cyrilzakka/clinical-trials huggingface dataset:
Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial

Iron deficiency anemia is a common complication in patients who underwent gastrectomy and leads to a deterioration in patient's quality of life. Therefore iron supplementation is one of the important treatments in postgastrectomy patients.

Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron supplementation has been emerged as another treatment option, but there are only a few studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron in patients underwent gastrectomy.

Therefore, this study aims to evaluate the iron supplementation method as intravenous injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy anemia.

Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and hemoglobin level lower than 11 g/dL will be included in this trial. After the registration, the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n = 179).

Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of life score at baseline and weeks 12 period will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥20 years of age
* Underwent gastrectomy for stage I or II of primary gastric adenocarcinoma
* Hb ≤11.0 g/dL at least one year after surgery
* Willingness to participate after signing informed consent

Exclusion Criteria:

* Calculated dosage using the Ganzoni formula \>1,500 mg
* Any medical condition may have caused the patient to be unsuitable for the completion of the study or placed the patient at potential risk from being in the study
* Underwent chemotherapy or on chemotherapy
* Drug hypersensitivity to iron isomaltoside
* Active acute or chronic infections
* Known intolerance to oral iron treatment
* History of anemia due to extensive bleeding or causes other than iron deficiency
* Untreated vitamin B12 or folate deficiency
* Blood transfusion, Erythropoiesis stimulating agents(ESA), oral iron or intravenous iron treatment within 4 weeks prior to screening
* History of bone marrow suppression treatment, active Hepatitis B or C, HIV or hematologic disorder other than iron deficiency
* Iron overload, hematochromatosis or hemosiderosis
* Pregnancy or nursing
* Creatinine clearance rate using Cockcroft-Gault formula \<30 mL/min
* Participation in any other clinical study within one month prior to screening
Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS

ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.

Septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. These failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. Pulmonary failure secondary to septic shock is characterized by edema, with ARDS being the most severe form. Sepsis is the second most common cause of ARDS after pneumonia. The incidence of ARDS in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality.

These failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. Conversely, the onset of ARDS onset warrants limiting hydro-sodium inputs. Currently, there are no data predicting the occurrence of ARDS patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock.

Exclusion Criteria:

* Minors or opposition to participation.
* Chronic dialysis patients
* Organ transplant recipients
* Confirmed urinary tract infection
* Subject with macroscopic hematuria
* Pregnant woman
Relative Potency of Inhaled Corticosteroids

To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.


Eligibility Criteria:
Inclusion Criteria:

* Sputum eosinophilia \>3%
* Adults age 18-70 years
* History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
* FEV1 ≥ 60% predicted
* Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
* Able to give written informed consent

Exclusion Criteria:

1. Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
2. Relevant seasonal allergen exposure within 4 weeks or within the course of the study
3. Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
4. Other respiratory diseases
5. Women who are pregnant or unwilling to use appropriate contraception during the study
6. Unable to withhold short-acting ß-agonist treatment for 6 hours before visit
BeAT1D: Benign Autoimmunity and Type 1 Diabetes

National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.

The overall objective of this study is to define the differential characteristics of autoimmune T and B lymphocytes across individuals with T1D, other forms of diabetes or autoimmunity, and no disease. The hypothesis is that the characterization of the autoimmune T and B lymphocytes involved in T1D development may allow us to clarify the pathophysiological mechanisms of disease and to identify novel biomarkers for diagnostic, prognostic and therapeutic follow-up applications.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes: type 1 diabetes, as defined by hyperglycemia and long-term insulin therapy started within 6 months from clinical onset; and/or the presence of at least one anti-islet auto-antibody.
2. Other forms of diabetes or autoimmune endocrinopathy: other forms of diabetes (e.g. type 2, ketosis-prone, familial, secondary, immunotherapy-induced diabetes); and/or other autoimmune endocrinopathies, isolated or multiple.
3. No diabetes: absence of diabetes or impaired glucose tolerance; absence of tumor, infectious or immune pathologies, or other conditions related to autoimmune or metabolic alterations that may bias the variables under study.
4. Lymphadenectomy planned in the frame of an abdominal surgery: pancreatic lymphadenectomy planned at the occasion of an abdominal surgery for the treatment of an underlying condition.

Exclusion Criteria:

For all participants: ongoing pregnancy; known HIV/HCV infection; absence of social security coverage; placement under judicial protection; absence of signature of the informed study consent.
Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

Acne vulgaris is a chronic inflammatory skin disease affecting the pilosebaceous unit. It is clinically characterized by comedones, papules, pustules, nodules, cysts and scarring on the face and trunk.

The severity of the disease ranges from mild comedonal acne to severe nodulocystic acne which can be permanently disfiguring.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.

The prevalence of self-reported acne and clinically confirmed acne was 34.69% and 24.39%, respectively. Females reported acne more frequently than males did (39.13% ).The prevalence of clinically confirmed acne was higher among females (28.64%) than males .

Its pathogenesis results from androgen-induced increased sebum production, altered keratinization, inflammation of infundibular epithelium and bacterial colonisation of hair follicles by Propionibacterium acne

There are several treatment modalities for acne vulgaris including topical like topical antibiotics, topical benzoyl peroxide, topical azelaic acid and topical retinoids. Systemic therapy like antibiotics, hormonal therapy and isotretinoin .

Adipokines may have a role in the pathogenesis of acne vulgaris and are associated with acne severity. Irisin, a hormone -like myokine, is one of the adipokines with anti- inflammatory and anti-oxidant effects

There is limited evidence for physical modalities (e.g., laser therapy, light therapy, chemical peels) and complementary therapies (e.g., purified bee venom, low-glycemic-load diet, tea tree oil) .

isotretinoin (13-cis retinoic acid) is the most potent known inhibitor of sebum production. The multiple modes of action for isotretinoin includs suppression of sebaceous gland activity, normalization of the pattern of keratinization within the sebaceous gland follicle, inhibition of inflammation and reduction of growth of Propionibacterium acne .

Eligibility Criteria:
Inclusion Criteria:

* Cases with moderate and severe acne.
* Clinical diagnosis of acne Disease
* Patient not receive any treatment for acne vulgaris at least six months duration.

Exclusion Criteria:

1 Pregnant and lactating women. 2. History of chronic liver disease . 3. Cardiovascular disorders . 4. Renal disease . 5. Hyperlipidemia . 6. Depression or mental illness. 7. Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis
Effects of Omegas 3 and 6 on Alcohol Dependence

Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.


Eligibility Criteria:
Inclusion Criteria:

* severe alcohol dependence
* no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range

Exclusion Criteria:

* history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies
* dependences other than alcohol and/or tobacco
* psychiatric disorders
* test laboratories results outside the reference range
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis - Peer Mentor Training

Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. This study involves the development and testing of a peer mentor training initiative as one part of an intervention study for people with early IA (EIA). Peer mentors will be trained and assessed to provide one-on-one support (information, emotional, feedback) to individuals who have recently been diagnosed with IA. This is one part of an intervention study. The other part is called Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentoring Program.


Eligibility Criteria:
Inclusion Criteria:

* To become a peer mentor are:

  1. Diagnosis of IA from a physician
  2. Disease duration more than 2 years and managing well
  3. Currently using medications (DMARDS/biologics) to treat arthritis
  4. Have completed an Arthritis Self-Management Program (ASMP) provided by The Arthritis Society and/or similar program and/or have sufficient knowledge and experience with teaching or providing mentoring support to an individual living with a chronic disease
  5. Able to participate in two approximately 5-hour training workshops
  6. Able to take part in ongoing assessment/evaluation activities (self-report questionnaire, interviews, observation, study activity log)
  7. Able to commit to the duration of the research study
  8. Willing to provide ongoing one-on-one support to an individual newly diagnosed with IA
  9. 18 years of age or older
  10. Able to speak, understand, read and write English

Exclusion Criteria:

* Do not meet inclusion criteria
Effects of Vitamin D and Calcium on Hyperglycemia and Dyslipidemia in Patients Gestational Diabetes

Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Another complication of GDM is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. The previous literature review indicates that micronutrients including vitamin D and calcium have a bearing on glucose and lipid profiles. Various studies have established that vitamin D improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. Furthermore, it is revealed that calcium induces vitamin D so that it could undergo its full metabolic effect. Hence, the addition of vitamin D and calcium together may enhance glycemic management and lipid profiles of GDM patients. The aim of the present work is to compare the impact of vitamin D and calcium supplementation on lipid profiles and hyperglycemia in GDM patients. It will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (HbA1c) and lipid profile (LDL, HDL triglycerides) and review the effect of this on pregnancy outcomes. These outcomes will be assessed by a randomized-controlled trial.

A randomized controlled trial study design will be used to assess the efficacy of vitamin D and calcium supplementation in lipid profiles and glycemic index among women with GDM.

The sample for the study will consist of 60 pregnant women diagnosed with GDM, aged 18-40 years, and between 24-28 weeks of gestation. Recruitment of participants will be done in antenatal clinics linked to \[Lady Willingdon Hospital Lahore\]. The diagnosis of GDM will be performed according to the results of OGTT following the international criteria.

Participants will be randomly divided to one of two groups:

* Intervention Group: This group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks.
* Control Group: This group will receive a placebo containing no active ingredients.

For randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. The study will be conducted as double blind; the participants and the researchers shall not know the group allocations.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18-40 years.
* Gestational age between 24-28 weeks.
* Diagnosis of GDM based on OGTT results.
* Willingness of participants to provide written informed consent.

Exclusion Criteria:

* Pre-existing diabetes mellitus (type 1 or type 2).
* Chronic kidney or liver disease.
* Use of vitamin D or calcium supplements in the last 3 months.
* Multiple pregnancies (twins, triplets).
* Any major pregnancy complications (e.g., preeclampsia).
The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.

The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.

In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in conformity with the guidelines of the Declaration of Helsinki.

The type of study was a randomized, cross over clinical trial to compare two treatments (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .

Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for the admission had to be at least \> 2 according to a semi-quantal scale (ranging from 0 to 6) and patients already under treatment for xerostomia or with xerostomia score \< 2, suffering from obesity, cancer, drug addiction or alcoholism were excluded.

The patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.

The study consisted of a preliminary selection during screening, the measurement of xerostomia and random allocation, first treatment period, wash out period and finally the second treatment period.

Eligibility Criteria:
Inclusion Criteria:

* suffering xerostomia
* degree of xerostomia at least \> 2 according to a semiquantal scare ranging from 0 to 6
* diabetes Type II \> one year, with stabilized oral hypoglycemic therapy from at least 6 months.
* concomitant chronic diseases pertaining to dyslipidemia, cardiovascular and/or gastrointestinal diseases, and anxiety/depression were accepted provided under adequate therapy since at least 6 months.

Exclusion Criteria:

* under treatment for xerostomia or with xerostomia score \< 2
* suffering from obesity (BMI \> 30 kg/m2),
* cancer of any type
* drug addiction and alcoholism
DISCOVER Study: Microscope-integrated Intraoperative OCT Study

Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.

In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.

Optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to the ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT functions almost like a light biopsy, allowing clinicians to visualize subtle changes in the tissue, such as macular edema or subretinal fluid. OCT in the clinic setting has become the gold standard for monitoring diseases such as macular degeneration and diabetic retinopathy;and it has become one of the most frequently ordered diagnostic test in ophthalmology.

Due to the restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-tops models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from the OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retinal diseases such as retinal detachment, macular hole and optic pit, that were not previously known. Our research team has been examining intraoperative OCT in the operating room using both a handheld and microscope-mounted portable spectral domain OCT probe with excellent success and an outstanding safety record.

In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.

Eligibility Criteria:
Inclusion Criteria:

* The study population includes any patient requiring ophthalmic surgery

Exclusion Criteria:

* Under the age of 18 years.
* Cognitive/Mentally impaired or unable to provide consent
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)

Filler study for smile lines in cheek folds


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 21-65 years of age
* Willing to comply with study visits and procedures
* Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study

Exclusion Criteria:

* History of trauma, acne scarring, burns, or other changes to skin in treatment area
* Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
* Use of injectable fillers in the lateral cheeks/perioral within last 2 years
* History of facelift in the last year
* History of facial nerve palsy