cyrilzakka/clinical-trials huggingface dataset:
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance \[CrCl\]/ glomerular filtration rate \[GFR\] 30 to 59 milliliter per minutes per 1.73 meter square \[mL/min/1.73m\^2\]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m\^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
* Anemia defined as baseline Hb concentration less than (\<) 10.5 gram per deciliter (g/dL)

Exclusion Criteria:

* Previous therapy with any ESA within 12 weeks prior to screening
* Renal allograft in place
* Immunosuppressive therapy in the 12 weeks prior to screening
* Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening
Effect of Propolis Application on Burn Healing

This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.

In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.

Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.

In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.


Eligibility Criteria:
Inclusion Criteria:

* adult (8-12 weeks)
* 200-300 grams
* Wistar-Albino rat
* with 4 second-degree superficial contact burn are at its back.

Exclusion Criteria:

* the death of the rat in the research process
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes mellitus diagnosed within 4 months
* Age \> 6 years of age
* Ability to swallow capsule
* Signed informed consent / assent

Exclusion Criteria:

* Other illnesses
Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula

The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are:

* Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants?
* Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula.

Participants will:

* Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone.
* Visit the clinic the week after surgery and then every 4 weeks for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* participants with complex perianal fistula
* provided written informed consent

Exclusion Criteria:

* participants with any inflammatory bowel diseases
* pregnant or lactating participants
* participants with contraindications for surgery
* participants with hepatitis
* participants with uncontrolled diabetes
* participants with alcohol or substance abuse
Project Options - The ABC Method

The present study explores the ability of dermatologists to influence patients' behavior using a novel and brief (3 minute) behavioral intervention in the context of naturally occurring patient interactions and shows promise for long term sustainability. The incidence of invasive skin cancers, cutaneous melanoma in particular, has nearly tripled in the U.S. between 1975 and 2004, making it the fastest rising incidence rate for all cancers in the United States. Dermatologists are in an ideal position to effect change in their patients. The present study will assess whether a brief intervention (The ABC-Addressing Behavior Change method) delivered to patients by dermatologists during a skin examination will increase the use of sun protection and reduce risk behaviors compared to patients who receive treatment as usual.

Skin cancer is the most common malignancy in the U.S. and the incidence and mortality from skin cancer is on the rise. Individuals can decrease their risk of skin cancer by engaging in protective behaviors such as limiting intentional and unintentional UV exposure, and wearing broad-spectrum sunscreens and protective clothing. Despite knowing the risks and receiving dermatological care, many patients with and without a history of skin cancer frequently forget to use UV protection or fail to use it in an optimal manner to reduce their UV risk. To address these concerns, Mallett and colleagues developed a 3-minute brief ABC intervention - Addressing Behavior Change. The ABC intervention is designed to be delivered by dermatologists in the context of a routine office visit involving a skin examination. Previous work by Mallett and colleagues showed dermatologists were highly motivated to deliver the intervention, quickly learned the requisite skills, delivered the intervention with fidelity, and showed minimal decay in knowledge, motivation, and skills over a 6-month period. This study builds on a previous study by conducting an examination of the efficacy of the ABC intervention on patients' motivations and behaviors utilizing a prospective longitudinal design.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for a skin exam with participating dermatologists

Exclusion Criteria:

* psoriasis
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster

A 3-month study was conducted in flood victims from affected villages in the Tumpat district, Kelantan. Participants were given either probiotic, Bifidobacterium infantis M63 (M-63 group) or no probiotics (control group) for three months. At baseline and 3-month, participants were assessed for thewater, sanitation and hygiene (WaSH) practices, abdominal symptoms, breath testing for hydrogen and methane to detect the presence of SIBO and also fecal samples for gut microbiota profiling.

There is an observed rise in cases of acute gastroenteritis and post-infectious irritable bowel syndrome (PI-IBS) during the peak flood period. One major reason is poor sanitation, water and hygiene practice by flood victims during the flood because of poor access to clean water. The mechanism how poor hygiene causes non-specific abdominal complaints is unknown. The investigators speculated that small intestinal overgrowth (SIBO) is the fundamental basis for the increase in reported cases of acute gastroenteritis and abdominal complaints among flood victims. The investigators further speculated that administration of antibiotics or probiotics could reduce the abdominal symptoms after three months.

Therefore, the intervention study was conducted for three months. Compliance of participants was checked by a diary given to participants in the M-63 group to document their daily intake of probiotics. This study will for the first time demonstrate the fundamental mechanism behind the poor WaSH practices and gastrointestinal disturbances after flood. Also this study would support a role for probiotic intervention to reduce abdominal complications when the next flood occurs.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years; flood victims who fulfilled the Rome III criteria for IBS developed after flood, able to perform breath-testing, able to provide stool specimens, and able to complete three months of prospective intervention.

Exclusion Criteria:

* Adults who took antibiotics or probiotics three months prior to and after flood had taken place; previous abdominal surgery and presence of significant medical and psychiatric co-morbidities.
Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients

Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity.

Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Schizophrenia inpatients
2. Overweight and with central obesity
3. agree to sign informed consent

Exclusion Criteria:

1. Diagnosis of IBS
2. Systemic antibiotic use during the past 4 weeks
3. Excessive water intake
Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.


Eligibility Criteria:
Inclusion Criteria:

* Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

* VA not worse than 0.60
* additional clinically relevant ocular or systemic conditions may be excluded
Taper Or Abrupt Steroid Stop: TOASSTtrial

This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.

In total, 573 patients will be enrolled. Patients will be randomly assigned in a 1:1 ratio to either prednisone in decreasing doses over 4 weeks or placebo.

Patients, treating physicians, and study personnel will be blinded to treatment allocation to either prednisone or matching placebo. At inclusion, we will perform a 250 micrograms Synacthen® stimulation test. The results of the test will be blinded to treating physicians and investigators, and its value to predict clinical outcome will only be assessed after completion of the trial. As a safety measure, all patients will be instructed about stress coverage as well as signs and symptoms of hypocortisolism and will be provided with emergency medication. Patients will be randomized to the standard (tapering) or the experimental (matching placebo) arm. Follow-up will be for six months. In order to improve adherence to the study and ensure feasibility, follow-up visits in most study centers will be by telephone only. Visits will be performed early after stopping glucocorticoids in both arms (i.e. at days 7 and 35) to ensure safety; the other two visits will be on days 90 and 180.

Amendment approved in 1-2018: former exclusion criterion 'status post organ transplantation' was revised and deleted

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Age ≥ 18 years
* Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion
* Therapy over ≥ 28 days, ≥ 7.5 mg average daily dose, with a cumulative glucocorticoid dose ≥ 420 mg prednisone-equivalent prior to inclusion
* Tapering not or no longer mandatory to treat underlying disease

Exclusion Criteria:

* Primary adrenal failure
* Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural)
* Incapability to administer glucocorticoid cover treatment in situations of stress
* Inability or unwillingness to provide informed consent
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium.

The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.


Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Diagnosis of septic shock
* Require mechanical ventilation and vasopressor therapy

Exclusion Criteria:

* Previous stroke
* Dementia
* Recent Craniotomy
Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Inguinal Hernia Surgeries

The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic inguinal hernia surgeries.

There will be three randomized groups: Group Control (no any block, n=30) Group M-TAPA (n=30), Group TAP (n=30). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed at the end of the surgery, before awakening the patients. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Arch Dimension and Inclination of the Upper and Lower Incisors Changes

It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis


Eligibility Criteria:
Inclusion Criteria:

* Complete permanent dentition, except third molars.
* Class I malocclusion, determined by Angle ANB 2 plus or minus 2
* Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient.
* Little index with minimum Irregularity 4-6 mm.
* Patients with x-rays of initial profile and at the end of alignment and leveling in good condition.

Exclusion Criteria:

* Models in poor condition that do not allow measurements.
* Patients who do not wish to participate in the study
* Patients with cleft lip and palate
* Patients with craniofacial anomalies
* Patients with previous orthodontic treatment
Olmesartan Pediatric Pharmacokinetic (PK) Study

Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years


Eligibility Criteria:
Inclusion Criteria:

* Age 12 months to 16 years inclusive
* Signed parental/guardian informed consent and assent from the subject
* Current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension
* Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated using the Schwartz equation
* Sexually active females of child-bearing potential must be practicing an acceptable method of birth control
* Negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)

Exclusion Criteria:

* Clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
* History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening
* Current treatment with more than 2 antihypertensive medications
* Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
* Serum albumin \< 2.5 g/dL
* Major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria
Feel4Diabetes-study

The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.

The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.

The Feel4Diabetes-intervention will be developed according to the results of systematic literature reviews, narrative reviews and surveys regarding existing research programs, legislation and policies as well as infrastructures, facilities and human resources, which will be conducted during the first phase of the project. It will be implemented in six Eurepean countries, namely Belgium, Bulgaria, Finland, Greece, Hungary and Spain. The process, impact, outcome, cost-effectiveness and scalability of the Feel4Diabetes-intervention will be evaluated and the results of the study will be disseminated via various communication channels.

Eligibility Criteria:
Inclusion Criteria:

* For children and their parents: low socioeconomic areas and/or vulnerable subgroups of population
* For children: first two grades of compulsory education.

Exclusion Criteria:

* Age range not within the inclusion criteria.