cyrilzakka/clinical-trials huggingface dataset:
Behavioral Intervention Program Based on Motivational Interview

The best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the adherence of adults to adequate oral health behavior.

Patient-related approaches may show better results in treatment of periodontal diseases. The best way for the dental surgeon to act using these methods is still inconclusive. The aim of this study is to evaluate the effectiveness of using motivational interviewing as part of the treatment of periodontitis in order to increase adult adherence to adequate oral health behavior. A randomized clinical trial, with a sample size of at least 72 subjects, \>18 years of age and with at least 18 teeth, will be investigated. Individuals in the test group will receive a collaborative communicative approach, inspired by the motivational interview, while the control group will receive the information/instructions in a conventional approach. The efficacy variables for evaluating the pattern of self-control of periodontal infection will be the bleeding on probing (BoP), gingival index (GI, primary efficacy variable), the plaque index (PI) and patient-based outcomes will be assessed using quality of life questionnaires. Additionally, questionnaires will be applied to obtain sociodemographic, behavioral and self-perception of oral health data. Univariate and multivariate analyzes will be performed and conducted in the Statistical Products Service Solutions software (SPSS, version 25). Thus, it will be possible to assess whether brief oral health education interventions centered on the individual can be used by dental surgeons in order to effectively improve oral hygiene behaviors in adults, obtaining better clinical results and a better quality of life for patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults, over 18-year-old;
* BoP (Bleeding on probing) in at least 30% of sites;
* Diagnosed periodontitis.

Exclusion Criteria:

* Smoking;
* Diabetes;
* Pregnancy (or the planning of pregnancy);
* Immunosuppressive illness or a medication, hepatitis, HIV, a bleeding illness or a anticoagulant;
* A need for the antibiotic prophylaxis;
* Hyposalivation or use of medications that cause hyposalivation
MAX-40279-01 in Patients With Advanced Solid Tumors

This is a multi-center, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with advanced solid tumor.

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

* Males and/or females over age 18.
* Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
* At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
* Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
* Life expectancy of at least 3 months.
* Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.

Exclusion Criteria:

* Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks (3 weeks for chemotherapy; 6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 2 years at the trial entry.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
* Laboratory values not within the Protocol-defined range.
* Cardiac disease , including congestive heart failure, myocardial infarction, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in Ontario. The goal is to determine whether and how rates of renal disease progression are affected by inflammatory markers, FGF23 levels, and genetic polymorphisms

This longitudinal cohort study will follow 2500 prevalent Chronic Kidney Disease (CKD)patients under the care of a nephrologist at 3 Southern Ontario Nephrology centres and all affiliated satellite centres with an estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min to determine the rate of their renal disease progression over a 36 months. All CKD patients older than 18 years of age may be included in this study. This study will analyze, with 6 month serial measurements, conventional biochemical, hormonal and metabolic parameters in addition to the demographics, clinical status, medications and blood and urine samples of these patients. This study will assess the influence of inflammation on FGF23 and genetic polymorphisms that may reflect the processes involved with disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to a nephrologist for evaluation of CKD or those currently seen by a nephrologist, with eGFR less than 60 ml/min
* Patients that are erythropoietin treatment naive
* Transplant patients with failing grafts requiring nephrologists follow-up
* Patients currently not receiving RRT consenting to be in the study
* Adults 18 years of age and older

Exclusion Criteria:

* Functioning Organ transplant
* Life expectancy less than 12 months
* Patients currently receiving RRT or who will likely initiate RRT within 6 months
* Patients unable or contraindicated to receive EPREX® as erythropoietin replacement therapy for the correction of anemia related to CKD
Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD

Rehabilitation of dyslexic children with (cental) auditory processing disorder.

The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).

Central Auditory Processing Disorder(C)APD is defined as difficulty for children with normal hearing to listen selectively in the presence of noise, to combine information from two ears properly, to process speech when it is slightly degraded, and to integrate auditory information when it is delivered faster than the individual with (C)APD can process.( The estimated prevalence of (C)APD in the school-aged population is approximately 2 to 5 %, and the estimated prevalence of (C)APD in the older adult population is 76 %. These percentages are higher than those affected by hearing loss.

Dyslexia and (C)APD are common comorbidities and since there is limited research on (C)APD within each related academic discipline. Furthermore the language, audiologiological , and cognitive nature of the disorder confirmed that a multi-disciplinary effort is needed in order to provide clinical decision and effective intervention for the (C)APD population. Hence Development of additional intervention tools for use in clinics, schools and home settings is warranted .

The aim of this work is to develop a novel Arabic (C)APD remediation program ,to study the outcome of the program and to validate it's effectiveness by comparing it to the Arabic computer based auditory training(CBAT) program.

Eligibility Criteria:
Inclusion Criteria:

1. dyslexic children with (C)APD
2. Age from 6-12 years.
3. No gender limit.
4. Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally.
5. Normal speech audiometry results.
6. Normal results on immitancemetry.
7. Average or below average IQ.
8. Normal language development.

Exclusion Criteria:

1. ADHD subjects. 2. Associated neurological and psychiatric disorders.

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Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Eligibility Criteria:
Inclusion Criteria:

* Are male or female at least 18 years of age and up to 55 years of age
* Must be skeletally mature
* Have a grade III or IV lesion in femoral condyle

Exclusion Criteria:

* Skeletally immature
* Osteoarthritic knees, osteonecrotic knees, osteophyte formation
* Use of any investigational therapy within thirty (30) days prior to the first visit
Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People

The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.


Eligibility Criteria:
Inclusion Criteria:

* aged 30-55 years
* grade II overweight (BMI≥27 but \<30 kg/m2)
* not to be adhered to any calorie restriction diet
* not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study

Exclusion Criteria:

* suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
* having undergone bariatric surgery and/or intestinal resection
* breastfeeding and pregnancy.
* not to give their signed, informed consent to be included in the study.
HydroCoil Cerebral Aneurysm Treatment Trial

The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.

With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.

Eligibility Criteria:
Inclusion Criteria:

1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
2. The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
3. Patients between (and including) 21 and 90 years of age.
4. Patient HUNT AND HESS Grade 0-3.
5. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
6. Aneurysm 5-20mm in maximum diameter.
7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
8. The patient has not been previously randomized into this or another related ongoing trial.
9. The aneurysm has not previously been treated (by coiling or clipping).

Exclusion Criteria:

1. Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
2. Target aneurysm has had previous coil treatment or surgically clipped.
3. Patient has an H\&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
4. Inability to obtain informed consent.
5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.

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A Preliminary Drug Drug Interaction Study With TA-8995

A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).


Eligibility Criteria:
Inclusion Criteria

* Healthy male subjects

Exclusion Criteria

* Receiving any other drug therapy
* Clinically significant medical history
* Abnormal laboratory results or ECGs
Learning Through Play (LTP) in My Own Way Plus CBT

Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.

Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.

The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.

Objectives:

1. Help mothers cope better with their depression.
2. Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.

Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of ID children aged 3 to 6 years, screened positive for depression
* Ability to complete a baseline assessment
* Ability to communicate in Urdu or English

Exclusion Criteria:

* Have a diagnosed serious medical or psychiatric condition
* Mothers of children with other medical illness
* Temporary residents unlikely to be available for follow-up
Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine.

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.

Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
* The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
* Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
* A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.

Exclusion Criteria:

* Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
* Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.
Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock

Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection; in septic shock profound circulatory, cellular and metabolic abnormalities are associated with an even higher mortality. Sepsis is a major healthcare problem, affecting millions of individuals around the world each year. Its incidence appears to be rising, and the mortality caused by septic shock in Germany in 2015 remains extraordinarily high (58.8%). It is well known - from the pathophysiological point of view - that these patients do not die from their infection per se but rather from multiple organ failure caused by their own overwhelming host response. This fact is so fundamental that it has been implemented as a key part of the 2016 sepsis definition (SEPSIS-3). Despite tremendous efforts during the last decades, innovative approaches targeting this fundamental hallmark of the disease, thereby reducing organ dysfunction, are lacking. Undoubtedly, there is an unmet need to expand the current standard of care for these patients by a more specific intervention.

The investigators hypothesize that early Therapeutic Plasma Exchange (TPE) in the most severely ill individuals will dampen the injurious maladaptive host response by removing injurious mediators thereby limiting organ dysfunction. The potential impact of this trial is of immense clinical relevance as it evaluates a promising adjunctive treatment option for a patient cohort suffering from an extraordinary high mortality. A positive trial result could truly change the current standard of care (SOC) - that is mostly supportive - of septic shock patients. Of note, there is neither a patent nor a direct commercial interest in such a trial.

Eligibility Criteria:
Inclusion Criteria:

* New onset of septic shock (\< 24 hrs), (SEPSIS-3 definition)
* Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose)
* Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)

Exclusion Criteria:

* Age \< 18 or \> 80 years
* Urogenital focus of infection
* Pregnancy
* Heparin-induced thrombocytopenia
* Known reaction against fresh frozen plasma (FFP)
Preventing Behavior Problems in Children With ADHD

This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.

Participants are randomly assigned to either a Multi-Setting Early Intervention group or to a Community Intervention group. The Early Intervention group receives parent training and assessment-based behavioral and academic intervention for 1 year, followed by either a high or a low intensity maintenance intervention for an additional 18 months. The Community Intervention group members receive psychotropic medication, special education services, and monthly sessions to obtain information about child development and medical functioning for 2 years. Participants are assessed on six occasions over 4 years. Parents and teachers assess children's behavior, academic performance, and archival data, including medical and school records.

Eligibility Criteria:
Inclusion Criteria:

* Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
* Preschool, nursery school, or group daycare enrollment at least 2 days per week
* Parents who can communicate in English

Exclusion Criteria:

* Plans to move out of the area in the near future
* Mental retardation, neurological damage, significant motor or physical impairments, or autism or other pervasive developmental disorder
* Inattentive ADHD or conduct disorder