cyrilzakka/clinical-trials huggingface dataset:
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics.

Therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from PHH by use of a mixed meal test (MMT).

The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions:

1. Subcutaneous (sc) placebo (saline) injection
2. Sc injection with 80 μg dasiglucagon
3. Sc injection with 200 μg dasiglucagon

Eligibility Criteria:
Inclusion Criteria:

* Documented postprandial hypoglycaemia (\<3.9 mmol/l) by 6-day CGM or during a MMT
* Documented plasma glucose concentration excursions \>5.0 mmol/l by 6-day CGM or a MMT
* Haemoglobin levels for women \>7.3 mmol/l and for men \>8.3 mmol/l
* Ferritin \>10 μg/l
* Cobalamin \>150 pmol/l
* Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l CKN-DASI-RYGB protocol version 1.0 6
* Normal electrocardiogram (ECG)
* Negative urine human chorionic gonadotropin (hCG) (for fertile women)

Exclusion Criteria:

* Treatment with medication(s) affecting insulin secretion or any antidiabetic drugs
* Treatment with antipsychotics
* Current participation in another clinical trial with administration of investigational drug.
* Previous exposure to dasiglucagon (otherwise known as ZP4207)
* History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis).
* Pregnancy
* Breastfeeding
* Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.
Mobile Message Intervention for Stroke Caregivers' Psychological Support

The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.

75% of stroke caregivers report severe caregiver burdens, with 60% of stroke caregivers reporting at least one depressive symptom in Hong Kong. However, caregivers can experience difficulties in accessing and fully utilising existing services due to the varying types of care needs and its intensities amongst stroke survivors.

Ecological momentary intervention (EMI) as an innovative and personalised intervention has shown great potential in supporting psychological well-being; yet, there are no studies on using EMI for the caregivers' psychological support. The proposed trial aims to reduce stroke caregivers' psychological distress by delivering EMI through instant messaging applications to provide personalised and real-time support led by healthcare professionals.

Stroke caregivers screened by Patient Health Questionnaire-9 (PHQ-9) with scores ranging from 5 to 19 will be recruited from multiple sites including community centres, rehabilitation centres and outpatient clinics in public hospitals in Hong Kong, and individually randomised into the intervention group (n=20) or control group (n=20). The intervention group will receive the personalised instant messages for 4 weeks. The control group will receive general health information and regular messages reminding them to participate in follow-up surveys. The primary outcome will be the score of PHQ-9 at 4 weeks. Secondary outcomes will include anxiety, perceived stress, and caregiver burden.

Eligibility Criteria:
Inclusion Criteria:

* Primary family caregiver of stroke survivor
* Able to read and communicate in Chinese
* Able to use mobile phone text messaging function
* PHQ-9 ranged from 5 to 19

Exclusion Criteria:

* Professional medical personnel and care assistants
* Has provided care for \<1 month prior to recruitment
* Has diagnosis of psychiatric disease or is currently taking psychotropic drug
* PHQ-9 ≥ 20 (i.e., severe depressive symptom)
* Currently participating in any type of psychological support intervention
Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19

The aim of this study is prospectively analyzing the histopathological, ultrastructural and microbiological findings from autopsies performed on patients with COVID-19.

The aim of this study is to increase the knowledge of the pathogenic mechanisms of the COVID-19 disease, that will allow us to improve the design of clinical and therapeutic strategies against the disease. This is the tool to improve the prognosis of patients with COVID-19.

The performance of systematic and regulated autopsies can help to manage it. However, despite the need to generate this knowledge and the strong impact on mortality caused by the COVID-19 pandemic, the evidence from post-mortem studies is very limited.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COVID-19 infection confirmed by PCR.
* Death related to active infection by COVID-19 or its complications.
* Informed consent given by the subject's relatives to perform an autopsy according to the autonomous community requirements.
* Informed consent given by the subject's relatives for the inclusion of samples in the Biobank.

Exclusion Criteria:

* COVID-19 infection diagnosed exclusively by serological methods.
* Advanced or terminal chronic disease.
* Inadequate security level of the autopsy room.
Fatty Acid Antiarrhythmia Trial (FAAT)

To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).

BACKGROUND:

Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. This project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted.

DESIGN NARRATIVE:

Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

The investigators therefore propose a pilot study to establish the effectiveness of NIRS Neurofeedback training in reducing the intensity of ADHD symptom expression on children, improvement of the cognitive and global functions associated with ADHD, effects on cerebral blood perfusion in the cortex and safety plus possible unknown side-effects.

Background:

Attention Deficit Hyperactivity Disorder (ADHD) is a mental condition originating in childhood, characterized by symptoms of lack attention, hyperactivity and impulsiveness associated with significant functional impairment. Currently, the use of neurofeedback as a non-drug alternative technique for treatment of ADHD has increasingly spread among the clinical and academic fields, producing relevant findings with regard to its effectiveness. The SCP Neurofeedback and EEG Neurofeedback have been the most studied techniques until the moment, with equipments and systems made available to the market at prices between US$ 10.000 and US$ 20.000, while NIRS Neurofeedback equipments can be found for around US$ 2.000. Due to the low cost of the necessary equipment's and easy access to the technology, the use of NIRS Neurofeedback was opted for in the search to evaluate the techniques effectiveness in the improvement of ADHD symptoms as well as the patients' cognitive performance.

This research is an open label treatment trial with NIRS Neurofeedback training of frontal and pre frontal lobes activation in children school-aged 7 - 12 years old with ADHD. Ten participants will be recruited over 3 months and will be offered 24 NIRS Neurofeedback sessions over 12 weeks, 2 sessions per week. The present study will be carried out as part of the care routine of the Child and Adolescent Psychiatry Services at Hospital de Clínicas de Porto Alegre. Primary outcome will be standard clinical behavioural rating scales. Secondary outcomes will include neuropsychological parameters, neurofunctional parameters using SPECT (Single Photon Emission Computed Tomography), global function, quality of life assessment, side effects and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ADHD clinically.
* Cognitive dysfunction: ≥11/2; standard deviation above norm in at least two neuropsychological measurements: executive functions (inhibitory control), gratification aversion and time processing
* Not having used ADHD medication in at least three months with parental consent for not treating ADHD with medication

Exclusion Criteria:

* Existence of another co-morbid mental disorder which is clinically relevant and demands treatment
* IQ \< 80
Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence

Injection of PRP and hyaluronic acid in stress incontinence patients

Operative details Dissection of the ant vag wall from the urethra and lower part of the bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck) then closure of the vag wall ( after removal of the excess vag tissue.

Eligibility Criteria:
Inclusion Criteria:

* stress incontinence patients

Exclusion Criteria:

* prolapse patients
Sphenopalatine Ganglion Block in Septorhinoplasty

Septorhinoplasty is a widely performed surgery that aims to correct both functional and aesthetic problems of the nose. Despite its expected clinical benefits, septorhinoplasty surgery causes postoperative pain, which affects the patient's functional recovery and satisfaction. Opioids, Non-steroidal anti-inflammatory drugs (NSAII), acetaminophen and local anesthetics are used in peroperative pain management in septorhinoplasty. Sphenopalatine ganglion block (SPGB), which has been recently described and has different application areas, is a regional analgesia technique that has been investigated for this purpose. Although there are studies on postoperative pain in septorhinoplasty surgeries, there are not enough studies on its effects on intraoperative pain.

This study may have positive effects on appropriate pain management, patient comfort and surgical outcomes as multimodal analgesia management in septorhinoplasty surgeries, and may make significant contributions to evidence-based practices.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing septorhinoplasty surgery
* Ages between 18-65
* ASA (American Society of Anesthesiologists) score I-II

Exclusion Criteria:

* Unavailable postoperative pain scores and analgesic use in the hospital registry system
* Local anesthetic drug allergy and toxicity
* Advanced organ failure
* Mental retardation

Patients who are pregnant
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers

The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity.

Physical exertion will be measured by a standardized treadmill test. Sexual activity will be performed in the study subject's home with his/her spouse or regular partner. Each study subject will wear a blood pressure and heart rate monitor at home during their sexual activity and will be asked to complete a one page diary upon completion of the activity. Normotensive and subject with mild hypertension will be studied to determine if hypertensive subjects have a relatively greater increase in their blood pressure during either physical exercise or sexual activity.

Eligibility Criteria:
Inclusion Criteri

1) Male or female age 40-80

Exclusion Criteria

1. Current sexual partner less than six months duration or sexually inactive patients defined as engaging in sexual intercourse less than one time monthly
2. Uncontrolled hypertension (resting blood pressure \>160/100); secondary hypertension; renal failure (serum creatinine \>3.0); congestive heart failure (NYHA functional Class III-IV); acute coronary syndrome; PCI or open heart surgery within past 3 months; cerebrovascular disease within the past 6 months and any other major medical or psychiatric disorder.

   * Individuals who regularly (more than 3 times weekly) perform rigorous physical exercise.
   * Individuals unable to perform an exercise treadmill stress test.
   * Lack of informed consent
EMDR Intervention for Psychological Trauma Among Syrian Refugees

To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.

In this project we aim to treat the posttraumatic stress disorder (PTSD) symptoms among Syrian refugees through an effective psycho-therapy technique called Eye Movement Desensitization and Reprocessing (EMDR). Randomly selected refugees will be assessed through MINI PLUS for the diagnose of PTSD. Eighty refugees with PTSD will be randomly allocated to either 7 sessions EMDR or wait-list control group.Symptoms of PTSD (MINI PLUS, HTQ, IES-R) and depression and anxiety (BDI, HSCL)will be assessed at pre- and post-treatment and 4 weeks follow-up.

However, to our knowledge this is one of the first intervention studies which will be conducted in a refugee camp. Therefore we expect to have some practical and logical problems. In order to see the feasibility and efficacy of EMDR among Syrian refugees, before the main study we aim to run a pilot study with less participants. In the pilot we will assess the posttraumatic stress symptoms with Impact of Event Scale-Revised (IES-R) and the depressive symptoms through Beck Depression Inventory (BDI-II).

Eligibility Criteria:
Inclusion Criteria:

* trauma symptoms

Exclusion Criteria:

* pregnancy
* current or past psychotic disorder
* current or past substance abuse or dependence
* serious physical illness
* active suicidal ideation
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent

Exclusion Criteria:

* 1. Active infection 2. Active bleeding
Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit

treatment of ventilator associated pneumonia in pediatric intensive care unit according to the American guidelines

to assess the degree of adherence of pediatric physicians of assiut university children hospital to the American guidelines of treatment of ventilator associated pneumonia in pediatric intensive care unit searching for defects,obstacles,or need to improve health service.

Eligibility Criteria:
Inclusion Criteria:

- Children of both sexes. - Aged from 1 month to 18 years. - The patients are fulfilling the diagnostic criteria of ventilator associated pneumonia.

Exclusion Criteria:

- Patients aged less than 1 month. - Patients who are intubated and mechanically ventilated for less than 48 hours.
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis

To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past
* Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking
* Patients who are ready to attend regular follow-ups

Exclusion Criteria:

* Patients who have undergone any treatment for OSF in past
* Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's
* Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol
MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

Heart failure affects over 5 million American adults and the risk of heart failure increases with age. Diastolic function typically declines with age. Targeting age-related causal factors leading to the decline in diastolic function in both women and men is a major public health initiative. In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function in older adults. As an exploratory aim, the investigators will determine whether there are differences between men and women in response to this supplementation.

Eligibility Criteria:
Inclusion Criteria:

1. 50 - 75 years of age
2. sedentary-to-recreationally active (\<3 days of vigorous exercise);
3. nonsmokers;
4. healthy, as determined by medical history, physical examination, standard blood chemistries.

Exclusion Criteria:

1. history of cancer
2. history of cardiovascular disease
3. unwilling or unable to take MitoQ supplement;
4. taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications (e.g., aspirin);
5. taking sex hormone therapy
6. presence of menses within last 1 year;
7. taking any other medications (e.g., antihypertensives, lipid lowering medications) that would interact with MitoQ or impact CV function
The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire

The goal of this pilot randomized controlled trial is to test the potential efficacy of Supplemental Nutrition Assistance Program Education (SNAP-Ed) among Bhutanese refugee adults residing in New Hampshire. The main questions are whether direct SNAP-Ed delivered through 6 lessons affects dietary quality and biomarkers of metabolic risk. Participants in the SNAP-Ed arm will be asked to participate in weekly lessons delivered in their homes by a bicultural and bilingual nutrition educator. Individuals in the control group did not receive SNAP-ED. All participants will be asked to complete surveys and provide blood and fecal samples prior at baseline and at the end of the study period (7 to 8 weeks).


Eligibility Criteria:
Inclusion criteria are (1) identifies as a Bhutanese refugee (2) 18 years and older (3) does most of the cooking and shopping for his/her household. Exclusion Criteria are (1) has been told by her/his doctor that she/he has diabetes (2) history of use of glucose lowering medications (3) pregnant or trying to become pregnant (4) currently diets for weight loss or dietary restrictions.
Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS).
* Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus.
* The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis).
* PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.

Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agreed to participate in the study and gave oral consent.
* Patient affiliated to a social security scheme
* Iliac and/or common femoral venous thrombosis
* Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms

And at least 1 of the following criteria:

* Visual analog scale greater than or equal to 5 and/or
* Venous claudication and/or
* Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.

Exclusion Criteria:

* Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.
* Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.
* Thrombosis of inferior vena cava proximal to the renal veins.
* Minors, pregnant women, adults under guardianship.
* Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.
* Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.