cyrilzakka/clinical-trials huggingface dataset:
Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. Although deemed ideal for lesions involving only the proximal MV (1,0,0 according to Medina classification ref), this device may be used also in more complex bifurcation lesions when additional DES are required in the distal MV and/or in the SB. In the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation lesions in a real-world population.

Despite a comprehensive understanding of the physiological and technical issues regarding the coronary bifurcations lesions, percutaneous coronary intervention (PCI) in this setting remains challenging. When compared with non-bifurcation lesions, treatment of bifurcation lesions is associated with increased adverse clinical events and inferior angiographic outcomes including procedural complications. This is due to several technical challenges, including both anatomical (proximal-to-distal vessel mismatch \[tapering\], angulation and calcification) and procedural (plaque shift, and side-branch \[SB\] closure) features. Current balloon-expandable drug-eluting stent (DES) have not been designed to treat the bifurcation lesions; in particular, the inability of DES to adequately scaffold and preserve the ostium of SB represents a the major reason of failure, because this is the most common site for restenosis. Recently a large variety of dedicated bifurcation stents have been developed in order to 1) provide an easier access to the SB and to scaffold more effectively its ostium, and 2) adapt to main vassel (MV) tapering, and to the bifurcation anatomy.

Eligibility Criteria:
Inclusion Criteria:

1. significant (≥70% diameter stenosis) bifurcation lesion;
2. MV reference diameter between 2.75 and 4.75 mm by visually estimated
3. SB reference diameter ≥2.25 mm by visual estimate;
4. bifurcation angle (between the distal MV and the SB) \<70° by visual estimate

Exclusion Criteria:

1. patients with contraindications to prolonged dual-antiplatelet therapy,
2. known sensitivity to "limus" compounds, stainless steel, titanium, or nickel;
3. inclusion in others studies on bifurcation lesions; and
4. all bifurcation lesions not satisfying the angiographic inclusion criteria reported above
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane

Quantium Medical Company has an ElectoEcenphalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.


Eligibility Criteria:
Inclusion Criteria:

* Patients affiliated to a national insurance scheme or benefiting from such a program
* Patients having given their written consent.
* Patients that must benefit from a general anesthesia with the aim of a surgical act of a duration of at least one hour
* Patients that must benefit from a general anesthesia including a maintenance by the sevoflurane.
* For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number

Exclusion Criteria:

* Pregnant or breast-feeding Women
* Patients having a limit of use of the Bispectral Index (BIS) or qCON monitor ,
* Patients having a contraindication in the propofol.
* Patients taken care in ambulatory surgery who could not be contacted within 24 hours following the surgical operation;
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.

This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.

- Vonoprazan 20 mg

This multi-center survey will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

Exclusion Criteria:

* Participants with previous history of hypersensitivity to ingredients in Takecab tablets
* Participants taking atazanavir sulfate or rilpivirine hydrochloride
* Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
* Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.
Chart Review of Laparoscopic Radical Cystectomy

The investigator intends to review retrospective de-identified data of patients who have had Laparoscopic Radical Cystectomies by the Department of Urology at UCIMC.

The investigator fills out a standardized form for each patient undergoing a laparoscopic radical cystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Review information on patients who had laparoscopic Radical cystectomy at UCIMC
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults

Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.

Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.

Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.

Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.


Eligibility Criteria:
Inclusion Criteria:

* adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods

Exclusion Criteria:

* severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.
Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy (≥37 weeks of gestation)
* Singleton pregnancy
* Primary cesarean

Exclusion Criteria:

* Previous cesarean section
* Previous uterine surgery
* Multiple gestations
* Mullerian anomalies
* Active labor
* Placenta previa/accreta
Dermacyd Silver Frutal (Lactic Acid) - Acceptability.

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in study N01221 \[NCT00280696\] and completed the evaluation period and transition period or patients who participated in study N01020 \[NCT00160615\]

Exclusion Criteria:

* Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Observational Study of Nelarabine in Children and Young Adults

This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).


Eligibility Criteria:
Inclusion Criteria:

* ≤ 21 years of age
* Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
* Prior treatment with at least two chemotherapy regimens
* Selected for treatment with nelarabine

Exclusion Criteria:

* Known hypersensitivity to the active substance.
* Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
* Males with partners of child bearing potential who are not willing to use condoms or abstinence
* Patients with persistent neurological toxicity (CTC grade \> = grade 2)
* Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.
MBSR on Nocturnal Hypertension

Objectives: To examine the feasibility and acceptability of treating nocturnal hypertension by mindfulness-based stress reduction program (MBSR). This will provide data essential for the main trial, which will also examine the definite effectiveness of MBSR to reduce nocturnal blood pressure (BP).

Hypothesis to be tested: MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension; and future main trial is feasible in terms of recruitment, dropout rate and adherence to MBSR/BP measurements.

Design and subjects: This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT (night-time Systolic BP (SBP) during sleep 120 mmHg) and stage I hypertension (awake SBP = 135-159mmHg), as detected by ambulatory blood pressure monitoring (ABPM). Participants will be allocated in 1:1 ratio by stratified block randomization (by age and presence of mood disorder) to receive MBSR (intervention group) or usual care (control group) respectively.

Instruments: ABPM/HBPM/MBSR patients' diary. Interventions: The generic 8-week MBSR will be taught by a certified MBSR teacher. Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period.

Main outcome measures: rate of recruitment/dropout/adherence to MBSR/BP measurements Data analysis and expected results: The rate of recruitment/dropout/adherence to MBSR/BP measurements will be presented.

The acceptability of MBSR and the trial will also be assessed by patients' interviews. A high level of rate of recruitment, adherence to both MBSR and BP measurements and acceptability to MBSR are expected.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed hypertension (HT) from clinical records (with or without anti-hypertensive medications)
* nocturnal HT (night-time systolic blood pressure \[SBP\] during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159 mmHg), as detected by 24-hour ambulatory blood pressure monitoring (ABPM)
* no change of dose and type of anti-hypertensive(s) in the prior 2 months

Exclusion Criteria:

* patients with atrial fibrillation (these patients have greater blood pressure variability)
* daytime office systolic blood pressure (BP) ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP)
* patients with known obstructive sleep apnoea
* history of dementia or psychotic illnesses
* patients with end-stage malignancies
* nocturnal worker, because they will have a reverse BP pattern to other participants
* patients receiving ≥3 BP medications at maximal tolerated doses
* previous participation in structured mindfulness program(s) of ≥8 weeks or regular daily meditation practices
* reported sleep time of \<4 hours per day
* patients who do not agree to keep the same dose of anti-HT medications during the trial period
* patients receiving anti-coagulants
The Effect of Core Stabilization Exercises in Female Wrestlers

This study was planned to investigate the effect of core stabilization exercise program on trunk muscle strength, spinal stability and upper extremity performance in elite wrestling athletes.


Eligibility Criteria:
Inclusion Criteria:

* Being between 14 and 21 years old and interested in wrestling
* Actively pursuing a life of wrestling
* Participate in training at least 4 days a week
* Wrestling in freestyle style.
* To confirm that there is no injury problem
* Being a licensed athlete

Exclusion Criteria:

* Experiencing any serious injury problems
Efficacy and Safety Study of Two Propofol Formulations

The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

Propofol (chemical substance 2, 6-Diisopropylphenol) is a short-acting intravenous general anaesthetic which is used for induction and maintenance of a general anaesthesia, for long-term sedation of ventilated intensive care patients or for short-term sedation in diagnostic and surgical procedures. As an active substance propofol produces good and readily controlled anaesthesia with smooth and problem-free recovery both in adult patients and in children over 1 month of age. One potential advantage of this formulation is that the MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with LCT-emulsions of propofol.

Eligibility Criteria:
Inclusion Criteria:

* Female and male adult patients, and at least 18 and maximal 65 years of age;
* ASA-classification I to II;
* Undergoing an elective surgery, the anaesthesia is expected to last at least 1 hour and no more than 3 hours;
* Will be under total intravenous anaesthesia;
* Willing to give their signed informed consent.
Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.

Chronic lymphedema is defined as swelling or edema (excess fluid in the interstitial space) that does not fully resolve overnight by elevating the limb or body part to the level of the heart. Chronic lymphedema is a major clinical problem that is difficult to treat. Osteopathic Pedal Pump is a simple manipulation technique anecdotally thought to reduce leg edema and chronic lymphedema. However, the clinical evidence is only anecdotal and no clinical trials have ever been conducted to test this observation. The purpose of the research is to measure the effectiveness of the Osteopathic Pedal Pump technique for treating lymphedema by measuring before and after treatment limb volumes. The second purpose of this project is to mentor osteopathic medical students in clinical research. There is also a great need to mentor Osteopathic Medical Students because relatively few pursue careers involving clinical research and the benefits osteopathic manipulative treatment remain under investigated.


Eligibility Criteria:
Inclusion Criteria:

* For phase one subjects must be age 18 or older, be a medical students at Rowan University School of Osteopathic Medicine and not have leg edema which does not resolve with overnight limb elevation. For phase two subjects must be patients at the NJISA in Stratford, NJ age 55 and over and have lower limb lymphedema. Lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb.

Exclusion Criteria:

* Exclusion criteria is the same for both phases. Because the measurements involve placing the lower limb into water subjects with an open wound, sore or cellulitis in the lower limbs will be excluded to ensure good hygiene. Because lymphatic pumping can cause a redistribution of volume in the body, subjects with decompensated heart failure, acute asthma, COPD exacerbation, or active cancer will be excluded. For obvious reasons, those with a non-healed or healing bone fractures will be excluded. Due to potential problems with informed consent those with a diagnosis of dementia on the chart problem list will be excluded.
Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs

Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial.

According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female subject aged ≥18 years and legally capable to provide informed consent
* Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET
* Well differentiated tumor
* Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria
* Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study
* Use of Lanreotide autogel® monotherapy by local label (SmPC).
* Concomitant locoregional therapy such as surgery, RFA or TAE is allowed.

Exclusion Criteria:

* Parallel participation in an interventional study
* Lanreotide treatment for more than 5 months prior inclusion into the study
* Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR).
* Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.