cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Implant-secured Removable Partial Denture

This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
* Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
* Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
* Patients with a sufficient bone volume for implant placement, without prior bone supply.

Exclusion Criteria:

* Patients with general counter-indications for implant placement.
* Patients suffering from a titanium allergy.
* Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
* Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
* Patient with an insufficient available bite level to deliver an attachment system (\< 7mm).
* Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment.
* Women who have reported to be pregnant.
* Patients deprived of liberty
Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate

Visit 1 - Initial Application:

* A patient candidate identified by the PI who meets all of the inclusion criteria and none of the exclusion criteria will be consented for the study.
* The medical history will be collected from the subject.
* The subject will receive routine hemodialysis
* Directly after the completion of hemodialysis, the following study drug application steps will occur:

  1. Site 1 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 1.
  2. Site 2 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 2.
  3. Second Compression per site: If bleeding has not stopped, repeat application with new gauze and same amount of ointment to each respective site and compress for 5 minutes more at each site.
  4. Third Compression per site: If after the second application and compression the bleeding persists repeat both application and compression for another 5 minutes (total time would be 13 minutes at this step).
  5. Test Failure: If after the third application to each needle site there is still bleeding, the testing would be considered a failure and routine procedures should be utilized to stop the bleeding.
* Any adverse events will be collected.

Visit 2 - Follow-Up:

• The 1 week follow up visit will be performed to review study drug application site and to collect any adverse events reported by subject

The clotting time will be compared to the clotting time at a different dialysis session in which no treatment will be used

Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients with fistulas (native arterio-venous)

Exclusion Criteria:

* Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.
* Active infection.
* Stenosis of fistula.
Laryngectomy Education

Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission. Many of these readmissions are related to stomal care, and it is thought that the readmissions could be prevented with better patient and caregiver education. The investigators are studying the effect of a comprehensive perioperative education program on 30-day unplanned readmission for patients undergoing total laryngectomy.

The comprehensive perioperative education program will include the following additional interventions:

-Preoperative visit with the speech pathologist for explanation of laryngectomy physiology, stomal education, and alaryngeal voice rehabilitation. Participants will be expected to undergo this intervention and to attend it with their "laryngectomy coach" (a family member or friend to accompany the patient through the education process), but failure to meet with the speech pathologist will not exclude a patient from the study.

* Preoperative education class with a designated ENT laryngectomy nurse for patient and caregiver. The hands-on class introduces the patient and laryngectomy coach to the basics of stomal care. Participants and their "laryngectomy coach" will be expected to attend the preoperative education class
* Printed laryngectomy journey guide given to patients at time of study enrollment for patient/caregiver. This journey guide details the preoperative, in-hospital, and post-discharge course and is provided as a reference throughout their journey.
* Formalized, nursing administered practical evaluation of minimal competency of laryngectomy care for patient and caregiver/laryngectomy coach.

This study will follow patients prospectively from the time of study commencement and then assess changes in patient knowledge before and after the education intervention. It will also compare rate of stomal complications and readmission rates to institutional historical averages to assess improvement in quality care.


Eligibility Criteria:
Inclusion Criteria:

* planned total laryngectomy at Barnes Jewish Hospital
* age 18 or older
* understand spoken or written English language
* able to provide informed consent.

Exclusion Criteria:

-none
Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency.

The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.

This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed of CVI
2. aged between 18 and 85 years and
3. with mobile or email address to send the study information and follow-up

Exclusion Criteria:

1. Mental or psychological condition that impairs the study development
2. comorbidities that impair the physical activity performance
3. surgical interventions during the 6 previous months before the intervention or during the study development
4. deep vein thrombosis
5. active leg ulcer
6. pregnancy.
Remifentanil and Atropine for Intubation in Neonates

The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.

Exclusion Criteria:

* Urgent intubations
* Cyanotic congenital heart lesions
* Anticipated difficult airway
* Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
* Pre-existing hyperkalemia
* Family history of malignant hyperthermia
* Prior enrollment
Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.

In sepsis, the release of 'neutrophil extracellular traps' (NETs) by activated neutrophils may contribute to organ damage by acting as scaffolds that trap blood cells and fibrin clots. Excessive NET formation can occlude the vasculature, promoting thrombosis and tissue hypoperfusion. This is a trial on a novel IV therapy for septic patients that shows promise in multiple animal models of sepsis. The therapy, DNase I, is an enzyme that helps to dismantle NETs by digesting cell-free DNA (cfDNA), the major structural component of NETs. The objective of this study is to conduct a Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients. The results of this study may justify a future Phase II trial of the efficacy and safety of DNase I for critically ill patients with sepsis.

This trial proposes

1. - To determine the safety, feasibility and maximum tolerated dose (MTD) of using DNase I in septic patients
2. - To evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, ICU length of stay, and mortality.
3. - To describe the effects of DNase I on blood coagulation and NETs release
4. - To collect samples for future studies on coagulation and immune function in sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. Age of ≥18 years
2. Admitted to the ICU in the last 48 hours
3. Suspected or proven infection as the admitting diagnosis
4. A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline
5. Expected to remain in the ICU for ≥ 72 hours

Exclusion Criteria:

1. No consent/inability to obtain consent from a substitute decision-maker
2. Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
3. Have a significant risk of bleeding as evidenced by one of the following:

   * Surgery requiring general or spinal anesthesia within 24 hours before enrolment
   * The potential need for surgery in the next 24 hours
   * Evidence of active bleeding
   * A history of severe head trauma requiring hospitalization
   * Intracranial surgery, or stroke within three months before the study
   * Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system
   * A history of congenital bleeding diatheses
   * Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed
   * Trauma is considered to increase the risk of bleeding
   * Presence of an epidural catheter
   * Need for therapeutic anticoagulation
4. Receiving DNase I by inhalation
5. Terminal illness with a life expectancy of fewer than three months
6. Pregnant and/or breastfeeding
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

Eligibility Criteria:
Inclusion Criteria:

* Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
* Able and willing to follow instructions
* Able and willing to provide informed consent

Exclusion criteria:

* Is monocular
* Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
* Had bilateral FA intravitreal implants
* Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System

The objective of this clinical investigation is to evaluate the safety and efficacy of the Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the superficial femoral artery (SFA) or the popliteal artery.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 of age.
2. Patient is Rutherford category 2-4.
3. De novo single lesion with a diameter stenosis (%DS) of ≥50%
4. Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of \<99%.
5. Target lesion stenosis has a length of ≤100 mm based on visual assessment.
6. Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment.
7. Angiographic evidence of distal runoff defined as minimum one patent tibial artery with a straight flow to the foot.
8. Patient is willing and able to provide written informed consent prior to any study specific procedure.
9. Patient is willing and able to comply with specified follow-up evaluations at the specified times.

Exclusion Criteria:

1. Prior PTA in the intended target lesion including 10 mm proximal or distal from the intended treatment area.
2. Evidence of thrombus in the target vessel.
3. Prior ipsilateral or contralateral lower limb arterial bypass.
4. Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure.
5. Target lesion is severely calcified.
6. Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
7. Any planned surgery within 30 days of the study procedure.
8. Renal failure (serum creatinine \> 2.0 mg/dL).
9. Female with childbearing potential without a negative pregnancy test.
10. Patient has had an organ transplant.
11. Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study.
12. In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a history of genital HSV documented by laboratory testing at screening
* Subject has experienced 4 or more episodes of genital herpes during the past 12 months

Exclusion Criteria:

* Subject is immunocompromised
A Phase 2 Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain (CYPRESS)

This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of RTA 901 in qualified participants with Diabetic Peripheral Neuropathic Pain (DPNP). Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and RTA 901-maching placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. A total of 384 participants will be randomized in this study. Each part will have 192 participants, with 64 participants randomized 1:1:1 to each treatment arm.

The duration of each part of the study will be approximately 20 weeks, including a Screening period of up to 2 weeks, a Run-in-period of 2 weeks, a Treatment period of 12 weeks, and a Follow-up period of 4 weeks. All participants in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in-periods.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Run-in Inclusion Criteria:

* Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening
* Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia);
* NPRS pain intensity score ≥ 4 on an 11-point scale at Screening
* A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B

Run-in Exclusion Criteria:

* Has neuropathy from a cause other than T1DM or T2DM
* Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression);
* Diabetic foot ulceration or infection within 90 days prior to Screening
* Prior participation in a study with RTA 901;

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Gait Rehabilitation in Diplegic Children

Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.

Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.

Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as spastic diplegia.
* They were able to follow simple verbal instructions.
* The use of Ankle Foot Orthoses.
* Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
* level I or II on the Gross Motor Function Classification System (GMFCS).

Exclusion Criteria:

* fixed contractures or deformities in the lower limbs.
* surgical orthopedic intervention.
* Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.


Eligibility Criteria:
Inclusion criteria:

* Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
* Planned clinical electrode trajectory that contacts caudate
* Age greater than or equal to 40
* Diagnosis of Parkinson's disease
* Able to participate in intraoperative testing
* English speaking

Exclusion criteria:

* Age less than 40
* Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
* Movement disorder other than Parkinson's disease
PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms

Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn, acid regurgitation, or dyspepsia that might result in resumption of therapy. A plausible physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH caused by blockage of the proton-pumps stimulates compensatory gastrin release. Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who had received eight weeks of esomperazole. The clinical symptoms occured in a different prevalence compared with placebo treated patients at ten weeks after withdrawal and until the end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients likely to benefit from it.

In this context, we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden discontinuation of esomeprazole 40mg.


Eligibility Criteria:
Inclusion Criteria:

* Treatment by esomeprazole 40mg since 4 weeks or more
* Esomeprazole withdrawal decided by the clinician
* Male and female aged 18-90 years
* Volunteers to participate to the study
* Must understand and read French language
* Must be able to give a written informed consent

Exclusion Criteria:

* Impairment of cognitive status
* Current indication to continue PPI treatment
* History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome
* Short-term treatment of documented ulcer disease, as part of a combination regimen for Helicobacter pylori (HP) eradication
* Prevention of ulcers due to non-steroidal anti-inflammatory drugs.
* Hepatic impairment (TP\<60%)
* Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole
* Current pregnancy or current breastfeeding
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)

This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with metastatic renal cell cancer(mRCC) based on the General Rule for Clinical and Pathological Studies on Renal Cell Carcinoma (4th Edition) before receiving avelumab plus axitinib as a first-line therapy.
2. Over 20 years of age at the time of metastatic renal cell cancer(mRCC) diagnosis.
3. Start treatment with avelumab plus axitinib as a first-line therapy for metastatic renal cell cancer(mRCC) from 20 December 2019 to 20 December 2020.
4. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained.
5. Deceased patients are also included for inclusion criteria 1-3.

Exclusion Criteria:

There are no exclusion criteria for this study.