cyrilzakka/clinical-trials huggingface dataset:
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19

The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.

It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs.

Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at time of informed consent
* Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
* Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio \>100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.

Exclusion Criteria:

* Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
* Active bacterial, fungal, or parasitic infection
* History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
* Current participation in an interventional clincial trial
* Subjects who have, at screening, been on mechanical ventilation for \>7 days Have evidence of kidney and liver failure at screening
* Have a hereditary complement deficiency
* Pregnancy or breastfeeding
Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation.

The main question are

* How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation?
* Does the use of a suction catheter guided ETT can improve its navigability through the nasal passage and reduce nasal passage time?

Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective oral and maxillofacial surgery in which nasotracheal intubation is preferred over orotracheal intubation to optimize surgical access.
* ASA physical status I-II
* Thai adult, aged 18-65 years old
* Normal Body Mass Index (BMI = 18.5-24.9)

Exclusion Criteria:

* Anticipated difficult airway (e.g., Mallampati classification 3-4, interincisal distance \< 35 mm., thyromental length \< 60 mm., limited neck mobility)
* Nasal infection or systemic infection
* Abnormal coagulation status or having bleeding disorder or taking anticoagulation/antiplatelet medication
* History of recurrent epistaxis since adulthood
* Allergic rhinitis that necessitates the use of glucocorticoids, antihistamine, antileukotriene or decongestant in the past 4 weeks
* History of nasal trauma or abnormality (e.g., trauma in mid-face region, nasal surgery, nasal polyps, chronic sinusitis, abnormal nasal vasculature, tumor in nasal region, radiotherapy in nasal region)
* Craniofacial deformity syndrome
* Using nasal oxygen or Continuous Positive Airway Pressure (CPAP)
* Previous nasotracheal intubation or nasogastric tube placement within 3 months
* Diagnosed as having a mental disorder

Drop-out criteria:

* Unable to complete intubation procedure
* Intubation failed on both nostrils
* When intubation was only possible with a tube smaller than 6.5 internal diameter (ID) in male and 6.0 ID in female
* Inadequate data collection
Effects of Fasting on Self Efficacy

The study aims to investigate

* if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with chronic diseases
* the effects of fasting on physical and mental well-being, quality of life and body awareness/image
* the association between patients characteristics and the perceived health benefit after fasting
* the association between Diagnosis according to traditional Chinese medicine and physical and mental well-being during the course of fasting
* experiences and perceptions of patients during fasting therapy

see above

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI\<18 or \>35, no eating disorder)

Exclusion Criteria:

* psychiatric disorder
* type 1 diabetes
* hepatitis
* severe somatic disorder (oncological disease, hepatological or nephrological)
* pregnancy
Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis

The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histological confirmation of breast malignancy
3. Primary or recurrent disease eligible
4. Patients after breast lumpectomy and that scheduled to receive radiotherapy
5. Patients that receive minimum of 45 Gy
6. Ability to complete questionnaire(s) by themselves or with assistance
7. Provide informed written consent

Exclusion Criteria:

1. Patients with prior radiotherapy to any portion of the planned treatment site
2. Tumour involvement of the skin
3. Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
4. Patient with other skin diseases/ skin disorders
5. Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
6. Recent use of any of the following within 21 days of first swab collection: o Systemic or topical steroids o Use of systemic immunosuppressant drugs o Use of ultraviolet light therapy
7. Prior usage of other topical and systemic medications within 21 days of first swab collection
8. Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
9. Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
10. Prior organ or bone marrow transplant
11. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment

Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. It has not yet been tested in toddlers.

The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with PTSD and their parents. A randomized control trial could examine the efficacy of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group.

Our research hypotheses are:

1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.
2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents.
3. These results will be preserved in a follow-up of 3-6 months post treatment. Following psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50 participants in each group).

Beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.

Eligibility Criteria:
Inclusion Criteria:

1. Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
2. Toddlers whose parents are living together

Exclusion Criteria:

1. Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
2. Toddlers with intelectual developmental disorder
3. Toddlers with an active psychosis
4. Toddlers with blindness or deafness
5. Toddlers who are currently taking psychotropic medication
6. Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms
7. Toddlers diagnozed with autism spectrum disorder
8. Toddlers who were exposed to domestic or sexual violence
Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis (TB) infection control known as FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively). It is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of TB to health care workers.

There is longstanding evidence that tuberculosis (TB) transmission is not from TB patients on effective treatment, but from unsuspected cases, and cases with unsuspected drug resistance. This study seeks to investigate the implementation of a refocused TB transmission control approach that we call FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively based on molecular drug-susceptibility testing \[DST\]). We will conduct this study at Hospital Nacional Hipólito Unanue in Lima, Peru. Our hypothesis is that FAST will reduce delays in identifying infectious TB patients (and unsuspected drug resistance) entering the hospital, facilitate timely effective therapy, and thereby reduce the risk of TB transmission in a cost-effective manner. We will assess the impact of FAST on TB transmission by evaluating IGRA conversions among health care workers at the intervention site, Hospital Nacional Hipolito Unanue (HNHU), and two control sites, Hosptial Nacional Arzobispo Loayza (HNAL) and Hospital Nacional Sergio Bernales (HNSB). We will also evaluate acceptability and barriers to/facilitators of FAST, novel screening strategies, and health care worker IGRA testing using a mixed methods approach.

Eligibility Criteria:
Inclusion Criteria (for patients):

* adult (≥ 18 years) patients who are receiving care in the emergency department or being admitted for inpatient care from any other hospital area
* patient presenting with cough or TB risk factors of prior or current TB diagnosis and/or contact of an individual with TB
* able to participate by providing a sputum sample and/or exhaled breath test sample

Exclusion Criteria (for patients):

* no specific exclusion criteria at initial screening if the patient meets the above inclusion criteria.

Inclusion Criteria (for health care workers):

* being an employee or intern at Hospital Nacional Hipolito Unanue (HNHU), Hospital Nacional Arzobispo Loayza (HNAL) or Hospital Nacional Sergio Bernales (HNSB) and deemed to be at risk of exposure to tuberculosis based on line of work
* age ≥ 18 years
* willing and able to provide informed consent for participation

Exclusion Criteria (for health care workers):

* no specific exclusion criteria
Vitamin D in Pregnancy

Danish pregnant women are recommended ad daily vitamin D supplement of 10 µg. Despite the fact that 9 out of 10 women take vitamin D supplements, more than 40% of pregnant women are vitamin D deficient, putting them at an increased risk of pregnancy complications like fetal growth restriction and pre-eclampsia. Our hypothesis is that pregnant women would benefit from an increased intake og vitamin D and that an intake of 90µg/day can reduce the prevalence of placenta-related pregnancy complications. Combining a double-blinded randomized trial (10µg vs.90µg) with collection of placental material, we want to test if the prevalence of pregnancy complications is reduced and explore how vitamin D affects placenta to improve our understanding of the disease pathology and risk factors.

As vitamin D (vit-D) is essential for growth and linked to placental function, health authorities recommend a daily 10µg vit-D supplement in pregnancy. Despite the fact that 9 out of 10 women take supplements, more than 40% of pregnant women are vit-D deficient, putting them at an increased risk of pregnancy complications like fetal growth restriction and pre-eclampsia. These conditions affect 6-10 % of all pregnancies, increasing the risk of preterm delivery, perinatal morbidity and mortality. In worse case, preeclampsia may also be fatal for the pregnant women herself. Around 20% of vit-D intake comes from the diet (e.g. fish, egg yolk) and the rest from sun-exposure. However, in Denmark, there is not enough sunlight from October to March to fuel vit-D synthesis underlining the need for supplementation. The high prevalence of vit-D deficiency indicates that current guidelines are not sufficient. Indeed, today´s recommendations date back to a small-scale 1986 Norwegian study not taking into account dietary differences such as the high intake of fish in Norway. Since then, accumulating evidence has linked exposure to pregnancy complications and vit-D deficiency per see to long-term health problems in the affected children. This include a higher risk of asthma, cardiovascular disease, diabetes, obesity schizophrenia, neurodevelopmental problems and multiple sclerosis. Notably, the affected women also suffer an increased risk of disease, e.g. heart disease in later life. Vitamin D supplements in the range of 90-100 µg are safe in pregnancy, but it is not yet known if and to what extent increased vitamin D supplementation prevents pregnancy-related diseases. Combining clinical testing of 90 µg vitamin D supplements, with identification of which placental pathways that are affected by vit-D would considerably improve our understanding of disease pathophysiology and the role of vit-D and improve the health of future generations in an easily implementable way.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women attending the nuchal translucency scan in week 11-13 of gestation as part of the national prenatal screening program

Exclusion Criteria:

* Age\< 18 years
* Women with calcium metabolism disorders,
* Women who gets doctor prescribed vitamin D treatment
* Women with chronic kidney disease
The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3

The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.

This randomized comparative study was performed in Liepaja, Latvia, on 99 outpatients, with vitamin D levels below 30 ng/ml. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Before intervention blood samples were taken to determine vitamin D3 level, creatinine, and GFR, each participant received vitamin D3 4000 IU daily for 30 days. After that blood test was performed again, to measure changes in vitamin D3 levels in the blood. Participants answered the questionnaire to collect information about things that might affect vitamin D3 levels, such as dietary habits, physical activities, usage of sunscreen, compliance, etc.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D3 level in the blood below 30 ng/ml.

Exclusion Criteria:

* Celiac disease, Crohn's disease, ulcerative colitis, autoimmune gastritis.
* Patients with mental health problems.
* Vitamin D level ≥ 30 ng/ml.
* Pregnant women.
* Any other illness or condition that the researcher deemed may interfere with the results.
* Patients who refuse the studies.
Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D

The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.

Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D \[25(OH)D\] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men.

A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.

Eligibility Criteria:
Inclusion Criteria:

* overweight (BMI 25-40 kg/m2)
* fasting triglycerides ≥ 1.5 mmol/L
* fasting insulin ≥ 60 pmol/L
* non-smoking
* stable weight in the past 3 months

Exclusion Criteria:

* diabetes
* chronic diseases
* taking drugs that could affect glucose or lipid metabolism
* taking dietary supplements or natural health products
* major surgery 3 months prior to the study
* fish or seafood allergy
* lactose intolerance
Comparison of Therapeutic Efficacy Between Intralesional Bleomycin and Cryotherapy in Plantar Warts

A randomized control trial to compare the efficacy difference between intralesional bleomycin and cryotherapy in treating plantar warts.

In spite of many available studies on bleomycin and cryotherapy in treating warts, little head-to-head research is carried out to compare the efficacy of these treatments. This study shows clear difference in the clearance of warts treated with intralesional bleomycin and cryotherapy.

Eligibility Criteria:
Inclusion Criteria

-healthy individuals of both genders between 18 to 50 years

Exclusion Criteria

* Pregnant and Lactating women
* history of vascular diseases/ chilblains
* Immunocompromised patients
* Treated previously for warts
GABA Treatment in Subjects With Type 1 Diabetes

test if a food supplementation with GABA can improve insulin production capacity in type 1 diabetes patients by turning alfa cells into beta cells in accordance with mice and cell studies.randomised parallel study with placebo as control

our results indicate that alfa-cells can be regenerated and used to regenerate functional beta-like cells in vivo in type 1 diabetes models. Aiming to eventually apply these findings to type 1 diabetic patients, we initiated multiple screens seeking for compounds inducing alfa-to-beta-cell conversion. Using the mouse as a model, we thereby found that GABA (gamma-aminobutyric acid) could promote a cycle of conversion of alfa-cells into functional beta-like cells,GABA being considered as a non-harmful food supplement, one could envision a trial in type 1 diabetic patients. Indeed, a putative cure for type 1 diabetes may include halting the autoimmune insult to the pancreatic beta-cells and restoring insulin secretion by expanding beta-cell mass by beta-cell-regeneration and/or preventing beta-cell apoptosis induced by cytokines. Immunosuppression initiated at the onset of type 1 diabetes has been shown to preserve beta-cell function, but is associated with significant toxicities. Other studies using nicotinamide and parenteral insulin have failed to prevent development of type 1 diabetes.

Objectives Primary objective: To investigate the effect and safety of the dietary supplement GABA provided at a dose of 6 g daily compared to placebo for 12 weeks on change in beta-cell function in patients with C-peptide negative type 1 diabetes as an adjunctive therapy to insulin treatment.

Population A total of 30 patients with C-peptide negative type 1 diabetes, randomised 2:1 GABA: Placebo.

Intervention After randomisation patients are treated with the dietary supplement GABA or matching placebo, titrated to 3 x 2g, or maximum tolerated dose, for 12 weeks. The insulin dose is reduced if needed according to Self-monitored blood glucose (SMBG) and hypoglycaemic episodes.

Eligibility Criteria:
Inclusion Criteria:stimulated c peptide \<0.03 mmol/l type 1 diabetes

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Exclusion Criteria:

* • Type 2 diabetes

  * Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
  * Pregnant or nursing women
  * Cancer unless in complete remission for \> 5 years
  * Treatment with oral glucocorticoids
  * Hypoglycaemia unawareness (unability to register low blood glucose)
  * Known or suspected hypersensitivity to trial product or related products
  * Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
  * Receipt of an investigational drug within 30 days prior to visit 0
  * Simultaneous participation in any other clinical intervention trial
  * Chronic systemic use of steroids
  * Seizure disorder
  * Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica