cyrilzakka/clinical-trials huggingface dataset:
ProMRI Study of the Iforia ICD System (Phase C)

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.


Eligibility Criteria:
Inclusion Criteria:

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:

* Age greater than or equal to 18 years
* Able and willing to complete MRI testing
* Able to provide written informed consent
* Available for follow-up visit at the study site
* Implanted with an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17.
* ICD implanted pectorally
* All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
* Underlying rhythm identifiable during sensing test
* All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX)
* Ventricular sensing is measurable and \>6.5mV
* Absence of phrenic nerve stimulation at 5.0V and 1.0 ms
* Pacing impedance is between 200 and 1500 ohm
* Shock Impedance is between 30 and 90 ohm
* Able and willing to use the CardioMessenger II

At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:

* Absence of phrenic nerve stimulation at 5.0V @ 1.0 ms
* \|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V (ICD Lead Only)
* All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX.)
* Ventricular sensing is measurable and \>6.5mV
* The ICD system has been implanted for at least six weeks.
* Subject did not have an ICD or lead explant, exchange or reposition in the previous 6 weeks.
* All lead pacing impedances are between 200 and 1500 ohm
* Shock impedance is between 30 and 90 ohm
* Battery status is at least 30% of capacity
RUBY Post-Market Registry on the Jada® System

The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.

The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.

Eligibility Criteria:
Inclusion Criteria:

• Use of the Jada System (inserted into the patient and connected to vacuum).

NOTE: There is no Exclusion Criteria in this protocol.
Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative.

At present, the extent to which dietary components can modify endothelial function, monocyte inflammation and glycemic variations is not well defined, although different carbohydrates are known to vary in their abilities to induce plasma glucose and insulin responses. Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk of T2D and coronary heart disease (CHD). We are examining using randomized control trials low vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from conventional aerobic training. Resistance Training has the potential to improve endothelial function or monocyte phenotype, but there is very little data in this area. We hypothesize that resistance training may augment the beneficial effects of a low-GL diet in improving metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 with BMI≥30 and/or your waist circumference ≥40 inches for males or ≥35 inches for females
* In good health as determined by the screening visit and review of medical history

Exclusion Criteria:

* Have a known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading or use of medications that influence CV function
* Have been in a weight loss or exercise program in the 6 months prior to participation
* Use tobacco products
* Have a syndrome or are prescribed medications that may influence body composition, insulin action, or CVD (e.g. PCOS, prednisone, methylphenidate, etc.)
* Have intolerance to lactose or gluten
* Pregnant
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease

This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or more
* Crohn's disease diagnosed for more than 3 months.
* Active Crohn's disease : CDAI score \> 150 + \[CRP \> 5 mg/L or faecal calprotectin \> 250mcg/g or endoscopic lesion or MRI lesion\]
* Indication of a biological therapy (anti-TNFα, vedolizumab ou ustekinumab).

Exclusion Criteria:

* Crohn's disease that doesn't fit the previous criteria
* Extended resection of small intestine (\>40cm)
* Chronic pancreatitis diagnosed before inclusion
* Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)
* Pancreatic enzyme replacement therapy
* Pregnant or breastfeeding woman
* Patient under the protection of a conservator
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients

The aim of the study is to assess the impact of pharmacist led mobile application on adherence and efficacy of medication in chronic kidney disease patients

This is a prospective randomized two group pharmacist-led interventional study that will be conducted in a private nephrology clinic. The study will involve introduction of the mobile phone applications to chronic kidney disease patients to improve their adherence to the prescribed medications.

Recruited patients will be randomly divided in two groups; intervention group and control group, with baseline evaluation of outcomes to be measured.

Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, with an access to the mobile application after a simple training for app usage. Both groups will be followed for a period of 3 months.

The study will include the development, validation and the testing for evaluating the specially designed mobile application.

Eligibility Criteria:
Inclusion Criteria:

* Stages 2-5 of chronic kidney disease
* Literate
* Ownership of android smart phone compatible with the application
* Poly-pharmacy

Exclusion Criteria:

* On dialysis due to loss of kidney function
* Pregnancy due to altered physiology
Assessment of Updated Evaluation Scores in Critically ILL COPD Patients Admitted to Assiut University Hospital

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of morbidity and mortality.Patients admitted to hospital present higher mortality rates.The investigators lack the specific tools that allow us to easily classify and establish the individual prognosis for each patient during their hospitalization.

Rational of the study:to identify the predictive factors for hospital mortality in critically ill patients admitted to hospital due to an episode of COPD exacerbation.

Material and Methods:

A) sociodemographic variables:

Age, sex, marital status, occupation, pack\\year.

B) clinical variables:

1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test (CAT ) while stable, previous to admittance.

3- Charlson comorbidity index and age adjusted model.

4- The APACHE II scale: the severity of the episode upon admittance, calculated using the APACHE II scale, using the worst value obtained in the first 24h after being admitted to hospital.

5- the Sequential Organ Failure Assessment (SOFA) scale.

6- Lab parameters: such as glucose, albumin and heamatocrit

7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse \> 109 beats/min, age \> 65 years.

8- Assessment of symptom of gastroesophageal reflux disease.

9-Glasgow scale score.

10-CURB 65 :"C" stands for "confused"; "U" stands for BUN greater than19 mg/dL; "R" stands for "respiration more than 30 breaths per minute""B" stands for blood pressure less than 90 mm Hg systolic or diastolic blood pressure 60 mm Hg or less; "65" stands ≥65 years.

11-CAUDA 70: C: Confusion, Acidosis (pH \<7.35), Urea \>7mmol/L, MRC Dyspnoea score \>4, Albumin \<35g/L, Age \>70 years. One point was assigned to each variable present, giving a six point scoring system.

12-The COPD and Asthma Physiology Score.

13-The early warning score.

14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component were added so that the ADO index ranged from 0 to 10.

Eligibility Criteria:
Inclusion Criteria:

* We include for study all patients critically ill hospitalized for COPD exacerbation during the study period

Exclusion Criteria:

* Patients who refuse to be admitted to hospital after having been properly informed, and their families as well, of the possible risks that they are assuming.
* Specific diagnosis: pulmonary edema, rib fractures, aspiration, pleural effusion, etc. upon admission.
* Other associated respiratory pathology that determines treatment: pulmonary fibrosis, kyphoscoliosis, neuromuscular pathology, upper airway obstruction, extensive tuberculosis sequelae.
The Feasibility of VR for OUD

This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.

The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.

Eligibility Criteria:
Inclusion Criteria

1.18 years or older

2. Current diagnosis of opioid use disorder

3. Current inpatient in detox ATS unit

4. Fluent in English

Exclusion Criteria

1. Active suicidality
2. History of seizures
3. History of psychosis
4. Severe visual impairment
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)

The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..

The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. While there is no concurrent control population, there is ample historical control data to be used for comparison.

The study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System. Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in the study will be followed for at least 24 months.

Eligibility Criteria:
Inclusion Criteria:

* 1. The patients has a planned fusion construct of at least five levels and will have the InterFuse (S) or (T) planned for L5-S1 and/or L4-L5.

  2. The patient has documented conservative (non-operative) treatment for at least 6 months.

  3. The patient has a VAS score of ≥ 60 mm for Back and/or Leg. 4. The patient has an ODI ≥ 40%. 5. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.

  6. The patient is willing and able to comply with study requirements. 7. The patient has agreed to participate in the study

Exclusion Criteria:

* 1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). Previous non-fusion surgery at the proposed treatment level(s) is acceptable.

  2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.

  3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).

  4. The patient has known neoplastic disease other than skin cancer. 5. The patient has a Body Mass Index (BMI) of greater than 40; BMI = wt (kg)/ht2 (m2).

  6. The patient has an active infection. 7. The patient is pregnant or is planning on becoming pregnant in the next two years.

  8. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.

  9. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum.

  10. The patient is currently enrolled in an investigational spine study. 11. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.

  12. The patient has symptomatic fibrous arachroiditis.
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
* Be scheduled for an ileostomy reversal procedure
* Be willing to follow instructions for incision care
* Agree to return for all follow-up evaluations specified in this protocol
* Sign informed consent

Exclusion Criteria:

* Anesthesia risk judged to be higher than ASA2
* Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
* Any condition involving compromised immune system
* Any condition known to effect wound healing, such as collagen vascular disease
* Known blood clotting disorder
* Be receiving antibiotic therapy for pre-existing condition or infection
* Concurrent use of fibrin sealants or other anastomosis care devices
* Be currently taking systemic steroids or immunosuppressive agents
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

* Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl \< 20 mL/min will not be included.
Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma

Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.


Eligibility Criteria:
Pre-Inclusion Criteria:

- Patient with suspicious ovarian carcinoma using clinical data, biological data (ca125) and radiological data (CT)

Inclusion Criteria:

* Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.
* Neo adjuvant chemotherapy

Exclusion Criteria:

* no neo-adjuvant chemotherapy
* no ovarian carcinoma at final pathological analysis
* less than 18 years old.
Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction

Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 % of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The psychological impact of hair loss due to Androgenetic alopecia can be profound.

Currently, two medications are Food and Drug Administration approved in the treatment of Androgenetic alopecia which are minoxidil, and finasteride. Both medications must be taken indefinitely for benefits to persist. Hair transplantation is the only current successful permanent option. Nowadays, the majority of surgeons use 2 techniques, the classic strip technique, and the follicular unit extraction technique. Advantages of follicular unit extraction over the strip technique are the lesser incidence of donor zone post-procedural discomfort and the barely visible scarring.

Platelet rich plasma is an autologous concentration of platelets in small volume of plasma and is an exciting therapeutic option for hair growth. Combining platelet rich plasma with follicular unit extraction surgery for the treatment of Androgenetic alopecia demonstrated that PRP is able to minimize the postsurgical follicle loss and potentiate the performance of grafted hairs.

Adipose derived stem cells are an effective mesenchymal stem cell population with enormous potential in different fields of regenerative medicine.

Adipose stem cells are needed to induce the proliferation of bulge stem cells of hair follicle. Furthermore, they can help in wound healing and vascular neogenesis.

Zanzottera et al. 2014 investigated the effect of adipose derived stem cells on wound healing and engraftment of the transplanted hair applied during hair restoration surgery for three patients with androgenetic alopecia. Despite their promising results, further clinical trials including larger number of patients are still needed to confirm their preliminary findings.

Eligibility Criteria:
Inclusion Criteria:

* male patients with androgenetic alopecia between 18 years and 60 years

Exclusion Criteria:

1. Patients with Non-androgenetic causes of hair loss.
2. Female patients with androgenetic alopecia.
3. Patients who received anti-hair loss treatment within the past six months.
4. Patients with history of bleeding disorders or on anticoagulant therapy.
5. Patients with history of chronic liver disease, cancer or connective tissue disorders.
6. Patients with current scalp infection.
SRAE With Embospheres for Hemorrhoids.

In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.

Symptomatic hemorrhoidal disease is a still important public health problem although there are many surgical and nonsurgical minimal invasive treatment methods. Treatment methods are not satisfactory or invasive in some percent of the patients. Superior rectal artery embolization(SRAE) for hemorrhoids is an adapted technique derived from Doppler-guided hemorrhoidal artery ligation (DGHAL). In this technique, the distal branches of the superior rectal artery arising from the inferior mesenteric artery is occluded endovascularly with coils. Its feasibility and safety were supported by articles. Collateralization and recurrence was seen following coil embolization. To prevent this , tri-acryl gelatin microspheres in 500-700 and 700-900 micrometers in size will be used. Safety and efficacy of embolization and using different sized particles will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of hemorrhoidal disease
* Patients with written informed consent
* Patients refusing surgery or other interventional methods
* Patients with high risk for surgery
* Patients accepting follow ups

Exclusion Criteria:

* Previous intervention
* Colorectal diseases other than hemorrhoids
* Patients with anal stenosis
* Patients with rectal prolapsus
* pregnant patients
* Patients with contraindications for technical steps or contrast usage.
* Patients do nor or could not give written informed consent
Saxagliptin and Atherosclerosis

Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and chemokines associated with atherosclerosis/inflammation.

The purpose of this study is to explore the effects of 3 months intervention with DPP-4 inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in circulating monocytes and adipose tissue.

A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic effect of DPP-4 inhibitors beyond glycaemic control alone.

Due to reduced sample size (recruitment problems) the main focus has changed and will now be on cellular aspects and gene regulation (initially secondary outcome measure).


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven coronary artery disease.
* HbA1c \> 6.5% and under treatment with either metformin and/or glimepiride.

Exclusion Criteria:

* Allergy or hypersensitivity to any of the drug's components.
* Heart failure in NYHA class III or IV.
* Severe liver failure, moderate or severe kidney failure
* Malignant disease.
* Active infectious disease.
* Acute coronary syndrome in the last 3 months.
* Pregnancy or breastfeeding.