cyrilzakka/clinical-trials huggingface dataset:
Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.

A new method for induction of labor to be studied

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with:

  * Age 18-45 years.
  * Live fetus with cephalic presentation.
  * Normal non-stress test with reassuring features (baseline heart rate 110-160 beats/min, baseline variability 5-25 beats/minute, and no decelerations) (National Institute for Health and Clinical Excellence 2017).
  * Gestational age of 37 weeks or more (Middleton et al. 2020).
  * Fetal weight less than 4 kilograms.
  * Bishop score less than 6 (Navve et al. 2017).
  * No labor pains.
  * No contraindications for vaginal delivery

Exclusion Criteria:

* o Presence of fetal distress.

  * Presence of thick meconium-stained amniotic fluid
  * Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.
Daratumumab Combined With Bortezomib and Dexamethasone in Mayo 04 Stage III Light Chain Amyloidosis

Patients with light chain (AL) amyloidosis who have advanced cardiac damage are at risk of premature mortality. There is ongoing unmet need for effective therapies to rapidly induce deep hematologic response and decrease the early death rate. Lately, trials of daratumumab in newly-diagnosed and relapsed/refractory AL amyloidosis have shown dramatic response rates. However, the benefits of upfront daratumumab in stage III AL patients, especially stage IIIb patients, have not yet been demonstrated definitely in prospective studies. Therefore, we designed a phase II, single arm clinical trial to investigate the efficacy and safety of co-administration of daratumumab with bortezomib and dexamethasone (BD) regimen in treatment-naïve patients with Mayo 04 stage III AL amyloidosis. We planned to enroll 40 patients, who would receive daratumumab and BD treatment for a total duration of 12 months. The primary endpoint is complete response and very good partial response at 3 months after treatment initiation. Secondary endpoints include overall survival, organ response and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old adults.

  * Biopsy proved treatment-naïve AL amyloidosis.
  * Mayo 2004 stage III.
  * dFLC \> 50mg/L.
  * Patient must provide informed consent.

Exclusion Criteria:

* Co-morbidity of uncontrolled infection.
* Co-morbidity of other active malignancy.
* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia.
* Co-morbidity of grade 2 or 3 atrioventricular block.
* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia.
* Seropositive for human immunodeficiency virus.
* Seropositive for hepatitis B (positive test for HBsAg). Participants with resolved infection (ie, HBsAg negative but positive for anti-HBc and/or anti-HBs) must be screened of HBV-DNA. Those who are PCR positive will be excluded.
* Seropositive for hepatitis C (except in the setting of a sustained virologic response).
* Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
* Neutrophil \<1×10E9/L，hemoglobin \< 7g/dL，or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: ALT or AST \> 2.5 × ULN, total bilirubin \> 1.5mg/dL，or eGFR \< 40mL/min (those with renal dysfunction due to renal involvement or renal hypoperfusion from cardiac amyloidosis could be included)
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of diabetes mellitus (type 1 or type 2)
* Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
* Written informed consent obtained in accordance with all local privacy requirements

Exclusion Criteria:

* Uncontrolled systemic disease
* History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
* Patients who have been previously treated for DME (two focal laser allowed)
* Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
* Elevated IOP or glaucoma diagnosis
* Any active ocular infection or inflammation
* Aphakia
* A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal)
* Anticipated need for ocular surgery during the study
* History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
* Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
* Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
* Must have disease free status as determined by imaging within 4 weeks of dosing
* Tumor tissue must be provided for biomarker analysis
* Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

* Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
* Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
* Subjects with active, known or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* predialysis stage;
* no ESA therapy during previous 3 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring hospitalization in previous 6 months;
* significant acute or chronic bleeding.
Cost-effectiveness of Interventions in First-episode Psychosis

Schizophrenia has very significant economic consequences. Costs fall on many different parts of society, especially on individuals with schizophrenia and their families. The first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. In addition, if left untreated for a long time, psychosis can impact many areas of a person's life. The evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. The provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. Only a few international studies, and none conducted in Spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from First Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode non-affective psychosis in Spain to date.


Eligibility Criteria:
Inclusion Criteria:

* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for a principal diagnosis of schizophreniform, schizophrenia, schizoaffective, brief reactive psychosis, or psychosis non otherwise specified.
* Living in the catchment area.
* No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
* Current psychotic symptoms of moderate severity or greater assessed by one of the five items of the Scale for the Assessment of Positive Symptoms (SAPS).
* First episode patients with at least one assessement at 3 years or 10 years.

Exclusion Criteria:

* Meeting DSM-IV criteria for mental retardation.
* Meeting DSM-IV criteria for drug dependence.
Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth

Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information + a booklet about prematurity given to the women at admission. The primary endpoint was the change in anxiety-state (before and after the information procedure) evaluated by the State Trait Anxiety Inventory-Y (STAI-Y).

Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. Material and methods.This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information

+ a booklet about prematurity given to the women at admission.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in the service of pregnancies and having a risk of premature delivery.
* Term \<34 SA

Exclusion Criteria:

* Term ≥ 34 SA
* no understanding of the questionnaire
* foetus presenting a pathology or malformation that is life-threatening
* patient presenting a risk of delivery before passing the pediatrician or presenting a risk of imminent delivery
* patient hospitalized without risk of premature delivery.
Edulcorants Effect in Caries Risk Schoolchildren

This double-blind RCT aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9 years-old schoolchildren. Considering a 20% difference among groups, the number of subjects needed per group was set in 87. Two-hundred-seventy-one children at risk for caries measured through Cariogram were selected and randomly assigned to three groups consuming twice a day snacks containing Stevia or Maltitol or sugar for 42 days. Parents filled out a standardized questionnaire regarding personal, medical and oral behavioural information. Bleeding on probing, plaque pH and cariogenic microflora were assessed at baseline (t0), after 21 (t1) and 42 days of snacks' use (t2) and 120 days after the end of use (t3). Cariogram was also repeated at t2.


Eligibility Criteria:
Inclusion Criteria:

* more than 1 initial carious lesion in the enamel (ICDAS 2-3),
* but no manifest lesion in the dentine,
* a salivary MS concentration ≥10\^5 CFU/ml.

Exclusion Criteria:

* Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.
Iressa Case Control Study in Japan

The purposes of this study are:

* To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
* To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment


Eligibility Criteria:
Inclusion Criteria:

* Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
* Patients who are to be treated with gefitinib or chemotherapy
* Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Exclusion Criteria:

* Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
* Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort
An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation

Detoxification diets aim to remove chemicals from the body that may cause short or long-term harm. However, little is known about detoxification diets from well-designed clinical trials. This trial examines the efficacy of Chef V's 21-Day Starter Challenge Detox diet. Participants will use Chef V's 21-Day Starter Challenge Detox as directed for the first 21 days of the trial and continue to use the Chef V Green Drink Supplement for an additional seven days. The primary outcomes of interest are the participant's perceptions of their health improvements and biomarkers that will be measured via blood draws.


Eligibility Criteria:
Inclusion Criteria:

* Must be in good general health with no chronic health conditions
* BMI under 35.
* Must own a scale at home.
* Must experience at least one of the following issues: the feeling of being tired at least several times a week, brain fog, sleep issues, trouble with focus and concentration, or having a busy, stressful life.
* A subgroup of 10 study participants must be diagnosed with T2D for ≥ 90 days, with an hbA1c of 7.5 to 10.5, inclusive
* Eat fast food at least twice a week.
* Does not exercise regularly.
* Does not consume fruits and vegetables daily.
* Must experience at least one of the following gastrointestinal problems: often bloating, excessive gas, heartburn, and irregular bowel movements.
* Must experience at least one of the following aches regularly: body aches, joint pain, back pain, or neck pain.
* Must be willing to go to Quest labs for two blood draws, one at baseline and the other at the study's conclusion.
* Willing to avoid bottled water for the duration of the study.

Exclusion Criteria:

* Suffers from pre-existing conditions that prevent them from adhering to the protocol.
* Anyone with known severe allergic reactions.
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
* Anyone unwilling to use the test product daily as directed.
Prophylactic Pulmonary Vein Isolation Study

This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.

Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.

Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.

Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).

Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).

The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.

The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.

Eligibility Criteria:
Inclusion Criteria:

* Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium

Exclusion Criteria:

* History of Atrial Fibrillation
* Need for emergent cardiac surgery
* Previous cardiac surgery
* Preoperative need for an intraaortic balloon pump or intravenous inotropes
* Current diagnosis of active endocarditis
* Mental impairment/or experience other conditions which may not allow subject to understand nature
* Significance and scope of study
* Pregnancy
Strength Training for Chronic Stroke Patients

The study aims to investigate the effects of strength training on maximal strength, walking ability and neural function in chronic stroke patients. The strength training intervention in this study is different to all previous interventions for stroke patients.

Maximal Strength Training (MST) involves weights of up to 90% of the participants 1 repetition maximum and has a focus on the explosive development of force. This study will use these principles for unilateral leg press and plantarflexion exercises. Only 2 previous studies have investigated high intensity strength training for stroke patients and they used intensities of 80% 1RM. Previous MST interventions have shown large increases in strength, rate of force development and this has transferred to improved walking economy.

The investigators predict that MST will give large increases in strength, improved rate of force development (RFD) and walking economy. The investigators expect that better neural function will account for the improvements. This study could provide evidence for the adoption of a completely different method of strength rehabilitation for stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* Under 67 years old
* Suffered from a stroke at least 6 months previously
* Living in the Trondheim area such that travel costs can be covered by 1500 NOK
* Must be able to walk, although use of aids is permitted

Exclusion Criteria:

* Participants must not have cognitive, visuospatial or comprehension deficits to magnitude such that it interferes with the ability to perform testing and training
* Participants must be medically unstable (e.g. uncontrollably high blood pressure (140/90), arrythmia, other heart instabilities or other known comorbid diseases)
* Participants must not be known to be pregnant
The Effect of Jigsaw Technique on Childhood Epileptic Seizure Management Knowledge and Attitudes of Nursing Students

The aim of this study is to examine the effect of the education given to nursing students with the Jigsaw technique and traditional method on their knowledge and attitudes about childhood epileptic seizure management.

It is important for nursing students, future health professionals, to gain sufficient professional knowledge and positive attitudes about epileptic seizure management in order to improve the quality of care they provide to children with epilepsy. Studies emphasize that the nursing education curriculum should focus more on education regarding epilepsy and epileptic seizures, and that different educational methods should be used to positively develop nursing students' knowledge and attitudes towards patients with epilepsy. One of the collaborative learning methods used in nursing education is the Jigsaw technique. Jigsaw technique is a student-centered and collaborative learning method that improves knowledge, skills and attitudes in nursing education.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study

Exclusion Criteria:

* Not attending trainings and not filling out data collection forms