cyrilzakka/clinical-trials huggingface dataset:
Sucrosomial Iron in Patients With Celiac Disease and IDA

Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which shows a high gastrointestinal absorption and high bioavailability with a low incidence of side effects due to lack of any direct contact with intestinal mucosa. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in CD patients.


Eligibility Criteria:
Inclusion Criteria:

* proven celiac disease
* iron deficiency anemia

Exclusion Criteria:

* other autoimmne diseases
* pregnancy psychiatric disorders
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score

Exclusion Criteria:

* Pregnancy, Breast Feeding
* Moderate/Sever Liver Disease: Child Score \> Or = To 7
* Fibrates Terminal Disease
* Contraindications To Receive ezetimibe
* Contraindications To Receive Statins
* Mental Disability
* Hypersensitivity To ezetimibe
* On another Clinical Research Trial
Gyeongsang National University Hospital Registry

The G-NUH registry is a two-center, real-world registry of percutaneous coronary intervention in patients with significant coronary artery disease. From January 2010, PCI-treated patients from Gyeonsang National University Hospitals (Jinju \& Changwon) were enrolled in this registry.

The aim of this registry is to investigate long-term clinical outcomes and predictors of adverse outcomes after percutaneous coronary intervention from the academic hospitals.

In the G-NUH registry, the investigators have collected and measured multiple hemostatic, physiologic and laboratory measurements (on-admission \& 1-month) and questionnarred from PCI-treated patients. This registry will focus on the impacts of these parameters on long-term clinical outcomes from East Asian patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Significant coronary artery disease
* Treated with PCI
* Multiple hemostatic or physiologic measurements

Exclusion Criteria:

* Medically treated cases
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.

Immunotherapy with natural killer (NK) cells may improve the results of treatment for patients with cancer. However, for better efficiency high doses of NK cells are required. For this purpose, NK cells were expanded in the presence of feeder K562 cells gene-modified for expression 4-1BBL and membrane bound IL-21. In the result of expansion, large number of activated NK cells are obtained.

Protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other protocol of chemotherapy) followed by expanded NK cells intravenous infusion. To sustain proliferation of donor NK cells in vivo patients receive 6 doses of Il-2 every second day. 10 patients will be enrolled in phase I to test different doses of NK cells: 20, 50, 70, 100 and \>100 x 10\^6/kg.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Relapsed acute myeloid or lymphoblastic leukemia
* Primary refractory myeloid or lymphoblastic leukemia
* Karnofsky or Lansky performance scale greater or equal to 70
* Written informed consent

Donor:

* Haploidentical family donor
* \> 18 years old
* Donor suitable for cell donation and apheresis according to standard criteria
* Written informed consent

Exclusion Criteria:

Patients:

* Uncontrolled infection
* Severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
* Positive serology for human immunodeficiency virus (HIV)

Donors:

* Pregnancy or breast feeding
* Positive serology for HIV, hepatitis B or C.
Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

This study aimed to evaluate the efficacy and safety of applying 5% lidocaine cream to the sensitive area of the glans penis after its precise localization under the penile biological vibration threshold test for the treatment of primary premature ejaculation.

This study was a randomized, single-blind clinical controlled trial. Eighty patients diagnosed with primary premature ejaculation in an outpatient setting were included in this study. They were randomly scored into two groups. Group 1 (n = 40) was given 1 ml of 5% lidocaine cream on demand. They were instructed to apply the lidocaine cream evenly in a circular pattern to the glans penis without precise application to the sensitive area of the glans penis. The treatment lasted for a total of 4 weeks. Group 2 (n = 40) had a penile biological vibration threshold test performed to detect loci with a lower threshold. They were instructed to apply 1 ml of 5% lidocaine cream to the sensitive loci on the glans penis for 4 weeks. Lidocaine cream was applied topically or uniformly to the glans penis 20 minutes before planned intercourse in both groups and washed off 10 minutes after application. Using intravaginal ejaculation before and after treatment latency, the Arabic Index of Premature Ejaculation, Premature Ejaculation Diagnostic Tool, and the International Index of Erectile Function Scale scores were combined to assess the efficacy and side effects before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* adult male (19-60 years old); stable partner for ≥3 months; Premature Ejaculation Diagnostic Tool (PEDT) score ≥ 11; penile biological vibration threshold test suggesting the presence of sensitive sites on the glans penis (vibration threshold \< 30 levels); no history of long-term use of specific medications; normal sex hormone levels; and no genital or secondary ejaculation. There was no history of long-term use of specific drugs, normal sex hormone levels, and genital or secondary sexual characteristics abnormalities.

Exclusion Criteria:

* (1) those with abnormal or malformed genital development; (2) those with allergic reactions to local anesthetics; (3) those who had been treated with central nervous system drugs or PE in the last 3 months; (4) those with a history of long-term alcohol abuse and trauma such as neurological and pelvic fractures; (5) those with long-term use of hypotensive drugs, diuretics, and sedative drugs (6) patients with a history of previous surgery and trauma to the reproductive system; (7) patients with PE due to hypogonadism, thyroid disease, and abnormal lipid metabolism.
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.

This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* \> 16 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa within the past 6 months
* Patients are able to elicit an FEV1 \>/= 40% of predicted value at screening
* Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing
* Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours

Exclusion Criteria:

* Use of any nebulized or systemic antibiotics within 4 weeks of starting study
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Uncontrolled diabetes or abnormal renal function
* Tobacco use (smoking) in the last 30 days
Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.


Eligibility Criteria:
Inclusion Criteria:

* BMI of at least 30 kg/m\^2
* elevated stress levels based on perceived stress scale score
* self-identified as black race

Exclusion Criteria:

* pregnant or are planning to become pregnant in the next year
* known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose \> 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
* history of psychiatric hospitalization in past 2 years
* history of substance abuse or eating disorder
* any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
* currently taking medications for weight loss
Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber

The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.

The researchers will compare the nursing educational intervention with the usual practice that is currently carried out in the unit for patients who are going to begin treatment in the hyperbaric chamber.

Participants will:

* Receive explanatory information through a camera triptych when the treatment is indicated.
* Come half an hour before the first session to receive a nursing educational intervention, with audiovisual support, on the operation of the camera.

The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.

An educational intervention will be applied to the intervention group that will begin on the same day that the treatment is indicated. That day, you will be given an informative brochure about the most important aspects you should know about the hyperbaric chamber. On the first day of the session, you will be asked to come half an hour early to explain, in more detail, what the hyperbaric chamber consists of and important aspects that you should take into account.

The control group will receive the same intervention that is currently being carried out. Once treatment is prescribed in the chamber, they come on the first day and receive a brief explanation of how it works before entering.

Eligibility Criteria:
Inclusion Criteria:

* Results in the Pfeiffer questionnaire\<2.
* That they understand Spanish or Catalan

Exclusion Criteria:

* That feel fear inside the hyperbaric chamber.
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.

This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* type 2 diabetes for \>=1 month;
* drug naive, or receiving stable doses of \<=2 oral antihyperglycemic medications;
* HbA1c 6.5-10.0% at screening;
* symptomatic, stable NYHA class 2 heart failure at screening.

Exclusion Criteria:

* type 1 diabetes;
* current or previous treatment with insulin;
* uncontrolled hypertension;
* NYHA class 1, 3 or 4 at screening.
Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

The purpose of this study is to assess the effects of a low energy, high protein tube feeding formula on body weight in tube fed patients who are obese. It will also assess study formula tolerance as well as impact of the study formula on lean body mass, blood pressure, blood sugar and lipids.


Eligibility Criteria:
Inclusion Criteria:

* Home Enteral Nutrition (HEN) patient receiving at least 90% of energy needs from enteral nutrition.
* BMI \> 30.
* History of stroke.
* Weight stable over the past month.

Exclusion Criteria:

* Diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy).
* Life expectancy of less than 6 months.
* Stage IV or higher kidney disease (GFR \< 30).
European Safety Registry in Ulcerative Colitis (P04808)

This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).

This is a prospective, observational, post-marketing safety surveillance registry of UC participants treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 participants (1000 Remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. Participants who started the registry on standard therapy may switch over to Remicade.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, of either sex, and of any race.
* Moderate-to-severe active UC, as defined by assessment by the treating physician.
* Must, within 30 days of Baseline, either:

  * Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (AZA), or methotrexate (participants in this category must be Remicade naïve) or
  * Initiate Remicade. Participants who have been treated in the past with Remicade, but who have discontinued for any reason and who are scheduled to receive Remicade within 30 days of the baseline visit must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion
* Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
* Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.

Exclusion Criteria:

* Female who is known to be pregnant or nursing.
* Previously treated with any other (investigational) biological drug for UC( other than Remicade) prior to Baseline.
* In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
* Participating in a blinded trial.

In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.
Multi Centre Study on TESS V2 Shoulder System

This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.

The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.

Eligibility Criteria:
Inclusion Criteria:

* Except in special cases, the "anatomic" type is indicated for:

  * Centered osteoarthritis of the shoulder
  * Humeral head fractures
  * Rheumatoid arthritis (with intact rotator cuff)
  * Avascular necrosis of the humeral head
* Except in special cases, the "reversed" type is indicated for:

  * Offset osteoarthritis of the shoulder
  * Massive and non-repairable rotator cuff tears
  * Rheumatoid arthritis (with degenerative rotator cuff)
* Revision in cases of:

  * Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
  * Conversion of a hemi-arthroplasty into a total arthroplasty
  * Increasing the size of the stem (length and/or diameter)
  * Replacing a glenoid prosthesis
  * Replacing a competitor's prosthesis
  * In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis
* Additional inclusion criteria include

  * Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
  * Willing to return for follow-up evaluations

Exclusion Criteria:

* Local or systemic infections.
* Severe muscular, neurological, or vascular deficiency of the affected joint.
* Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
* Any concomitant complaint likely to affect the functioning of the implant.
* Allergy to any of the implant components.
* Local bone tumors.
* Patient over 18 under law supervision
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing POEM procedure for any esophageal motility disorder
* Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy

Exclusion Criteria:

* Esophageal varices
* Esophageal neoplasms
* Non-correctable coagulopathy
* Failure to provide an informed consent
Electrostimulation System WoundEL for Leg Ulcers Healing (

Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing.

Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.

Patients with a leg ulcer will be randomized to the "usual treatment" or "WoundEL" group.

The progress of the leg ulcer will be monitored every 2 weeks for 8 weeks or sooner if wound healing occurs. All leg ulcers will be examined at 10 weeks to check for healing or the condition of the leg ulcer if it has not healed. A third-blind party will also assess the ulcer condition at 10 weeks, based on standardized photographs.

The consumption of analgesics, pain and quality of life will be compared in the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Venous leg ulcer evolving for at least 3 months, the area of which is between 4 cm² and 200 cm² and the smallest axis of which is less than 10 cm and the largest axis less than 20 cm;
* Have a Systolic Pressure Index (IPS) at the ankle between 0.89 and 1.3 and / or a systolic pressure measurement at the big toe greater than or equal to 60 mmHg;
* Accept the port of venous compression;
* Presenting superficial and / or deep venous insufficiency, documented on a Doppler echo dating less than one year;
* affiliated to a social security scheme or beneficiary of such a scheme;
* Having given their free, informed and written consent.

Exclusion Criteria:

* Untreated infected wound;
* Cancerous ulcer;
* Treated with systemic corticosteroids or chemotherapy;
* for which a skin graft is necessary;
* Contraindications for the treatment of leg ulcers with the WoundEL system;
* Pregnant or lactating women;
* Vulnerable people or under legal/judicial protection
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)

The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)


Eligibility Criteria:
Inclusion Criteria: Men or women of nonchildbearing potential; 18-50 years old; healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.