cyrilzakka/clinical-trials huggingface dataset:
Burs Versus Curettes in Root Planing.

This study compares the efficacy of diamond burs and Gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. Two quadrants of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were treated with Gracey curettes. Also 21 hopeless teeth received root planing either with diamond burs or curettes or no treatment at all and were then extracted for microscopic evaluations.

Gracey curettes are the most widely used instruments for root planing and regarded as the gold standard, but their usage is technic sensitive and time consuming for the clinician and efficacy reduces in deep pockets, root irregularities, and furcations. Alternative sonic, ultrasonic and rotary instruments have been investigated for potential benefits in improving mechanical access. Sonic and ultrasonic instruments are used for scaling, but they cannot provide smooth root surfaces.

Intensiv Perio Set is a rotating diamond bur system developed for odontoplasty, scaling and root planing. It is used only in right angle hand piece, at rotation speeds of 6000 rpm, with reduced pressure application. These burs have two different head types for morphologically different areas; flame or tapered, three different grains; 75, 40, or 15 μm, with either a short or long neck for each unit. Burs with 75 μm grain are used only in odontoplasty, whereas, 40 and 15 μm burs are used for scaling and root planing.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of generalized chronic periodontitis (Armitage 1999)
* presence of at least 3 teeth (1 molar, 2 non-molar teeth) with probing depth ≥ 5 mm in each quadrant

Exclusion Criteria:

* presence of any known systemic disease or using medications that affect periodontal tissues
* antibiotic treatment and/or periodontal treatment within the past 6 months
* tobacco usage during the last 12 months
* being pregnant or in the lactation period
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with schizophrenia
* Miminum PANSS score of 60 when randomized

Exclusion Criteria:

* Planned, regular use of antipsyhotics within 1 week of randomization
* Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery

The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

This pilot study focuses on an intervention (freelisting) designed to elicit supportive oncology communication intentions among the patient-caregiver-provider triad prior to an outpatient oncology encounter. The goal is to shape communication behaviors during the encounter to improve outcomes of the encounter.

Eligibility Criteria:
Inclusion Criteria:

* patients will:

  1. be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
  2. not be receiving specialty palliative care or hospice,
  3. read/speak English, and
  4. be able to provide written informed consent.
* caregivers will:

  1. identify as the individual who is primarily involved in the patient's care,
  2. be able to attend the oncology encounter,
  3. read/speak English, and
  4. be able to provide written informed consent.
* providers will:

  1. specialize in gynecologic oncology, and
  2. provide outpatient care at IUSCCC gynecologic oncology clinic.

Exclusion Criteria:

patients and/or caregivers will be excluded if either one or both demonstrate:

1. cognitive impairment, or
2. speech/hearing difficulties precluding participation.
Fit for Function: A Community Wellness Program for Persons With Stroke

The purpose of this study is to evaluate whether persons with stroke participating in a 12-week community based wellness program for persons who have had a stroke, experience improved mobility (6 Minute Walk Test), balance, (The Short Portable Performance Test and Timed Up and Go), strength (JAMAR hand grip dynamometry), level of physical activity (Rapid Assessment of Physical Activity), reintegration in community (Reintegration into Normal Living Index), self efficacy (Patient Activation Measure) and Quality of Life (Stroke Specific Quality of Life Scale) compared to persons who do not participate in the program.

The program will be delivered through a partnership between Hamilton Health Sciences, the YMCA and McMaster University. Participants will attend the YMCA for exercise sessions several times a week and receive education on how to take care of themselves after a stroke. The staff who will deliver the program will have specialized training on how to help people with stroke to exercise safely and effectively. Control group participants will be provided with YMCA memberships but will not have access to stroke specific education and group exercise classes.

Staff assisting the control group will be trained in safety and contraindications after stroke, but will not receive the additional specialized training in exercise/education programs for persons with stroke.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥18years
* living in the community
* able to ambulate ≥10 meters with or without an assistive device
* able to tolerate 60 minutes activity with rest intervals
* have clearance from a physician to participate in the program
* can independently follow instructions
* are not involved in active rehabilitation

Exclusion Criteria:

* musculoskeletal contraindications to exercise
* unstable cardiovascular conditions
* unstable medical conditions
* significant cognitive impairment
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated

The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neoplasm in advanced stage
* Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent
* 1-6 episodes of BTcP within any of 3 days previous to registration into study
* Signed Informed Consent

Exclusion Criteria:

· More than 6 episodes of BTcP within any of 3 days previous to registration into study
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as signed informed consent
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
Lumax 740 Master Study

The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.

  * Legal capacity and ability to consent
  * Signed patient informed consent

In addition for HF-T devices:

* Bipolar LV-lead with a min. distance of 15 mm between tip and ring
* True bipolar RV lead

Exclusion Criteria:

* Standard contraindication for single, dual, or triple chamber ICD.

  * Age \< 18 years
  * Pregnant or breast-feeding woman
  * Cardiac surgery planned within the next 6 months
  * Life expectancy of less than 6 months
  * Participating in any other clinical study of an investigational cardiac drug or device
Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)

This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC).
* Availability of tumor sample.
* Patients who are going to receive at least one dose of anti-PD1antibody (nivolumab or pembrolizumab).

Exclusion Criteria:

* Nasopharynx, maxillary sinus, nasal/nasal vestibule squamous tumors
* Patients who are receiving concomitantly any other tumor-specific treatment (chemotherapy, radiotherapy, any monoclonal antibodies different from anti- PD-1 antibodies).
Anxiety, Stress and Pain & Myocardial Infarction

People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing Posttraumatic Stress Disorder (PTSD) after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress, and PTSD after an acute myocardial infarction.

People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing PTSD after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress and PTSD after an acute myocardial infarction.

Patients will be examined during three times - in the acute myocardial infarction period (Day 1-3), before dismissal (Day 5-14) and after 6 months for a follow-up. During all times they will be given questionnaires asking about their levels of stress, anxiety and general well-being as well as tests checking their cognitive abilities (thus to find out if they decrease over time). Moreover, blood samples checking cortisol levels as well as metanephrine levels will be taken in order to objectify the levels of stress that are stated by the patients. Furthermore, clinical evaluations, laboratory runs (troponin), ECGs and echocardiographies will be done at all three points in time.

The goal is to detect the biopsychosocial relations and to develop better prevention.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate in the study
* men and women 19-90
* after myocardial infarctions
* no psychiatric disease before myocardial infarction
* no other severe disease influencing the immune system

Exclusion Criteria:

* non fulfilment of inclusion criteria
* non-compliant patients (dementia, delirium)
* steroid-therapy
The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms.

In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date.

The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England.

Adrenal insufficiency is a clinical condition that is associated with a deficiency of adrenal hormones, mainly: glucocorticoids and mineralocorticoids. Cushing syndrome is also a condition that stems from the existence of persistent high cortisol level in the body. The majority of Cushing syndrome cases are exogenous (iatrogenic or due to use of medication).

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms.

In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date

The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England. This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymialgia rheumatica, giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease).

This study will be based on the analysis of existing primary care health records routinely collected, linked to hospital and mortality data.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old or over
* Registered in a participating general practice for more than 1 year during the study period
* Minimum of 1 year prior to study entry meeting CPRD data quality
* Diagnosed with at least one of the 6 chronic inflammatory diseases

Exclusion Criteria:

* Patients aged under 18 years during the study period
* Registered in general practices that did not consent to data linkage
Treatment Benefits of Berberine Supplementation for Women With PCOS

Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence suggest that Berberine dietary supplementation helps in improvement of symptoms associated with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the treatment benefits of Berberine in women with PCOS.

Berberine (BBR) is an isoquinoline derivative alkaloid that occurs in several plants including Oregon grape, barberry, tree turmeric, goldenseal, yellowroot, Amur corktree, Chinese goldthread, prickly poppy and Californian poppy.

Berberine supplementation has been suggested to improve the symptoms associated with PCOS. Berberine;

Reduces Insulin Resistance Lowers Blood Sugar Levels Aids in Weight Loss Improves Cholesterol Levels Regulates Menstrual Cycles Reduces Inflammation Helps Restore Hormonal Balance Improves Fertility Helps Combat Depression Helps Fight Fatty Liver Disease Improves Body Composition

The present RCT is aimed to investigate the effect of Berberine on these symptoms associated with PCOS.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18 and 45 years
2. PCOS diagnosis as per the Rotterdam Criteria (any two of the following features:

   * Irregular periods (allso called oligomenorrea) or no periods (amenorrhea),
   * Higher levels of andregens present in the blood (hyperandrogenism), or physical characteristics of elevated andregen levels such as acne, male-pattern balding, or excess hair growth on face, chin, or body
   * Polycystic ovaries visible on an ultrasound
3. Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria)
4. With no desire for pregnancy within 6 months
5. Able to give informed written consent

Exclusion Criteria:

1. Women who are currently taking or have teken in the last three months medications known to alter insulin physiology, oral contraceptives, ovulation induction drugs, anti- obesity or cholestrol lowering drugs, or any supplement known to interfere with insulin and androgen metabolism such as inositols, curcumin, lipoic acid, cinnamon, gymnemic and other botanical extracts.
2. Women undergoing in vitro fertilization treatment.
3. Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST.
4. Presence of liver, or renal disease
5. Pregnant or lactating or menopause women
Trial of a Parenting Discussion Group in Panama, Central America

The present study aims to examine the effectiveness of a parenting intervention, the Triple P Positive Parenting Program Level 3 discussion groups "dealing with disobedience". Triple P is a system of interventions to support families and was developed at the University of Queensland in Australia in the 1980's. As few studies have tested the effectiveness of parenting programs in developing countries, the present study took place in a developing country, Panama.

In a recent study carried out in Australia, this same intervention was found effective in reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam, Milne \& Sanders, 2011).

This is a randomized controlled trial (RCT) with two groups (waiting list versus Triple P discussion groups) and measurements at pre-intervention, post intervention, three and six months follow up.

The intervention trialed was a 2-hour, one-session discussion group on child noncompliance. Groups were composed by a maximum of 10 parents and were facilitated by the principal researcher, who is an accredited practitioner. The groups were interactive and discussion based, and a power point presentation with embedded-video clips were used to aid the facilitator. The key points that were covered in the discussion group included reasons for disobedience, parenting traps, encouraging good behaviour, and managing disobedience. Parents also received a workbook that included the content covered in the discussion group and 2 follow up telephone calls to check how they were doing after.

Participants were randomly assigned to a treatment group (Triple P discussion groups) or to a waiting list group. A statistician independent from the research team generated a random list of numbers. Randomization was stratified based on the level of child behavioural difficulties (high or low) measured at baseline. In order to ensure allocation concealment, sequentially-numbered, opaque, sealed envelopes (SNOSE) were opened after participants agreed to take part in the study and completed a baseline assessment. After randomization, those assigned to the waiting list group were assessed at time 1 (baseline) and then 4 weeks, 3 months and 6 months after the first assessment. Those assigned to the treatment group were assessed at time 1 (baseline), 2 weeks, 3 months and 6 months after the intervention. Assessments were carried out by a research assistant who was blind to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be Panamanian
* must have at least one child between 3 and 12 years old
* must report some level of difficulty in dealing with their child behaviour.

Exclusion Criteria:

* no report of difficulty in dealing with child behaviour
* illiteracy
Junctional AV Ablation in CRT-D: JAVA-CRT

Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).

This study is designed to evaluate if patients with AF indicated for CRT will have significant reduction in left ventricular end-systolic volume when randomized to atrioventricular junction (AVJ) ablation. In this study, subjects will be randomized to receive CRT-D or CRT-D with AVJ ablation. Randomization will be stratified by enrolling center (1:1 ratio).

Eligibility Criteria:
Inclusion Criteria:

* Optimal pharmacologic therapy is defined by published guidelines from the American Heart Association and the American College of Cardiology
* Initial implantation of CRT-D or prior implantation of CRT-D within one year
* Ischemic or nonischemic cardiomyopathy
* LVEF ≤ 35%
* NYHA class II-IV (ambulatory)
* QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients
* Continuous AF \> 3 months when no further efforts to restore sinus rhythm are feasible or pursued

Exclusion Criteria:

* Ventricular rate \> 110 bpm at rest despite maximal medical therapy
* Ventricular rate \< 50 bpm at rest
* Heart block/symptomatic bradycardia that necessitates permanent pacing
* Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
* Severe aortic or mitral valvular heart disease
* Prior AVJ ablation
* Any medical condition likely to limit survival to \< 1 year
* Patients with ACC/AHA Stage D refractory Class IV symptoms listed for transplant or requiring inotropic support
* Contraindication to systematic anticoagulation
* Renal failure requiring dialysis
* AF due to reversible cause e.g. hyperthyroid state
* Pregnancy
* Participation in other clinical trials that will affect the objectives of this study
* History of non-compliance to medical therapy
* Inability or unwillingness to provide informed consent
* Patients with short-lived AF or those in sinus rhythm are ineligible