cyrilzakka/clinical-trials huggingface dataset:
An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome

The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit.

This study is a prospective (the study follows a group of individuals over time), open label (all people involved know the identity of the intervention), multicenter, single arm (one group of patients receiving the same treatment), observational study to observe the response rate and safety of decitabine when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit. It will be assessed if the treatment duration could be prolonged by appropriate toxicity management such as an active antibiotic prophylaxis or dose and schedule modification, and whether this leads to potentially increased clinical benefits such as higher response rate, longer time to Acute Myeloid Leukemia, and prolonged overall survival. For safety evaluation, adverse events and peripheral blood findings will be collected. The patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including Chronic Myelomonocytic Leukemia (CMML)
* Patients with an International Prognostic Scoring System \>= Int-1
* Patients who were never treated with hypomethylating agent (azacitidine and decitabine)
* Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. Women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
* Patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Patients diagnosed with Acute Myelogenous Leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases
* Patients with active infection of virus or bacteria
* Patients who used to be treated with azacitidine or decitabine
* Patients who are hypersensitive to excipients of decitabine
* Patients who are pregnant or breast-feeding.
Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

Skin moisturizing and elasticizing efficacy of an amino acid food supplement

Primary end point of this study was to evaluate the moisturizing and elasticizing activity of "Nutrakos®" Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An additional aim of this study was to evaluate the product tolerance both by investigator and volunteers.

Eligibility Criteria:
Inclusion Criteria:

* female sex,
* 35-70 years,
* skin phototype II and III according to Fitzpatrick's classification (see par. 8.2.1)
* accepting to not change their habits regarding food, physical activity, body cosmetic and cleansing products;
* accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy;
* lactation;
* smokers;
* alcohol or drug abusers;
* skin phototype I, IV, V and VI according to Fitzpatrick's classification
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test at T0 and at the end of the study (T1M);
* Body Mass Index (BMI) variation (± 1) during the study period;
* change in the normal habits regarding food, physical activity, body cosmetic and cleansing use during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 6 months;
* dermatitis;
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
* diabetes;
* endocrine disease;
* hepatic disorder;
* renal disorder;
* cardiac disorder;
* pulmonary disease;
* cancer;
* neurological or psychological disease;
* inflammatory/immunosuppressive disease;
* drug allergy;
* anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year before the study);
* using of drugs able to influence the test results in the investigator opinion.
Airway Ultrasound As an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery

The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* listed for elective surgery
* airway assessment is possible prior to anesthesia

Exclusion Criteria:

* refusal to be enrolled in study
* airway assessment is not possible prior to anesthesia
Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.

Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 year-patient
2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:

   * Rapid urease test or Histology
3. Inform consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication
2. Contraindications or allergic reactions to the study drugs
3. Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
4. Decompensated Liver cirrhosis or chronic kidney disease (GFR\< 30)
5. Mental disorders or alcohol or drug addiction
6. Pregnancy or lactation
Ventilation With High Oxygen Content and Postoperative Pneumocephalus

The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.

Background: Postoperative pneumocephalus is a common complication in patients undergoing craniotomies. Even though the treatment of postoperative pneumocephalus with the use of supplemental oxygen is well documented, yet not reports have shown its role for the prevention of this condition. We suggest the use of intraoperative ventilation with 100% oxygen as prophylaxis for the incidence and severity of postoperative pneumocephalus in patients undergoing intracranial surgery.

Objectives: The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.

Study Methods: A single-blinded, prospective study, randomizing 80 patients per group, expecting 80% power to detect a 20% decrease in pneumocephalus volume for the interventional group. Inclusion criteria: Patients \>18 years, scheduled to undergo elective craniotomy, and be willing to give written informed consent.

Study Procedures: Once the tumor resection is completed and hemostasis started (beginning of stage 2), patients will be assigned to receive either 1:1 oxygen/air gas mixture (control group) or 100% oxygen (intervention group) until the end of the surgery. All patients will receive postoperative supplemental oxygen via nasal cannula. CT scan will be performed within 1 to 6 postoperative hours as standard of care. A blinded radiologist will review all CT scans and assess the extent and frequency of postoperative pneumocephalus.

Clinical Outcomes: Patients' demographic data, length of stage 2, period of time between the end of surgery and CT scan, and pneumocephalus volumetric measurements will be compared between groups. Baseline neurological status will be compared with clinical and imaging postoperative findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study

Exclusion Criteria:

* History of severe cardio-pulmonary disease.
* Bleeding disorders
* Previous neurosurgeries requiring cranial reconstruction
* Head trauma
* Decreased consciousness related to cerebral edema
Ice Cream Enriched With Protein and Positive Emotions

The primary aim is to investigate if protein-enriched ice cream has the feasibility to increase intake of protein without substituting other foods in hospitalized older patients and secondary, if the protein-enriched ice cream has the feasibility to increases the energy intake and evokes positive emotions in older hospitalized patients

Methods/Design:

This study is conducted as a four days non-blinded randomised cross-over feasibility study with 24 hospitalized older patients. The intervention is conducted at the hospital. The intervention is two days with two protein-enriched ice cream daily with the aim of increasing the intake of protein and energy. The patients are asked to answer a questionnaire concerning the emotions the protein enriched ice cream evoke.The patients will be randomised to receive the standard menu the first two days followed by two days with standard menu plus protein-enriched ice cream or in the opposite order. The randomisation will be done by using sealed envelopes.

Recruitment:

Only admitted patients will be a part of the trial. The ward staff will identify the patients there are eligible to the trial as close as possible to the day of admission. The ward staff will ask those patients who meet the inclusion criteria if they will participate in the trail. The patients receive oral and written information on the trial and those who agree to participate are asked to sign a statement of consent before participating. The patients can at any time withdraw their consent and leave the trial.

Sample size:

The sample size is estimated to 24 patients, who will be their own control.

Statistical analysis:

Non-parametric statistical tests, median and range will be performed due to the small sample size and skew distribution. The Wilcoxon signed rank test for paired data, and Fisher's exact test for categorical data. Evoked emotion are measured as the percentages of patients who choose a particular emotion term.

Eligibility Criteria:
Inclusion Criteria:

- older admitted hospital patients age 65 or older, capable \& Danish speaking (able to read and understand the oral and written information and give written consent), able to eat, eat ice cream and expected to stay at the hospital least four days.

Exclusion Criteria:

* terminally ill, tube feed, need of special diets, any medical indication suggesting that they should not participate or are on a weight reduction scheme
Theory of Mind in Children With DCD

The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor).

During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).


Eligibility Criteria:
Inclusion Criteria:

* Age of child: from six to 12 years old
* Confirmed diagnosis of DCD by a multidisciplinary team (including a physician)
* Child lives in Flanders or the Netherlands
* Child has Dutch as the mother tongue

Exclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD)
* Blood related siblings of the child
* Parent/legal guardian does not have an adequate level of Dutch
* (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))
Communication Skill and Related Factors Among Oncology Nurses

This study is a 1-year quantitative method research.Data collection will be divided into oncology nurses and cancer patients.To explore the related factors of clinical oncology nurses on the psychological aspects of cancer patients.

Background:Nurses who care for cancer patients on the front line play an important role in the psychological care, distress assessment and management of cancer patients. Most of these cancer patients do not directly express their concerns to the nursing staff. Nursing staff should be able to assess and identify psychological needs through verbal and non-verbal messages during the nursing period, and provide effective information, general psychological support and rich psychological support in nursing measures. The ability to communicate empathetically and avoid ignoring psychological needs that may cause distress to the patient. Therefore, an in-depth understanding of the first-line tumor nurses interacting with patients, and the related factors that affect communication with patients, such as workload, fatigue, self-confidence, etc., are crucial factors for detecting psychological problems in cancer patients. It directly affects the body and mind of cancer patients, and exploring its related factors is of course an important topic.

Purpose: Understand current clinical oncology nurses, work load, emotional state, self-confidence, comfort ability, empathy and communication ability related factors, and add patients' measurement of nursing staff's communication ability, empathy and satisfaction, through nurses The results of the patients and nurses are closer to the current clinical situation.

Method:This study is a 1-year quantitative method research. It is a cross-sectional descriptive correlation research, using a structured questionnaire to collect data which will be collected by oncology nurses and cancer patients.

Eligibility Criteria:
Nurse

Inclusion Criteria:

* Over 20 years old (inclusive).
* Nursing staff who are currently working in cancer-related positions and have clinical contact or care for patients.

Exclusion Criteria:

* Nurse who have resigned.

Patient

Inclusion Criteria:

* Over 20 years old (inclusive).
* Diagnosed as a cancer patient by doctors.
* Patients who are known disease status.
* Patients who are currently hospitalized in cancer wards.

Exclusion Criteria:

* People with mental illness.
* Those who are unconscious and unable to complete the interview for this study with language or conversation.
* Those who are unwilling to accept interviews and participate in research surveys.
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis

This study aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.

Carpal tunnel syndrome(CTS), a type of median nerve neuropathies, is the most common peripheral nerve entrapment syndrome. Most cases are idiopathic but CTS can be associated with rheumatologic disorders. There isn't any gold standard technique in diagnosis of CTS. Electrodiagnostic studies (EDS) are usually performed to confirm diagnose, to differentiate other diseases or to detect severity. But EDS have some disadvantages such as EDS are time consuming, uncomfortable, may require interventional procedures, can not directly assess the anatomy of the median nerve and its surrounding structures. For these reasons, the use of ultrasonography (US) in the diagnosis of carpal tunnel syndrome has been investigated for a long time. Most of them focused on the cross-sectional area(CSA) of median nerve. Fewer studies have investigated the vascularity of the median nerve. But there is conflict results because conventional Doppler techniques may fail to show small vessels or slow blood flow. Superb microvascular imaging (SMI) is a new ultrasound technology that can diferentiate blood flow signals from artifacts by using a new algorithm. In carpal tunnel syndrome hypervasularitation of median nerve has showed by SMI. To our best knowledge, there isn't any study assessing median nerve hypervascularity by using SMI in PsA. So we aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.

Eligibility Criteria:
Inclusion Criteria:

* PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study.

Exclusion Criteria:

* Patients were not included in the study if they had a history of wrist or hand fracture, surgery, neurologic disorders such as radiculopathy, polyneuropathy or cerebrovas-cular disease, a history of conditions associated with an increased incidence of CTS such as diabetes mellitus, pregnancy, hypothyroidism or severe systemic diseases.
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Presence of suicidal ideation and/or suicidal behavior in the past month
* Between the ages of 18 and 70
* Able to read, write, and understand English well enough to complete study procedures
* Owns a smartphone

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with completion of study procedures
Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)

The BRAEBON VTS is a low-cost, portable device that is being developed to take continuous and real-time vital sign measurements of COVID-19 patients, both in the hospital and home setting. This study is being undertaken to test the BRAEBON VTS and validate against industry standards.

In response to the COVID-19 pandemic, the BRAEBON Vital Signs Monitor (VTS) has been developed with funding from the National Research Council of Canada Industrial Research Assistance Program through the federal government's Innovative Solutions Canada (ISC) program. The VTS will measure peripheral capillary oxygen saturation (SpO2) and pulse via photoplethysmography (PPG), temperature, blood pressure (BP), heart and respiration rates, electrocardiogram (ECG), head position and movement over a continuous period. This monitor can be used remotely, and importantly will be low-cost so it can be accessed widely. Data from the VTS is transmitted wirelessly to a portable basestation which is a smartphone or tablet device via a customized application. This study will test the VTS both within the clinical environment and in the remote home environment to see how well it monitors patients effected by COVID-19 needing care, as well as satisfying an unmet need for remote monitoring across the healthcare system.

This study will compare the newly developed VTS with an industry gold standard of polysomnography (PSG) in the sleep laboratory, or in the home with the MediByte Jr (home sleep apnea test).

Approximately 150 patients will be recruited to the study across two different settings which includes a hospital setting and a remote setting, within the home environment.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a sleep evaluation using polysomnography
* People referred to the sleep clinic
* Persons over the age of 18

Exclusion Criteria:

* Unable and/or unwilling to consent
* No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)
CHANGE -it is About Life

Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values.

In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus University Hospital
* Diagnose ICD-10:F2 spectrum
* Waist circumference \> 88 cm for women or \>102 cm for men

Exclusion Criteria:

* Not willing to participate