cyrilzakka/clinical-trials huggingface dataset:
Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth \[PD\], and clinical attachment level \[CAL\]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with a known systemic disease;
* known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group;
* on systemic ALN/bisphosphonate and therapy ATV/statin group;
* with aggressive periodontitis;
* who used tobacco in any form;
* alcoholics;
* immunocompromised patients;
* and pregnant or lactating females were excluded from the study
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
* Both genders with an age ≥ 18 years at randomization
* Subjects with a suspected survival time of \> 3 months
* Signed informed consent

Exclusion Criteria:

* Any known or suspected systemic infection
* Use of metronidazole is not allowed during the investigation period
* Any known sensitivity to silver or other components/products used in this study.
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Participation in another investigational study while participating in this study.
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Immunostimulants under studies carried out under an IRB approved protocol.
* Treatments of intercurrent non-fungal infection.
* Allowed but requires monitoring during fluconazole therapy:
* Barbiturates.
* Phenytoin.
* Oral hypoglycemics.
* Coumarin-type anticoagulants.

Patients must have the following:

* Diagnosis or presumption of fungal infection under defined conditions.
* Written informed consent either from the patient or the patient's legal guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Burns \> 30 percent of the body.
* Diagnosis of AIDS or AIDS related complex (ARC).
* HIV positive unless they have a malignancy.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate to severe liver disease as defined by specific lab values.
* Unlikely to survive more than 24 hours.
* Evidence of previous amphotericin B sensitivity.

Concurrent Medication:

Excluded:

* Concomitant antifungal agents other than the study drugs.
* Immunostimulants, except for studies carried out under an IRB approved protocol.

Concurrent Treatment:

Excluded:

* Lymphocyte replacements.

Patients with the following are excluded:

* Defined disease conditions listed in Exclusion Co-Existing Conditions.
* Unlikely to survive more than 24 hours.
* Previous participation in this study; reentry for the same infection is not allowed.
* Known to be unable to take amphotericin B due to acute toxicities.

Prior Medication:

Excluded:

* Previous fluconazole therapy for this infection.
Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa

The study will perform to follow-up UC-MSCs and CM transplantation. 18 patients will be called back to be examined after 5 years of UC-MSC and/or CM transplantation.

The study will be performed on 18 patients who received UC-MSC and CM transplantation in 2018. The study is included as retrospective cohort since the transplantation happened 5 years ago. Patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observation results will be written in the observation table and analyzed by a statistic.The study will be performed at Rumah Sakit Jakarta Eye Center and Rumah Sakit Umum Pusat Dr. Sardjito Yogyakarta.

Eligibility Criteria:
Inclusion Criteria:

* Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50%
* Willing to sign informed consent as research subjects
* Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue
* Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherent Tomography (OCT) examinations, electroretinogram examinations and fill out a quality of life questionnaire

Exclusion Criteria:

* Pregnant or nursing women
* Positive result of HIV test
* Have a history of eye tumours
* In the immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
* Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma
* Do not come to control according to the schedule determined by the researcher (loss to follow up)
Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project

Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP. The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.


Eligibility Criteria:
Inclusion Criteria:

* Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al.
* Intend to participate in the intervention and perform all the tests included in the study.
* Able to read and understand informed consent, as well as the objective of the study.
* Able to walk and move without outside help.
* Able to communicate without problems
* Be between 18 and 65 years old.

Exclusion Criteria:

* Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered).
* Having lumbar surgery as source of pain.
* Having acute or terminal illness.
* Having medical prescription that prevents the performance of the tests.
* Having injury or circumstance that makes it impossible to perform the tests correctly.
* Having other physical or mental illness that prevents participating in the intervention.
Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Fasting low density lipoprotein \& triglyceride levels as defined by the protocol.
* Self described South Asian race
* Subjects with coronary heart disease or at high risk of coronary heart disease.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

Primary Objective:

• To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate.

Secondary Objectives:

* To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of TGF-β1, IL-6, IL-1α, and IL-10 and the development of CTCAE grade 2+ symptomatic pneumonitis.
* To examine the associations between serum measures of TGF-β1, IL-6, IL-1α, and IL-10 and:
* Exhaled breath condensate measures of the same biomarkers, and
* The development of CTCAE grade 2+ symptomatic pneumonitis.
* To examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of CTCAE grade 2+ symptomatic pneumonitis.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old.
* Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician.
* Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists.
* Willing and able to tolerate exhaled breath collection.
* Able to provide informed consent.

Exclusion Criteria:

* Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration.
* Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly).
* Any systemic antibiotic use within 2 weeks of registration.
Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry

Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with standard indications to CIED surgery being treated with antiplatelet agents and/or anticoagulants (any commercially available device or approved and marketed drug can be included).
* Patients able to provide written informed consent
* Patients willing to attend the planned follow-up visits

Exclusion Criteria:

* Patient with life expectancy less than 12 months as per investigator's judgement
The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects

The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Prior exposure to dasatinib
Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Indication to a knee or hip arthroplasty under general anesthesia
* Sinusal rhythm

Non Inclusion Criteria:

* Pregnant women
* Black skin
* Dialysis
* Cardiac arrythmia
* Sepsis
* Use of another hemodynamic monitoring during surgery
Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor

This study will assess the programmatic implications (including feasibility, acceptability, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Eligibility Criteria:
Inclusion Criteria:

* women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent

Exclusion Criteria:

* women with known contraindications to prostaglandins
Analysis of the Effectiveness of Aquatic Exercise on the Static and Dynamic Balance in Pregnant Women

Research about the balance in pregnant women who perform water exercise and those who do not engage in any type of sporting activity. The initial objectives are to know if there is an improvement in the balance in women who perform aquatic exercise reviewed at the end of pregnancy versus those who do not, through the use of a podiatric platform. This experimental randomized controlled study (RCT) will be carried out in sports centers and / or public or private municipal swimming pools in the south of Galicia The recruitment of passive pregnant women (control group) will be carried out in the health center of Pontevedra Virxe da Peregrina in the first visit to the midwife in the 10th and 12th week of gestation, while the recruitment of the active pregnant women (group experimental 1 and experimental group 2) in the teaching centers of the aquatic exercise sessions in the same weeks of gestation. The women of the three groups will have a low-risk normoevolutive pregnancy and will be studied in the first and third trimesters. The instruments that will be used to obtain data will be through an initial questionnaire, a platform and study of stability through the center of gravity and base of podiatric support. The plan for analyzing the data will be done through SPSS 17.0.


Eligibility Criteria:
Inclusion Criteria:

* The criteria for inclusion of the sample are: 1. Women aged between 20 and 35 years since before 20 years and after 35 years it is associated with a greater maternal and perinatal risk.2. The intensity of the physical workload must be moderate to very light . 3. The gestational age (EG) in which they are captured must be delimited between 10 and 12 weeks of gestation (SG) without any obstetric risk or associated pathology, primiparous or multiparous.

Exclusion Criteria:

* Exclusion and withdrawal criteria. The exclusion criteria will be: 1. Present any type of absolute / relative obstetric contraindication. 2. Not to have notions of swimming. 3. Multiple pregnancies. 4. Pregnant women with cognitive / physical disability. 5. Present some diagnosed pathology that alters the normal balance as neurological, traumatological or podiatric diseases.

The appearance of any warning signs / symptoms such as vaginal bleeding, feeling light-headed or faint, difficulty breathing before doing exercise, chest pain, headache, muscle weakness, pain or swelling in the calves, Regular and painful contractions in the uterus and drip of fluid through the vagina, will imply the abandonment of the physical exercise program that was developing.
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease

Peripheral arterial disease (PAD) is a condition where the blood vessels in the legs get blocked. It affects one out of every five adults over the age of 65. As it is the main cause of amputations, the NHS performs over 20,000 operations every year to prevent them. People with PAD benefit from tablets to thin their blood as this improves outcomes after surgery and prevents heart attacks and strokes. The main tablets for this purpose are aspirin and clopidogrel. These work in most people, but up to a third of patients do not get any benefit from them, as their bodies cannot process them. We call this resistance to therapy (RT).Because blood thinning is particularly important after operations people with RT may be at higher risk of their operation failing leading to amputation and/or problems such as heart attacks and strokes. Testing for RT has not traditionally been performed because it requires complex laboratory procedures. Recent development in technology now means that bedside tests are available for RT. We will use a simple beside test for RT in patients with severe PAD. We will use this test to see how many of these patients have RT and whether this affects their risk of complications after an operation. If we find that RT does affect outcomes for patients with PAD, the information obtained will be used to plan future research to determine if changing blood thinning therapy in people with CR improves their outcomes after surgery.

Patients with peripheral arterial disease, a condition whereby arteries in the legs become narrow or blocked, are not only at a higher risk of limb loss but also of suffering heart attacks and strokes. To manage this risk and to ensure surgery for the blocked arteries is successful, they are prescribed tablets to make their blood less sticky, called antiplatelet agents. Aspirin and clopidogrel are the two tablets most commonly prescribed for this purpose.

In some patients, these two tablets are not effective as expected, because of interactions with other medications they are on or because their bodies cannot process them. This is known as resistance to antiplatelet therapy.

The main aim of this study is to establish how common resistance to aspirin and clopidogrel is in patients with peripheral arterial disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years.
* Patients with severely symptomatic aorto-iliac and infra-inguinal peripheral arterial disease.
* Patients with the ability to provide written informed consent.
* Patients on antiplatelet therapy

Exclusion Criteria:

* Patients under the age of 18 years.
* Patients unable or unwilling to provide written informed consent.
* Patients with acute limb ischaemia of the lower limb.
* Patients with aneurysmal disease of the arteries of the lower limb.
* Patients with severe diabetic foot sepsis.
* Patients with a known history of clotting disorders
* Patients with inherited bleeding disorders
Observatory of Prolymphocytic Leukemia T

Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-.

The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.

On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.

Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .

Main objective: Better manage prolymphocytic T leukemias.

Secondary objectives:

* Molecular characterization of prolymphocytic leukemia T.
* Study of the response to treatment, disease-free survival, overall survival.
* Impact of prognostic factors on response to treatment, and survival.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 or over
* Patient with prolymphocytic T leukemia

Exclusion Criteria:

* Absence of signature of informed consent