cyrilzakka/clinical-trials huggingface dataset:
Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth

Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key.

Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults.

The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.

The investigators will conduct a split-mouth design randomized clinical trial assessing the effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in edentulous elderly adults.

Aim and purpose

1. To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
2. To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.
3. To examine soft tissues volumetric changes pre and post- surgery using intraoral scans and bone changes using cone-beam computed tomography (CBCT) around mandibular implants in edentulous patients.

Eligibility Criteria:
Inclusion Criteria:

* mandibular edentulous
* \> 60 years old

Exclusion Criteria:

* physical or psychological impediment for dental surgery
* dental extraction \< 6 months in the mandible
* anticoagulant treatment
Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz

This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable \[greater than 400 Copies/mL\] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen).

HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome

In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. This was originally a multi-center study, but it has been closed at all other sites. It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. Safety and viral load data continue to be collected.

Eligibility Criteria:
INCLUSION/EXCLUSION CRITERIA:

Subjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. There has been and will be no other new enrollment. Thus, subjects who were not previously enrolled are excluded.

Subjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment.
A Study to Assess Nomlabofusp in Adolescents and Children with Friedreich's Ataxia

The goal of this clinical trial is to evaluate the safety and tolerability of nomlabofusp (CTI-1601) in adolescents and children with Friedreich's ataxia (FRDA).

This is a randomized, double-blind, placebo-controlled study evaluating a weight-based dose of nomlabofusp versus placebo in adolescents and children with FRDA. The study will consist of at least two cohorts with at least 12 to 15 participants in each cohort. Participants will be dosed once daily (QD) for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has genetically confirmed diagnosis of FRDA manifested by homozygous GAA repeat expansions, with repeat sizing (if available) included on the diagnosis report.
2. Male or female subjects ≥ 2 to \< 18 years of age at screening.
3. Subjects must weigh ≥ 10.0 kg.
4. Subject must be able to traverse a distance of 25 feet with or without some assistive device (e.g., cane, walker, crutches, self-propelled wheelchair) and meet the following requirements:

   1. Be able to sit upright with thighs together and arms crossed without requiring support on more than 2 sides;
   2. Be able to transfer from bed to chair independently or with assistance if, in the opinion of the investigator, the degree of physical disability does not result in undue risk to the subject while participating in the study; and
   3. Perform basic age-appropriate daily care, such as feeding themselves and personal hygiene, with minimal assistance.

Exclusion Criteria:

1. Subjects who are confirmed as compound heterozygous (GAA repeat expansion on only 1 allele) for FRDA.
2. Subject has any condition, disease, or situation, including a cardiac condition or disease, that in the opinion of the investigator could confound the results of the study or put the subject at undue risk, making participation inadvisable.
3. Subjects currently receiving or having received omaveloxolone within 30 days prior to Screening.
French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire

Low back pain is a very common disease. Among the persons suffering of acute low back pain, about 10% are at risk of developping chronic pain. A screening questionnaire assessing this risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french translation of this questionnaire. Patients suffering from acute low back pain will be asked to fill in several questionnaires at day 0, and 6 and 12 month later.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients presenting at the clinical care setting with acute low back pain
* pain lasting for less than three months
* cumulated sick leave less thant six months

Exclusion Criteria:

* unability to sufficiently read and understand French
* presence of red flags as according to the New Zealand Acute Low Back Pain Guide
IV Acetaminophen for Postoperative Analgesia

The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
* American Society of Anesthesiology patient classification status I-II

Exclusion Criteria:

* Regular preoperative use of or opioids,
* Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
* Subjects converted to open laparoscopic cholecystectomy
* Known allergy/hypersensitivity to acetaminophen
* Use of opioids prior to commencement of the study (\<7 days)
* Patients with chronic pain conditions or disease requiring pain control
* Abnormal liver function
* Known or suspected alcohol, drug or opiate abuse or dependence
* Patients with a BMI of greater than 35
* Other physical, mental or medical conditions that could effect participation.
* Abnormal renal function; serum creatinine\>2gm/dl
Heart Inflammation and Mental Stress Study

The aim of the study is to investigate the neural underpinnings of cardiovascular reactivity to mental stress as a function of HIV and hypertensive risk.

The main objectives of the study are to assess (1) patterns of brain activity/connectivity that confers greater cardio-autonomic/emotion regulation, (e.g., heart rate variability, blood pressure reactivity, inflammatory-immune activation, etc.), during rest, mental stress, and anger-related distress, (2) whether changes in breathing pace mitigate task-based effects on cardio-autonomic-immune regulation, and (3) whether these patterns vary as a function of HIV or pre-hypertensive (HTN) status-related changes to the brain structures underlying cardioautonomic and emotion regulation.

Eligibility Criteria:
Inclusion criteria:

1. pre-hypertension screening.
2. HIV-antibody testing.

Exclusion criteria:

1. current use of anti-lipid, antihypertensive, or heart rate altering medications;
2. current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension;
3. current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes;
4. history of trauma, cerebral infarction or hemorrhage;
5. current diagnosis and/or treatment for hypertension;
6. severe cognitive impairment;
7. current treatment or diagnosis of psychiatric illness;
8. metal implants or debris within the body; or pregnancy;
9. body mass index \> 35;
10. use of hormone replacement therapy; and current smoker.
Improving Adherence to Rabies PEP Guideline Recommendations

This quasi-experimental, quality improvement study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED). Previous research identified opportunities to improve patient selection and delivery of rabies immune globulin (IG) as recommended by Centers for Disease Control and Prevention (CDC) guideline recommendations for rabies postexposure prophylaxis (PEP). The purpose of this study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) rabies PEP electronic health records (EHR) enhancements, (2) education to ED staff, and (3) education to patients. Adherence to quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG for 12 months following implementation (post-implementation group) will be compared with a historical control group.

BACKGROUND: Rabies infection can occur in humans when key elements of the rabies PEP regimens are omitted or incorrectly administered. The CDC Advisory Committee on Immunization Practices (ACIP) recommends that patients who are exposed to rabies virus should receive prompt and thorough wound cleansing followed by administration of human rabies IG and rabies vaccine. Previous research identified three opportunities to improve adherence to CDC guideline recommendations for rabies PEP: (1) infiltration of rabies IG into and around the wounds, if anatomically feasible, (2) administration of rabies IG at an anatomical site distant from rabies vaccine administration, and (3) avoiding administration of rabies IG into the buttock.

STUDY DESIGN: This quasi-experimental, quality improvement study evaluates adherence to 6 quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG before and after implementation of the rabies PEP quality improvement bundle. The quality improvement bundle includes EHR enhancements, ED staff education, and patient education. Patients who receive at least one dose of rabies IG or rabies vaccine at a study site during the study period will be included in this study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 12 months following bundle implementation. The primary outcome is full adherence to all 6 quality indicators for rabies IG selection and delivery.

Eligibility Criteria:
Inclusion Criteria:

• Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility

This prospective observational study will include critically ill patients with hemodynamic compromise. It will compare passive leg raising and a mini volume challenge (MVC) carried out on every patient sequentially. The endogenous release of stress hormones will also be assayed in order to investigate their modifying effect on the hemodynamic reaction of the participants. The effect of fluid resuscitation on renal perfusion will also be assessed and the data compared with the release of cystatin C.

Fluids are administered either before starting with or during ongoing vasopressor treatment in critically ill patients with hemodynamic instability. The endogenous release of stress hormones, namely renin, vasopressin, norepinephrine and cortisol, may be variable in critically ill patients, which may have a modifying effect on the hemodynamic response. Passive leg raising (PLR), a validated, simple and dynamic test, is currently recommended for testing fluid responsiveness. The test might possibly be false negative under extreme dehydration or increased intra-abdominal pressure. This prospective observational study aims to compare PLR and MVC with 300 ml Ringer acetate solution administered as a bolus within 5 minutes in critically ill medical patients with a hemodynamic instability. MVC will be carried out in every participant following PLR. Blood samples will be collected immediately before PLR for measurement of renin, copeptin A, cortisol and norepinephrine in those patients not yet receiving a vasopressor. These biomarkers will be compared with the Magnitude of fluid responsiveness. Additionally, renal resistive index will be assessed with ultrasound immediately before PLR and 1 and 24 hours after fluid challenge and the data compared with Initial serum cystatin C in those patients who have not yet developed acute renal failure. Blood samples for measurement of angiopoietin-2, a marker of capillary leak, will be drawn immediately before PLR and the data will be correlated with the amount of fluid required for Initial resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* mean arterial pressure \<65 mm Hg and/or
* blood lactate \>2 mmol/l and/or
* mottling or capillary refill \>3 seconds and/or
* oliguria and
* critical care decision for testing fluid responsiveness

Exclusion Criteria:

* cardiopulmonary resuscitation
* uncontrolled bleeding
* irreversible brain damage
* pregnancy and lactation
* Age under 18 years
Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes

The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.

The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes ≥ 1 year
* CSII ≥ 6 months
* Previous education to flexible insulin therapy
* Patient willing to use sensors and smartguard option for 1 year
* A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes

Exclusion Criteria:

* No access to a computer and/or to the web making it impossible to follow patients through telemedicine
Medication Education for Dosing Safety

Acetaminophen and ibuprofen are two of the most commonly used medication products among children \<12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these medications at home. This study will be a randomized controlled trial of a brief medication safety intervention, and examining parental knowledge and implementation of appropriate weight-based dosing.


Eligibility Criteria:
Inclusion Criteria:

* parents of children between ages of 90 days to 11.9 years
* being discharged with a plan for use of liquid acetaminophen (any age) or ibuprofen (limited to those \>6 months old). The clinical team will determine planned medication use.
* parental fluency in English or Spanish
* ability to be reached by telephone over the next 7 days
* planned discharge home.

Exclusion Criteria:

* presence of a complex chronic condition in the child
* planned use of a non-standard weight-based medication dose.
* Families will also be excluded if the adult with the child is not a parent or legal guardian.
Effects of TNT on Pain, ROM and Disability in Patients With RC Tendinopathy

EFFECTS OF TENDON NEUROPLASTIC TRAINING ON PAIN, RANGE OF MOTION AND DISABILITY IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY

Rotator cuff tendinopathy is a condition where the shoulder's tendon suffers small tears or inflammation, often causing pain frequently arises from repetitive overuse or the natural aging process Regular overhead activities can aggravate the shoulder's wear and tear, leading to tendinosis. The purpose of this study is to evaluate and compare the impact of tendon neuroplastic training with standard treatments on pain levels, functional disability, and the range of motion in patients suffering from rotator cuff tendinopathy. Data were collected from Riphah rehabilitation clinic Lahore. Nprs , goinmeter and Spadi questioner were used before and after the intervention. Assessment was done through the tool before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have a current shoulder complaint lasting at least three months prior to the time of enrollment
* Pain is located in the proximal lateral aspect of the upper arm (C5 dermatome)
* Positive Hawkins-Kennedy test

Exclusion Criteria:

* Bilateral shoulder pain
* Less than 90 degrees of active elevation of the arm
* Corticosteroid injection within the last six weeks
* Radiologically verified fracture
* Glenohumeral osteoarthritis
* Surgery or dislocation of the affected shoulder
* Symptomatic arthritis in the Ac joint
* Frozen shoulder
* Symptoms derived from the cervical spine
Virtual for Care Atrial Fibrillation Patients Using VIRTUES

Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. In addition to the chart review, patients with atrial fibrillation who have recently gone to the emergency room or have been hospitalized will be approached and asked if they want to use an electronic health care system that can be accessed by both themselves and their health care providers. Along with the system, patients will be given a Health Canada approved heart rhythm sensor, so patients will be able to record their heart rhythm when they feel symptoms and send the information to the heart rhythm team. The heart rhythm team will then make real-time recommendations to the patient about how they can manage their rhythm and symptoms. Patients will be asked to complete satisfaction and quality of life surveys. Our goal is to provide efficient and effective care for patients with AF, resulting in decreased repeat ED visits.

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* documented symptomatic new-onset or pre-existing, non-valvular AF
* ER visit or hospitalization for primary AF in the last 6 months
* proficient in the English language

Exclusion Criteria:

* unable to provide informed consent
* planning to move/relocate during the period of study
* current pregnancy
* patient is a prisoner/incarcerated
* no access to a smart device with Bluetooth capabilities
* planned percutaneous coronary intervention, coronary artery bypass graphing or heart valve surgery within the next year
* any medical condition making 1 year survival unlikely