cyrilzakka/clinical-trials huggingface dataset:
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML

The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with core-binding factor acute myeloid leukemia

The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).

Eligibility Criteria:
Inclusion Criteria:

* Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
* In status of complete remission after one to two courses of induction therapy
* Total bilirubinic acid ≤ 35μmol/L, AST/ALT\<2 times abnormal level, serum creatinine \< 1.5mg/ml
* Cardiac function: EF ≥ 50%
* Hydroxyurea can be used for patient with white blood cell count ≥ 50\*109/L
* ECOG (Eastern Cooperative Oncology Group) score: ≤ 2

Exclusion Criteria:

* Relapsed/refractory AML
* Serious liver/ kidney dysfunction
* Cardiac function level: 2 above
* Female in pregnancy or lactation
* With serious infection diseases or other diseases
* Not obey the principle of clinical study
Compliance in Non Invasive Mechanical Ventilation

Database study of the adherence to treatment to non-invasive mechanical ventilation


Eligibility Criteria:
Inclusion Criteria:

* patients in non invasive mechanical ventilation and affiliated by the respiratory centre of the East of Denmark
* registered in telemedical solution in the period from 01.01.2020 to 04.01.2022
* Age above 18 years

Exclusion Criteria:

-
Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients

The aim of this study is to determine the effects of an acute session of physical exercise on cognitive functioning and humor of traumatic brain injury patients and to investigate whether different cognitive responses can be achieved with different intensities of exercise (moderate and vigorous).

The investigators hypothesize that while moderate intensity physical exercise may be beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients, as physical fatigue may impair alertness and other higher cognitive functions.

It is well known the benefits of physical exercise to cognitive functioning, which have been demonstrated in animal studies and in those with healthy humans or with individuals with some type of pathology. Nevertheless, there are few studies investigating the effects of acute physical exercise on cognitive functions of people with traumatic brain injury, even though they frequently have impairments in several cognitive domains due to their brain damage.

The effect of two intensities of physical exercise (moderate and exhaustive) in attention, processing speed, memory, executive control and decision making will be investigated in patients with TBI. For that matter, their performance will be compared to non-brain injured subjects submitted to the same protocol and to TBI patients submitted to a stretching session.

Each subject will be submitted to a neuropsychological evaluation before and after the physical exercise in order to determine if there is an improvement in cognitive performance post-exercise.

Eligibility Criteria:
Patients with TBI eligible for participation in this research study must meet the following inclusion criteria:

Inclusion Criteria:

* diagnose of moderate to severe TBI
* be at least six-months post-injury
* have a neurologist that allowed to enroll into the study
* be able to take part in a cycloergometer-protocol, attested by the laboratory (CEPE) physician
* brain injury must have occurred in adult life
* provided written informed consent for participation

Exclusion Criteria:
Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

* Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
* Patients who exhibited adverse drug reactions
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome

This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.

PRIMARY OBJECTIVES:

I. To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy.

II. To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to topical cryotherapy in this study situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply bags filled with crushed ice to hands and feet for 15 minutes before, for 60 minutes during administration, and for 15 minutes after finishing administration of paclitaxel.

ARM II: Patients receive paclitaxel intravenously (IV) over 60 minutes on weeks 1-12.

In both arms, courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 30 days for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to complete questionnaires by themselves or with assistance
* Planned paclitaxel at a dose of 80 mg/m\^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase \[PARP\] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
* Life expectancy \> 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patient has score of 0 or 1 on the neurotoxicity evaluation, as determined by the healthcare provider

Exclusion Criteria:

* Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
* Diagnosis of fibromyalgia
* Any prior exposure to neurotoxic chemotherapy
* History of Raynaud?s disease, cryoglobulinemia
Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale

In the first part, after a brief introduction, the advantages and disadvantages of immediate dentures are compared. There is a detailed discussion on assessment and treatment planning which includes history taking, examination of the soft and hard tissues, current prostheses, occlusion as well as discussion on investigations required and formulating a diagnosis. The first part ends with a summary of types of immediate dentures and denture designs.

An Immediate denture is a complete or partial removable prosthesis that is fitted immediately after extraction or modification of teeth. The prosthesis replaces the missing/modified teeth and where required, the adjacent hard and soft tissues. It is constructed prior to the extraction of teeth and is used immediately to provide function and aesthetics which are lost as a result of tooth removal and avoid the embarrassment patients may have with living without teeth, while waiting for the tissues to heal prior to definitive tooth replacement.1 (See image 1) Some clinicians take impressions on the day of the extractions and fit the dentures a few days later. These dentures are fraught with challenges as the alveolar ridge begins to resorb soon after. Therefore an immediate denture is only truly an immediate denture when fitted on the day of the extractions.

The use of a removable prosthesis within the UK is currently around 19% of adults in the general population 2 and in spite of this decreasing trend, as patients retain their natural dentition into older age,2 there is still a need for prosthodontic replacement as teeth are lost as a result of caries, periodontal disease, tooth wear or trauma. 3,4,5 The provision of an immediate denture can be challenging and close co-operation between patient, technician, and clinician is required.

Eligibility Criteria:
Inclusion Criteria:

* Good physical and mental health
* Willing to give informed consent
* Normal maxilla-mandibular relationship Angle Class I
* Adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam CT
* Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses

Exclusion Criteria:

* Uncontrolled diabetes
* Smoking habits
* Radiotherapy
* Clinical or radiographic signs of pathologic conditions, osteoporosis
* Patients on corticosteroids
* Bruxism
A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.

The main questions it aims to answer are:

* Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
* Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
* Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
* Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?


Eligibility Criteria:
Inclusion Criteria:

* COPD Patients, defined by FEV1/FVC \<0.7, who

  * agree with informed consent
  * have no history of acute exacerbation within 3 months
* Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who

  * have smoking history with at least 30 pack-year
  * agree with informed consent
  * do not use medication for chronic respiratory disease

Exclusion Criteria:

* Withdrawal of informed consent
* History of acute exacerbation or antibiotics use within 3 months
* Difficulty to collect adequate stool, sputum and blood samples
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.

The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects.

The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Currently smoke at least ten cigarettes a day
* Have been smoking for at least one year
* Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview
* Can speak and write fluent conversational English
* Are between 18 and 70 years of age
* Are willing to make a smoking cessation attempt
* Score 26 or higher on the Montreal Cognitive Assessment

Exclusion Criteria:

* Have a history of myocardial infarction in the past 6 months
* Have a contraindication to NRT with no medical clearance from the primary care provider or study physician
* Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco
* Are pregnant
* Meet criteria for a current manic episode based on structured clinical interview
* Are currently enrolled in another smoking cessation trial
* Are currently imprisoned or in psychiatric hospitalization
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.

* Signed informed consent prior to initiation of any study-related procedures.
* Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.

Exclusion Criteria:

* Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
* Pregnancy or breast-feeding.
* AST and/or ALT \> 3 times the upper limit of the normal range.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
* Known hypersensitivity to bosentan or any of the excipients.
68Ga-DOTATATE Neuroblastoma Imaging Pilot

Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.

Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.

Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.

Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot

Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.

Study population: Children and adults with biopsy-proven or suspected neuroblastoma

Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma
* Planned 123I-MIBG imaging
* Able and willing to provide signed informed consent in French or English (for the adult candidates or the parent/legal tutor of the pediatric candidates)
* Aged between 1 day and 21 years old (inclusively).

Exclusion Criteria:

* History of another cancer in the past 5 years other than non-melanomatous skin cancer.
* Currently under a randomized control trial with unknown allocation;
* Currently under treatment;
* Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
* Medically unstable or unable to undergo scan.
* Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for at least 12 hours after 68Ga-DOTATATE injection).
* Prior allergic reaction to somatostatin analogues
Pediatric Perioperative Satisfaction Questionnaire

The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.

Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire

Eligibility Criteria:
Inclusion criteria:

* children 7 years and older
* elective surgery
* general anesthesia
* abiliy to understand and read questions

Exclusion criteria:

* emergency
* cognitive trouble
* intellectual disability
Speech Intelligibility in Noise Using the Hearing in Noise Test (HINT)

The main purpose of the study is to estimate speech intelligibility in noise. A Norwegian Hearing in Noise Test (HINT) for children will be implemented, and test results for normal hearing (NH) children and adults will be collected. Test results for groups of hearing aid (HA) users and test results for cochlea implant (CI) users will be collected and compared to the NH group and between groups of HA users and CI users. A group of single sided hearing loss patients will also be included. Binaural benefits of two ears, two HAs and two CIs will be estimated.


Eligibility Criteria:
Inclusion Criteria for the different groups:

1. Normal hearing group (note that some subjects are already recruited in the normal hearing group):

   * audiometric thresholds less than or equal to 25 dB HL for octave frequencies between 250 Hz and 8000 Hz
   * Adults between age 18 and 50 years
   * Children at different age groups between 6 and 12 years old
2. Unilateral hearing loss group

   * Single-sided hearing loss.
   * Using hearing aid or willing to try hearing aid on the side with hearing loss to estimate a potential binaural benefit with hearing aid.
   * Unilateral hearing loss inclusion criteria is thresholds within 25 dBHL and 70 dBHL for frequencies {125,250,500} Hz. Inclusion region increasing linearly with octave frequency to 40 dBHL and 95 dBHL for frequency 8000Hz. In addition a single threshold outside this hearing threshold inclusion region is accepted.
   * Contralateral normal hearing with audiometric thresholds less than or equal to 25 dB HL for octave frequencies between 250 Hz and 8000 Hz
3. Group with Severe hearing loss at high frequencies

   - Inclusion criteria is bilateral hearing loss within hearing levels where frequencies below 750 Hz can be normal or elevated down to 65 dBHL, for frequencies 1000 Hz and 1500 Hz all HL thresholds are accepted, frequencies 2000 Hz and above have threshold criteria 85 dBHL or above.
4. Adult CI users with unilateral and bilateral CI

   * All adult patients will be tested to the level of their performance.
   * HINT SRTs will be collected if HINT score in quiet is above 70%.
5. Bilateral CI users (Children)

   1. Sequential CIs group

      * Children that has got two CIs in two different operations, and operations are not within one year.
      * Inclusion of some of the patients participating in another ongoing sequential CI-study at the ENT department,and who has a HINT score above 70% in quiet. The requirement of a quiet percentage score above 70% is due to the bilateral benefit testing/estimation.
   2. Simultaneous CIs group

      * All children that has got two CIs in the same operation or sequentially within one year.
      * Children older than 6 years old.
      * Children as young as 5.5 years old can be included if they are considered ready for extended HINT testing.

Exclusion Criteria:

* None
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

The aim of the study is to investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician.

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute coronary syndrome (including STEMI), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.

The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Eligibility Criteria:
Inclusion Criteria:

* Suspected acute coronary syndrome
* Verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

Exclusion Criteria:

* Patient refuses consent to teleconsultation
* No suspected acute coronary syndrome