cyrilzakka/clinical-trials huggingface dataset:
Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)

Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders
* Age 18 years or older
* Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.

Exclusion Criteria:

* Acute promyelocytic leukemia (APL)
* Previous or concurrent malignancies other than AML
* Previous treatment with colony-stimulating factors, interleukins or interferons
* Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
* Antibody-based or cell-based immunotherapies
* Respiratory insufficiency with pO2 \<60 mmHg
* Heart failure NYHA III° or IV°
* Elevated creatinine \>2.0 mg/dl
* Elevated bilirubin \>2.0 mg/dl
* Pregnancy or lactation
* Females without adequate contraception
* Known HIV and/or hepatitis C infection
* Severe neurologic or psychiatric disease
* Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
* Concerns for subject's compliance with the protocol procedures
* Lack of willingness to record and circulate personal disease-related informations defined in the study protocol
Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia

The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

Research Questions:

Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?

Research Hypothesis:

In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.

Eligibility Criteria:
Inclusion Criteria:

The presence of perimenopausal bleeding

* Early stage endometrial carcinoma.
* Endometrial hyperplasia with/without atypia.

Exclusion Criteria:

* Obese patients i.e., BMI\< 29 k.g/m2.
* Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
* Presence of adnexal mass.
* End stage endometrial carcinoma stage 3 \& 4.
WHITBY: Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation StudY

Tinnitus - the awareness of sound without any outside source - affects around 15% of people and can cause anxiety and depression. Treatment options are limited and do not address tinnitus directly (e.g., reduce its loudness). To do that, we must change brain activity causing tinnitus. Low-dose electrical stimulation, using a technique called transcranial Direct Current Stimulation (tDCS), is a promising approach. The technique is safe and easy to administer. Several small studies have tested tDCS for tinnitus showing some benefits.

To assess whether these benefits will generalise to other patients, we need to conduct a randomised controlled trial - a large, rigorously controlled experiment based on prior agreed procedures. Clinical trials are expensive and time-consuming to run and thus require meticulous pilot work to establish the most effective treatment regimens and the most sensitive measures of treatment outcome. The current study aims to provide such pilot information for a clinical trial of tDCS treatment of tinnitus. Using a total of 40 patients, we will establish how to best to administer tDCS and measure resulting changes in tinnitus perception and associated brain activity.

The current study is a crucial first step towards determining whether or not tDCS can effectively treat tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Suffering from subjective idiopathic tinnitus
* Sufficient understanding of English to be able to provide informed consent
* Able to safely undergo tDCS

Exclusion Criteria:

* Aged under 18
* Not suffering from tinnitus or suffering from objective tinnitus
* Insufficient understanding of English to be able to provide informed consent
* Unable to safely undergo tDCS as assessed by tDCS Safety Questionnaire
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease

The CUE1 device is a non-invasive wearable device for people with Parkinson's Disease (PD) approved for sale in the UK. The CUE1 device utilises two established methods to improve motor symptoms in PD, namely pulsed cueing and vibrotactile stimulation. Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom.

Study design and eligibility: This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD. 20-25 participants aged \>60 years with PD will be recruited from a movement disorder service to the study.

Methodology: Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home. Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes. The participants will complete a daily diary of useability and acceptability for 4 weeks. A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals under the care of a Cambridge University Hospitals Foundation Trust movement disorder service with an established clinical diagnosis of Parkinson's disease based on the UK Brain bank criteria

Exclusion Criteria:

1. Co-existing significant neurological disorder (disabling stroke, multiple sclerosis, dementia, motor neurone disease),
2. Atypical parkinsonian disorder diagnosis (e.g. multiple systems atrophy, progressive supranuclear palsy or cortical basal degeneration syndrome)
3. co-existing physical impairment or disability causing significant mobility impairment (severe lower limb osteoarthritis)
4. trauma or pain to the sternum
5. use of other medical device e.g. pacemaker, deep brain stimulator, TENS machine etc
6. lacking capacity to consent to the study
7. Sensitivity to medical adhesives
8. Existing participant in intervention research trial
Clinical Application of PD-1 Inhibitor in Colorectal Cancer for Improving Survival

This trial is a single-center retrospective study. Eligible patients receiving PD-1 inhibitor treatment will enrolled.

In patients with colorectal cancer (CRC), curative surgery combined with chemotherapy ( FOLFOX or CAPOX regimens) has become the standard treatment. However, 20 to 30% of these patients will develop distant metastasis, which ultimately results in death. Oxaliplatin- and fluoropyrimidine-based doublet chemotherapy does not adequately meet the clinical need for tumor shrinkage and downstaging. There is an urgent need to explore drugs with different mechanisms of action in combination with chemotherapy to improve efficacy. Relatively few trials of preoperative therapy have been reported, In recent years, the emergence of immune checkpoint inhibitors has revolutionized cancer treatment. Given the limitations of current treatment strategies in achieving optimal clinical outcomes, this retrospective study aims to research the disease-free survival rates and overall survival (OS) in CRC patients using PD-1 inhibitors.

Eligibility Criteria:
:

Inclusion Criteria:

Willing and able to provide written informed consent. Histological or cytological documentation of adenocarcinoma of the colorectal. Eastern Cooperative Oncology Group's (ECOG) performance status of 0 or 1. CT or MRI scans (done within 30 days of registration) of the chest, abdomen, and pelvis all without clear evidence of distant metastatic (M1) disease.

No clinically significant obstruction, perforation, or bleeding related to the primary tumor.

No previous systemic anticancer therapy for colon cancer disease. Adequate bone marrow, hepatic, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment

Exclusion Criteria:

Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years before randomization.

Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.

Heart failure grade III/IV (NYHA classification). Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.

Subjects with known allergy to the study drugs or any of its excipients. Current or recent (within 4 weeks before starting study treatment) treatment of another investigational drug or participation in another investigational study.

Breast-feeding or pregnant women Lack of effective contraception.
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:

1. Confirmation of efficacy and safety for medical practice use.
2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
3. Investigation of the incidence status and the risk factors for interstitial lung diseases.

Implemented as a Drug Use Investigation by Central Registration System

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Exclusion Criteria:

* Patients not administered Torisel.
* Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain

The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabiliation coordinators at primary health care centres.

The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabilitation coordinators at primary health care centres.

Furthermore, the aim is to identify hindering and facilitating factors for feasibility, usability and implementation of the Demand and Ability Protocol intervention (DAP) in primary health care.

Research questions:

1. What is the effect of DAP for patients regarding sick leave, health, work ability, and trust in the manager compared to matched controls who do not recieve DAP?
2. How do patients and managers experience their participation in the intervention and how do they experience the usability of the DAP?
3. What facilitating and hindering factors exist for the introduction and implementation of DAP in primary health care, and how do rehabilitation coordinators (REKO) and medical doctors experience the feasibility and usability of the intervention?

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of CMD and/or chronic pain
* have a job
* be on full-time or part time sick leave
* accept the manager's involvement.

Exclusion Criteria:

* been on full-time sick leave for more than 6 months before the first contact with REKO
Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI.

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.

Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

Exclusion Criteria:

* Emergency PCI,
* Elevation of cTnI before PCI taken at the preadmission clinic,
* Women of child-bearing age,
* Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
* Severe comorbidity (estimated life expectancy \< 6 months).
Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500

JUC is a commercially available wound care spray. It is evaluated for the efficacy when using as a hygienic hand rub following the protocol described in the European standard EN 1500:1997 "Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement (phase 2/step 2)". A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol by using Escherichia coli K12 NCTC strain 10538 as test organism.

Before the intervention, the bactericidal activity of JUC was validated in accordance with the prEN 12054. A total of 15 volunteers were recruited, hands were washed immediately prior to the intervention. Then, both hands of each volunteer were immersed into a contamination fluid of E. coli. Then, hand rub was performed with JUC or alcohol. Culture samples were collected before and after the hand rub by rubbing the fingertips and thumb tips of each hand ont he base of a Petri dish containing appropriate medium. The culture inoculation, incubation, appropriate dilutions, and colony count were performed.

Eligibility Criteria:
Inclusion Criteria:

* healthy and absence of significant illness

Exclusion Criteria:

* Visible wounds on hands
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency

The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle activation during gait and on Range of ankle motion in postmenopausal females with Chronic Venous Insufficiency in initial stages in comparison to a placebo control group.

Chronic Venous Insufficiency (CVI) is a very common disease. Patients with this pathology present peripheral muscle pump impairment and restricted range of ankle motion. Few data are available on the use in chronic venous insufficiency patients of Kinesio Taping, a physical therapist's elastic dressing that permits action on muscle activity and joint range.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 75 years.
* Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)

Exclusion Criteria:

* Chronic Venous Insufficiency (\> grade C3)
* Arterial disorders
* Cardiorespiratory disease
* Contraindications for Kinesio Taping technique including thrombosis, wounds, severe trauma, generalized edema secondary to cardiac or renal problems, carcinomas, intolerability of/allergy to surgical tape and pregnancy.
Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body.

Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.

The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug.

The secondary objective is to investigate the tolerability of rogaratinib.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in any Bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician.
* Participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol.
* Any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption.
* Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment.

Exclusion Criteria:

* Ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study.
* Patients with a beta-human chorionic gonadotropin (hCG) test consistent with pregnancy.
* Participants are using one or more of the prohibited medications listed in the respective feeder study protocol
* Negative benefit / risk ratio as determined by the investigator
* Positive pregnancy test for on-treatment participants
Continuous EMG Measurements in Children With Asthma During Sleep

The objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.


Eligibility Criteria:
Inclusion Criteria:

* Paediatrician diagnosed asthma or bronchial hyperresponsiveness
* Aged 4 till 18
* Admitted to the paediatric ward of Medisch Spectrum Twente

Exclusion Criteria:

* Admittance to the ICU
* Patient has ICD or pacemaker
* Parents and/or patient cannot understand or speak Dutch
* Does not fit in one of the available Hexoskin shirts
Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing

Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.

In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.

Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Woman after spontaneous or operative vaginal delivery
* Perineal pain score of at least 2 NRS

Exclusion Criteria:

* Women after cesarean delivery
* Refuse to participate
* Under 18 years of age
* Magnesium sulfate treatment not related to the study
* Contraindication for magnesium sulfate treatment
* Workers of the local obstetric department
Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood strategy.

Neurologic deficits in children with single ventricle physiology are believed to be associated with the reconstruction of the aortic arch during the initial Norwood procedure as a neonate. In the last few years, a new management strategy (the 'Hybrid' strategy) has been proposed which defers the aortic arch reconstruction to a second stage procedure at 4-6 months of age.

Proponents of the Hybrid strategy assert that the avoidance of cardiopulmonary bypass and circulatory arrest in the neonatal period will avoid neurologic injury in the critical neonatal period and thereby result in superior long-term neurologic outcomes.

We are testing whether the Hybrid management strategy is associated with superior neurologic outcomes or not.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation.
2. Informed consent of parent(s) or legal guardian.

Exclusion Criteria:

1. Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate;
2. Recent history of significant cerebral bleed or necrotizing enterocolitis;
3. Severe hemodynamic instability;
4. Any other major congenital abnormality (i.e. congenital diaphragmatic hernia, tracheoesophageal fistula) or clinically significant acquired extra-cardiac disorder (e.g. meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis).