cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants

The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

There are growing numbers of evidence indicating the beneficial effects of normal enteric flora (probiotics) with regard to the host defense against infection. In vitro and in vivo studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory effects on other pathogenic bacteria.This evidence, along with the results of recent clinical studies, has demonstrated the beneficial effects of probiotics in the prevention of NEC in VLBW infants.However, most of the studies reported nosocomial infection as a secondary outcome and the findings were controversial regarding probiotics efficacy in preventing nosocomial infections. There is only one study that was aimed to investigate effects of probiotic on the incidence of nosocomial infection.

Given the potential benefit of probiotics against infection and the lack of clinical studies in this regard, we conducted a randomized clinical trial to determine whether probiotic supplementation (in the form of Lactobacillus acidophilus and Bifidobacterium infantis) could reduce nosocomial infection rate among preterm VLBW infants in a intensive care nursery setting.

Eligibility Criteria:
Inclusion Criteria:

* Very Low Birth Weight (VLBW) preterm infants (Gestational age \< 35 weeks , BW \< 1500 g ) admitted to the NICU who survived the first 3 days of life

Exclusion Criteria:

* Infants with chromosome abnormality or severe congenital defects, especially gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) and infants with unstable hemodynamic status
Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

In the present proposal the investigators wish to assess the effect of a single session with the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on baseline airway blood flow (Qaw) and in Qaw variation, in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation that the treatment will transiently increase the Qaw, and to a greater extent in the current smokers and patients with asthma who have endothelial dysfunction.

Endothelial shear stress activates nitric oxide synthase (NOS), leading to endothelium-dependent vasodilation. This can be accomplished through exercise or with a device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) that is also called pGz. WBPA produces systemic vasodilation, by exerting shear stress on the vascular endothelium, activating endothelial NOS and releasing NO in animal models and human subjects. Cigarette smoking is associated with attenuated vascular relaxation responses in the systemic circulation. Patients with asthma also exhibit endothelial dysfunction in the airway. In this study the investigators wish to assess the effect of a single pGz session on baseline Qaw and delta Qaw in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers to test if this treatment will increase the vascular relaxation responses.

Eligibility Criteria:
Inclusion Criteria:

15 healthy never-smokers, 15 smokers (\> than 1 year smoke history) and 15 never-smokers asthmatics; FEV1 \> 80% (except for asthmatics subjets)

Exclusion Criteria:

Women of childbearing potential who do not accepted birth control measures; pregnant and breast feeding; cardiovascular disease or use of cardiovascular drugs; respiratory infection during the 4 weeks preceding the study; use of inhaled or systemic glucocorticoids, leukotriene modifiers or theophyllines in asthmatics; FEV1 \< 80% on the screening day (excepted for asthmatics subjets)
Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration

Several methods have been proposed for the measurement of pulsatile ocular blood flow (POBF). The pneumatic tonometer, which is commercially available, assesses POBF by measurement of intraocular pressure (IOP) changes during the cardiac cycle. The investigators have recently developed a method for the measurement of ocular fundus pulsation, which is based on laser interferometry. In contrast to the Langham system the method is non-contractile and yields a high topographic resolution. Moreover, the pneumatic tonometer assesses the ocular pressure pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. These two parameters are related by the ocular rigidity, which refers to the mechanical properties of the eye coats.

Age-related macular degeneration (AMD) is the most common cause of blindness in the industrialized nations. The mechanisms behind this severe eye disease are, however, still obscure. It has been hypothesized that alterations in choroidal blood flow and ocular rigidity may contribute to the development and progression of AMD. However, there is currently little data to confirm this hypothesis. The present study is an attempt to investigate choroidal blood flow and ocular rigidity by employing laser interferometric measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AMD (defined as soft drusen \> 63 µm, hyperpigmentation and/or hypopigmentation of the retinal pigment epithelium (RPE), RPE and associated neurosensory detachment, (peri)retinal hemorrhages, geographic atrophy of the RPE, or (peri)retinal fibrous scarring)
* Age between 50 and 90 years

Exclusion Criteria:

* Evidence of any other retinal or choroidal vascular disease
* Regular use of pentoxifylline in the last month before the trial period
* Evidence of a choroidal neovascular membrane
* Diabetes mellitus
DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Had protocol-defined pulmonary embolism (PE)
* Has stable systolic blood pressure (SBP) \>90 mm Hg
* Has evidence of right ventricular (RV) dysfunction
* Has executed informed consent

Exclusion Criteria:

* Has history or plans for thrombotic therapy outside protocol allowance
* Has other contraindications for participation
* Has laboratory results outside protocol-specified limits
* Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives
* Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise:

  1. the safety or well-being of the participant or the participant's offspring
  2. the safety of study staff
  3. the analysis of results
Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.

Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.

Adolescent idiopathic scoliosis is the most common deforming orthopedic condition.

Preoperative anxiety is increased by operating time, post-operative pain level, neurological and hemorrhagic risk.

The aim of the study was to purpose five sessions of Yoga and Meditation before surgery, remotely and face-to-face.

Observance of the 5 sessions will tell us if this protocol is feasible and appropriate. Preoperative anxiety intensity will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age from 8 to 17 years
* Female and male gender
* Planned idiopathic scoliosis surgery

Exclusion Criteria:

* Physical inability to do simple yoga postures during the initial session
* Neurological spinal deformity (cerebral palsy, severe epileptic disease, myopathy)
* Misunderstanding of the french language
* Recent history of characterized depressive episode: hospitalization and/or antidepressant treatment in the last 6 months
* Time between the first YOMEPOP session and the date of the operation less than 28 days
* Refusal of permission to take picture
* Failure to obtain informed consent from one of the parents with parental authority
* Absence of affiliation to a French social security scheme or beneficiary of such a scheme
* Patient with a legal protection measure
The DETECT Project

This study aims to assess the all-cause mortality at 2 years of patients treated by a paclitaxel drug-eluting devices or non-drug-eluting devices after an endovascular femoropopliteal artery revascularization based on the French National Healthcare Data System (SNDS).

Endovascular intervention is considered as a first-line treatment for femoropopliteal atheromatous lesions. During the 2000s, the superiority of auto-expandable stent compared to percutaneous transluminal angioplasty had been demonstrated, in terms of effectiveness. Over the past decade, paclitaxel drug-eluting balloons or stents were successfully assessed in order to prevent intimal hyperplasia and to treat restenosis.

Nevertheless, in 2018, Katsanos and al. reported in a meta-analysis a higher risk of death at 2 and 5 years for patients treated by a paclitaxel drug-eluting balloons or stents versus non-drug-eluting devices. This study presents many limitations despite being performed as a systematic review of randomized clinical trials. Since then, several studies have been conducted without any statistical trends in favor of a higher mortality in patients treated by drug-eluting stents or drug-coated balloons.

Analysis based on US or Germany databases in tens of thousands of patients has been published but individual data were unavailable. In France, there is no national report about the safety of paclitaxel drug-eluting devices prescribed in the case of endovascular femoropopliteal artery treatment. Therefore, this study aims to compare the risk of all-cause death of patients treated by paclitaxel-eluting devices versus non-drug-eluting devices in this indication at a national-scale using real-life data from SNDS.

This analysis of the SNDS database will allow (i) to identify all patients across France treated by endovascular intervention for a femoropopliteal revascularization and to know precisely the medical device used; (ii) to reduce confusion bias based on the characterization of patients thanks to their data of medical follow-up, treatment, hospitalization and LTD (long-term condition); (iii) to document their care pathway, especially drugs delivery and diagnosis associated to possible hospitalization, or to all-cause death, in order to compare the 1-, 2- and 5-years prognosis according to the medical device used.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old on day of hospital admission for the hereafter related surgical procedure
* Affiliated member to the French Social Security system
* Admitted in a French hospital, public or private, between October 2011 and December 2019
* Benefitting from an endovascular femoropopliteal surgical procedure coded with ≥ 1 of the 9 codes of the Common Classification of Medical Procedures (EEAF001, EEAF002, EEAF003, EEAF004, EEAF005, EEAF006, EEPF001, EEPF002, EELF002)
* Associated to the reimbursement by the health insurance scheme for one device of interest cited in the SAP (statistical analyses plan)

Exclusion Criteria:

-
Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure

The investigators are examining the relationship between heart rate and heart contraction in patients with heart failure and pacemakers, aiming to improve quality of life.

Heart rate lowering is a cornerstone of the management of chronic heart failure (CHF) and the degree of lowering is closely related to improvements in longevity, hospitalisation rate and heart function. The investigators have shown that increasing heart rates using pacemakers does not increase exercise capacity in CHF patients. This might be because the optimal heart rate range for contraction is narrower for patients with CHF. At higher heart rates, heart contraction might be less strong. The investigators now want to examine the relationship between heart rate and heart contraction in patients with heart failure and pacemakers. Tailored pacemaker heart rate setting's, individually optimised for heart contractility as assessed by cardiac ultrasound, will be investigated to examine the effects on exercise tolerance .

Eligibility Criteria:
Inclusion Criteria:

* stable CHF
* Cardiac Resynchronisation Therapy (CRT) device for \>3 months,
* able to walk on treadmill

Exclusion Criteria:

* unable to walk on treadmill,
* unstable angina pectoris
* uncontrolled heart rate
* prescribed calcium channel blocker
* significant aortic stenosis
* significant airways disease
Implementing an Intervention Named Volitional Help Sheets to Reduce Smoking Behaviour Among Young Adults in Indonesia

Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.

The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.

Eligibility Criteria:
Inclusion Criteria:

* Smokers whose ages are 20-45 years old

Exclusion Criteria:

* Non-smokers whose ages are below 20 years old and above 45 years old
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia.

To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.

To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.

Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital.

Inclusion criteria are as follows:

All individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.

Eligibility Criteria:
Inclusion Criteria:

* All individuals age 18yrs and above capable of rendering consent
* Known ITP confirmed by response to intravenous immune globulin (IVIG), glucocorticoids, or winRho and exclusion of all other possible causes of thrombocytopenia
* Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]
* Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.

Exclusion Criteria:

* Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism
* Chronic active hepatitis
* Those infected with HIV
* Patients receiving concomitant radiotherapy
* Gravid females
* Congenital thrombocytopenias
Anticoagulation After GI Bleeding Pilot Study and Registry

PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.

This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18 years or older
2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).
3. OAC therapy discontinued for current acute GI bleed and not yet resumed
4. Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)
5. Planned to resume DOAC post-bleed
6. At moderate to high risk of re-bleeding as per clinical care team
7. Clinical hemostasis achieved as per clinical care team
8. Able and willing to comply with follow-up examinations contained within the consent form

Exclusion Criteria:

1. Mechanical heart valve
2. VTE in the context of major transient risk factor and completed 3 months of treatment
3. GI bleeding managed surgically (e.g. gastrectomy, colectomy)
4. Active or previously treated gastrointestinal cancer
5. Life expectancy from other causes of less than 3 months
6. Platelet count \< 50,000/µL (or \< 50x109/L)
7. Renal dysfunction (Creatine Clearance \<30 mL/min as calculated by the Cockcroft-Gault formula)
Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Compare results of Instep Plantar Fascial release with and without gastrocnemius recession

Plantar fasciitis is one of the most common causes of heel pain. Approximately 2 million Americans seek treatment for plantar fasciitis every year, with 10% of the population developing plantar fasciitis over a lifetime. The vast majority of cases respond to conservative care; however, the 5-10% of cases that are recalcitrant to conservative measures may require surgical intervention. Several surgical options do exist and are cited in the literature for treatment of recalcitrant plantar fasciitis. One such approach is the instep plantar fascial release, utilizing an approximately 2-3 cm plantar incision over the prominent fascial band, just distal to the fat pad of the heel. It has been demonstrated that many patients with plantar fasciitis also have an isolated contracture of the gastrocnemius, known as gastrocnemius equinus. Gastrocnemius recession is performed to correct an isolated gastrocnemius contracture and recent studies have demonstrated its successful use in the treatment of recalcitrant foot pain. To date, no prospective studies exist examining the utilization of the gastrocnemius recession in combination with instep plantar fascial release in the treatment of recalcitrant plantar fasciitis. This prospective randomized trial will aim to compare the use of instep plantar fasciotomy both with and without gastrocnemius recession in the treatment of plantar fasciitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have failed conservative treatment for greater than 6 months.
* Patients with recalcitrant plantar fasciitis and simultaneous gastrocnemius contracture in the ipsilateral limb. Contracture will be defined as the inability to dorsiflex the ankle past neutral with the knee in extension.

Exclusion Criteria:

* Adjunctive procedure at the time of surgery.
* History of heel spur surgery, plantar fasciotomy or extracorporeal shockwave therapy.
Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians

Previous research has shown that Asian Indians are at relatively high risk for developing diabetes, heart problems and high blood pressure.

The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.

Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for developing metabolic abnormalities like diabetes mellitus. This research study may provide information as to how useful endothelial dysfunction will be to detect people at risk of metabolic abnormalities and heart disease at an early stage.

Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians will be enrolled. Caucasians will serve as the control group for this study.


Eligibility Criteria:
Inclusion Criteria:

* Asian Indians and Caucasians between the ages of 20 and 65 living in the boroughs of New York City and the Long Island area.

Subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results).

Exclusion Criteria:

* Subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (CAD), hyperlipidemia, systolic blood pressure below 90 mm Hg and liver or kidney disease will be excluded.
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma

A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 years or older
* Histologically confirmed diagnosis of classical HL
* Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens
* Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
* Eastern Cooperative Oncology Group (ECOG) 0 to 2

Exclusion Criteria:

* Laboratory parameters not within the protocol-defined range
* Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
* Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
* Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy
* Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug
* History of lymphoma involving the central nervous system
* Evidence of active or prior hepatitis infection.