cyrilzakka/clinical-trials huggingface dataset:
Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study

The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.


Eligibility Criteria:
Inclusion Criteria for implanting an Absorb scaffold:

* age \< 55 years OR
* lesion length \> 24mm OR
* multiple lesions to be treated
Antihistamines in Eosinophilic Esophagitis

Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18, male and female.
* Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (\>15 eosinophils per hpf on at least 2 esophageal levels)
* Subjects must be able to give appropriate informed consent

Exclusion Criteria:

* Not willing or able to sign consent.
* Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
* Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
* Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
* Patients with known allergies or hypersensitivity to anti-histamines.
* Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
* Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
* Patients who are pregnant.
Use of Sodium Bicarbonate in Patients Treated With Topiramate

Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.

Children on topiramate are at a risk of renal tubular acidosis and subsequent development of renal stones. Sodium bicarbonate has been shown to reduce renal tubular acidosis in other populations. To date, no data exist on the efficacy of correction of renal tubular acidosis in pediatric patients on topiramate. We are proposing to investigate the efficacy of 4 weeks of oral sodium bicarbonate therapy to reduce tubular acidosis in patients on topiramate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy receiving oral topiramate for a minimum of 3 months

Exclusion Criteria:

* pre-existing renal impairments (ie nephropathy, primary nephritis)
* receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).

Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age ≥ 50, and ≤ 89.
3. Diagnosis of active CNV secondary to neovascular AMD.
4. BCVA ETDRS letters between 19 and 73.
5. Demonstrated a meaningful response to anti-VEGF therapy.

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD.
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement.
3. Absence of RPE tear at Screening.
4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months.
5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.
6. Uncontrolled diabetes defined as HbA1c \>8.0%.
Developing a Program for Transition to Adult Care for Youth With Chronic Conditions : a Mixed Method Study

Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP: qualitative survey. Interviews with carers, young people and parents. Chronic Diseases studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey. Vote on internet : carers, patients' associations, young people and family. Chronic Diseases studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic Diseases studied: all.


Eligibility Criteria:
Inclusion Criteria:

* Youth with chronic diseases after transfer to adult care
* Parents or guardians of these youth.
* Professionals caregivers from pediatric services and adult services involved in transition

Exclusion Criteria:

-
Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.

PRIMARY OBJECTIVES:

I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.

SECONDARY OBJECTIVES:

I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.

OUTLINE:

Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

Eligibility Criteria:
Inclusion Criteria:

* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have a surgical target =\< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Have the ability to understand and the willingness to sign a written informed consent document
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Require more than one localization needle for localization of the surgical target (bracket localization)
* Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
* Have a prosthesis/implant in the operative breast
* Have a cardiac pacemaker or defibrillator device
* Be contraindicated for surgery
* Be pregnant
PREMO Study: to Investigate Port REMoval Outcomes

A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.

A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.

Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.

This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.
* Patients planned for an elective TIVAD removal under local anaesthesia.
* Patients able to participate in the study and willing to sign an informed consent.
* Patients able to understand and read Dutch.

Exclusion Criteria:

• History of fever and/or chills following last flushing procedure
The Role of Influenza as a Trigger for Acute Myocardial Infarction: a CALIBER Study

The purpose of this study is to examine the incidence of acute myocardial infarction (MI) occurring after an influenza-like illness using linked primary care and disease registry databases.

This study will measure the incidence ratio for MI occurring in time periods after presentation with an acute respiratory illness compared to baseline time periods using the self-controlled case series method, with reference to the timing of the influenza season (defined by national virological and clinical surveillance data). It will also validate accuracy and completeness of information on MI in the GPRD using linked anonymised data from both MINAP and Hospital Episode Statistics.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be registered with a GPRD 'up to standard' practice during the study period 01/01/1999-31/12/2008
* They must have a record of an incident myocardial infarction (defined by a Read codelist submitted to and agreed by GPRD) that occurs both within their registration and the study period
* They must have at least 6 months between their registration date and the date of the incident MI
* They must have accessed primary care on at least one occasion for a respiratory illness during the study period

Exclusion Criteria:

* Not fulfilling above criteria
Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction

This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema

A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were obtained. Inclusion criteria for the study were either gender between 18 to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia, hypotension, renal dysfunction, and a history of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were excluded from the study.

All the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID) for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication adherence level using the Dose-Nonadherence scale. All the patients were kept under a close follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and tolerability outcomes were assessed as per the operational definition.

Eligibility Criteria:
Inclusion Criteria:

* Either gender
* between 18 to 80 years of age
* Diagnosed with Heart failure with reduced ejection fraction (HFrEF)
* New York Heart Association (NYHA) class II-IV
* Left ventricular ejection fraction (LVEF) ≤ 40%
* Stable on any dose of beta-blockers, ACEI or ARB

Exclusion Criteria:

* Refused to participate in the study
* Patients with hyperkalemia
* Patients with hypotension
* Patients with renal dysfunction
* History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer

In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status \< 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic HER2-positive breast cancer
* WHO performance status \< 3

Exclusion Criteria:

* Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
* Severe dyspnoea
* Abnormal organ function including cardiac
Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage

Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken.

In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage.

A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated.

If postpartum haemorrhage develops (blood loss) \> 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated.

The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.

See 'brief summary'

Eligibility Criteria:
Inclusion Criteria:

- Pregnancy, gestation age \> 24 weeks

Exclusion Criteria:

* Age \< 18
* Adults incapable of giving informed consent
* Gestational age \< 24 weeks
Evaluating URMC's Massive Transfusion Protocol

The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Center's current Massive Transfusion Protocol.

Upon arrival of trauma level one designated patients the treating team evaluates the patient's injuries. If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study. Study procedures include collection of a blood sample following the transfusion of each shipment, through shipment 5, of blood products outlined in the current Massive Transfusion Protocol.

Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic state through resuscitation. One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.

Due to the critical need for medical intervention, consent procedure will be waived at time of enrollment. An authorized representative for the patient will be identified and approached to obtain consent for use of data collected.


Eligibility Criteria:
Inclusion Criteria:

* Trauma level 1 patient initiated under Massive Transfusion Protocol
* Age greater than or equal to 18 years old

Exclusion Criteria:

* Females who are pregnant
Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 19 and 55
* Signed informed consent

Exclusion Criteria:

* Presence of medical history or a concurrent disease
* Has a history of hypersensitivity to IP ingredients
Multimodal Exercises on Sprint Performance of Rugby Players

This study is designed to evaluate the effects of a multimodal exercise program in the sprint performance and kinematics of adolescent rugby players. For this, an experimental study with an intervention group (IG) and a control group (CG) is designed. During 6 weeks of the 2022-2023 preseason of rugby seven, IG will include a multimodal exercise program in their training routine. Meanwhile, CG will maintain their training routine. The study will be developed in the Sport High Performance Centre of Balearic Islands during the season of rugby seven (from August to September, 2022). All rugby athletes from under-16 and under-18 autonomic rugby teams will be invited to participate in this study throughout an email invitation from their regional rugby federation. Prior to the beginning of the study, all participants will sign the inform consent, or their legal tutors in case of minors. The Ethical Committee of the local university approved this study (278CER22) according to the Declaration of Helsinki.

One week before intervention period, sociodemographic and sportive data will be registered (age, sex, body mass, height, and sport experience). Body mass and height will be evaluated with a ±100-g precision digital weight scale (Tefal, France) and a t201-t4 adult height scale (Asimed, Spain), respectively. Also, the rugby players will complete a familiarization process consisting on a standardized warm up and 3 progressive sprints (i.e. 30 m at 50%, 70% and 90% of maximal effort).

All testing procedure (pre-test and post-test) will be completed at a similar daytime (between 17h and 19h) on the same natural grass field. The test procedure listed in our study will consist on two maximal 30-m sprints to obtain mechanical variables of horizontal force-velocity profile and kinematics during sprinting.

Players from IG will perform a multimodal exercise program two days per week during six weeks. This program will include running technical drills, exercises for lumbopelvic stabilization and resisted sprints. This program will be supervised by two experts in this field.

The investigators hypothesize that those rugby players who add the multimodal exercise program to their training routine will increase mechanical and kinematics variables of sprint performance.


Eligibility Criteria:
Inclusion Criteria:

* to have at least 14 years old
* to have at least 2 years of experience as rugby player

Exclusion Criteria:

* to have sustained a lower limb or lumbopelvic injury during the previous 6 months to start of the study
* to have sustained a lower limb or spine surgery during the previous 12 months to start of the study
Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries

Living donor nephrectomy surgeries can be performed in lateral position with laparoscopic technique which necessitates pneumoperitoneum. Considering the position and the pneumoperitoneum, lungs can be affected macroscopically. In this study, it is aimed to observe whether lungs are affected by the aforementioned entities. The hypothesis is based on possible deterioration of the lungs due to the physical features of laparoscopic nephrectomy. Lung Ultrasound Score (LUS) will be used to evaluate the actual condition of lungs. Accordingly, one hemithorax is consisted of 6 different zones, and depending on the existence of vertical B lines (that refers to atelectasis and consolidation) each zone is scored 0 to 3. Higher scores reflect worse lung conditions that is associated with the severity of atelectasis. The LUS will be performed at three time points that are 5 minutes after intubation (T1), at the end of surgery and before extubation (T2), and at 30th minute in the postanesthesia care unit (T3). Primary outcome will be the difference between T1 and T3, secondary outcomes will include perioperative blood gas analyses, intraoperative mechanic ventilator parameters, intraoperative total amount of fluid given, postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Kidney donors
* Nephrectomy for transplantation
* Laparoscopic surgery

Exclusion Criteria:

* Chronic obstructive pulmonary disease grade III-IV
* existing structural lung disease (eg. interstitial lung disease)
* Pulmonary hypertension (\>25 mmHg)