cyrilzakka/clinical-trials huggingface dataset:
Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion

The objective of this study is to assess if prolonged storage time of a packed red blood cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such as cardiac surgery patients. The investigators will also evaluate the potential reversal effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood transfusions.

Patients will be randomized into one of the three groups:

I. Blood transfusion stored for less than 10 days II. Blood transfusion stored for more than 30 days III. Blood transfusion stored for more than 30 days days plus inhalation of Nitric Oxide at 80 part per million for an hour during blood transfusion.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Elective cardiac or aortic surgery
3. One or more blood transfusions scheduled for clinical reasons
4. Presence of an arterial catheter and pulmonary arterial catheter

Exclusion Criteria:

1. Emergent cardiac surgery.
2. Patients requiring irradiated or washed blood transfusions.
Machine Learning Predict Acute Kidney Injury in Patients Following Cardiac Surgery

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The investigatorshere developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes.

The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years who underwent cardiac surgery

Exclusion Criteria:

* data miss greater than 10%
Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis

Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids require formulations with mild to moderate potency while high-potency corticosteroids era required in less responsive conditions. The aim of the present study is to compare the safety and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid) versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5% prednisolone cream will be as effective as 0.1% betamethasone cream and will be an alternative option to treat corticosensitive dermatosis in body areas where the use of fluoridated corticosteroids is contraindicated, such as the face.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with corticosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis, psoriasis) mild to moderate in intensity;
* Compliance of the subject to the treatment protocol;
* Agreement with the terms o the informed consent by the participants
* Subjects who did not use the following medicines before inclusion: topical corticosteroids or other therapies to dermatitis (30 days); oral corticosteroids (180 days); parenteral corticosteroids (180 days); immunomodulators/immunosuppressor (30 days); any drug under investigation (1 year); any therapy for the studied clinical conditions (180 days); keratolytic agents (30 days); emollient agents (30 days); tazarotene (30 days); vitamin D (topical or oral, 30 days); methotrexate (30 days); acitretin (2 years); UV light (30 days); PUVA therapy (30 days).

Exclusion criteria:

* Pregnancy or risk of pregnancy
* Lactation
* History of allergy of any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility
* HIV positivity
* Drug abuse
* Subjects without previous response to topical corticosteroids
* Subjects with intense sun exposure within 15 days of the screening
Effects of L-Theanine in Boys With ADHD

This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of attention deficit hyperactivity disorder (ADHD)

Exclusion Criteria:

-
Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism

High levels of fatty substances in the blood increase the risk of developing coronary heart disease and having a heart attack. The investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. The investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). The investigators are developing new techniques to measure these processes in healthy people. Ultimately a deeper understanding of the regulation of this process might lead to the development of new treatments for fat accumulation in the liver and high blood fat levels and related disorders. The present study is an investigation of how these processes relate to various bodily characteristics such as thinness and fatness and the distribution of fat in the body.

The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism.

Purpose and design:

The investigators are asking the research question: "How does the amount and type of sugars consumed, such as those found in soft drinks, influence postprandial fatty acid and liver fat metabolism?"

It is known that consuming fructose by itself or with glucose can increase plasma triglyceride concentrations and liver fat amounts but it remains unclear how this happens.

To address this research question investigators want to undertake detail physiological studies, in a randomised cross-over study where individuals will be studied twice after the consumption of a single test meal that will contain different amounts of glucose and fructose with the same amount of dietary fat.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* BMI \>19 \<35kg/m2
* No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism

Exclusion Criteria:

* Age \<18 or \>65 years
* Body mass index \<19 or \>35kg/m2
* A blood haemoglobin \<120mg/dL
* Any metabolic condition or relevant drug therapy
* People who do not tolerate fructose
* Smoking
* History of alcoholism or a greater than recommended alcohol intake
* Pregnant or nursing mothers
* Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
* History of severe claustrophobia
* Presence of metallic implants, pacemaker
* Haemorrhagic disorders
* Anticoagulant treatment
Morton's Neuroma: Manipulation Versus Steroid Injection

This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.

The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of morton's neuroma
* over 18 years of age
* presenting VAS score \> 30mm

Exclusion Criteria:

* diabetes,
* rheumatoid arthritis
* fibromyalgia.
* Those currently taking Statins or analgesics
* previous neuroma surgery
High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients

A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients

OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the treatment of cognitive impairments in 120 chronic patients with schizophrenia.

METHODS:

1. Clinical Trial: The study consists of 8 weeks of treatment.
2. Assessment Procedures:

2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks.

2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists, which is comprised of a total score and 5 age-adjusted index scores for attention, language, delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese version of RBANS has been evaluated for the test-retest reliability and clinical validity between schizophrenia patients and control subjects. Cognitive performance was measured at baseline and at 8-weeks.

2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks.

2.5 Weight gain measurement: weight gain every week

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizopherenia by two senior psychiatrists
* Male
* Right-handed
* Between 18 and 60 years and Han Chinese
* Duration of symptoms at least 60 months
* Received stable doses of antipsychotic drugs at least 12 months
* With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS \< 24)

Exclusion Criteria:

* A DSM-IV Axis I diagnosis other than schizophrenia
* Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
* Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
* Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
* Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
* Education level less than 5 years by subject report,
* Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
* Subjects who suffered from alcohol or illegal drug abuse/dependence
Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.

Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
* Preoperative total corneal astigmatism ≥0.75D;
* Unilateral or bilateral cataract removal by phacoemulsification;
* Clear intraocular media other than cataract;
* Willing and able to complete all required postoperative visits;
* Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

Exclusion Criteria:

* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.
Study SOLACE SEPSIS

A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients

This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for the trial if they meet all of the following criteria:

  1. Age criteria: 18 - 90 years
  2. Septic shock - Sepsis 3 criteria :

     1. acute change in total SOFA score ≥ 2 due to infection
     2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
     3. blood lactate level ≥ 2 mmol/L within last 24 hours
  3. Likely need for fluid resuscitation

     1. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation \< 70% iv. clouded sensorium/poor mentation
     2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both \> 12% iii. distensibility index of inferior vena caval diameter \> 12%
  4. Signed the relevant informed consent form

Exclusion Criteria:

* Subjects will not be eligible for the trial if they meet any of the following criteria:

  1. Poor transthoracic echo windows
  2. Actual body weight \> 160 kg
  3. Hypernatremia: \[Na\] \> 150 mEq/L
  4. Cardiac tamponade
  5. Uncorrected severe valvular heart disease or life-threatening arrhythmia
  6. Moribund patients likely to die before the study protocol is completed
  7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH \< 7.0, K \> 7.0mmol/L
  8. Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l
  9. Pregnancy and lactation
Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA

The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
* Signed written informed consent before participation in the trial

Exclusion Criteria:

* Known hypersensitivity against any of the ingredients of the investigational product
* Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial
* Local hormonal therapy (vagina/vulva) within 3 months before the trial
* If in the opinion of the investigator the patient should not participate in the study for any reason
Quality of Life in Patients Undergoing Parathyroidectomy

There are three specific aims in the present study:

1. To validate the investigators' translated version of parathyroidectomy assessment of symptoms (PAS) questionnaire.
2. To evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism.
3. To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.

Either primary or secondary hyperparathyroidism may necessitate parathyroidectomy in some patients to improve the related biochemical abnormalities or symptoms, or both. Many patients diagnosed with hyperparathyroidism today do not have the classic or historical severe manifestations such as osteitis fibrosa cystica or nephrocalcinosis. The well-known pentad of symptoms - painful bones, kidney stones, abdominal groans, psychic moans, and fatigue overtones - is more common, although most patients have few dramatic symptoms. The multifactorial causes for many of the symptoms that patients have make it difficult to know to what extent surgical intervention will alleviate the symptoms. Several endocrine surgeons from the western countries have used a standardized health status assessment tool such as the SF-36 (the Medical Outcomes Study Short-Form Health Survey) to assess symptoms and health state in patients with hyperparathyroidism. Results of the studies confirmed that these patients are indeed impaired in several domains and even seemingly "asymptomatic" patients benefit from parathyroidectomy. More recently, Canadian surgeon Pasieka designed and validated a disease-specific surgical outcome tool, the parathyroidectomy assessment of symptoms (PAS) score, for patients with hyperparathyroidism. Using this tool, several studies from different countries showed that the study group of patients with hyperparathyroidism had significantly more symptoms than controls, and some of the symptoms are remarkably ameliorated after surgery. In Taiwan, only a small number of studies have evaluated neuropsychiatric function and neuromuscular abnormalities in these patients. None of the studies has used a patient-based measure of health status or quality of life intended to capture patient-reported perceptions of health and function.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and older

Exclusion Criteria:

* Subjects who are illiterate or unable to complete questionnaire
* Excluded by patient's clinician prior to recruitment
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders

Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Eating Disorder, less than 18 years of age

Exclusion Criteria:

* unable to read and understand English
Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients

The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist \[NAVA\]) is superior compared to pressure support and pressure control ventilation.


Eligibility Criteria:
Inclusion Criteria:

* intubated, mechanically ventilated patients
* meeting criteria for ARDS
* mean arterial blood pressure \> 65 mmHg (with or w/o vasopressors)

Exclusion Criteria:

* pregnancy
* increased intracranial pressure
* contra-indication naso-gastric tube
* diagnosed neuro-muscular disorder
* recent (\<12 hours) use of muscle relaxants
* exclusion from sedation interruption protocol as used in our institution
* open chest or- abdomen
* very high inspiratory flow rate during supported ventilation
* inability to obtain informed consent
Palliative Morphine With or Without Concurrent Modafinil

Oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. However, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. Given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. Given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and confirmed malignancy
* Able to orally consume tablets
* Blood Pressure: Systolic \<144mmHg; Diastolic \<92mmHg
* Normal blood sugar
* No active systemic infections
* Consenting
* Oral morphine being consumed as a part of terminal symptom palliation

Exclusion Criteria:

* Candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future
* Poor performance status (Karnofsky Performance Status score \<50)
* Prior history of hypertension, diabetes, tuberculosis, epilepsy
* Prior history of psychiatric and neurological illness
Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population

The EpiCOPDpt Study (Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population) primary objective is to estimate the prevalence of Chronic Obstructive Pulmonary Disease (COPD) in the Portuguese population aged 20 and over. It is a cross-sectional study of a representative sample of the Portuguese population aged 20 and over, using standardised post-bronchodilator spirometry. Questionnaires will be applied to collect sociodemographic, economic, clinical, and therapeutic data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 years and over, with permanent or temporary residence for at least one year in the national territory;
* Written informed consent for study participation.

Exclusion Criteria:

* Any condition that makes it impossible to perform spirometry, in accordance with standards of the joint American Thoracic Society/European Respiratory Society, and as described in the "Contraindications for spirometry testing" section of the Study Procedures Manual;
* Any condition that makes it impossible to perform the bronchodilation, as described in the "Contraindications for bronchodilation" section of the Study Procedures Manual;
* Severe cognitive disability that may interfere with the person's capability to participate in the study.