cyrilzakka/clinical-trials huggingface dataset:
High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML

Determine the effects of escalated dose of daunorubicin in induction treatment of adult patients with acute myelogenous leukemia who are younger than 60 years of age.

1. Induction chemotherapy

   * For patients randomized to receive regular dose of Daunorubicin (Arm I) will be given Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 45 mg/m2/day by continuous iv infusion over 24 hours daily for 3 days.
   * For patients randomized to receive higher dose of Daunorubicin (Arm II) will be given Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 90 mg/m2/day by continuous iv infusion over 24 hours daily for 3 days.
2. Reinduction chemotherapy

   * Bone marrow aspiration and biopsy will be performed on day 14 of induction chemotherapy. If the bone marrow is hypoplastic and contains no more than 5% blast cells, further chemotherapy will be deferred and the marrow examination will be repeated at the time of ANC ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral blood for the evaluation of complete remission. If more than 5% blast cells persist or if the marrow cellularity in the biopsy specimen exceeds 15%, a course of reinduction chemotherapy will be given.
   * Reinduction chemotherapy consists of Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 5 days along with Daunorubicin 45 mg/m2/day by continuous iv infusion over 24 hours daily for 2 days in both arms.
3. Postremission therapy

   * The same postremission therapy will be given to the patients in both arms.
   * Four courses of Cytarabine 3 g/m2 will be administered in a 3-hour iv infusion every 12 hours (twice daily) on days 1, 3, and 5 for a total of six doses per course. After the four courses of Cytarabine therapy, patients will receive two monthly treatments with Cytarabine (200 mg/m2/day by a 3-hour iv infusion for 5 days) and Daunorubicin (45 mg/m2 by rapid iv infusion on the first treatment day).
   * If patients have HLA-matched sibling or unrelated donors, allogeneic stem cell transplantation will be performed.
   * A complete remission will be defined as ≤ 5% blasts in a normocellular bone marrow with ANC ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral blood and the disappearance of all blasts in bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed AML or RAEB
* 15 years of age or older, but younger than 60 years of age
* Adequate hepatic and renal function
* Normal cardiac function with LVEF ≥ 50% on MUGA scan or echocardiogram
* Written informed consent

Exclusion Criteria:

* promyelocytic leukemia or chronic myelogenous leukemia
* significant infection
* prior chemotherapy history for leukemia
Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure

The purpose of this First-in-Human study is to evaluate the safety of using the Clotild® system to guide the endovascular thrombectomy (EVT) device to the clot location during EVT for the treatment of an acute ischemic stroke eligible to EVT, whatever the EVT device chosen. A secondary purpose is to assess the clinical performance, defined as the feasibility of measuring clot electrophysiological parameters in vivo during EVT procedures.

Clotild® is a neurovascular guidewire equipped with the Sensome proprietary impedance sensor. The latter allows the measurement of the electrophysiological characteristics of the surrounding tissues. Clotild® could categorize the thrombus occluding the cerebral blood vessel, and support the neurointerventionist during mechanical thrombectomy for the treatment of ischemic stroke. The aim of the study is to evaluate the safety and the performance of the device. The electrophysiological measurements will be used to update Clotild®'s database and thus improve the prediction accuracy of the model in providing physicians with insights for mechanical thrombectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT
2. M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT
3. Informed Consent by subject, subject's Legally Authorized Representative (LAR) or anyone approved by the Ethics Committee (EC) and/or regulatory agencies to provide consent on behalf of the subject.

Exclusion Criteria:

1. Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.
2. Current participation in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
3. Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion
4. Pregnancy or lactating subjects
Traditional Dietary Advice Vs. Mediterranean Diet in IBS

Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy.

There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies.

The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.


Eligibility Criteria:
Inclusion Criteria:

* IBS Symptom Severity Scale(IBS-SSS) \> 75
* Online access
* English literate

Exclusion Criteria:

* Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea)
* Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
* History of eating disorder
* Body mass index \<20
* Current dietary interventions
* Current use of opioids/antibiotics
* Titrating dose of neuromodulators
* Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations
* Pregnant
* Diabetes mellitus
* Scleroderma
* Memory impairment
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI

This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).

This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥18 and ≤75 years of age.
* Diagnosed or highly suspected cIAI.
* Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure \< 90 mmhg); c. abdominal pain; d. nausea and/or vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.
* Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood/urine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.
* Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.
* Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form .

Exclusion Criteria:

* Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
* Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.
* Abdominal wall infection or abscess (infection has not spread into abdominal cavity).
* The creatinine clearance rate in the screening period is ≤50mL/min.
* The estimated survival time is less than 4 weeks.
* Those who have a history of drug abuse or drug abuse within 6 months before screening.
* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
* Any physiological or psychological disease or condition that may increase the risk of the experiment, affect the compliance of the subject with the protocol or affect the completion of the experiment as judged by the researcher.
* Subjects are directly related persons who participated in this research.
Effect of Dexamethasone on Labor Induction

Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the a statistician did coding to identify groups of users of pill A or pill B, 14 pills are used vaginally. The patients and the researcher is blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.

Study design:

This study was a clinical trial with the control group, blinded, randomized with a block method that was done at Kamali Hospital, Karaj, Iran.

This study was carried out between October 2019 and June 2021. At first, the researchers registered this study on the RCT(randomized controlled trial) site with the following number: IR.ABZUMS.REC1399.067.

A written consent form was obtained from all patients and the ethics committee of Alborz University of Medical Sciences confirmed the study protocol.

Study selection:

The sample size required to compare the mean of the two groups, with a 95% confidence interval and 90% test power, and considering the technical difference of 0.5 hours, was estimated to be 84 people. Then patients, randomly assigned using the block method with statistician help, were divided into two groups of 42 cases and control.

The present study was performed on 82 full-term pregnant females (38 weeks or more).they had an indication for termination of pregnancy, by accident, and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally. The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher. Group A received 14 dexamethasone tablets with a dose of 0.5 mg for vaginal use and also group B received 14 placebo tablets for vaginal use.

Patients who were Iranian, Prim gravid pregnancy with Normal Body Mass Index (BMI), Single Pregnancy presentation cephalic in Sonography, Aged 18 years old to 35 years old, Gestational age 38 weeks, Bishop score 2 and less, with Normal Non-Stress Test (NST), Estimate of Fetus Weight 2500-4000 gr and didn't take hormonal, herbal and chemical drugs and having a healthy water bag were enrolled to this Study.

Patients who had Medicine and Midwifery Complications, Lack of Desire for Cooperation, Fetal Immobility, and Maternal Bleeding were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Iranian Women
* Primigravid pregnancy
* Normal of Body Mass Index
* Single Pregnancy
* presentation cephalic in sonography
* Gestational age 38 weeks
* Bishop score 2 and less
* Normal Non Stress
* Test Estimate of Fetus Weight 2500-4000 gr
* Didn't take hormonal, herbal and chemical drugs
* having a healthy water bag

Exclusion Criteria:

* Have Medicine And Midwifery Complication
* Lack of Desire for Cooperation
* Fetal Immobility
* Maternal Bleeding
The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services

Current home care service are to a large extent task oriented with a limited focus on care recipient's involvement. Furthermore, studies have shown that low care recipients' involvement might decrease older people's quality of life. Person-centred care focusing on involvement has improved the quality of life and the satisfaction with care for older people in health care and nursing homes but there is a lack of knowledge about the effects and meaning of a person-centred interventions in aged care at home. Present study describes the evaluation of a person-centred and health-promoting intervention.

This is a non-randomised controlled trial with a before-after approach. The investigators will include 270 home care recipients \>65 years, 270 family members and 65 staff in intervention group and control group respectively. Participants will be recruited from a municipality in northern Sweden. The intervention involves letting the person and family together with contact nurse prioritise care content and make rearrangements to make sure the home care service maximises the potential to satisfy psychosocial, physical, and functional needs and increasing health. Outcome assessment will focus on; a) quality of life (primary outcomes), thriving and satisfaction with care for older people, b) caregiver strain, informal caregiving engagement and satisfaction with care for relatives, c) job satisfaction and stress for care staff. Evaluation will be performed by questionnaires and interviews.

Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services and the study result will hopefully lead the way in establish a person-centred and health-promoting model in aged care and living conditions for older people.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for care recipients will be:

* persons 65 years or older
* living at home with granted HCS
* have at least two visits per month, and
* be Swedish speaking

Inclusion for family members:

* be defined by the care recipients as his/her family member, and
* Swedish speaking

Inclusion for staff:

* have an employment for more than 6 month in the HCS district at baseline, be a contact staff and
* Swedish speaking
* Care recipients who apply for HCS in the district during the study period will be offered the intervention but not be included in the evaluation

Exclusion Criteria

* No exclusion criteria
Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users

BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask.

The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time.

ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy.

AIMS

The aims of the study are:

1. To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks
2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks
3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask

It is hypothesised that:

1. The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.
2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.
3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 yrs old
* Diagnosed with obstructive sleep apnoea
* Been using CPAP therapy for at least 6 months

Exclusion Criteria:

* Has a lung disease/condition
* Using bilevel therapy
* Is unable to participate for the duration of the study
The Effects of Inhaled Nitric Oxide After Fontan Operation

Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Male/female patients
* Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
* Written parental permission to participate in this research study

Exclusion Criteria:

* Any condition which the PI feels will interfere with the patient's safe and effective participation
Antithrombotic Activities of Sotagliflozin Vs. Empagliflozin

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible if they meet all of the following criteria:

* Male or female volunteers older than 18 years old.
* Disease-free as assessed by medical history and physical examination.
* Ability to provide signed informed consent.

Exclusion criteria:

Subjects will be excluded if they meet any of the following criteria:

* Pregnant or lactating women
* History of clinically relevant cardiovascular, pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness.
* Use of medication within one month prior to study drug administration or within six times the elimination half-life (whichever is longer), except for oral contraceptives or occasional use of acetaminophen or an antihistamine.
* History of drug abuse or alcohol consumption \>20 g/day \[125 ml (30ml=1oz) glass of 10% wine = 12.5 g, 40 mL aperitif of 40% = 17 g, 250 mL glass of 6% beer = 15g\]
* Loss of \>400 mL blood or blood donation within 3 months.
* Conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.
Prospective Database for Acute Myeloblastic Leukemia

Prospective Database for Acute Myeloblastic Leukemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML