cyrilzakka/clinical-trials huggingface dataset:
Immediate Implant With Different Filling Materials

36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.


Eligibility Criteria:
Inclusion Criteria:

* Patient medically free from systemic diseases.
* Age above 18 years.
* A single maxillary anterior or premolar tooth that cannot be restored.
* No acute infection is present.
* Patients with sufficient quality and quantity of bone.
* Free from history of bruxism.

Exclusion Criteria:

* A medical condition that would prevent implant surgery.
* Existence of non-treated generalized progressive periodontitis.
* Patients who are smokers.
Effect of Beans Compared to Beef on Satiety in Older Adults

This human clinical trial is using a randomized crossover design to examine the effect of two varieties of beans compared to beef on satiety and food intake in older adults.

This human clinical trial is using a randomized crossover design that includes 3 study visits separated by washout periods of at least 1 week. Each study visit will last approximately 4 hours and will occur at the Human Nutraceutical Research Unit (HNRU) at the University of Guelph. Study visits will occur in the morning and begin with measurement of fasting body weight. Participants will then complete a baseline satiety questionnaire before they consume a breakfast test meal (that includes either red kidney beans, black beans or extra-lean ground beef). After the breakfast meal, participants will complete a palatability questionnaire. They will also complete more satiety questionnaires at 15, 30, 45, 60, 120, 150 and 180 minutes. After 180 minutes, participants will be consume an ad libitum pizza lunch meal until they are comfortably full. Participants will then be sent home with a food scale and instructions to record everything they eat and drink for the remainder of the day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* ≥60 years old
* BMI between 18.5-30 kg/m2

Exclusion Criteria:

* Medication use that is not at a stable dose (at least 3 months)
* Natural health product use that is not at a stable dose (at least 3 months)
* Antibiotic use in the past 3 months
* Overnight shift work
* Alcohol consumption \>14 drinks/week or \>4 drinks/sitting
* Anaphylactic food allergy
* Pulse (beans, lentils, chickpeas, dried peas) consumption \>4 servings per week
* Recent or intended significant weight loss or weight gain (\>4 kg in previous 3 months)
* Breakfast skipping ≥4 days per week
* Vegan diet
* Dislike or unable to consume beans, ground beef, shredded cheddar cheese, white tortilla wraps or frozen cheese pizza
* Three Factor Eating Questionnaire scale scores \>11 for Cognitive Restraint, \>9 for Disinhibition, and \>8 for Hunger
* Diagnosed hypertension (blood pressure \>140/90mmHg) that is not managed
* Diagnosed digestive-related condition (i.e. Celiac Disease, constipation, gastritis, gastroesophageal reflux disease, gluten intolerance, hemorrhoids, inflammatory bowel disease (Crohn's, Ulcerative Colitis), irritable bowel syndrome, lactose intolerance)
* Diagnosed cognitive-related condition (i.e. Alzheimer's Disease, amnesia, dementia, generalized anxiety disorder, major depressive disorder, Parkinson's Disease, schizophrenia, traumatic brain injury)
* Medical condition that does not have stable management for at least 3 months
* Medical or surgical event requiring hospitalization in the past 3 months
* Tobacco use
* Cannabis use
* Vape use
Omega 3/6 Fatty Acids for Reading in Children

The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves mainstream schoolchildren's reading ability. The secondary objective was to assess whether Omega 3/6 improves cognitive functions such as attention, memory, learning, language/communication, problem solving and social ability.This was a 3-month randomised, double-blind, placebo-controlled study followed by one-way crossover (placebo to active treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo. All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities. Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and problem solving); Social and Communication Disorders Checklist (to evaluate social ability)

This was a 3-month randomized, double-blind, placebo-controlled study (Period 1) followed by one-way crossover (placebo to active treatment) for an additional 3 months (Period 2). Participants were randomized to receive three Omega 3/6 capsules twice daily (corresponding to a daily dose of 558 mg EPA, 174 mg DHA, and 60 mg gamma-linolenic acid) or identical placebo capsules (palm oil). All daily doses were taken at home supervised by the parents. All outcome measures were assessed at baseline and at the 3- and 6-month follow-up visits. The participants were mainstream schoolchildren in the 3rd school year (aged 9-10 years). Exclusion criteria were continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year, significant medical conditions (e.g. diabetes, epilepsy), intellectual disability, attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.

Eligibility Criteria:
Inclusion Criteria:

* mainstream schoolchildren in the 3rd school year (aged 9-10 years).

Exclusion Criteria:

* continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year
* significant medical conditions (e.g. diabetes, epilepsy)
* intellectual disability
* attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.
Functional Capacity in Patients Post Mild COVID-19

Patients recovered from mild coronavirus 2019 (COVID-19) disease without pulmonary involvement may experience long-term physical impairment and dyspnea. The investigators aim to characterize physiologic limitations in patients who recovered from mild COVID-19.

Methods: Pulmonary function tests (PFTs), 6-minute walk test (6MWT), echocardiography and cardiopulmonary exercise test (CPET) will be completed in patients recovered from mild COVID-19 disease with prolonged dyspnea (Subgroup "A") and compared to patients recovered from moderate/severe COVID-19 (subgroup "B") and to non-COVID-19 patients with unexplained dyspnea (subgroup "C").

Infection with severe acute respiratory syndrome coronavirus-2 leads to severe disease requiring hospitalization in 20% of the cases. Respiratory failure from severe acute respiratory syndrome coronavirus-2 infection can range from mild pneumonia and hypoxia to life threatening hypoxia secondary to severe acute respiratory distress syndrome requiring intensive care unit and mechanical ventilation in about 12-24% of the hospitalized patients. Most patients are discharged with minimal or no long-term oxygen therapy while others are discharged with ongoing respiratory symptoms and long-term oxygen therapy. In the longer term, there is a significant concern that severe coronavirus disease 2019 can lead to organizing pneumonia and severe acute lung injury with evolution to widespread fibrotic changes as seen in fatal cases of coronavirus disease showing pulmonary fibrosis at autopsy. Studies in severe acute respiratory syndrome survivors, another corona virus infection, showed persistent and significant impairment of exercise capacity and health status over 24 months based on PFTs, 6-minute walk test and health questionnaire. Infection with respiratory syndrome coronavirus-2 has been also associated with multiple direct and indirect cardiovascular complications including acute myocardial injury, myocarditis, arrhythmias, and venous thromboembolism. However, long term cardiovascular consequences from coronavirus disease 2019 are still unknown. The investigators sought to determine the pulmonary, cardiac and other physiologic limitations in patients who recovered from severe coronavirus disease 2019 with physiologic tests including PFTs, echocardiography and cardio-pulmonary exercise test which is currently the most comprehensive physiologic test that can differentiate between the different limitations and add novel data regarding short and long term physiologic consequences of coronavirus disease 2019.

Eligibility Criteria:
Inclusion Criteria:

* Patients recovering from COVID-19 with a documented infection with severe acute respiratory syndrome coronavirus-2 and cognitive ability to sign informed consent and physical ability to participate in exercise tests.

Exclusion Criteria:

* Patients with severe pulmonary, cardiac disease prior to COVID-19, pregnant women, and patients with active infection or cancer.
Study of Computer-Based Treatment for Drug Dependence

The purpose of this study is to evaluate the whether an automated telephone-based system is useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The Recovery Line support system is a Therapeutic Interactive Voice Response system based on cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of modules presenting the basic principles and strategies of CBT. Each module includes learning sections and activities sections to provide direct guidance in using skills. The Recovery Line support system is interactive and also includes a questionnaire to help patients identify problems and recommend modules for use, as well as an inspiration section, an introduction, and an immediate assistance menu. Following development of an initial system the current trial will recruit 40 patients receiving buprenorphine maintenance from a physician provider in the local community. Patients will be randomly (flip of a coin) to receive the Recover Line Support system or to treatment as usual with their physician. Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR system for a four week period. Primary outcome variables will be how long patients remain in treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured by weekly drug screens. It is expected that patients assigned to TIVR will better treatment outcomes than patients assigned to TAU.


Eligibility Criteria:
Inclusion Criteria:

* are at least 18 years old
* have initiated buprenorphine maintenance treatment from an approved physician in the previous two weeks

Exclusion Criteria:

* are a current suicide or homicide risk or meet criteria for psychiatric disorder that would interfere with ability to complete study
* are unable to read or understand English
* have a life-threatening or unstable medical problem
Clinical Estimation of Dental Anxiety

Introduction: Dental anxiety (DA) is treatable and preventable when dental personnel correctly estimate the patient's level of DA. Objective: To evaluate dental personnel's ability to estimate DA.

Method: All public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination. The patient rated DA using the Modified Dental Anxiety Scale (MDAS) and a Visual Analogue Scale of dental anxiety (DA-VAS). The patient also recorded gender, age, level of education and confidence in handling DA. After the examination, the dental personnel estimated the patient's level of DA (eDA) on a VAS. The examiner also recorded gender, age, profession, years of experience, country of education, interest in DA, special education concerning DA and confidence in ability to handle DA.

Eligibility Criteria:
Inclusion Criteria:

Adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden during a two week period.

Exclusion Criteria:

inability to fill in the questionnaire
An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple Sclerosis

The aim of this case series was to document the effectiveness and compatibility of Rebif 44 or 22 µg in the therapy of the chronic multiple sclerosis (MS) under practical conditions on a large collection of subjects. In addition, the side effects possibly occurring in the initial phase of therapy and satisfaction of the subject as well as the treating doctor was also documented.

Interferon beta-1a is established as therapy of the first choice in the treatment of the chronic MS. The PRISMS study has shown that the therapy with Rebif reduces the frequency and seriousness of clinical attacks or episodes over 4 years and the progress of the disability slows down. This clinically identifiable effectiveness is supported by the significant decrease in the nuclear spin-tomographically provable disease activity and total lesion stress. The interferon-beta therapy cannot heal the MS but the therapy with Rebif can however reduce number and seriousness of attacks or episodes and can clearly delay progress of the disability. The Rebif therapy is a long-term treatment, as a result the subject may not feel the positive effects immediately, but effects of the therapy can only be noticed after a longer period.

At the beginning of the therapy, interferon-beta-specific side effects such as fever, fever-like symptoms, muscle and joint pains as well as reactions at the injection points can occur. The described reactions are individually dependent on respective subjects in duration and seriousness, however they are normally mild and temporary.

OBJECTIVE

The objective of this study was to document the effectiveness and compatibility of Rebif 44 or 22 µg proven in clinical studies in the therapy of the chronic MS under practical conditions on a large collection of subjects. Especially the handling of injection aid of Rebiject II when using with Rebif pre-filled syringe was documented.

The observation period in this study was 3 months per subject and approximately 500 subjects with clinically safe diagnosis of a chronic MS and ability to walk (also with aids) were recorded in the case series. Demographic data as well as details about the diagnosis, course, current status and previous therapy of MS was recorded at the beginning of the case series. All data collected within the framework of the therapy, such as e.g. of blood count test or determination of the liver function test values for checking the possible influence of Rebif on these parameters was part of the case series and hence were documented.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinically safe diagnosis of a chronic MS and ability to walk (also with aids).

Exclusion Criteria:

* Subjects with primary chronically progressive course of the MS
* Pregnant or nursing female subjects
* Subjects with severe depressions
* Epilepsy subjects whose symptoms cannot be cured adequately with therapy
* Subjects with existing systemic concurrent diseases (e.g. diabetes, heart, liver, kidney diseases)
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma

This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.

BIW-8962 is a monoclonal antibody which targets the GM-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. This is a Phase 1/2 study design. The Phase 1 component will establish the active biologic dose (ABD) or the maximum tolerated dose (MTD) as well as the appropriate dosing frequency based on the pharmacokinetics of the antibody and approximately 45 subjects will be enrolled in this part of the study. The initial dosing frequency will be every two weeks and the doses to be tested will range from 0.03 mg/kg to 10 mg/kg. Once the recommended Phase 2 dose and frequency have been established in Phase 1, the efficacy of the drug will be investigated in approximately 35 subjects in Phase 2.

The study did not proceed beyond the Phase 1a portion.

On 30 Nov 2010, Kyowa Hakko Kirin Pharma, Inc. (KKP) notified Investigators of the decision to terminate BIW-8962-001 due to a lack of efficacy in Multiple Myeloma.

The Phase 1 Part B and the Phase 2 components of the study were not conducted. The study was terminated and summarized in an abbreviated clinical study report (submitted 26 June 2012; SN045). Kyowa Kirin Pharma has no current plans to pursue the use of BIW8962 in multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory myeloma
* M-protein in serum and/or urine by IMWG criteria.
* Bone marrow plasma cells or plasmacytoma
* Related organ or tissue impairment (CRAB)
* Subjects without detectable M protein are eligible if they have an abnormal serum free light chain ratio (FLC) or if they have at least 10% plasma cells in the bone marrow

Exclusion Criteria:

* Ongoing infection
* Cardiac disease
* Uncontrolled hypertension
* Active liver disease
The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.

The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.

the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).

220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, \& Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with enlarged prostate presenting with LUTS or urine retention

Exclusion Criteria:

* Unfit patients
* Renal impairment
* active UTI
* urethral strictures
Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial

Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief than placebo in patients with chronic pancreatitis.

Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom that brings the patient to clinical attention. Pain in chronic pancreatitis is multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension, inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage gated calcium channel blocking agent) can result in significant reduction of pain in CP.

In this study, the investigators will study the efficacy of the combination of antioxidants and pregabalin in reducing pain and compare that with placebo. The investigators will randomize patients with documented chronic pancreatitis with recurrent/persistent pain after undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants + pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the secondary outcomes will be change in the number of painful days, analgesic requirements, quality of life and depression scale. Pain score will be quantified by the Izbicki pain score and visual analog scale; while quality of life and depression will be measured by the EORTC QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively and analysis will be done on a intention to treat and per protocol basis. With an expected improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10% drop out rate, the required sample size in each group will be at least 40.


Eligibility Criteria:
Inclusion Criteria:

1. Epigastric pain +/- radiation at least thrice in one month over the past three month.
2. Endotherapy/Surgery and ducal clearance

Exclusion Criteria:

1. Age \<18 and \>65yrs
2. MPD and biliary obstruction
3. Pancreatic neoplastic lesions
4. Acute flare
5. Pancreatic pseudocysts
6. Pregnancy
7. Cardiac and renal diseases
8. Use of other anti epileptics
9. Hypersensitivity to gabapentin/pregabalin
Digital Image Correlation in Right Ventricular Evaluation

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

Eligibility Criteria:
Inclusion Criteria:

* open heart surgery, patient acceptance and informed consent, age 75 or more

Exclusion Criteria:

* patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.
Efficacy of Local Food Extracts at Different Storage Times

Local lyophylized food extracts are available useful in skin prick test and atopy patch test to confirm food allergy. However, the investigators want to know the duration that the investigators can keep the extracts for the usage in this purpose.

Food allergy incidence increases world wide. The diagnosis mostly depends on history. Skin prick test and atopic patch test are useful in finding the causative foods in some cases. The local food extracts have been shown to be at least as effective as commercial ones. From previous study the investigators keep the extract at 2-8 degree Celsius for 1-3 months for the usage. The investigators want to evaluate the duration that the extracts are still useful in diagnosis food allergy

Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)

Exclusion Criteria:

* Chronic diseases such as heart disease, liver, renal and severe sepsis
* Severe allergic symptoms such as anaphylaxis
* Extensive skin rashes
* Pregnancy