay in critically ill patients. However, the validity of these results may be limited by inappropriate diagnoses of malnutrition, small sample size, possible treatment bias, and sub-optimal statistical adjustment. This study aimed to further examine the aforementioned associations by addressing these limitations.

Design:

* Prospective cohort study

Setting:

* 35-bedded integrated intensive care/ high dependency unit in Ng Teng Fong General Hospital. Patients' status can be changed between ICU-status and HD-status within the same ICU-/ HD-bed

Participants:

* All adult patients who will be admitted to the unit between August-2015 to October-2016 for ≥ 24 hours

Intervention:

Nil. Given the observational nature of this study, no attempt will be made to standardize care, including nutritional practices.

Measurement:

* As per routine care, a validated nutritional assessment tool \[7-point Subjective Global Assessment (7-point SGA)\] will be used to determine patients' nutritional status within 48 hours of ICU admission
* The primary outcomes will be hospital mortality and ICU length of stay. To measure hospital mortality, all patients will be followed until hospital discharge or death for up to one year after ICU admission. For ICU length of stay (in days), duration will be measured from the date of the first ICU admission to the date of the first change in ICU-status to HD-status or discharge to the general ward

Analysis:

* Modified Cox regression model with robust variance and logistic regression will be used to determine the associations between nutritional status and hospital mortality. Analyses will be conducted in two ways: 1) presence versus absence of malnutrition, and 2) dose-dependent association for each 1-point decrease in the 7-point SGA
* Multiple linear regression will be applied to determine the associations between nutritional status and ICU length of stay

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old who had ≥ 24 hours length of stay in the ICU
* received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU

Exclusion Criteria:

* Nil