cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Induction Versus Expectant Management

A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous - no previous pregnancy beyond 20 weeks
2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

1. Project gestational age at date of first ultrasound is \> 20 weeks 6 days
2. Plan for induction of labor prior to 40 weeks 5 days
3. Plan for cesarean delivery or contraindication to labor
4. Breech presentation
5. Signs of labor (regular painful contractions with cervical change)
6. Fetal demise or known major fetal anomaly
7. Heparin or low-molecular weight heparin during the current pregnancy
8. Placenta previa, accreta, vasa previa
9. Active vaginal bleeding greater than bloody show
10. Ruptured membranes
11. Cerclage in current pregnancy
12. Known oligohydramnios, defined as AFI \< 5 or MVP \< 2
13. Fetal growth restriction, defined as EFW \< 10th percentile
14. Known HIV positivity because of modified delivery plan
15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
16. Refusal of blood products
17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
18. Delivery planned elsewhere at a non-Network site
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.


Eligibility Criteria:
Inclusion Criteria:

* ECOG ≤ 3
* Age from 6 to 70.
* Diagnosed with WAIHA or MAIHA.
* Meets the criteria of relapsed / refractory AIHA.
* Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
* Signed informed consent.
* Organs in good function.

Exclusion Criteria:

* Nursing woman
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
* Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
* Secondary AIHA caused by drugs or infection.
* Received rituximab in 8 weeks before enrollment.
* Previously received treatment with BTK inhibitor.
* Previously received organ or stem cell transplantation.
* Have a history of thrombosis or organ infarction.
* Diagnosed with an active stage of connective tissue disease.
* Have a history of lymphoproliferative tumors or any other malignant tumors.
* Have other inherited or acquired hemolytic diseases.
* Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.
* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.
* Have a history of mental illness.
* Inability to understand or to follow study procedures.
Long Term Outcome in ICU Treated COVID-19: New Chronic Diseases

Additional chronic diseases one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed in comparison to two control cohorts.

The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.

ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on comorbidity, medications and death are provided from the National board of health and welfare.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 1 July 2020. ICU-cohort.

or randomly selected from all patients admitted to hospital but not ICU with the ICD 10 diagnosis U07.1 in the national patient registry, matched on age, legal gender and region (four per ICU patient) before 1 July 2020. Hospital cohort.

or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient)

Exclusion Criteria:

* Missing a Swedish personal identification number
Open Lung Protective Ventilation in Cardiac Surgery

Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.

The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery planned with CPB and sternotomy.
* Age \> 18 years old.

Exclusion Criteria:

* Urgent surgery : cardiac transplantation, aortic dissection, active endocarditis.
* Aortic arch surgery with circulatory arrest.
* LVAD surgery.
* Acute or chronic preoperative hypoxemia (PaO2 \< 65 mmHg in air).
* Preoperative shock state requiring catecholamines.
* LVEF \< 40%.
* Pulmonary hypertension with systolic pulmonary artery pressure \> 50 mmHg.
* Severe right ventricular dysfunction (TDI tricuspid annular systolic velocity \< 10 cm.s-1).
* Chronic kidney disease (Glomerular filtration rate \< 30 mL/min).
* Body Mass Index \> 35kg/m2.
* Patient's refusal.
Using Affectionate Communication as a Response to Acute Stress

This study will examine the effects of tending to significant social relationships on managing and reducing stress.

Stress is a large part of daily modern life; however, it can cause a number of long-term problems for mental and physical health. Recent research has confirmed that there are definite mental and physical health benefits of maintaining significant positive social bonds. Many of these benefits appear to be associated with the ability to regulate stress that is caused by environmental challenges. Drawing on close relationships and expressing affection may help people to recover from stress more effectively. This study will evaluate the tend-and-befriend theory, which suggests that engaging in behaviors aimed at maintaining and strengthening significant social bonds can act as an adaptive response to acute stress.

All participants in this study will undergo a series of standard laboratory stressors designed to elevate cortisol levels. Cortisol, also known as the "stress hormone," is activated and secreted within the body in response to stress. Current research suggests that displaying signs of affection toward a loved one can lower cortisol levels, causing the body to relax and recover from a stressful situation more quickly. After lab tests have been completed, participants will be randomly assigned to an experimental or control group. Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well. Participants will also provide a self-report of their current stress level at the end of the study. Participation in this study will last approximately 2 hours. By examining associations between the communication of affection and responses to acute stress, this study may eventually lead to the development of new and better treatment options for people with constant acute stress.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Weigh at least 110 pounds
* Moderate to no anxiety about having blood drawn

Exclusion Criteria:

* Hypertension or diabetes
* Current or recent pregnancy
* Colorblindness
* History of cancer
* Current use of alpha blockers, beta blockers, or steroids
3D-printed Implant Overdentures

A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* completely edentulous
* ranging in age from 50 to 65 years
* Angle's class I skeletal relationship, normal facial symmetry.
* Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
* appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures

Exclusion Criteria:Metabolic disorders affecting osseointegration such as hepatic disorders

* osteoporosis and diabetes mellitus.
* Temporomandibular disorders, anticoagulant therapy or bleeding disorders
* sharp mandibular residual ridge or flabby tissues
* neuromuscular disorders, and class II and III Angle's classification skeletal relationship
* Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions
A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 20 years of age or older
2. Ability to understand and the willingness to provide written informed consent
3. Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
4. Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential

Exclusion Criteria:

1. Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
2. Chronic obstructive pulmonary disease
3. Ejection fraction at screening or baseline \<40%
4. Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula \>450 msec in males and \>470 msec in females)
5. Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase \>2 × upper limit of normal \[ULN\]; serum creatinine \> 1.5 × ULN)
6. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
7. Received an investigational compound within 30 days before enrolling in the study
8. Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
9. Pregnant or lactating female (conception during the study should be avoided)
10. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
11. Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator
12. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)
A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid

The purpose of this study is to assess the the ability of a single dose of LAS40468 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®) administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments

This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of LAS40468 and a single dose of salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable asthma.

The study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of Investigational Medicinal product (IMP) administration.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both inclusive)
* Patients with a confirmed 6-months' history of asthma at the time of enrolment into the trial
* Patients treated with short-acting beta-agonists or inhaled corticosteroids at a stable dose and regimen (up to the equivalent of 1600 μg/day of beclometasone dipropionate) for at least 4 weeks prior to screening
* Patients whose (pre-salbutamol) forced expiratory volume in 1 second (FEV1) at screening is \>60% of the predicted normal value after a washout of at least 6 hours for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if applicable
* Patients with a FEV1 absolute increase of at least 250 mL over baseline value after inhalation of 4 puffs of 100 μg of salbutamol in one of two pulmonary function tests performed within 10-15 min

Exclusion Criteria:

* Patients with clinically significant respiratory or pulmonary diseases other than asthma or history of thoracic surgery
* Patients with a Body Mass Index (BMI) \< 18 or \> 40kg/m2 (both inclusive)
Sit-to-stand and Peripheral Muscle Strength in COPD

Background: Individuals with COPD may present reduced peripheral muscle strength, which leads to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower extremity muscles' performance are required. Objectives: To assess the muscle strength of COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the responsiveness of STST to a PR program with specific strength training (SPR), compared to usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed before and after PRs.

Background: Individuals with COPD may present reduced peripheral muscle strength, which leads to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower extremity muscles' performance are required. Objectives: To assess the muscle strength of COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the responsiveness of STST to a PR program with specific strength training (SPR), compared to usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed before and after PRs.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis for COPD according to the GOLD criteria.
* no exacerbations over the previous four weeks
* completing PR program
* smoking history ≥10 pack years
* regular treatment with inhaled bronchodilators and inhaled steroids

Exclusion Criteria:

* any unstable medical condition
* Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF

This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥40 years based on the date of the written informed consent form
* Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
* In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
* Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. If the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for IPF
* Meeting all of the following criteria during the screening period:

  * FVC ≥40% predicted of normal
  * DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.
  * forced expiratory volume in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value

Exclusion Criteria:

* Acute IPF exacerbation within 6 months prior to screening and/or during the screening period
* Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
* Female patients who are pregnant or nursing
* Abnormal ECG findings
* Use of any investigational drugs for IPF within 4 weeks prior to screening
A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Out-patients 18 years of age and older, who have agreed to participate in the study
* Diagnosed with a Neuroendocrine tumour (NET) and receiving treatment with Somatuline Autogel

Exclusion Criteria:

* Subjects for whom there are reasons that may hinder the conduct of the study (patients who have difficulty expressing themselves or who are unable to complete the questionnaires, or with insufficient data in the their files will not be enrolled in the study).