cyrilzakka/clinical-trials huggingface dataset:
Effect of Periodontal Treatment on Salivary Biomarkers

The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.

treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.

Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.

Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients
* moderate - sever chronic periodontitis

Exclusion Criteria:

* systemic disease
* pregnancy
* subjects under the age of 18
Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-month duration ofthe clinical research study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Pregnant or lactating subjects.
PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices

Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.

The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.

Background and purpose:

Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients.

The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT).

Methods:

Data is collected in anonymized form from all centers willing to contribute data.

Hypothesis:

The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).

Eligibility Criteria:
Inclusion Criteria:

* Durable LVAD implantation
* VO2 in stable post implant phase

Exclusion Criteria:

* No VO2 data available
* Concomittant RVAD (temp/durable device)
The Modulatory Role of Communicated Treatment Rationale on Treatment Expectation Effects in Depression.

Placebo groups in clinical trials on depression show impressive improvements. Yet, there is little research on the mechanism underlying this effect. The aim of this study is to assess how patients' treatment expectations modulate the placebo treatment effects.

We expect that patients' treatment expectation determines placebo responses and treatment outcomes, and that this expectation is influenced by the disorder explanations (information about the illness models) typically provided during the initial medical encounters that precede treatment.

In the study we aim to manipulate depressed patients' expectations by providing two different clinician-delivered illness and treatment rationales (biological/ psychological). Patients will then receive placebo treatment (pharmacological/ psychological), that is either congruent or incongruent with the previously communicated treatment rationale.

Hypotheses:

1. Providing a treatment-congruent treatment rationale leads to a better outcome than providing treatment-incongruent rationales.
2. Treatment-congruent explanations reduce the risk of side effect development, in particular in the medication arm.
3. Inter-individual differences in the effect of provided treatment rationale are associated with pre-treatment experiences and expectations, depression severity and comorbid anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression according to the 'Structured Clinical Interview for DSM-V' (SCID)
* Age\>17
* Comorbidity is allowed if major depression is the dominant clinical problem
* Concordant medication is allowed if kept constant for the four weeks before and until the end of the trial (with the exception of benzodiazepines and if not contraindicated together with Buscopan)
* Fluency in German
* Informed consent

Exclusion Criteria:

* Severe depression (BDI\> 30) or suicidality
* Psychosis
* Significant neurological diseases
* Other mental or physical disorder with substantial influence on disability
* Benzodiazepine intake
* Any intolerance against Buscopan and sucrose or any medical condition/treatment conflicting with Buscopan intake
Pre-hospital Care Profile of Road Traffic Injury Victims- Kerala

Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. This study aimed to describe the prehospital care of RTI victims presenting to the emergency department in Jubilee Mission Medical College and Research Institute, Thrissur.

Management of trauma is a neglected field in developing nations.Road Traffic Injuries (RTI) cause around 1.35 million deaths worldwide annually according to the statistics of World Health Organization (WHO) and in India 150000 death per year. An overwhelming proportion of these deaths occur before patients even reach the hospital. Two third (60.7%) of the accident victims belonged to the age range of 15 to 44 years. This indicates that active and productive age people are the one affected by road traffic accidents related injuries in turn adding to higher economic loss to the country. Lack of medical attention is attributed to nearly 30 per cent of deaths at site and 80 per cent of the remaining patients died within an hour of injury (golden hour). Most of these deaths are due to airway management failure, respiratory failure or continuing hemorrhage that are preventable causes with appropriate prehospital and subsequent hospital emergency care. Mortality due to RTI is increasing, especially in Low and Middle Income Countries (LMIC). There is a lack of research on the effectiveness of pre-hospital care in India. Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI in several countries.This study aimed to describe the prehospital care of RTI victims presenting to the emergency department (ED) in Jubilee Mission Medical College and Research Institute, Thrissur.

Eligibility Criteria:
Inclusion criteria:

All Road traffic injury (RTI) patients presenting to ED within 24 hours of injury

Exclusion criteria:

Individual's not consenting to be part of the study or withdrawing consent later on

Cases where pre-hospital care provider could not be traced or where reliable patient data could not be collected even after repeated interview.
Effectiveness of Computer-Aided Versus Clinical Simulation Sessions on Knowledge, Attitude and Practice of Ergonomics

A healthy dentist is one of the most important components of a successful dental practice. It is estimated that more than half of practitioners have some kind of painful work-related musculoskeletal disorders.

It was reported that 80% of dental students were not aware of ergonomic posture during dental procedures. It is believed that dental students with knowledge of ergonomic principals would be able to maintain their health. Some studies demonstrated that the frequency and severity of WMSDs might decrease by training the dentists on ergonomic principles.

This study will be carried out on dental interns in Department of Pediatric Dentistry and Dental Public Health, in Faculty of Dentistry-Cairo University. The procedures will be carried out by postgraduate student Nourhan Saad Mohamed who has M.D.S. (2018) - Cairo University- Egypt, and works as Assistant Lecturer in Future University in Egypt. The procedures will be done without assistant at a lecture room and outpatient clinic of Pediatric Dentistry in Cairo University.

At baseline, evaluation of knowledge, attitude and practice (KAP) on ergonomics in dentistry will be do e through a self-structured questionnaire.

Afterwards, the participants will be split into two groups. One group will recieve training on ergonomic principles through clinical simulation session, while the other group will recieve training through Computer-aided sessions.

KAP will be re-evaluated after the training sessions to evaluate the change in KAP about ergonomics.

Eligibility Criteria:
Inclusion Criteria:

* Dental interns who accept to participate in the study.
* Graduates of governmental or private dental schools.

Exclusion Criteria:

* Interns with history of chronic musculoskeletal disorders.
* Interns who perform other physical activities which required forced posture.
* Interns with history of fracture in the ribs or vertebrae.
Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

One hundred participants with planned follow-up (decision according to clinical routine) at the Pain Centre will be consecutively recruited. After signed informed consent, the participants will wear two accelerometers during one week, one for recording sleep and one for recording physical activity. The participants will be asked to fill out a sleep and pain diary during the same week. Furthermore, the participants will fill out questionnaires regarding sleep, life style, mental fatigue and self-efficacy. All study participant are included in the Swedish Quality Registry for Pain Rehabilitation (SQRP). Data from the SQRP will be used regarding patient health characteristics, pain and pain associated symptoms, health related quality of life, sleep and self-reported physical activity level. Data regarding co-morbidity, drug use, pharmacological treatment and other interventions at the Pain Center will be collected from the patient charts. In addition, the participants blood pressure and neck circumference will be measured. Blood samples will be analysed for biomarkers associated with pain and sleep disturbance.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain (i.e. pain \> 3 months)
* Planned follow up at the Pain Centre
* Age ≥18 years
* Consents to participation in the study

Exclusion Criteria:

* Inadequate knowledge of the Swedish language
* Alcohol or substance abuse
* Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
* Malignant disease with short expected survival
The Impact of Dietary Flavanols on the Gut Microflora

The primary propose of this study is to determine the impact of flavanol-rich cocoa on the growth of the human gut microbiota.

A randomised, placebo-controlled, double-blind, cross-over human intervention study will be conducted in 20 healthy human volunteers to test the impact of a high-flavanol containing meal on the growth of the large intestinal bacteria (microflora). The high flavanol test meal will contain 495 mg of flavanols and the low flavanol control will contain 23 mg of flavanols. The two intervention diets are otherwise matched for macro- and micronutrient content. Changes in the gut microbiota will be determined by measuring bacterial population levels in human faecal material using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridization. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* a signed consent form
* age of 18-50 years inclusive
* BMI between 20-26

Exclusion Criteria:

* pregnant or lactating
* allergy to milk products
* sensitivity to alkaloids and/or caffeine
* gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, -inflammatory bowel syndrome, or other chronic gastrointestinal complaints)
* diabetes mellitus
* hypertension (\>150/90 mm/Hg)
* anaemia and gall bladder problems
* not consuming probiotics, prebiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study.
CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II)

This is a multi-center survey of patients who are currently receiving lipid-lowering medications and have a moderate or higher cardiovascular (CV) risk. The survey will be conducted in the Russian Federation. Data collection for each study subject will be done within one physician visit. If an enrolled subject comes to the visit not fasting (for at least 8 hours), an appointment for the blood tests will be made for another day.

This is a multi-center survey of patients who are currently receiving lipid-lowering medications and have a moderate or higher CV risk. The survey will be conducted in the Russian Federation.

Data collection for each study subject will be done within one physician visit. If an enrolled subject comes to the visit not fasting (for at least 8 hours), an appointment for the blood tests will be made for another day.

Prior to the assessment of the first subject at a site, each investigator will complete an investigator questionnaire on his/her experience and perception of the management of hypercholesterolemia in his/her patients.

Prior to the assessment, subjects will record on a patient questionnaire their awareness of hypercholesterolemia, their current treatment schedule, their perception, and compliance.

The investigator will complete a Case Report Form (CRF) with the subject's demographics, known cardiovascular risk factors, cardiovascular medical history, current lipid-lowering drug therapy, and the reason for this therapy.

Fasting blood samples will be taken in tubes to test for total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), glucose, creatinine, hemoglobin A1c, hemoglobin, and hematocrit at a central laboratory in the Russian Federation.

Eligibility Criteria:
Inclusion Criteria:

* Properly obtained written informed consent from the potential subject.
* On lipid-lowering drug therapy for at least 3 months (90 days), with no dose change for a minimum of 8 weeks (56 days).
* Scheduled blood tests for total cholesterol (TC), HDL-C, LDL-C, glucose, creatinine, HbA1c, Hb, and hematocrit on the visit when they are considered for survey participation, or these tests must be decided to be necessary for study-unrelated purposes during that visit.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide written informed consent.
* The cognitive status of a potential subject and/or their home environment (in the investigator's opinion) might compromise the compliance with the treatment regimen during the past 8 weeks.
* A low CV risk.
* Participating in any other clinical trial.
Cohort Study on Associations Between Purinergic Receptor SNPs and Osteoporosis Risk

Background: Osteoporosis is a high-prevalence disease with a strong genetic component. Nucleotides, including ATP (adenosine 5'-triphosphate) and its purinergic receptors, play a role in bone physiology. Single nucleotide polymorphisms (SNPs) in the P2X7 receptor gene were recently found to be associated with fracture risk in a cohort of postmenopausal women.

Objective: To investigate associations between purinergic receptor SNPs and osteoporosis risk in humans. Genetic data from a fracture cohort in the Netherlands with high prevalence of osteoporosis will be analyzed. Furthermore, effects of aberrant purinergic receptor signalling on bone turnover markers will be assessed ex vivo.

Design: The cohort will include app. 1,000 fracture patients of 50 years and older, who will be recruited at the Maastricht University Medical Center during standard medical follow-up after a clinical fracture. The standard medical follow-up includes assessment of bone mineral density (BMD) by Dual-Energy X-ray Absorptiometry (DXA), if necessary followed by medication for osteoporosis. Prior to medication, blood samples will be collected from fracture patients to be genotyped for purinergic receptor SNPs and analyzed for biochemical markers of bone turnover. Systemic correlates of osteoporosis will be compared between osteoporotic subjects (i.e. low BMD) and non-osteoporotic controls (i.e. normal to high BMD). Subsequently, whole blood assays in patient subgroups (n=20 per subgroup), based on BMD and purinergic receptor SNPs, will be performed to evaluate ex vivo effects of ATP and related nucleotides bone markers.

Study population: Patients of 50 years and older attending an outpatient osteoporosis clinic at the Maastricht University Medical Center for standard medical follow-up after a clinical, non-pathological fracture.

Primary outcome parameters: BMD and purinergic receptor SNPs.

Secondary outcome parameters: Bone markers.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 years and older;
* Clinical fracture;
* Attending osteoporosis outpatient clinic for standard medical care.

Exclusion Criteria:

* Disease of bone metabolism (e.g. bone tumours, hyperparathyroidism);
* Unwillingness to donate blood for DNA analyses;
* Failure of bone densitometry (DXA-scan).
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets

A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
* The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 15% due to the upper limit (18,5 to 28,63) and total body weight \>50kg
* An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A history of suicidal thoughts, behavior or suicide attempts
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Known hypersensitivity to alprazolam or any components of the product
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* A positive bHCG exam for women
* Subjects with myasthenia gravis or acute narrow angle glaucoma
Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block

In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.

In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Eligibility Criteria:
Inclusion Criteria:

* elective general anesthesia
* Female gender
* Between the ages of 18-65

Exclusion Criteria:

* ASA ≥ 3
* Pregnancy
* Contraindication to use of anesthetic drugs
* Kidney failure
* Liver failure
* Heart failure
* BMI \<18 and BMI \> 35 kg/m2
* anticipated difficult airway
* neuromuscular disease
* Use of drugs that impair neuromuscular transmission
* Patients who develop unexpected massive hemorrhage
* Those who do not have the ability to read, understand and sign the consent form
* Refusal of patient