cyrilzakka/clinical-trials huggingface dataset:
Corticosteroid Treatment for Acute Respiratory Distress Syndrome

It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome and to investigate whether corticosteroid attenuate its levels. In addition, to explore the effect of corticosteroid therapy on the prognosis of ARDS.

The acute respiratory distress syndrome (ARDS) is caused by an inflammatory injury to the lung that is characterized clinically by acute hypoxemic respiratory failure. Pathologically complex changes in the lung are manifested by an early, exudative phase followed by proliferative and fibrotic phases. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and disordered deposition of collagen, all of which may be responsive to corticosteroid therapy. Systemic corticosteroids have been considered a potentially beneficial therapy. However, several studies have failed to provide convincing evidence to prove the efficacy of corticosteroids in decreasing the mortality of ARDS. For the secondary outcomes, such as oxygenation improvement and reduction of the duration of mechanical ventilation, have shown consistent findings in favor of corticosteroid therapy. However, the underlying mechanisms that account for the anti-inflammatory actions of corticosteroid in ARDS patients have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism. Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with ARDS. The aim of this study is to determine the role of steroid on IL-18 levels in serum of patients with ARDS and its effect on prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent;
2. Aged 18-85 years;
3. Confirmed diagnosis of ARDS by Berlin criterion

Exclusion Criteria:

1. Active tuberculosis and disseminated fungal infection;
2. Chronic corticosteroid application
3. Patients with organ dysfunction, such as severe liver dysfunction, adrenal insufficiency, severe cardiopulmonary dysfunction;
4. Hypogammaglobulinemia or other autoimmune disease;
5. Acquired immunodeficiency syndrome;
6. Refuse to use corticosteroid;
7. Pregnant or nursing
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity

This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-64 years (both inclusive)
* Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive)
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
* Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 ng/mL (30 Nanometer (nM)) at screening
* Parathyroid hormone (PTH) outside normal range at screening
* Total calcium outside normal range at screening
* Calcitonin greater than or equal to (≥) 50 pg/mL at screening
* Amylase greater than or equal to (≥) 2 times upper limit of normal
* Lipase greater than or equal to (≥) 2 times upper limit of normal
* Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers

To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female patients
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* History or evidence of abnormal bleeding or clotting disorder
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.

The study is conducted to evaluate the effect of Ascorbic acid as a final flush on post operative pain after single visit root canal treatment in cases with symptomatic irreversible pulpits.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old and to 60.
* Male or female.
* Patients seeking root canal treatment.
* mandibular molar teeth with symptomatic irreversible pulpits with preoperative acute or moderate pain with hot and cold stimulation with normal periapical radiographic appearance .
* healthy patient (ASA I,II).
* Patient who can understand NRS and sign informed consent.

Exclusion Criteria:

* Medically compromised patients having significant systemic disorders. (ASA III or IV).
* History of intolerance to NSAIDS.
* External root resorption.
* Internal root resorption.
* Vertical root fracture.
* Periapical lesion.
* Pregnancy.
* Use of ibuprofen in the last 12 hour.
* Bleeding disorder.
* Long term corticosteroid use.
* Mobility Grade II or III.
* Pocket depth more than 5mm.
* Previous root canal therapy.
* Non-restorability.
* TMJ problems, bruxism, clenching or traumatic occlusion.
* Inability to perceive the given instructions.
Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that have already started sexual activity;
* Subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit;
* Subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, IUD, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study;
* Subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (Legal representative).

Exclusion Criteria:

* Subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial;
* Menopausal women;
* Known hyper-sensibility to any of the products' components;
* Pregnant or lactating women;
* Subjects with active genital ulcer and/or with Genital herpes diagnosis;
* Diagnosis or suspicion of Inflammatory pelvic disease;
* Diagnosis of Vulvar condyloma acuminata;
* Subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics;
* Transplanted subjects;
* Subjects with history of active autoimmune diseases or with immune suppression;
* Subjects under the usage of medication or therapy described on the protocol item "Prohibited Treatments";
* Subjects that have participated on a clinical trial in the last 12 months (Conselho Nacional de Saúde - Resolução 251, de 7 de agosto de 1997, item III, sub-item J), unless the subject can have a direct benefit, in the investigator opinion;
* Subject that have a kinship or bond with any employees of Sponsor or Research center;
Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)

Although the essential role of iron during pregnancy is well established, concerns have been raised that current iron supplements given routinely during pregnancy may also have harmful consequences, such as increased oxidative stress and enhanced risks of infection, pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of adverse effects is the appearance of non-transferrin-bound iron after oral administration of iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could promote injurious free radical reactions that might add to the oxidative stress of pregnancy.

The present study will determine if oral administration of 60 mg of iron as ferrous sulfate during the second trimester of pregnancy is followed by the appearance of non-transferrin-bound iron two hours later. The investigators will examine the influence of a variety of factors, including iron status and previous use of iron supplements. Detection of non-transferrin-bound iron after administration of an iron supplement to pregnant women would be an important new observation that could lead to re-evaluation of current methods of iron supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Age 18 to 45 years
* singleton pregnancy
* between 24 and 28 of gestation (at study day)
* regular visits at prenatal clinic
* capability and willingness to comply with study protocol
* voluntary signed informed consent

Exclusion Criteria:

* Multiple pregnancy
* Acute or chronic disease or disorder
* Incapability of following the study protocol
* Homelessness
* Active drug/alcohol dependence or abuse history
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea

The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium-long term.

The hypothesis of the study states that by applying that method to the patients, a decrease or disappearance of pain in menstruation should happen, as well as an improvement in quality of life and sleep deficiency.

The study will consist of:

* An interview, lasting 30 minutes, in which the characteristics of the study will be explained. In case of wishing to participate, it will be required to sign the informed consent document and to fill out the medical history sheet.
* An evaluation phase: in which it will be necessary to fill out a number of questionnaires during two consecutive menstrual periods.
* An intervention phase: consisting of 12 30-minute treatment sessions, once a week. The patients will be randomly assigned to one of the two groups. In both groups, a current will be applied to different locations on the legs. The technique will be performed through four/two electrodes leg attached to the skin. This stimulation will not be painful at any time nor will it have harmful effects on the patients health. In this phase, the individual should continue filling out the questionnaires provided in each period. On the last day of treatment, a scale of satisfaction with the treatment will be retrieved.
* A re-evaluation phase: in which the individual shall fill out a number of questionnaires a month, 3 and 6 months after finishing the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 43.
* Women with regular menstrual cycles (range between 21 and 35 days).
* Women with a visual analogue scale (VAS) between 4 and 10 (moderate to severe pain) during at least 50% of annual menstrual cycles and / or during the last 3 cycles in the suprapubic area, abdomen, lower lumbar area , perineum and / or medial side of the thighs during the first and / or second day of your menstrual cycle.
* Sign the informed consent document to participate in the study.

Exclusion Criteria:

* Women on hormonal therapy or who have an Intrauterine Device implanted.
* Women diagnosed of secondary dysmenorrhea by their gynecologist (endometriosis, ovarian cyst, etc.) in the last 18 months.
* Women who have underwent a surgery during the study.
* Women who have underwent abdominal and pelvic surgery or who have given birth (vaginal or cesarean section) in the last 6 months.
* Women with lesions on the skin of the upper-internal face of the ankles (scars, erosions or cysts).
* Women who are pregnant or planning a pregnancy.
* Women with pacemakers, uncorrected coagulopathies, severe comorbid disorder, cancer (in the last 5 years or now), severe mental disorders or neuropathies that affect the nerves of the pelvis or lower extremities.
* Physiotherapy or electrotherapy treatments that are related to the pathology or study areas of the month prior to the start of the study.
The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.

To investigate if administration of 3 weeks og GH (10-30 microgram/kg/day) and subsequent Pegvisomant (10-15 mg/day) influence serum concentrations of the inflammatory variables Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and the newly discovered acute phase protein YKL-40. The study involves 12 healthy volunteers age from 22-65 years.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, normal blood tests

Exclusion Criteria:

* Previous cancer
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves.

Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis.

Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.


Eligibility Criteria:
Inclusion criteria:

* Patients with Ulcerative colitis (UC) aged between 18 and 60
* Scheduled for or have previously undergone subtotal colectomy and ileostomy.
* Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical Mezalasin only.

Exclusion criteria

* Rectal inflammation of Mayo Score \>1
* Poor sphincter function, perianal disease
* Uncertainty regarding UC diagnosis P
* Previous colorectal cancer or severe dysplasia
* Primary Sclerosing Colitis diagnosis
* \>2 year since subtotal colectomy
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
* Males must be surgically sterile or agree to practice acceptable forms of birth control
* Chronic hepatitis C virus (HCV) infection at screening
* Fibrosis stage F3 or greater, documented by acceptable tests
* Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
* Use of contraindicated medications within 2 weeks of dosing
* Clinically significant abnormalities or co-morbidities
* History of solid organ transplant
* Abnormal laboratory tests
* Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients

The aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or L-arginine in infertile women with PCOS. This study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome

d prospective Study Trial. We will recruit patients diagnosed with PCOS according to Rotterdam criteria of PCOS and who present to outpatient clinics at Beni-Suef University Hospital. Infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or L-arginine

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary infertility associated with PCOS as defined by the revised Rotterdam criteria
* Normal values of the following laboratory tests: thyroid function, prolactin level, and husband's sperm analysis and hysterosalpingography

Exclusion Criteria:

1. Patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type I or II) or malignancy.
2. Patients who consumed myoinositol, metformin, SGLT2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months.

3. Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.

4. Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome. 5. Presence of hypersensitivity to any of the study medications.
Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel for Cardiovascular Risk

This is a prospective pilot study of participants who have stable coronary heart disease (CHD). Participants undergo risk stratification using the SomaLogic Cardiovascular Disease (CVD) Risk Panel blood test at baseline and again 4-12 months after the initial test. Participant surveys and chart abstractions are conducted at baseline and follow-up to collect feedback about the test report and actions taken. Care teams may consider using the risk information from the SomaLogic panel to address care gaps. Medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, body mass index (BMI), lipid and c-reactive protein (CRP) measurements, and physician's clinical judgment.

This is a prospective pilot study of participants who have stable coronary heart disease (CHD). Objectives of this study are to understand whether CVD Secondary Risk Panel scores change from baseline to follow-up (4-12 months after baseline) and actions taken, if any, based upon the results. Participants are surveyed to learn what the test results mean to them and assess if the results affect adherence to therapy and lifestyle choices (diet, exercise, alcohol, and tobacco use). In addition, this study will investigate the characteristics of patients that physicians choose to test with the CVD Secondary Risk Panel, and what actions the care team takes because of the results of the test. Medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, BMI, lipid and CRP measurements, and physician's clinical judgement. Chart abstractions and participants surveys occur at the baseline and follow-up visits, and charts may be abstracted annually for up to 10 years post enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 40
* Stable CHD documented by at least one of the following: history of myocardial infarction \>6 months prior to study enrollment, angiographic evidence of at least 50% stenosis, abnormal CAC score, prior evidence of inducible ischemia by treadmill or nuclear testing, or a history of coronary revascularization
* Ability to provide informed consent

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Less than 40 years of age
* History of myocardial infarction in the prior 6 months.
* Treatment for malignancy (other than basal or squamous cell carcinomas of the skin) within the last 2 years
* Pregnancy
* Individuals deemed ineligible by the Investigator