cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)

The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.


Eligibility Criteria:
INCLUSION CRITERIA

* Male or non-pregnant female greater than or equal to 18 years of age
* Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure
* PCI to be performed with a femoral approach

EXCLUSION CRITERIA

* Known or suspected pregnancy in women of childbearing potential
* Thrombolytic therapy within the previous 24 hours
* Undergoing primary PCI for ongoing ST-segment elevation myocardial infarction (STEMI)
* Undergoing rescue PCI after failed thrombolysis
* Any other elective PCI scheduled within the following 30 days after the index PCI
* Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intracranial tumor or aneurysm; recent (\<1 month) trauma or major surgery (including bypass surgery); active bleeding
* Uncontrolled arterial hypertension
* Recent (\<48 hours) or planned spinal/epidural anesthesia or puncture
* Impaired haemostasis: known International Normalized Ratio (INR) \>1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/µL)
* History of hypersensitivity or contraindication to heparin or LMWH
* Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for vitamin-K antagonist therapy
* Treatment with a direct thrombin inhibitor, low molecular weight heparin, or unfractionated heparin within the 24 hours preceding enrolment
* Use of abciximab within the previous 7 days or, tirofiban, or eptifibatide within the past 12 hours of index PCI
* Inability to give informed consent or high likelihood of being unavailable for follow-up
* Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial
Electronic Health Record-Integrated Patient-Generated Data

The purpose of this study is to find out if patients that receive supportive messaging with response adaptation are more likely to adhere to patient-generated data collection and electronic health record integration, compared to patients that do not receive supportive messaging.

This project will directly inform re-usable strategies to support the integration of important patient-generated data (PGD) into the electronic health record to improve clinical care and research. For this application, investigators propose to develop and test the PGD translational science innovation in patients recovering from sepsis. This diverse patient population frequently suffers from long-term complications that are ideally suited for development and demonstration of strategies to collect, integrate, and examine PGD and builds directly on the study team's robust research portfolio on improving sepsis recovery.

Eligibility Criteria:
Inclusion Criteria:

* Discharged alive from the hospital without hospice care who meet clinical criteria for infection and organ dysfunction consistent with sepsis
* Enrolled into the Sepsis Transition and Recovery program
* Enrolled or willing to enroll as an Epic MyChart user

Exclusion Criteria:

* Discharged from the hospital with hospice care
Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on heart and lung function, quality of life, ability to work, symptoms of breathlessness and functional status of patients one year after their initial diagnosis and treatment for PE


Eligibility Criteria:
Inclusion Criteria:

1. First episode of acute symptomatic PE that was objectively diagnosed\* within last 10 days
2. Treated with anticoagulants
3. ≥ 18 years old

   * PE will be diagnosed if there is a high probability V/Q scan (as per PIOPED Study criteria 66), an intraluminal filling defect in segmental or larger vessels on CTPA or a constant intraluminal filling defect or abrupt cut-off of vessels greater than 2.5 mm diameter on pulmonary angiography 8,10. Patients with non-definitive test results (e.g. low or intermediate probability V/Q scan, subsegmental PE on CTPA (\~5% of PE patients 12) will not be included in order to have a strictly defined population of patients with definite PE.

Exclusion Criteria:

1. Contraindication or unable to perform CPET or 6MWT (amputated or paralyzed limb(s), severe lower extremity arthritis, preexisting cardiopulmonary condition precluding exercise including unstable angina or myocardial infarction in last 6 weeks, uncontrolled hypertension, serious cardiac dysrhythmia on resting EKG \[severe bradycardia or tachycardia, sick sinus syndrome or multifocal premature ventricular contractions\] and syncope)
2. Contraindication to CTPA (allergy to iodinated contrast, CrCl or eGFR \< 30 ml/min)
3. Severe comorbidity (congestive heart failure \[LVEF \< 35%\], severe COPD or restrictive lung disease \[FEV1\<50%, chronic need for oxygen therapy\])
4. Previous DVT (as \~40% of patients with proximal DVT have asymptomatic PE on lung imaging 67)
5. Life expectancy \< 1 year (e.g. active or terminal cancer, end-stage cardiac or respiratory disease).
6. Pregnancy or lactation
7. Unable to read questionnaire in English or French
8. Unable to return to study centre for required follow-up visits
9. Unable or unwilling to provide written informed consent
ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER

Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.


Eligibility Criteria:
Inclusion Criteria:

* Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
* Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
* No signs of active periodontal disease in the selected tooth.
* Good oral hygiene

Exclusion Criteria:

* The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
* The presence of Acute periapical infection.
* The presence of any local factor that may interfere with extraction as tooth ankyloses
* Subjects who had undergone therapeutical radiation. (187)
* Patients who had been subjected to or who were under bisphosphonate therapy
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression

The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.

The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks.
2. Outpatients who are aged 18 through 65 years at time of informed consent.
3. Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).
Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas

Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored

Background: About 2000 children and adolescents under the age of 18 develop cancer each year in Germany. Because of more differentiated diagnostics and standardized treatment protocols, a high survival rate can be reached for many types of the disease. Nevertheless, patients face a number of long-term effects related to the treatment. As a result, physical and psychological consequences have increasingly become the focus of research in recent years. Social dimensions of health have rarely been investigated in pediatric oncology so far. Yet, there are no robust results that allow an estimation of whether and to what extent the disease and treatment impair the participation of children and adolescents and which factors mediate this effect. Social participation is of great importance especially because interactions with peers and experiences in different areas of life are essential for the development of children and adolescents.

Methods: Data are collected in a longitudinal, prospective, observational multicenter study. For this purpose, all patients and their parents who are being treated for cancer in one of the participating clinics throughout Germany will be interviewed within the first month after diagnosis (t1), after completion of intensive treatment (t2) and half a year after the end of intensive treatment (t3) using standardized questionnaires. Analysis will be done by descriptive and multivariate methods.

Recruitment: Patients will be consecutively recruited in one of the participating clinics throughout Germany.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed with confirmed leukemia, brain tumor or sarcoma
* age 10-18 years
* written informed consent of the patient and of one of the parents if they are under the age of 18

Exclusion Criteria:

* having a relapse or secondary tumor
* insufficient command of German
* profound cognitive and physical impairments
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma

OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.

II. Determine the toxic effects of this drug given at the MTD in these patients.

III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients.

OUTLINE: This is a dose-escalation study of motexafin gadolinium.

Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma

  * Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem
  * Contiguous involvement of the thalamus or upper cervical cord allowed
* Performance status - ECOG 0-2
* More than 2 months
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL (transfusion allowed)
* No glucose 6 phosphate dehydrogenase deficiency
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 1.5 times normal
* Creatinine no greater than 1.5 times normal
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent immunomodulating agents
* No other concurrent chemotherapy
* Concurrent corticosteroid therapy allowed for increased intracranial pressure only
* No prior cranial radiotherapy
* No prior motexafin gadolinium
* No other concurrent experimental agents
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?

We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Females
* Above 50 years
* Younger with serum concentration of 25(OH)D below 50nmol/l

Exclusion Criteria:

* No sunbed use last ½ year
* No sun holiday last ½ year
* No intake of vitamin D above 10 microgram/day
Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.

The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.

The primary objective of this study is to evaluate the validity, reliability and reproducibility of the dental measurements obtained on the digital models with iTero® in comparison with those obtained on the plaster models (gold standard) and on the digital models with Lava Digital®.

The secondary objective is to compare two different impression materials (i.e. alginate and polyvinylsiloxane (PVS)) and determine whether the impression material used affects the accuracy of the measurements.

Statistical analysis:

* Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models.
* A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS).
* A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models.
* Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 12 and 30 years old (male or female)
* complete permanent dentition from first molar to the other first molar
* no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth

Exclusion Criteria:

* Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)
Gastric Emptying of Water and Sports Drink in Labor

To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.

This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.

Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.

Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.

Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 36 weeks or greater
* American Society of Anesthesiology Physical Status 2 or 3
* Induction of labor or early labor (cervical dilation \< 6cm)
* Singleton gestation

Exclusion Criteria:

* Recent food ingestion (\<3 hours)
* Preeclampsia
* Receiving magnesium sulfate
* Having received narcotics within 12 hours
* Diabetes mellitus
* Multiple gestations
* Active nausea or reflux symptoms
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device

This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to understand the nature of the study and to give free informed consent
* Must be over 20 and referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

* Pregnancy
* Pacemaker wearer
* Allergies to any material of the device
Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort

The primary objectives are to evaluate the prevalence of LARS and Quality of Life in rectal cancer patients 3 years after anterior resection, to investigate if anastomotic technique is a risk factor for major LARS and to study the prevalence of colostomy 3 years after anterior resection and evaluate stoma function according to the stoma scale in EORTC QLQ-CR29.

All patients who have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 have been identified in the Swedish Colorectal Cancer Registry (SCRCR). Three years after surgery the patients were sent a questionnaire including the LARS (Low Anterior Resection Syndrome)-score, the quality of life questionnaire EORTC QLQ 30 and CR29 in addition to a questionnaire regarding prevalence of remaining stoma.The patient cohort will be divided into two groups operated with total (TME) or partial (PME) mesorectal excision for further analyses. Patients with a stoma will be analysed separately.

Prevalence of major LARS and Quality of Life, QoL, 3 years after anterior resection will be assessed by the EORTC QLQ-C30 and by calculation of LARS Score with categories "no" (0-20 points), "minor" (21-29) and "major" (30-42). The LARS score will be dichotomized into the categories no/minor and major LARS.

Stoma function will be evaluated by the stoma scale in EORTC QLQ-CR29.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rectal cancer in Sweden
* Operated on with anterior resection between Q1 2015 and Q4 2017 in Sweden, with or without defunctioning stoma

Exclusion Criteria:

* Age \<18 years
* Dementia,
* Unable to understand Swedish language
Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of intervention will be followed by 12 weeks of washing out.

Modern lifestyle has dramatically changed the daily rhythms of life. Physical activity, diet and light exposure are no longer restricted to daytime hours due to increased shift work. Recent scientific reports have shown that shift work leads to disruption of circadian rhythms and promotes diabetes, obesity and cardiovascular disease. Until now only few studies investigating circadian rhythm disturbances in the context of type 2 diabetes and obesity have been conducted in man. Thus, knowledge of the molecular pathways and the responsibles genes in man are missing and have been identified only in animal studies.

The objective of the project is to achieve breakthroughs in the understanding of the causality between inner clock rhythm disturbances and the development of type 2 diabetes and obesity. The provided data on the interaction between genes, epigenetics, metabolism, cardiovascular function and the internal clock are intended to contribute to identify novel biomarkers and novel therapeutic approaches focusing on circadian rhythms to reduce the occurence of diabetes and obesity in shift worker.

Eligibility Criteria:
Inclusion Criteria:

* Male and female above the age of 18
* Night shift workers on regular night shifts (at least 6 months before inclusion into the study and at least 4 night shifts per month during the study period

Exclusion Criteria:

* pregnancy or breast feeding
* Known autoimmune disease
* Current or relevant history of physical or psychiatric illness
* Evidence of renal insufficiency or liver disease
* Known or suspected intolerance or hypersensitivity to the study medication
* Use of certain drugs within 4 weeks prior to the inclusion to the study