cyrilzakka/clinical-trials huggingface dataset:
Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation

This study evaluated the effectiveness of socket grafting material, combination of plate-rich fibrin and calcium sulfate. 5 subjects were grafted with this material, 5 subjects were grafted with combination of plate-rich fibrin and xenograft.

Calcium sulfate (CS), an alloplastic material, is widely accepted as a socket grafting material and undergoes rapid and complete resorption. Studies have shown that CS creates an osteoconductive lattice that stimulates bone ingrowth into a defect. PRF poses multiple growth factors, anti-inflammatory cytokines and adhesion molecules. It is biologically active up to one week. The combination of these 2 materials will serve as good grafting material for tooth socket, in order to preserve vertical and horizontal dimensions.

Eligibility Criteria:
Inclusion Criteria:

* maxillary premolar teeth requiring extraction
* neighboring mesial and distal sound/restored teeth present
* alveolar bone level (measured from periapical radiographs) more than 50% of the root length
* age ranges from 25-55 years

Exclusion Criteria:

* bony fenestration of the socket wall confirmed from CBCT scan
* acute signs of infection
* periodontally compromised teeth
* absence of buccal plates
* any systemic disease which may hinder the healing process
The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing off pump coronary artery bypass.

Exclusion Criteria:

* Patient refusal
* Preoperative vasopressor use
* Preoperative mechanical circulatory support
* Concurrent cerebrovascular or head and neck surgery
* Technical difficulty of measuring brain oxygen saturation
* Redo coronary artery bypass surgery
Global Electrical Heterogeneity and Clinical Outcomes

This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.


Eligibility Criteria:
Inclusion Criteria:

* records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications

Exclusion Criteria:

* absent baseline pre-implant digital ECG;
* missing data on clinical predictors and covariates;
* missing ICD programming data (including number of intervals to detect \[NID\] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing \[ATP\] programming);
* missing outcomes data.
* records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age with histologically confirmed prostate cancer
* Radiographic evidence of at least one bone metastasis
* Failure of at least one hormonal therapy as evidenced by a rising PSA
* Serum testosterone level of \<50 ng/dL
* ECOG PS 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* Current or prior oral bisphosphonates for bone mets
* Life expectancy of less than 6 months
PRIORITY-CONNECT 2 Pilot Trial

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.

Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.

The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years undergoing major gastrointestinal elective surgery, including liver, pancreas, oesophagus, gastric and colorectal cancer resections with curative intent
* Consulting with a gastrointestinal cancer surgeon at least 1 week prior to scheduled surgery

Exclusion Criteria:

* Cognitive impairment such that they are unable to provide informed consent
* No access to a smart device (including mobile phone, tablet, laptop or desk computer with camera) or no internet connection
Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction

The study will be conducted to examine the effects of abnormal growth pattern and cerebrovascular blood flow measurements on fetal frontal lobe development with the advancing ultrasound technology. Antenatal assessment of frontal lobe development will enable clinicians to predict neurodevelopmental problems that may develop postnatally. In addition, this study will examine the effects of FGR on frontal lobe development.

Fetal growth restriction (FGR) affects up to 10% of all pregnancies. The International Society of Ultrasound in Obstetrics \& Gynecology (ISUOG) adopts the Delphi consensus criteria for the definition of FGR. These criteria include estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd percentile or EFW or AC \< 10th percentile with abnormal Doppler findings or decreased growth percentiles. FGR is a cause of perinatal morbidity and mortality. These perinatal outcomes include cardiovascular, endocrine and neurodevelopmental disorders. Fetal growth restriction, which is associated with lower neurobehavioral test scores, is associated with significant postnatal costs for both the health care system and families. Previous literature has shown that three-dimensional ultrasonography of intracranial structures reveals significant differences between fetuses with FGR and gestational age-appropriate (AGA) fetuses. However, the limited use of three-dimensional ultrasonography has hindered clinical applications. The frontal Anterior-Posterior Diameter (FAPD)/Occipital-Frontal Diameter (OFD) ratio has recently been used to assess frontal lobe development in fetuses with congenital heart disease. The FAPD is obtained by measuring from the inner line of the frontal bone along the fetal brain midline to the posterior edge of the CSP. This measurement refers to the frontal lobe of the fetal cerebrum. This study was designed to investigate the FAPD/ OFD ratio and frontal lobe development in fetuses with FGR and to evaluate cerebrovascular flow and anterior midbrain structures in FGR fetuses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy hearts between the ages of 18-40
* Singleton pregnancies
* 32 to 37 weeks gestational week range

Exclusion Criteria:

* Multiple pregnancies
* Fetuses with fetal karyotype abnormalities
* Pregnant women with co-morbidity
* Fetuses with fetal intracranial hemorrhage
* Fetuses with cranial anomalies
* Maternal obesity preventing measurement
CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention

Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.

This intervention has been adapted based on feedback from previous focus groups with adolescents, clinical staff, community stakeholders, and a CEDARS workgroup.

Participants will be divided into two groups - 20 in the intervention group and 20 in the waitlisted group.

Adolescents in the intervention group will participate in 7 weekly, 1-hour sessions. This online intervention will feature positive affect and stress reduction skills delivered via self-paced and self-guided modules. The skills are taught through brief didactic and semi-interactive videos followed by invitations and opportunities for practice within the session and at home. Participants will complete a baseline, mid-point, and post-intervention survey to determine the influence of the intervention.

There will be one follow-up survey with participants after the intervention. The survey will take place 1 month after the program has concluded.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents ages 14-19
* Adolescents able to speak and understand English fluently
* Adolescents with reliable internet access (for virtual access to online modules)

Exclusion Criteria:

* Individuals younger than age 14 and older than age 19
* Individuals who are not able to speak or understand English fluently
* Individuals without reliable internet access
Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

The purpose of the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back.

This research aims to define a novel field-infiltration nerve block. We will use ultrasound guidance to inject local anesthesia into the potential space between the muscle bodies of the erector spinae. The medial branch of the dorsal ramus of each thoracolumbar nerve innervates the muscle and skin overlying the erector spinae muscle to the midline. By anesthetizing each nerve we believe minimally invasive (1-2 level) back surgery may be completed with less pain and preclude the side-effect laden opioid analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult

Exclusion Criteria:

* Pregnant women (a urine pregnancy test will be done on all females of childbearing age)
* Liver dysfunction
* Elderly
* Impaired cardiovascular function
* Individuals on amiodarone or history of back surgery
* History of medical allergy to local amide type local anesthetics
* Medical allergy to chlorhexidine
* History of paresthesias
* Inability to lay flat
* Home oxygen requirement
* History of seizures
* Only adults will be eligible.
The Development and Evaluation of a Novel Duodenoscope Assessment Tool

Endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed using duodenoscopes for the treatment of pancreatic and biliary diseases. Although outcomes in endoscopic retrograde cholangiopancreatography (ERCP) procedures are measured mainly in terms of procedural success and complications, currently there are no objective tools to assess the technical performance of the duodenoscopes.

The Center for Interventional Endoscopy has maintained a multicenter database that prospectively evaluates the technical performance of duodenoscopes for performing ERCPs. Our objective is to analyze the database in order to summarize the technical performance of duodenoscopes during ERCPs and evaluate the reliability of the duodenoscope assessment tool.

Outcomes in ERCP are measured mainly in terms of procedural success and complications. Recently, disposable duodenoscopes have been developed to overcome the challenges associated with reusable duodenoscope-related infections. While it is important to measure the technical performance of the newly developed disposable duodenoscope relative to conventional reusable scopes, presently, there are no objective tools to accomplish this task. The aim of this registry is to assess the reliability of a newly designed assessment tool to evaluate the technical performance of the currently available duodenoscopes. The duodenoscope assessment tool will be completed by each endoscopist after performing the ERCP and this data will be summarized and analyzed to assess the technical performance of the duodenoscopes and also to assess validity of the duodenoscope assessment tool. This is a multicenter study, with data collection from multiple centers across the United States.

Eligibility Criteria:
Inclusion Criteria

1. Aged 18 years or older
2. Undergoing ERCP using a duodenoscope

Exclusion Criteria

1. Aged less than 18 years old
2. Not undergoing ERCP using a duodenoscope
The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration

Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures
* Any gender, aged 21 - 65
* In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
* Healthy intact skin on the palmar aspect of both left and right forearms
* Fluent in English

Exclusion Criteria:

* Current use of any medication
* Pregnancy
* Known allergic reactions to components of the local anesthetic such as sulfites
* History of vasovagal response to venipuncture or vaccination
* History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
* Decreased sensation to the palmar aspect of either forearm
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.

Study Design:

* Multicenter
* Phase III
* Randomized
* Double Blind
* Prospective and Comparative
* Experiment duration: 105 days
* 5 visits
* Efficacy
* Adverse event

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand the study procedures agree to participate and give written consent.
* Diagnosed with type 2 diabetes mellitus (t2dm)b
* Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.

Exclusion Criteria:

* Pregnancy or risk of pregnancy.
* Lactation
* Any pathology or past medical condition that can interfere with this protocol
* Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
* Known hypersensitivity / intolerance to acarbose or any of its excipients
Long Term Efficiency of the Hair2Go Device

The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.

The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.

This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
2. Healthy males and females, between 18 and 65 years of age.
3. Willing to sign informed consent.
4. Willing to follow the protocol schedule.
5. Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
6. Willingness to avoid shaving 1 week prior to the visits.

Exclusion Criteria:

1. Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
2. Subject had electrolysis treatment within the last 6 months over the treatment area.
3. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).
Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults

The study looks at the comparative effects of food products made with pea, lentil, and oat flour of various particle sizes on postprandial glycemic response, appetite and food intake, and amino acid release in healthy adults.

A total of 60 participants (30 males, 30 females) will take part in this study at the University of Toronto. Twenty participants will be recruited to each one of three trials (pea, lentil or oat) and will attend 4 study sessions where they will consume crackers/porridge made with pea, lentil, oat, or wheat flours of different particle sizes. Questionnaires will be filled out to assess their recent food intake, physical activity, sleep quality, stress level, appetite, physical comfort, and energy/fatigue level, as well as tastefulness of the food. Blood samples will be collected at fasting and at various time points over a 2 hour period after eating to measure blood glucose, insulin, and amino acid concentrations. Before leaving, participants will receive an all-you-can-eat pizza meal to assess their food intake.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* BMI 18.5-29.9 kg/m2
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to maintain current dietary supplement use throughout the trial.
* Willing to abstain from alcohol consumption for 24h prior to all test visits.
* Willing to avoid vigorous physical activity for 24h prior to all test visits.
* Understanding the study procedure and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

* Smoking
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, a malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
* Presence of a gastrointestinal disorder or surgeries within the past year.
* Known to be pregnant or lactating.
* Unwillingness or inability to comply with the experimental procedures and to follow our safety guidelines.
* Allergies to peanuts and nuts.
* Known intolerances, sensitivity or allergy to any ingredients in the study products: pea flour, lentil flour, oat flour and whole wheat flour.
* Regular breakfast skipping (consumes breakfast less than 5 days a week)
* Extreme dietary habits (i.e Atkins diet, very high protein diets, etc.) or restrained eaters, identified by a score of ≥ 11 on the Eating Habits Questionnaire
* Uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg) as defined by the average blood pressure measured at screening.
* Weight gain or loss of at least 10lbs in previous three months.
* Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week).
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment.
Evaluation of PTB Screening in ANC in Lusaka, Zambia

This is a pilot pulmonary TB screening program done in three antenatal care clinics in Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to determine the sensitivity and specificity of symptom-based TB screening.

5000 pregnant women attending antenatal clinics will be evaluated by piloting a TB symptom questionnaire as part of the general health screening done at each visit. Due to the atypical and subclinical presentation of TB in HIV infected patients, culture will be performed on all HIV-infected pregnant women, with or without symptoms, and on all symptomatic HIVnegative women. Referrals for TB treatment in accordance with current national guidelines will be offered.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* 18 years or older
* HIV-negative women with any TB symptoms or HIV-infected women regardless of TB symptoms
* Attending first ANC visit at one of program clinics

Exclusion Criteria:

* HIV negative without any TB symptoms
Primary Hyperoxaluria Mutation Genotyping/Phenotyping

Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo RKSC research staff.

During your study visit, we will draw one tube, about two teaspoons (1 to 1 ½ teaspoons for children), of blood from your arm. White blood cells from the sample will be used as a source of DNA for genetic testing. We will use the DNA to try to identify mutations (changes) in one of the genes that can cause primary hyperoxaluria. This will be done by comparing it with the structure of these genes in normal individuals, patients with primary hyperoxaluria, and family members of primary hyperoxaluria patients. In family members of primary hyperoxaluria patients, a 24 hr urine test may also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Ages birth to 99 years in whom clinical information is available from medical records
* Patients with a diagnosis of PH confirmed on previous genetic testing
* Patients with clinical suspicion of primary hyperoxaluria (elevated urine oxalate of greater than 0.8 mmol/1.73 m2/day (\>70 mg/1.73 m2/day), history of kidney stones, and/or nephrocalcinosis documented by medical history or imaging studies
* First or second degree family members of a patient with primary hyperoxaluria

Exclusion Criteria:

* Stone formers who do not have confirmed PH and do not meet the inclusion criteria for clinical suspicion of primary hyperoxaluria
* Unwilling or unable to provide consent/assent.