cyrilzakka/clinical-trials huggingface dataset:
The Use of Corticotomy for Upper Incisors Retraction

We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group. Both groups will start orthodontic treatment. Once a 0.019\*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. Canines will be retracted in the conventional manner. Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .

So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
* Overjet less than 10 mm
* Normal or increased growth pattern (Diagnosed by Y-axis angle)
* Mild to moderate crowding (Less than 3 mm)
* After canines retraction , at least 3 mm space should be available distal the lateral incisors
* Midline deviation shouldn't be more than 3 mm

Exclusion Criteria:

* Medically contraindicated patients to oral surgery .
* Existence of general health issue that affect orthodontic teeth movement
* Previous orthodontic treatment
* Mixed dentition
* Hypodontia (Except third molars)
* Bad oral hygiene
Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

The purpose of this study is to determine the feasibility of identifying novel etiologic agents associated with SARI in patients who have required intubation and in whom, after analysis, a causative agent was not identified by standard microbiologic (culture) and multiplex real-time Polymerase Chain Reaction (PCR) platforms. Taking into account that isolation of any pathogens is generally time sensitive, the study will evaluate subjects that are culture negative at the time of consent. Not all subjects will actually prove to be culture negative. Additionally, the study will compare etiologic agents identified on broncho-alveolar lavage (BAL) to etiologic agents identified by routine upper airway testing on all subjects with SARI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Willing to provide informed consent; or a legal representative is willing to sign informed consent;
* Intubated due to an independent clinical decision by a clinician responsible for the patient's clinical care and NOT affiliated with the research);
* Meet WHO's SARI definition (modified) - all of the criteria below:
* History of fever, subjective feverishness or measured fever of ≥ 38.0 °C, or hypothermia as defined for Systemic Inflammatory Response Syndrome (SIRS) (\<36.0 °C );
* Cough or other respiratory symptoms, such as rapidly progressing dyspnea;
* Onset within the last 21 days (as long as the clinical condition is considered acute and due to the severity it requires intubation); and
* Requiring hospitalization

Exclusion Criteria:

* Intubated for reasons other than SARI (cardiovascular accident, surgery);
* Known microbiologic diagnosis of SARI or respiratory illness:
* Any contraindication to BAL by bronchoscopy as determined by the treating physician
* Bacterial culture or other microbiologic testing for underlying etiology positive would be excluded;
* In women: Pregnancy
The Effects of Weight Loss on Psoriatic Arthritis

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.

Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms.

* Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups.
* Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian.
* BETY exercise training will be given by a registered physiotherapist.
* The subjects will be followed for 12 weeks.
* Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* overweight/obese
* diagnosed with PSA

Exclusion Criteria

* pregnancy or lactation
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* cancer histologically proved
* patient eligible for sentinel node detection
* contraceptive methods for men and women of childbearing age
* signed informed consent form
* patient affiliated to the social security system

Exclusion Criteria:

* neoadjuvant chemotherapy or hormone therapy
* adenopathy (s) clinically suspicious or positively cytopenic
* women who are pregnant or breast-feeding
* associated pathology that may prevent patient of receive indocyanine green
* ongoing participation in another clinical trial with an investigational drug
* patients deprived of liberty or under supervision
* impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
* Have provided appropriate written informed consent

Exclusion Criteria:

* None
Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.

All available retrospective and prospective data from pediatric MS participants who have received at least 1 dose of natalizumab before turning 18 years old and before 31Mar2015 will be used in this study. Prospective data are defined as data to be collected in the future, i.e., from new participants not included in the first data transfer or additional data from existing participants that were not included in the first data transfer. Existing biospecimen samples will be evaluated but not collected as part of this study.

Eligibility Criteria:
Key Inclusion Criteria:

* All available retrospective and prospective data from pediatric MS patients who have received at least 1 dose of natalizumab before turning 18 years old and before 31 March 2015.
* In addition, patients must be registered in TOUCH (US patients only), enrolled in a Biogen sponsored postmarketing observational study (e.g., TOP (NCT00493298) or TYGRIS (NCT00477113,NCT00483847)), or in a country-specific TYSABRI registry.
* Adequate data received by Biogen by 30 September 2015 will be used for this meta-analysis including data collected after a patient may have turned 18 years old.

Key Exclusion Criteria:

* Data received by Biogen after 30 September 2015 will not be included in the statistical analyses

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005

Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice.

This study involves a nationwide questionnaire which has two components. The initial pilot survey will attempt to identify all institutions currently practicing ECMO or those intending to do so in the future, and are willing to participate in prospective data collection. The second phase will involve a monthly survey of these centres regarding the extent of ECMO use, practice details implemented, and outcome data.

It is hoped that the collection of this information will later assist in the development of guidelines for this expensive and presently unsubstantiated practice, together with the construction of appropriate training programs for staff.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving ECMO in Australia and New Zealand
Effect of Low-level Laser Prior to the Induction of Fatigue

The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

Male and female individuals aged 18 to 23 years will be evaluated. The Research Diagnostic Criteria for Temporomandibular Disorders will be applied for the determination of the presence or absence of temporomandibular disorder. Each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. Before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. Low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. Pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

Exclusion Criteria:

* Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity


Eligibility Criteria:
Inclusion Criteria

1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age).
2. Willing and able to give informed consent before any protocol procedures are performed.
3. Able to adhere to visit schedules and all protocol required study procedures.
4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
3. A serious adverse reaction after a previous (influenza) vaccination.
4. A history of Guillain-Barré syndrome.
5. Known to be allergic to constituents of the study vaccines.
Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. 12 years of age or older at time of consent/assent.
2. Received HSCT within the past 12 months.
3. Diagnosis of TMA that persists for at least 72 hours after initial management of any triggering agent/condition.
4. A TMA diagnosis based on meeting the laboratory-based criteria during the Screening Period and/or ≤14 days prior to the Screening Period.
5. Body weight ≥ 30 kilograms at Screening or ≤7 days prior to the start of the Screening Period (date of consent).
6. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception.
7. Participants must be vaccinated against meningococcal infections if clinically feasible. Participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis. Participants \<18 years of age must be re-vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae if clinically feasible.
8. Participants or their legally authorized representative must be capable of giving signed informed consent or assent.

Exclusion Criteria:

1. Thrombotic thrombocytopenic purpura (TTP) evidenced by ADAMTS13 deficiency
2. Known Shiga toxin-related hemolytic uremic syndrome as demonstrated by positive test.
3. Positive direct Coombs test indicative of a clinically significant immune-mediated hemolysis not due to TMA.
4. Clinical diagnosis of disseminated intravascular coagulation (DIC).
5. Known bone marrow/graft failure for the current HSCT.
6. Diagnosis of veno-occlusive disease which is unresolved at the time of Screening.
7. Human immunodeficiency virus (HIV) infection.
8. Unresolved meningococcal disease.
9. Presence of sepsis requiring vasopressor support.
10. Pregnancy or breastfeeding.
11. Hypersensitivity to murine proteins or to one of the excipients of ravulizumab.
12. Any ongoing or history of medical or psychological conditions unrelated to HSCT-TMA that could increase the risk to the participant or confound the outcome of the study.
13. Respiratory failure requiring mechanical ventilation.
14. Acute and/or chronic heart failure with an ejection fraction ≤ 40%.
15. Previously or currently treated with a complement inhibitor.
16. Participation in an interventional treatment study of any therapy for TMA.
Improved Prescribing for Older Nursing Home Patients

Research aim:

To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\< 1.5-2 years).

The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents.

Design:

A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\< 1.5-2 year) of long term care wards.

Intervention:

The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2).

Outcome measures:

The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain.

Discussion:

The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.

Additional information on the method:

We included 2 nursinghome organizations in september, 2 in october, and 3 in november.

Eligibility Criteria:
Inclusion Criteria:

Nursing home patients:

* Age 65years and above
* Living at long term care wards in nursing homes
* Living at a long term care ward for at least 4 weeks before start of the study

Exclusion Criteria:

* Temporary nursing home patients (i.e. geriatric rehabilitation or end-of-life/hospice care)
* Life expectancy \< 4 weeks
* Life expectancy clearly \> 1.5 - 2 years (i.e. patients with Huntingtons disease)
Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer

This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.

PRIMARY OBJECTIVES:

I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

II. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients.

OUTLINE:

Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.

After completion of study, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically or clinical confirmed tissue diagnosis of a cancer
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients will be excluded if their cancer cannot be confirmed
* Refusal to sign the informed consent