cyrilzakka/clinical-trials huggingface dataset:
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes

A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.

The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in the developed world and is a major morbidity associated with diabetes, often leading to pain, suffering, and a poor quality of life for patients. Chronic diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.The pathophysiology of chronic diabetic ulcers is complex and still incompletely understood, the most important predisposing factors being diabetic neuropathy and vasculopathy. Both micro and macroangiopathy strongly contribute to development and delayed healing of diabetic wounds, through an impaired tissue feeding and response to ischemia. HIF-1α and VEGF, as well as the NO production from iNOS, may contribute to limitation of hypoxic injury by promoting angiogenesis and wound healing. Experimental and pathological studies suggest that suggest that he incretin hormone glucagon-like peptide-1 (GLP-1) may improves VEGF generation, and promote pancreatic islet viability through the up-regulation of HIF1α.

Therefore, aim of this study is to evaluate the effect of the augmentation of GLP-1, by inhibitors of the dipeptidyl peptidase IV (DPP-4), such as vildagliptin, on HIF-1α, VEGF and iNOS in diabetic chronic ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Oral hypoglycemic agents treatment
* Chronic foot ulcers
* Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test \>30 -mmHg, anklebrachial index values \> 0.7 and \< 1.2 with toe pressure \> 30 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg
* Written consensus

Exclusion Criteria:

* Active Charcot disease
* Ulcers resulting from electrical, chemical, or radiation burns
* Collagen vascular disease
* Ulcer malignancy
* Untreated osteomyelitis, or cellulitis
* Ulcer treatment with normothermic or hyperbaric oxygen therapy
* Concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy
* Recombinant or autologous growth factor products
* Skin and dermal substitutes within 30 days of study start
* Use of any enzymatic debridement treatments
* Pregnant or nursing mothers
Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy

The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery.

The hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery.

H1-1: Comedy therapy has an effect on pain levels in patients after Uretero-Renoscopy surgery.

H2-0: Comedy therapy has no effect on anxiety levels in patients after Uretero-Renoscopy surgery.

H2-1: Comedy therapy has an effect on anxiety levels in patients after Uretero-Renoscopy surgery.

Intervention Group

After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.

Control Group

After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old,
* Not having any visual or auditory problems,
* Not having any communication problems,
* Not having any psychiatric problems.

Exclusion Criteria:

* Not accepting to participate in the study or wanting to leave,
* Having had complications during the perioperative process.
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.


Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.

The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.


Eligibility Criteria:
Inclusion Criteria:

* Lower limb amputation at least 6 months prior to inclusion
* Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS
* Outpatients, aged 18 years and above
* Written informed consent

Exclusion Criteria:

* Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation)
* Subjects taking any analgesic medication (except for rescue medication as defined in this protocol)
* Subjects with expressed dissatisfaction with their prosthesis comfort
* Pregnant or breast-feeding women
* Any malignant disease
* Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry.
* Subjects unable to comply with the study assessments
* Subjects with documented or suspected alcohol or drug abuse
A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced/metastatic non-small cell lung cancer
* Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

* Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
* History of or known brain metastases
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp\[a\]).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Lipoprotein (a) \> 150 nmol/L
* Evidence of atherosclerotic cardiovascular disease

Exclusion Criteria:

* Severe renal dysfunction
* History or clinical evidence of hepatic dysfunction
* Malignancy within the last 5 years
* Currently receiving, or less than 3 months at Day 1 since receiving \> 200 mg/day Niacin
BIO|STREAM.ICM Obesity

The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

This submodule of the BIO\|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI \>30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.

Eligibility Criteria:
Inclusion Criteria:

* Patient is already enrolled in the BIO\|STREAM.ICM registry
* Patient BMI \> 30

Exclusion Criteria:

* Patient clinically indicated for or already implanted with another cardiac active device
Effect of the Use of a Therapeutic Conciliation Document at the Outlet of Hospital, on the Emergency Use of Hospital Care in Patient Aged Over 75 Years Old.

The drug iatrogenesis represents an important public health problem. In the Iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge

The drug iatrogenesis represents an important public health problem with 5-10% of the grounds of hospitalization after age 65, and more than 20% after 80 years. Based on this observation, the health authority has proposed in 2011 the realization of therapeutic drug conciliation particularly in the elderly with multiple pathologies and multiple drugs. Taking into account the central role of the family practitioner in prescriptions, and the importance of coordination information such as output of hospitalization (vector of many malfunctions), we have achieved a therapeutic drug conciliation sheet (TDC) based primarily on the information needs by family practitioner after hospitalization of their patients. The issue of this study is to assess the interest for the use of a such TDC on the decrease in the rate of rehospitalization in the target population.

To do this, we are proposing a multicenter observational study. Randomization would be across the centres. The study would focus on 750 patients more of 75 with polymedication. The follow-up will last 6 months.

The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge. The first secondary objective will be identical to the main objective but rated at 6 months and the second secondary objective will be to assess the impact of the use of the TDC on overall mortality at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* age ≥75 years
* patients with a medical prescription, including at least three different allopathic molecules including at least a treatment in one of the following therapeutic classes:
* cardiovascular treatment: antiarrhythmics, antihypertensive drugs, anticoagulants and antiplatelet all classes
* treatment of the central nervous system: analgesics, benzodiazepines, antidepressants, hypnotic, antipsychotic drugs of all classes.

  * family practitioner identified
  * trusted personne identified
  * Hospital output project establishes

Exclusion Criteria:

* not speaking french patient
* short survival time
Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis

Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage literature. How the brain injury affects cerebral oxygenation in patients with CVT is not currently known. Some of the factors that can affect cerebral oxygenation in patients with CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the cerebral oxygenation.


Eligibility Criteria:
Inclusion Criteria:

-Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.

Exclusion Criteria:

* Patients on inotropic support
* Systolic blood pressure \< 90 mmHg
* Haemoglobin oxygen saturation \<95%
* Refusal of consent
* Age \<16 and \> 65 years
* Known history of diabetes or hypertension
* Pregnancy
* Any contraindication for application of cerebral oximetry sensors
Escape Room Game in Oncology Nursing

This research will be conducted to evaluate the effect of the escape room game activity applied to nursing students taking oncology nursing courses on their academic self-efficacy and critical thinking motivation.

Considering the characteristics of cancer patients and the complexity of care, it is essential to include a separate oncology nursing course in the education curriculum to increase the qualifications of nursing students. During undergraduate nursing education, clinical practices for care in oncological diseases are limited. New approaches are needed that will contribute to increasing the effectiveness of the educational processes of nursing students. Escape room game-based educational approaches, which have begun to be used in nursing education in recent years, are presented as an example of this situation. Escape games are defined as a type of student-centered activity designed to improve students' learning and skills in professional development programs. The main purpose of using escape games in nursing education is to create practice environments where students will gain clinical decision-making competence in order to provide safe and qualified patient care services. This research was designed to determine the effect of the escape room game applied to students taking oncology nursing courses on their academic self-efficacy and critical thinking motivation.

Eligibility Criteria:
Inclusion Criteria:

* Being enrolled in the Oncology Nursing course and volunteering to participate in the study

Exclusion Criteria:

* Not completing the game during the escape room game and/or filling in the scales and forms incompletely
PGL5001 Proof of Concept Study in Inflammatory Endometriosis

This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001 orally administered for up to 5 months with concomitant DMPA administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the parts A2 and B are double-blind.

The target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* The Subject must provide written informed consent prior to initiation of any study related procedures.
* The Subject must be an adult woman of reproductive age, aged from 18 and above.
* The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
* The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
* The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.

Exclusion Criteria:

* The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
* The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
* The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
* The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
* The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
* The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazol, continuous oral combined oestroprogestogens).
Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells

The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or more.
2. Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters \> 30 mm but \< 50 mm).
3. Patients accepting to sign a specific informed consent.

Exclusion Criteria:

1. Unstable coronary artery disease.
2. Congenital heart disease.
3. Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
4. Any chronic inflammatory or autoimmune disease.
5. Prior administration of G-CSF; EPO; GM-CSF.
6. Liver failure.
7. Prior oncologic disease or ongoing cancer with a life expectancy \< 1 year.
8. Dementia.
9. Pregnancy.
10. Patients aged \< 18.
Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form and HIPAA document
* Willing and able to comply with all study procedures
* Be at least 10 years of age at the time of enrollment
* LogMar 0.7 or better, in each eye
* History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye);
* have a current diagnosis or history of open angle glaucoma or ocular hypertension;
* have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months;
* have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
* have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
* manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study
* have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

PRIMARY OBJECTIVE:

I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue.

SECONDARY OBJECTIVE:

I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results.

OUTLINE:

Patients undergo ultrasound without contrast. Patients then receive perflutren lipid microspheres (Definity) intravenously (IV) over 15 minutes and undergo CEUS.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Be conscious, willing and able to comply with all study procedures and be available for the duration of the study
* At least 21 years old
* Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System \[BIRAD\] 4, 4A, 4B, 4C or 5)
* Patient with an at least 1 cm mass located at \< 3 cm depth, approachable by 2.5 inch needle
* Be medically stable as determined by the investigator
* If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity

Exclusion Criteria:

* Females who are pregnant or nursing
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
* Patients on life support or in a critical care unit
* Patients with unstable occlusive disease (e.g., crescendo angina)
* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
* Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV)
* Patients with recent cerebral hemorrhage
* Patients who have undergone surgery within 24 hours prior to the study sonographic examination
* Patients with known hypersensitivity or allergy to any component of Definity
* Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
* Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli