cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Sublingual Sprayable Microemulsion of Vitamin D on Inflammatory Markers in COVID-19 Patients

This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups. Vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) is given three times daily after breakfast, lunch, and dinner (daily dose 12,000 IU) to patients with blood vitamin D levels below 30 ng/ml. The control (placebo) group recieves a placebo spray in the same daily regimen.

This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups.

The aim of this study is to investigate the impact of the high dose vitamin D supplementation on laboratory markers of systemic inflammation such as CRP, ferritin and IL-6 in hospitalized patients with COVID-19. The blood samples are analyzed at the Joint Laboratory of the Pauls Stradins Clinical Univesity Hospital. Patients with confirmed SARS-CoV2 infection (PCR) will be randomly divided into two groups: the intervention group receives vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) of 4,000 IU three times daily after breakfast, lunch and dinner; the control group receives the same regimen of placebo spray.

A total of 100 inpatients will be selected for the study. All patients will receive standard care for COVID-19 and existing comorbidities (diabetes, arterial hypertension, etc) according to hospital-approved protocol. The primary outcome is defined as the change in the level of the inflammatory marker and the disease's severity.

Population. Disease severity is defined by the blood oxygen saturation level. Mild clinical manifestation is characterized by SpO2≥94%, moderate 90%≤SpO2\<94% and severe - SpO2\<90%. Age, BMI, GFR, vitamin D and COVID-19 severity are considered as randomization parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 and over
* Vitamin D level below 30 ng/ml
* Positive SARS-CoV-2 test

Exclusion Criteria:

* Patients with mental health problems,
* eGFR ≤30 ml/min,
* 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
PICAROS - Acalabrutinib RWE on 1L CLL in Spain

This is a multicenter non-interventional study (NIS) on patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit in Spain

This is a multicenter, non-interventional study (NIS) based on ambispective (including retrospective and/or prospective) real-world data collection of patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit, from approximately 50 Hospitals in Spain. Patients who had already initiated acalabrutinib therapy will be identified by the investigators and offered to participate in the study.

The start of acalabrutinib treatment (index date) must be prior to the first site initiation visit. Therefore, the clinical decision of starting patient on acalabrutinib has independently occurred prior to the patient inclusion into this study. Patients' eligibility for study inclusion is regardless of their current status of acalabrutinib therapy, for example, patients already deceased or discontinued therapy are still eligible to be included into this study. Patient data will be collected both retrospectively and/or prospectively up to 3.5 years from the first site initiation visit. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old at starting acalabrutinib treatment.
* Diagnosis of CLL.
* Start of acalabrutinib treatment (index date) in treatment-naïve CLL patients or those switching in first-line between first-generation BTK inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit. Decision to administer acalabrutinib must be made and documented prior to inclusion into the study and must follow local clinical practice.
* Informed consent (for alive patients).

Exclusion Criteria:

* Enrolled in any clinical trial during acalabrutinib treatment.
* Patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the Spanish language or their health status.
Distribution of CYP2D6 Multiplication, CYP2D6*5, and Clinical Implications in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia

Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6\*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.

VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Eligibility Criteria:
Inclusion Criteria:

* Post operative patients who get analgesic tramadol

Exclusion Criteria:

* No exclusion criteria
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis

The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* moderate carotid artery stenosis

Exclusion Criteria:

* history of arteritis
* heavily calcified plaque
* uncontrolled hypertension
* poorly controlled diabetes
* hypercholesterolemia
A Study of Nasal Glucagon in Participants With a Common Cold

The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes NG and the effect of NG on the body. The study will last up to 30 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participant presenting a score of 2 or 3 on nasal congestion and/or nasal discharge associated with at least one other symptom of common cold, as determined by the 8-item Jackson cold scale at screening and prior to dosing of period 1.
* Participant with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kilogram per square meter (kg/m²).
* Light-, non- or ex-smokers.
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, electrocardiogram \[ECG\] and urinalysis).

Exclusion Criteria:

* Presence of any nose piercings.
* History of significant hypersensitivity to glucagon, oxymetazoline or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
* Presence of severe fever (more than 39.5 degrees Celsius) at screening or prior to dosing of period 1.
* Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors.
* Presence or history of Type 1 or Type 2 diabetes.
* Presence or history of significant hypoglycemia or hyperglycemia.
* Use of beta-blockers, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before day 1 of the study.
* Fasting blood glucose above 6.1 mmol/L at screening, following a 12-hour fasting period.
* Fasting blood glucose assessed with a glucose meter above 6.1 mmol/L approximately 0.5 hour before each dosing.
Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators

The COVID-19 pandemic has deeply and globally impacted usual procedures and patients management in cancer centers. The aim of this study is to set-up and collect indicators to follow-up the activities of different cancer pathologies before and during the pandemic. Patients loss' of chance will be analysed in term of diagnosis and access to care (surgery, antineoplastic treatments).

Data collection will focus on the analysis of 2 specific pathologies for French patients in the "Auvergne-Rhône Alpes" Area: peritoneal carcinosis and hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.

Exclusion Criteria:

* Patients who did not allow the reuse of their medical data for research
Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting

Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.

For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Subjects who have been performed a colonoscopy

Exclusion Criteria:

* Subjects being previously performed colon surgery.
* Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
* Subjects with extreme limitations due to disease.
* Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
* Subjects who have undergone a colonoscopy during their participation in another clinical study.
Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs

DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.


Eligibility Criteria:
Inclusion Criteria:

Known AFF group

1. A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
2. Is a patient at the UHN osteoporosis clinic.

Comparison Group

1. Must be scheduled for a bone mineral density scan at UHN
2. Have been on any bisphosphonate for 5 years or longer, and;
3. Have unexplained symptoms of leg, hip, thigh, or knee pain.

Exclusion Criteria:

* There are no exclusions
A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants

The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.


Eligibility Criteria:
Inclusion Criteria:

* Overall good health, on the basis of full physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Body weight 50 - 100 kilogram (kg), body mass index (BMI) 18 - 30 kilogram per meter square (kg/m\^2), inclusive at screening
* Platelet count within range: 145 to 350\*10\^9/liter (L), inclusive at screening
* Hematologic values, coagulation profile, renal and liver function within normal range at screening or if out of range and considered not clinically significant by the investigator
* Non-smoker for at least the previous 3 months prior to screening and negative urine cotinine test at screening and admission

Exclusion Criteria:

* History of any clinically significant medical illness or disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Has a disease or disease treatment history associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease
* Has a personal history of genetic or congenital prothrombotic condition or new conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction, cerebral vascular accident/stroke, deep vein thrombosis, pulmonary embolism, hemophilia, or menometrorrhagia
* Participants who had received hematopoietic growth factors within 3 months prior to study drug administration
* Donation of blood or blood components within 90 days prior to drug administration
Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study

This study attempts to verify whether different types of catheters could impact on patients' feelings at the first-time catheter insertion at urodynamic study.

Each patient will undergo an insertion of only one type of a catheter and will rate his/her pain and discomfort feelings.

Urodynamic study usually starts with non-invasive uroflowmetry following by insertion of a urethral catheter (nelathon or tiemann tip) for measuring of post-void residual of urine. Insertion of a urethral catheter is usually accompanied by a discomfort and sometimes even a pain. In order to minimize these unpleasant feelings urodynamic technician uses gel with anesthetic agents.

Single-use sterile catheters without any equipment and no coating can be used with lubricants and nowadays are the standard equipment at urodynamic study. Non-coated standard catheters are widely considered in the literature to cause an increase in urethral irritation, poor patient satisfaction, increased bacteriuria, and long-term urethral complications. Single-use sterile catheters with hydrophilic coatings, ready-to-use solution, with gel on the surface of the catheter or gel in the wrapping. Hydrophilic-coated catheters are characterized by having a layer of polymer coating, which absorbs and binds water to the catheter up to 10 times its own weight. This results in a thick, smooth and slippery surface reducing friction between the catheter surface and the urethral mucosa during insertion. The coating layer remains intact upon introduction into the urethra and ensures lubrication of the urethra in its entire length. Coloplast Speedicath hydrophylic catheters are designed for single use and are pre-coated to allow ease of insertion and removal, thereby reducing the risk of urethral mucosal irritation that can be more prevalent in an non-coated product.

Up today, there are no studies to verify whether a patient has different feelings with different type of catheters during the first-time urethral cauterization at urodynamic study.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients
2. Age 18 and above
3. Scheduled and consented for urodynamic study
4. Able to sign an informed consent and agree to be included to a study.

Exclusion Criteria:

1. indwelling catheter
2. use of pain killers in 24 hours prior to urodynamic study
3. persistent abdominal, perineal or pelvic pain or discomfort prior to a study
4. prior or suspected urethral stricture
5. urinary tract infection
6. positive asymptomatic urine culture prior to urodynamic study
7. scheduled for a transurethral cystoscopic examination at the same day
Effect of Phototherapy on Serum Calcium

Through this study our aim was to evaluate whether significant change in serum calcium level occurs in term newborns who are undergoing phototherapy and to find out the association between effect of phototherapy on serum calcium level and birth weight, postnatal age and type of feeding.

Jaundice is the yellow discoloration of skin, sclerae, and other tissues caused by the deposition of bilirubin.

Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life, and about 10% of breastfed babies are still jaundiced at 1 month. Jaundice is a common cause of readmission to hospital after early discharge of newborn infants.

The most common form of hyperbilirubinaemia observed in neonates is due to unconjugated or unbound bilirubin. High levels of unconjugated bilirubin are managed by treatment of the underlying cause (e.g. dehydration and sepsis), provision of phototherapy, administration of immunoglobulin (in certain cases of haemolytic anaemia) and, in very severe cases, exchange transfusion. If left untreated, extreme elevation of unconjugated bilirubin can lead to permanent brain damage (kernicterus) and/or death.

However, exchange transfusion is associated with a significant morbidity, and even mortality while phototherapy has several disadvantages which include increasing the duration of hospitalization, costs and mother-child separation . It also has some reported side effects as rash, loose green stools, dehydration, ocular hazards, oxidative injury, hyperthermia and water loss and may be associated with some long-term side effects such as melanocytic nevi, skin cancer, allergic disease, patent ductus arterious and retinal damage .

Some studies are available concerning the prevalence of hypocalcemia in neonates after phototherapy, but the results varied based on where the studies were conducted. So, more studies were required to reach a definite conclusion. Through this study our aim was to evaluate whether significant change in serum calcium level occurs in term newborns who are undergoing phototherapy and to find out the association between effect of phototherapy on serum calcium level and birth weight, postnatal age and type of feeding.

Eligibility Criteria:
Inclusion Criteria:

* Stable term neonates with jaundice who require management with phototherapy and are fed with full strength formula or breast fed.

Exclusion Criteria:

* Jaundiced neonates with hypocalcemia.
* Jaundiced neonates needing exchange transfusion.
* Jaundiced neonates suffering from hypothyroidism.
* Jaundiced infants of diabetic mother.
* Jaundiced infants with other illness as severe RDS, perinatal asphyxia,Sever sepsis or hemolytic disease of newborn.
* Jaundiced infants with congenital abnormalities.
Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris

The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.

The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject of any ethnic background of 12 years or older.
* Subject with mild or moderate facial acne vulgaris defined as an Investigator Global Assessment (IGA) score at 2 or 3 on a 0-4 scale.
* Subject with any skin phototype according to T.B. Fitzpatrick skin phototype definitions.

Exclusion Criteria:

* Subject with severe acne (IGA\>3) with nodules, cysts, scars or extra-facial lesions,
* Female subject who is pregnant, lactating or planning a pregnancy during the study,
* Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,
Feasibility and Effects of Activity Trackers Among Alcohol Users Receiving In-patient Treatment for Alcohol Use Disorder

The main objective is to assess the feasibility and effectiveness of using activity trackers to increase physical activity and improve the emotional state of people receiving an in-patient treatment for alcohol use disorder


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years old or older.
* Be undergoing inpatient treatment for alcohol use disorder.

Exclusion Criteria:

* Finishing the treatment before 4 weeks.
Topical Application of Latanoprost in Diabetic Retinopathy

Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.

The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-36 years old
* Diabetes mellitus with retinopathy

Exclusion Criteria:

* Pregnancy
* Previous ocular disease other than diabetic retinopathy
* General disease with possible influence on the eye