cyrilzakka/clinical-trials huggingface dataset:
Prosthetic Maintenance of Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Frameworks

The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Twenty-four participants were randomly assigned to two groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr framework, while Group II received a mandibular implant-retained overdenture reinforced with a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable denture.

Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous selection, with two implants placed in the mandibular canine areas through a two-stage surgical technique facilitated by a radiographic and surgical stent. Following this, patients were provided with maxillary and mandibular complete removable dentures relined with soft liners. After the subsequent three-month osseointegration period, ball attachments were introduced. Patients were randomly allocated to two groups based on the type of prosthesis they received. Group I received mandibular implant-retained overdenture reinforced with the Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced with the PEKK framework, both groups received complete removable dentures for the maxillary arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures in both groups was conducted twelve months post-denture insertion.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 50-70 years old.
* Completely edentulous patients
* Systemically free from any disease that contraindicates implant placement.
* A minimum of 12 -15 millimeters of bone height and 6 mm bone width at canine areas diagnosed from the pre-operative cone beam CT.
* Sufficient inter-arch space (15mm) to accommodate the mandibular implant-retained overdentures.

Exclusion Criteria:

* Patients with bone or mucosal diseases.
* Heavy smokers.
* Patients with uncontrolled metabolic disorders such as diabetes mellitus.
* Patients with parafunctional habits.
* Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
Effect of Eggplant Extract on Lipid Profile During Fasting and Postprandial Period

The purpose of this study was to assess the effect of eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test in a randomized, double-blind, placebo-controlled clinical trial.

Dry eggplant extract(Solanum melongena) has been used by the population as an alternative treatment for dyslipidemia. It is a vegetable rich in flavonoids, which are polyphenol anti-oxidants found in foods. Studies suggest an inverse relationship between the ingestion of foods rich in flavonoids and mortality from coronary artery disease. The aim of this study was to assess the effect of administering eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test.

Participants underwent a baseline clinical evaluation conducted by a doctor, who assessed whether the volunteer was apt to participate in the study. Diabetics, smokers and users of hypolipidemic medication were excluded. After signing an informed consent form, 59 healthy volunteers of both genders were randomized to take either capsules containing 450 mg of dry eggplant extract or placebo. Both interventions were administered in quantities of two capsules, twice a day, for 14 days, and both patient and doctor were unaware of the drug in use.

The main outcome measure was lipid profile, which was checked during fasting on days 0 and 14, and also during postprandial period on the 14th day, when participants underwent a lipid overload test immediately after ingesting 900 mg of eggplant extract or placebo, as per prior randomization. The nutritional analysis of the meal contained 361 kcal and 22.5g of total fat, 14.5 g of which was saturated and 251mg of cholesterol. Laboratory exams were taken (total cholesterol, triglycerides, HDL-C). LDL-C was calculated according to the Friedewald formula: LDL-C = CT - HDL-C - TG/5. The nutritional value of food records was conducted with the help of Diet Win for Windows nutritional evaluation software.

Anthropometric evaluation was also performed, including body weight, height and abdominal circumference, at baseline and on day 14, by the same investigator, blinded to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Baseline clinical evaluation conducted by a doctor
* Informed consent form

Exclusion Criteria:

* Diabetes Mellitus
* Smoking
* Use of hypolipidemic medication
Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine

The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).

The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the treatment of postoperative abdominal wound healing impairments (with intact fascia) results in a decrease of time until achievement of wound closure (with confirmation after 30 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.

Eligibility Criteria:
Inclusion Criteria:

* Acute subcutaneous abdominal wound-healing impairment after surgical intervention
* Sizes of wound opening (maximum diameter ≥ 3 cm)
* Wound surface ≥ 9 qcm

Exclusion Criteria:

Lack of infrastructure for outpatient continuation of treatment and study-specific interventions

* Existence of an open abdominal fascia
* Acute serious organ failure
* Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
* Ongoing / during 3 weeks after chemo therapy
* Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies
Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber

This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.

The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for cataract surgery via the anterior chamber
* A negative urine pregnany test at Visit 1 or 2
* Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent.

Exclusion Criteria:

* Patient who are known to be hypersensitive to HPMC or other components of the device
* Patients with corneal scars or corneal dystrophies interfering with study measurements
* Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
* Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
* Any person dependent on the investigator or employees of the investigation site institution or the Sponsor
* Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
* Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act
Re-engagement at Discharge 2

Early post-discharge mortality is high among Zambians living with HIV admitted to the hospital. This may be due to missed opportunities in post-discharge care, such as inadequate follow-up and treatment. In this study the investigators will develop and pilot a new approach to post-discharge HIV care to improve care coordination and treatment adherence.

Many people living with HIV (PLHIV) have poor outcomes following hospitalization, including high mortality, readmission, and gaps in HIV care engagement. This is likely multi-factorial and not all etiologies may be modifiable. While high mortality may due to incurable cancer, the majority of deaths in PLHIV are thought to be caused by infectious diseases for which treatments exist. However, succumbing to these life-threatening infections after discharge may be due to poor understanding of discharge instructions, lack of post hospital care, and poor understanding of required follow up. Psychosocial support also plays a role in the mental and physical health of these sick patients.

In ReCharge 1, the investigators gathered formative data and identified at least three major factors that undermine HIV clinical outcomes after hospital discharge. First, there are gaps in continuity of care between the discharging facility and outpatient. Second, support from family is often suboptimal due to lack of understanding on the cause of illness, lack of HIV status disclosure, and the cost of care. Third, HIV comorbidities may underpin or complicate the immediate reason for discharge or the post-discharge engagement in care. These data were disseminated to local experts in Zambia including from the Ministry of Health and used to create a new care model for post-discharge HIV care. The care model draws from other successful programs in Zambia. In ReCharge 2 the investigators now propose to pilot the program and assess feasibility, acceptability, and potential for clinical impact.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* HIV-positive
* Hospitalized for at least 1 night at study site
* Clinically stable and expected to be discharged according to their clinician
* Objective evidence of suboptimal HIV outcome, defined as HIV viral load above the lower limit of the assay or T-cell cluster of differentiation 4 count \<=200.

Exclusion Criteria:

* Unable to provide informed consent
* No phone
* Planning to reside outside of Lusaka urban district after discharge
Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries

Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.

A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

Eligibility Criteria:
Inclusion Criteria:

Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.

Exclusion Criteria:

* Infection at site of injection.
* Patient refusal.
* Psychiatric or physical illness that lead to inability to cooperate, speak or read.
* Abdominal operations under spinal anesthesia.
* History or evidence of coagulopathy.
* Known allergies to drugs used .
* Preexisting neurological disorders.
Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial

Bells palsy is a sudden paralysis of half of the facial muscle. The BP is idiopathic and 70% responds well with drug therapy. There are many complementary therapies such as , tapping, electrical stimulation, and massage that adds to the recovery of condition. However, efficacy of neural mobilization in BP is not reported in the scientific literature.

Bells Palsy responds well with drug therapy such as prednisolone and antiviral drugs for the duration of 10-12 days. However, the administration of these drugs produce adverse side effect. Therapist use a number of techniques to maintain the physiological properties of facial muscles. However, adding a new technique would add to the arsenal of techniques available for the therapist. The research is intended to determine the effect of adding Neural mobilization in the recovery of Bells Palsy. A randomized controlled trail is intended to include 60 participants divided into two groups. Experimental group will receive Neural Mobilization with conservative treatment and control group will receive conservative treatment only.

Eligibility Criteria:
Inclusion Criteria:

* The first episode of Bell's palsy.
* Modified House-Brackmann scale III-IV.

Exclusion Criteria:

* Diabetic
* Recurrent Bells palsy
* facial palsy
* History of stroke
* Any cerebrovascular accident
* epilepsy
Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral
* Primary or recurrent

Exclusion Criteria:

* body-mass index over 40kg/m2, severe co-morbidities
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.

The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).

We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 and \<21 years
* Persistent asthma according to national guidelines criteria
* Asthma Control Test (ACT) score ≤19
* Prescribed a preventive (controller) asthma medication in the past 6 months
* Access to a smartphone compatible with the PEAKmAAP and NutriMap
* Access to the internet
* Able to read and speak English

Exclusion Criteria:

* Significant underlying respiratory disease other than asthma, such as cystic fibrosis
* Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
* Current smoker
* Participation in the investigator's or other asthma clinical trials in the previous 6 months
Intraoperative Warming Comparison of Devices

Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.

Various warming methods, such as warm blankets, forced-air warmers and circulating water mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are cutaneous approaches that rely on heating the peripheral tissues in order to increase the thermal core temperature. Application of cutaneous warming system blankets/pads are limited by location/extent of operative site; for example, in certain procedures such as laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of skin surface is available for warming application. The Dynatherm vitalHEAT technology takes advantage of the body's natural thermoregulatory system to channel thermal energy to the body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat hypothermia during the peri-operative period through a combination of localized heat and vacuum application to one hand \& forearm; this application 1) opens the arteriovenous anastamoses located in the palm of the hand and 2) conductively warms the extremity thus effectively warming the blood flow to the body's core. The vital heat vH2 system is a portable and compact warming device which provides a non-invasive approach to warming patients during surgery.

The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2) Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends during surgery and 3) comparison of the subjects' post anesthesia care unit temperature trends and hypothermic symptoms such as shivering.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open abdominal surgical procedures with an expected duration of 2 to 4 hours and requiring general anesthesia
* American Society of Anesthesiologists(ASA) physical status I-III
* Patient age: \> 18 years and \<80 years

Exclusion Criteria:

* Patient age: \< 18 years and \>80 years
* Patients with break in skin integrity on the extremity selected as the application site
* Patients with history of upper extremity peripheral vascular disease
* Patients with history of allergic skin conditions of the upper extremities
* Patients with history of bleeding disorders/coagulopathy
* Patient with history of malignant hyperthermia
* Patients who are pregnant
* Patient unwilling or unable to give informed consent
Comparison of Telemedicine Versus Traditional Practice in a University Health Center

This study is to determine if telemedicine visits provide similar quality and patient/physician satisfaction as traditional office visits in a college health population.

This study which is open to students at Arizona State University who require follow-up care after their visit to ASU Health Services. Patients who are seen by a Mayo Clinic physician working at the ASU Health Services are randomized to either be seen for followup at the health center with the same physician or seen at the health center by the same physician at Mayo clinic utilizing telemedicine.

After the visit, patients and the physician will fill out an patient satisfaction survey and the record will be reviewed by an independent investigator for determining quality of care by reviewing the record.

Eligibility Criteria:
Inclusion Criteria:

* Arizona State University students who require a follow-up care visit.
* ages 18 and above

Exclusion Criteria:

* patients who are medically unstable to be randomized to a telemedicine visit.
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study

The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).

More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics.

This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events.

The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.

Eligibility Criteria:
Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure
Kinesiotaping Therapy for Clavicular Fractures FRACTURES:

This is a multicenter prospective randomized controlled study. Forty patients in whom conservative treatment for clavicle midshaft fractures was indicated between January 2018 and July 2019 were included.

The investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. The investigators hypothesized that kinesiotaping reduces the disadvantages of conservative treatment, such as early-phase pain, high nonunion rates, and a prolonged time to return to work, and yields better clinical and functional outcomes by providing good mechanical support and neutralizing the deforming muscle forces around the fractured clavicle.

The investigators divided into 2 groups and followed one group of patients with clavicle fractures only with shoulder sling, while the other group were followed with kinesiotherapy treatment and shoulder arm sling. They investigated the effect of kinesiotherapy treatment on early pain and returning time to work.

Eligibility Criteria:
Inclusion Criteria:

Participants with midclavicle fracture within 24 hours

Exclusion Criteria:

Participants with open fractures,
Hemopatch Versus No Hemopatch (Renal Transplant)

Kidney transplantation remains one of the most common organ transplanted today but the surgical technique has changed very little from the original pelvic operation. The deceased donor renal transplant poses a particular challenge to the surgeon due to lack of detailed pre operative vascular assessment. The hemopatch is a promising new sealing synthetic hemostatIc agent with a novel dual mechanism of action that is more convenient to apply rather then using other hemostatic agents, which require warming and/or mixing.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age and capable of giving informed consent
* Patients scheduled for deceased donor renal transplant surgery

Exclusion Criteria:

* Patient undergoing live related transplant surgery.
* Patient having uncorrectable bleeding diathesis.
* Any patient in the no hemopatch group requiring additional haemostatic agents for achieving hemostasis like fibrillar or surgical.