cyrilzakka/clinical-trials huggingface dataset:
Implant/Abutment Module Stability of Original vs Compatible Connections

Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.

The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.

The hypothesis is that original components will present significantly better stability than non-original abutments.


Eligibility Criteria:
Inclusion Criteria:

* Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.

Exclusion Criteria:

* general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
* patients \<18 years of age,
* smoking habit (\>10 cigarettes/day),
* sites with acute infection or requiring regenerative procedures,
* Full Mouth Plaque Score
* Full Mouth Bleeding Score \>25 %,
* pregnant and lactating.
Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques

Context: The central venous catheter is used in intensive care units for several indications, including the administration of drugs with sclerosis potential, infusion solutions and hemodynamic monitoring. It can be accessed by per cutaneous puncture using the Seldinger technique, which is an extremely common procedure in intensive care units. The displacement or accidental removal of central venous catheter caused by poor fixation have received little attention, but imply potentially life threatening caused by the complications which can result from the removal of the catheter and the need for reinsertion. Among these complications, can mention the interruption of vital therapies (inotropic and vasopressor drugs) and hemorrhagic shock. In fixing the catheter, the literature is not sufficient to assess whether sutures, staples or tapes are associated with a higher risk of infections. Objective: To compare the efficiency in fixing the short stay central venous catheter using the "Ballerina" technique associated with flap fixation to the usual fixation technique and to observe differences in colonization of microorganisms on the device insertion site. Methods: The investigators propose an individual study, analytical, intervention, longitudinal, prospective, controlled clinical trial and randomized to be developed in the Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio Clinical Hospital in The University of Sapucaí Valley and Intensive Care Unit Adult Clinical and Surgical of The Hospital e Maternity Santa Paula. After admission of the patient in the Intensive Care Unit and obtaining informed consent and informed, with indication of the short stay central venous catheter, the patient will be allocated through a table of random numbers for the groups: Habitual Fixation (n = 31) and Fixation with "ballerina" technique and flip (n = 31). The participants will evaluate fixation efficiency and colonization of the device's insertion site.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for the use of central venous catheters ;
* Both genders ;
* Age greater than 18 years;
* Admitted to the intensive care unit;
* Informed Consent signed ( by the patient or family ) ;

Exclusion Criteria:

* Device repositioning Need for abnormal pathway or malposition after installation;
* No more indication of the central venous catheter use before the minimum period of 03 days ;
Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Age between 18 and 30 years
* BMI ≤ 26

Exclusion Criteria:

* Known present disease including diabetes mellitus
* BMI \> 26
* Uses any medication
* Consumes \> 21 units of alcohol per week
Tablet Distraction for Pain Control During Venipuncture

Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.

The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.

Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.

The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 13 years
* Need for venipuncture
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Children with epilepsy
* Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
* Inability to perform venipuncture on hand or arm
* Children with cognitive impairment or unable to report their pain verbally
Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient, female/male subjects of any race, 18-75 years of age.
* Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study
* Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2.
* Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).
* Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
* Written informed consent and written authorization for use or release of health and research information obtained.
* Willing to complete all required study visits, procedures, and evaluations including photography.

Exclusion Criteria:

* Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
* Patients with any uncontrolled systemic disease
* Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis
* Patients with known or suspected trichotillomania disorder
* Patients with a history of glaucoma and/or increased ocular pressure
* Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan)
* Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse
* Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
* Patients with permanent eye and/or eyebrow make-up
* Any eyebrow tint or dye applications within 2 months prior to study entry
* Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows
* Participation in another investigational drug or device study within the last 30 days
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.

This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.

Eligibility Criteria:
Inclusion Criteria:

* Regional macroscopic nodal metastatic melanoma in one nodal basin region only which has been completely resected.
* melanoma involving lymph nodes at high risk of local recurrence (details in protocol)
* No evidence of metastases
* No active major cancer within 5 years
* Normal blood tests
* WHO performance status of 0 or 1
* Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy
* Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout treatment
* No major concurrent illnesses likely to cause death within 2 years
* Written informed consent has been given

Exclusion Criteria:

* Evidence of active or previous local recurrence or in transit disease
* Evidence of distant metastases on clinical or radiological investigation
* Patients with prior cancers
Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease

Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* female sex
* a diagnosis of chronic kidney disease or end stage kidney disease
* age 18-51

Exclusion Criteria:

Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.
Temporary Biventricular Pacing

The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* mitral or tricuspid valve surgery patients identified as having preoperative Right Ventricular dysfunction and Left Ventricular Ejection Fraction less than 45 percent

Exclusion Criteria:

* Patients with in-situ biventricular pacemakers
* Pregnant or lactating females
Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement

The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.

Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo a total knee replacement due to osteoarthritis.
* Symptoms of the knee for at least 6 months prior to study start.

Exclusion Criteria:

* Key-hole surgery performed on target knee within 3 months prior to study start.
* History of disorders in which part of the immune system is missing or defective.
Causes of Complicated Appendicitis at Referral Hospital

The study was conducted on a medical record of previously treated patients for acute appendicitis at HFSUH, Harar, Ethiopia. The study design was case-control with a total sample size of 402.

The case-control study conducted at HFSUH was proceeded following the university's protocol and after passing institutional ethical review permission.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with acute appendicitis

Exclusion Criteria:

* incidental appendectomy patients
Mothers' Experience of Category 1 Cesarean Section

The aim of this qualitative prospective study is to investigate how mothers experience a category 1 cesarean section in a hospital where the partner is present in the operation room during the entire process (induction of general anestesia, cesarean section, possible resuscitation of newborn).

Mothers will be included in the study, if they wish to participate, on day 1 or 2 following the cesarean section and a brief, structured interview will be held concerning her experience of the cesarean section.

Clinical baseline data regarding the mother, the cesarean section and the infant will be collected from patients files.

Mothers will be contacted again three months after the cesarean section, and a semi-structured interview will be held via telephone. At the end of the interview a screening for posttraumatic stress will be performed, using the PTSD-8 tool. The interviews will be recorded and transscribed verbatim.

Content of interviews will be analysed using manifest content analysis. NVivo software will be used for coding interviews.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who had a category 1 cesarean section in Kolding Hospital, Denmark during a 1-year period

Exclusion Criteria:

* Not speaking/understanding Danish
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children.

Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo tympanostomy tube insertion in the clinic.
* Children 6 months to 21 years old
* Signed parental consent, and child assent documents as applicable.
* Parent is fluent in English.

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
* Anatomy precludes sufficient visualization and access to the tympanic membrane.
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework

In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Interprofessional telemedicine for movement disorders is feasible and may provide similar care as in-person visits; however, the majority of studies to date have shown benefit in Parkinson's disease and further validation in other movement disorders is necessary.

In this randomized controlled trial the aim is to study the acceptability, feasibility, and patient and clinician outcomes when a neurological consultation is provided for patients with DIMDs either in-person or through telemedicine. The investigators will apply the evaluation framework RE-AIM (Reach and Effectiveness, Adoption, Implementation, and Maintenance) to comprehensively assess the factors that may impact study success and program implementation. Mixed methods will be implemented to gather outcome data from mental health clinicians that refer patients and the patient participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to provide consent
* Willing to have their Mental Health Clinician (MHC) share sensitive clinical information with the Neurology team
* Able to travel to Neurology clinic
* Have connectivity to Zoom using wi-fi or cellular data, either at home or a comfortable and private setting (such as MHC office)

Exclusion Criteria:

* Currently hospitalized
* Neurologist determines patient requires care outside of the scope of the study
StatStrip Glucose/Ketone Meter System Ketone Evaluation

The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Ketone testing methods that quantify beta-hydroxybutyrate (β-OHB), the predominant ketone body, are used for diagnosing and monitoring ketoacidosis, a life-threatening complication of hyperglycemia. The performance of the StatStrip Ketone test strip using the Nova StatStrip Glucose / Ketone Hospital Meter System on venous and capillary whole blood will be assessed.

The primary objectives of this study are:

1. To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
2. To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
2. Adult subjects (≥ 18 years old) that are healthy.
3. Subjects willing and able to consent to participating in the study.
4. Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.

Exclusion Criteria:

1. Subjects unable to consent to participating in the study.
2. Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
Noninvasive Hemoglobin Monitoring by Spectrophotometry in Blunt Abdominal Trauma Patients for Conservative Management

We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I to III, of either sex, 18 -80 years of age, non-sedated non-intubated patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation.

Exclusion Criteria:

* Patients with fever, hypothermia, history of a neurological, psychiatric, dementia or, who are taking psychotropic drugs Patients with unstable hemodynamic status, and unconscious patients.
Curing HCV in Incarcerated Patients

Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City \& County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).

Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity to screen for HCV, initiate curative treatment, and link patients to community HCV providers to complete their treatment. This demonstration project will be funded by the Gilead's Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San Francisco Department of Public Health's Jail Health Services will treat 100 patients. Intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve SVR for those who are discharged from jail prior to HCV treatment completion. Navigators will provide short-term case management services by linking patients to medical and social support services. This demonstration project will be facilitated by the Jail Health Services' HIV \& Integrated Services (formerly Forensic AIDS Project).

Eligibility Criteria:
Inclusion Criteria:

* a detectable HCV viral load
* no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of \< 30 mL/min.
* Must start HCV treatment while detained
* HIV positive or negative status
* HBV positive or negative status
* treatment-naïve or experienced
* with or without cirrhosis

Exclusion Criteria:

* a limited life expectancy of less than 12-months due to non-liver related comorbid conditions
* current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months.
* severe renal impairment defined as creatinine clearance of \< 30 mL/min or end stage renal disease (ESRD) on hemodialysis
* pregnant