cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia

The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the medical ICU or IMU.
* Hemoglobin less than 10 g/dL.

Exclusion Criteria:

* Clinical bleeding. Defined as any bleeding needing an intervention. An intervention could be an increase in the frequency of hemoglobin monitoring, a transfusion, a procedure, or a consultation intended to prevent or treat bleeding.
* Hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia).
* Bone marrow disorder (e.g. aplastic anemia, leukemia, marrow infiltration disorder, chemotherapy within the last 8 weeks).
* Jehovah's Witnesses.
* Patient is comfort care measures only.
* Refractory shock: Mean arterial blood pressure below 65 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.03 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min.
* Severe acidosis: pH below 7 in more than one arterial blood gas in the past 24 hours, in the absence of diabetic ketoacidosis.
* Surgical admission diagnosis.
* Pregnancy.
* Current prisoner
EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP).

Methods: This randomized controlled, single-blind, experimental study was completed with a total of 33 RP patients, 18 of whom were interventions, and 15 were controls. The intervention group was given pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for six months in the postoperative period, and the continuity of the exercises was checked by telephone. On the other hand, no intervention was applied to the control group other than routine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Having the mental competence to understand the questions,
* Radical prostatectomy was performed due to the diagnosis of localized prostate cancer,
* Continuing post-operative follow-up,
* No incontinence problem before surgery,
* Anatomically free of genito-urinary system pathology,
* Those who volunteered to participate in the study were recruited.

Exclusion Criteria:

- With bladder insufficiency (dysfunction),

• Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.
Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved.

Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming.

In this study investigators will study whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. A retrospective study found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment.

This pilot study will allow the investigators to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute myeloid leukemia
* ability to receive treatment for acute myeloid leukemia at the research center
* elevated values of CLL1A and CD45RA positive cells at the time of diagnosis
Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers

Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. Budesonide and Procaterol therefore have complementary effects, treating two different components of asthma.

Test drug: SYN006 HFA MDI Batch No: BPP-033-088 Dosage Form: HFA Metered Dose Inhaler Active Substance: Budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose Dosage regimen: Multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen consecutive doses

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
* Healthy adults, aged between 20 and 40 years old.
* Subjects with Body Mass Index (BMI) of \>=18.5 and \<=25.0 (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
* Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
* Clinical laboratory test: within limit of normal range or acceptable to investigator.

Exclusion Criteria:

* History of drug or alcohol abuse within the past year.
* Medical history of severe drug allergy or sensitivity to analogous drug.
* Evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to Period I dosing.
* Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. Creatinine \> 2UNL (upper normal limit); Liver enzymes \> 2UNL; Total bilirubin \> 2UNL.
* Planned vaccination during the time course of the study.
* Taking any clinical investigation drug from 2 months prior to Period I dosing.
* Use of any medication, including herb medicine from 4 weeks before dosing.
* Donation of 500mL of blood in the past 3 months prior to dosing or donation of 250mL of blood in the past 2 months prior to dosing.
* A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
* A positive test for HIV antibody.
* In screening subjects will be given training to ensure that subjects are able to correctly use the investigational products. If the subjects, the use of the investigational products lack of proficiency will not be included in this study.
* Students of National Defense Medical Center.
* For female subjects, if they meet any of the following criteria:

  1. Lactating women
  2. Positive pregnancy test (urine) at screening, or prior to dosing
  3. Do not use adequate contraception during the study
  4. Women taking oral contraceptives
Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa

The aim of this study is to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP).

This randomized controlled trial aims to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP) on aspects such as vulnerability to stress, perceived stress, psychopathological state, general self-efficacy, resilience, satisfaction with social support and visual field. This study has two groups: 1) cognitive - behavioral therapy group, and 2) Standard intervention or control group. The two interventions will be conducted for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Retinitis Pigmentosa (legally blind RP patients).
* meet the membership criteria of the Spanish National Association of ONCE.
* having a reduction of the visual field of at least 10 degrees in both eyes
* having an age between 18 and 65 years.

Exclusion Criteria:

* no visual remainders (advanced retinosis).
* no studies.
* cognitive impairment, determined by the Spanish Mini-Mental State Examination - MMSE test.
* mobility problems
* high risk of falls associated with retinosis, measured by the Morse scale, with a score over 50 points.
Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study

The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems

The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems.Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm \[10\].

* Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients.
* Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics.
* Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced).
* Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics).

The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form filled out completely

Eligibility Criteria:
Inclusion Criteria:

* • Teeth with a single root canal with nearly the same apical diameter (#15)

  * Vital pulp exposures due to caries or trauma with asymptomatic pulpitis
  * Restorable teeth

Exclusion Criteria:

* • Patients with immune deficiencies or systemic illnesses

  * Pregnant women
  * Cases of re-treatment
  * Symptomatic non-vital teeth that require root canal therapy
  * Presence of root resorption
  * Teeth with anatomic variations
  * A cute periapical abscess cases with pus discharge
  * A patient who has several teeth that need to be treated in order to eliminate the likelihood of pain referral
  * Periodontal diseases
  * Patients on analgesics, anti-inflammatory drugs, sedatives, or antibiotics seven days before therapy
Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets

The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of Annona muricata as add-on therapy in a hypertensive population.

Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial.

The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of Annona muricata leaves.

The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM tablets in a population of African hypertensives.

Blood pressure profile, lipid profile, serum creatinine and transaminases profiles will be recorded and analysed at baseline and two months following enrolment.

The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of Annona muricata as add-on therapy in a hypertensive population.

Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial.

The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of Annona muricata leaves.

The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM tablets in a population of African hypertensives.

Blood pressure profile, lipids profile, serum creatinine and transaminases profiles were will be recorded and analysed at baseline and two months following enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure between 130/85 mmHg and 159/99 mmHg
* No antihypertensive therapy (determined by the investigator), except the hygiene dietetic measures, for at least 3 months
* No history of hepatic or renal insufficiency
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
* Out of sight.
* Withdrawal of consent
Wireless Handheld 8-lead ECG Device Performance in Heart Patients (Rapid Rhythm)

This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device with the conventional 12 lead ECG. As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm.

An Electrocardiogram (ECG) 6 electrode, wireless handheld device held on the chest is being developed to allow diagnosis of heart rhythm problems without the need for connecting electrodes to the chest, arms and legs as in a standard 10 electrode (referred to as a 12-lead) ECG measurement. A faster and simpler yet accurate method for acquiring ECG data may be useful in many healthcare settings, including screening for irregular heart rhythms such as Atrial Fibrillation (AF), which is a risk factor for stroke. The wireless 6 electrode device has an extension arm for the handset with 4 additional electrodes (also positioned on the chest) to give a full 12 lead ECG signal. This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device (used on the chest with the subject seated) with the conventional 12 lead ECG (used with electrodes on the chest, arms and legs with the subject lying down). As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm. Adult patients attending the clinics at Central Manchester University Hospitals NHS Foundation Trust for an ECG assessment are eligible to participate in the study. A maximum of 500 patients will be recruited to the study in order to find the number of cases with Atrial Fibrillation required to properly compare the methods. A subset of patients with normal ECGs will have additional measurements with both methods whilst lying down, reclining at an angle and sitting upright to investigate any effects of body posture on chest based ECGs.

Eligibility Criteria:
Inclusion Criteria:

1. Patient attending an adult cardiology or anti-coagulation clinic appointment, at clinics at Central Manchester University Hospitals NHS Foundation Trust (including the Manchester Heart Centre).
2. Patients on cardiac wards 3 and 4.
3. Aged 18 years or above.
4. Male or Female.

Exclusion Criteria:

1. Aged less than 18 years.
2. Unable to give informed consent.
3. Does not wish to participate in the study.
4. Any patients with visible breaks to the skin, rashes or inflammation in the chest area on the day of the test
5. Bedridden or otherwise unable to transfer between chair and bed for both seated and supine measurements
Effects of Orthognathic Surgery on Root Resorption and Soft Tissues

The aim of this study is to evaluate the three-dimensional tomographic and photographic evaluation of the provision of two different orthognathic surgeries on hard and soft tissues with informative Class III deformity due to maxillary retrognathia and mandibular prognathia.

Patients who will undergo non-extraction surgery will be randomized as 'Pre-Surgery' (SEC) and 'Early Surgery' (EC). Maxillary advancement and mandibular recession will be calculated and a total of 24 patients, 12 in each group, will be included in the study. Millimetric (length, dehiscence, fenestration) and volumetric measurements and soft tissue anthropometric points will be measured in three-dimensional recordings taken at the beginning of treatment (T0) and after debonding (T1). Cone beam computed tomography (CBCT) images will be transferred to NNT and 'Mimics 18.0' programs for measurements. Three-dimensional photographs will be evaluated in the 3dMDvultus program. Shapiro-Wilk test will be used for normality, 'two independent samples t-test' and 'Mann Whitney U test' will be used for intra-group and inter-group comparisons.

Eligibility Criteria:
Inclusion Criteria:

* They must be over 18 years of age,
* Skeletal Class III malocclusion and need double jaw orthognathic surgery,
* Minimum crowding (patients with crowding between 0-3 mm),
* Complete 3D records before surgery and at the end of treatment,
* No decay on their teeth,
* Good oral hygiene,
* Healthy periodontal tissues.

Exclusion Criteria:

* History of trauma,
* Congenital anomalies or craniofacial deformities
* Congenital tooth loss (excluding wisdom teeth)
Early Systolic Notching in Pulmonary Embolism

Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary embolism (PE), is the third most common acute cardiovascular syndrome after myocardial infarction and stroke. In a study conducted by critical care and emergency physicians, lung ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT, and focused cardiac US in terms of right ventricular strain were demonstrated with different diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic value for PE alone in the literature. In a recent study, it is stated that a new cardiac finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in massive and submassive emboli. However, the limited patient population and the exclusion of many patient groups limits the applicability of the study and its use in other patient groups. With this study, it was aimed to determine the diagnostic value of ESN finding within the emergency department conditions by keeping the patient population wider.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism

Exclusion Criteria:

* Pregnant women,
* Patients under 18 years of age,
* Those who received thrombolytic therapy,
* Poor ultrasound imaging.
Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome

The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain

Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. In this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.

Eligibility Criteria:
Inclusion Criteria:

* Complaint of myofascial pain
* Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)

Exclusion Criteria:

* pregnancy
* presence of coagulopathy, or the use of anticoagulants
* a history of surgery on the block area
* allergic to bupivacaine
* decline to participate
Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients

Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.

Current monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.

Urethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).

The device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.

The probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.


Eligibility Criteria:
Inclusion criteria:

1. 18 years of age or more,
2. Male or female,
3. High-Risk surgical patient,
4. Life expectancy expected to exceed 72 hours,
5. Willing to participate and signed informed consent,
6. Affiliation to the French social security system.

Non inclusion criteria:

1. Pregnant or lactating woman,
2. History of recent urological surgery (bladder surgery, prostate surgery...),
3. Known stricture or "impossible insertion" last hospitalization,
4. Traumatic injury to the lower urinary tract,
5. History of radiotherapy of pelvic or genital area,
6. Genital malformation (Hypospadias...).