cyrilzakka/clinical-trials huggingface dataset:
Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

This retrospective observational study included patients (pts) with percutaneous coronary intervention (PCI) of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. The investigators included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Two different methods were compared: group A represents patients with a simple strategy without any treatment of the side branch (SB). Group B consisted of patients where the SB was treated (PCI and/or stenting).

For the treatment of bifurcation lesions we used the concept of "provisional stenting", indications for the treatment of the SB were residual stenosis \> 50 %, TIMI flow reduction \< 2. Final-kissing PCI was intended in all patients of group B.

MACE during follow-up was evaluated in all patients.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with a bifurcation lesion, where the side branch was covered with a stent placed inside the main branch.

Exclusion Criteria:

* Patients with an in-stent-restenosis, patients with a therapy using a drug coated balloon during the procedure (inside the main branch and/or the side branch) and patients where the side branch was not covered by the stent inside the main branch.
The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants

In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.

In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.

Eligibility Criteria:
Inclusion criteria:

* Full-term infants (born at gestational age =37 weeks).
* Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
* Boys and girls
* Apparently healthy at birth and screening
* Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
* Age at enrolment: =28 days of age
* Exclusively formula fed for at least 5 days prior to inclusion
* Exclusively formula fed during the entire intervention period
* Parents agreeing to initiate complementary feeding after finalization of the study
* Being available for follow up until the age of approximately 3.5 months
* Written informed consent from parent(s) and/or legal guardian(s) aged =18 years

Exclusion criteria:

* Gestational age \<37 weeks
* Birth weight \<2500 g or \>4200 g
* Age at enrolment: \>28 days
* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
* Illness at screening/inclusion
* Incapability of parents to comply with the study protocol
* Illiterate parents (i.e. not able to read and write in local language)
* Participation in another clinical trial
* Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
* infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula
The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer

Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.

This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology;
6. Patients should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher;
7. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria:

1. Personnel involved in the formulation or implementation of the research plan;
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.


Eligibility Criteria:
Inclusion criteria to be assessed at screening:

1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).
4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.

Main exclusion criteria to be assessed at screening:

1. Constipation is thought to be drug-induced (except for opioids)
2. Disallowed medication is being used
3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
4. Subject is suffering from secondary causes of chronic constipation.
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

Randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the clinical effect on coughing in patients with non-cystic fibrosis (non-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive pulmonary disease (COPD)

In the management of non-CF bronchiectasis, bronchodilator treatment (LABA)and use of inhaled corticosteroids (ICS) is still a matter of debate. Previous studies have claimed beneficial effects of ICS (with or without bronchodilator), such as improvement of the HRQL, a reduction in daily sputum volume and/or exacerbation frequency. However, in all previous studies there was no clear exclusion of patients with asthma or COPD, or no use of placebo. The current study will be the first study evaluating the effect of ICS/LABA treatment in non-CF bronchiectasis excluding patients with asthma and COPD.

This is a prospective double-blind randomized controlled trial comparing Formoterol-beclomethasone 12/200 mcg BID versus placebo to evaluate the reduction in cough measured by the Leicester cough questionnaire. Secondary objectives are the improvement of health-related quality of life and symptoms, reduction in sputum production, pulmonary function (FEV1) and the frequency of exacerbation. Furthemore, we will assess the inflammatory response in serum and sputum.

After a wash-out period of 1 month, eligible subjects will be randomized to treatment with formoterol-beclomethasone or matching placebo. All subjects will be treated with the regimen of medication for 3 months. An end-of-study (EOS) visit will be performed after completion of the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patient (wheezing, cough and dyspnoea);
* Proven and documented diagnosis of BE by high resolution computed tomography ;
* Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%
* Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
* Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;
* Coughing on the majority of days for more than 8 weeks;
* Ability to follow the inhaler device instructions;
* Ability to complete questionnaires;
* Written informed consent.

Exclusion Criteria:

* Possible asthma according to the definition of the Global Initiative for Asthma (GINA);
* Positive histamine provocation test
* Known intolerance for ICS or LABA;
* Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
* Expected to die within 72 hours after enrolment;
* Cigarette smoking history of \> 10 pack-years or current smokers;
* Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values.
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis

The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.

The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.

Eligibility Criteria:
Inclusion Criteria:

* The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
* The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.

Exclusion Criteria:

* The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
* Pregnant or breast-feeding females.
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.

This is a randomized, 3-treatment, 3-period, 6-sequence, crossover, placebo- and active-controlled, double-blind for ALXN1840, open-label for moxifloxacin, in healthy adult participants. Participants will be domiciled in the clinic for 7 days during Treatment Period 1 and for 6 days during Treatment Period 2 and 3. A single oral dose of each treatment (ALXN1840, matching ALXN1840 placebo, or moxifloxacin) will be administered on Day 1 of each period following an overnight fast of at least 10 hours. There will be a minimum 14-day washout between study intervention administrations for each treatment period. Cardiodynamic, pharmacokinetic, and safety assessments will be performed at certain times during the study. An end-of-study visit will occur 14 days (±2 days) after the last dose.

Eligibility Criteria:
Inclusion Criteria:

1. Nonsmoker.
2. Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass index ≥18.0 and ≤30.0 kg/meter squared.
3. Willing and able to follow protocol-specified contraception requirements.
4. Participant has no clinically significant history or presence of ECG findings.

Exclusion Criteria:

1. History or presence of clinical and/or lab disorders.
2. Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years.
3. Participant has abnormal blood pressure, defined as a supine blood pressure \<90/50 millimeters of mercury (mm Hg) or \>140/90 mm Hg.
4. Serum potassium, calcium, or magnesium levels outside the normal range.
5. Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.
6. Female participant has hemoglobin \<10.8 grams/deciliter (g/dL) and male participant has hemoglobin \<12.5 g/dL.
7. Clinically significant multiple or severe allergies.
8. Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total bilirubin greater than upper limit of normal (with the exception of Gilbert's syndrome).
Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke

Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes.

Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis.

This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.

Exclusion Criteria:

* Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse.
* Patient not willing to participate to the study
Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows

A reliable method for monitoring sleep, stress, and burnout among cardiology fellows is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 21 Cardiology Fellows Thomas Jefferson University Hospital for 6 months.

Conventional methods of qualifying personal wellbeing are limited by poor insight about the emotional and behavioral corollaries of stress and burnout (e.g., depersonalization, sleep alterations, heart rate variability). While self-care is often the preferred option for those coping with stress or burnout in challenging situations, it may be the only option in low-resource settings with limited access to professional management. Similarly, many healthcare workers and trainees acknowledge that self-care is a critical component to overall wellbeing, yet they also admit that multiple barriers interfere with the effectiveness of this practice. First, self-care interventions can only be effective if impacted persons recognize the need for interventions, act on that need, and learn which methods are effective on an individual basis. Furthermore, testing modalities (e.g., hormonal assays, polysomnography, electrophysiology) for stress and its downstream syndrome of burnout not only are prohibitively expensive, but they also require significant time and cannot be broadly disseminated within reasonable limits. As such, approaches for monitoring parameters of wellness are critically needed, and if successful, those data can allow for streamlined mental health interventions for those completing fellowship training before symptoms of burnout escalate further.

Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with executive function metrics post 12- or 24-hour call in a 12-month period.

Hypothesis: Less total sleep hours will correlate with lower scores on executive function testing (Stroop test).

Aim 2: To determine the physiologic effects of sleep deprivation from 12- and 24-hour call on heart rate variability, REM sleep, deep sleep and respiratory rate, over a 12-month period.

Hypothesis: Less total and restorative (REM and deep sleep) will correlate with lower executive function scores and higher call burden (frequency and duration) will be associated with a prolonged return to baseline in sleep metrics (total sleep, REM sleep, deep sleep, sleep consistency).

Eligibility Criteria:
Inclusion Criteria:

* Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
* Own a smart phone for Bluetooth pairing with WHOOP strap 4.0

Exclusion Criteria:

* Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Pathway for Produce Prescriptions in Diabetes Management

Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with Type 2 diabetes
2. have clinically screened positive for food insecurity and/or be income-eligible to receive Medicaid and/or SNAP-benefits
3. ≥ 18 years of age, and
4. be a patient at a participating healthcare site.

Exclusion Criteria:

1. people who pregnant or nursing and
2. plans to move away during the study period.
Protein and Magnesium in Ulcerative Colitis

The aim of the study is to improve the quality of nutritional therapy for patients admitted with Acute Severe Ulcerative Colitis (ASUC) treated with high-dose steroids. This study consists of two randomized interventions and one observational part regarding protein, magnesium, and metabolic stress. First an interventional part aims to explore the effect of a high-protein diet during and after admission on different parameters regarding protein turnover.Second the study aims to explore the degree of magnesium depletion in ASUC. In case of magnesium depletion, the study aims to investigate whether oral magnesium supplementation can regain body stores of magnesium. Last the study aims to observe the degree of metabolic stress, including, the degree of insulin resistance, in ASUC during admission and under treatment with high-dose steroids compared to three weeks after discharge.

Patients with Acute Severe Ulcerative Colitis (ASUC) may have an altered protein turnover due to inflammation, reduced dietary intake and/or accelerated protein loss. Despite this the level of dietary protein needed to maintain nitrogen balance has never been described in patients with ASUC. Clinical symptoms of ASUC include frequent and bloody diarrhea which alone or simultaneous with a risk of reduced dietary intake and weightloss can lead to magnesium depletion. Magnesium depletion can cause severe symptoms including cardiac arrhythmia and neuromuscular dysfunction which might worsen the disease further. The prevalence of magnesium depletion in ASUC has never been described and furthermore it is not known whether oral supplementation are able to reverse the condition in patients with ASUC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Cognizant
* Must speak or read Danish or participate in relevant communication in interpreting or translating the study material.
* Diagnosed with Acute Severe Ulcerative Colitis (ASUC) (documented in the patient journal)
* Admitted at "Lever-, Mave-, og Tarmsygdomme/ LMT" at Aarhus University Hospital and in medical treatment with high-dose intravenous steroid (Solumedrol 40 mg x 2 daily)

Exclusion Criteria:

* Pregnant and/or lactating women
* Plasma creatinine \> 200 µmol/L (protein intervention only)
* Patients receiving tube- or parenteral feeding (protein intervention only)
* Receiving any kind of magnesium supplementation 6 months prior to inclusion (magnesium intervention only)
* Diagnosed with Type 1 or Type 2 Diabetes Mellitus (observational part only)