cyrilzakka/clinical-trials huggingface dataset:
Efficiency of Canine Retraction Using Different Reactivation Intervals

Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
* Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion Criteria:

* Systemic diseases that would interfere with bone metabolism
* Craniofacial syndromes
* congenitally missing or extracted permanent teeth.
* periodontally compromised patients
* smokers
* pregnant women
* previous orthodontic treatment
The Bipolar Lithium Imaging Scan Study.

The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome.

Brain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.

Introduction Lithium treatment is considered the first-line pharmacological treatment for bipolar disorder. However, individual responses vary greatly, which undermines the ability to achieve rapid stabilization in many patients with bipolar disorder. The neurobiological mechanisms underlying lithium's action are still largely unknown, which hampers the development of clinically applicable predictors for individual treatment response. The recent introduction of ultra-high-field lithium magnetic resonance imaging offers a promising avenue to better link brain measures with clinical responses to lithium treatment.

Methods and Analysis This is a longitudinal observational study involving 80 adults with bipolar disorder who are initiating lithium as part of their regular treatment regimen. Ultra-high-field lithium magnetic resonance imaging of the brain will be performed within four weeks of reaching stable therapeutic serum lithium concentrations. The primary outcome is clinical response to lithium treatment at one-year follow-up, as measured using a validated questionnaire. Linear regression analysis will be used to establish correlations between brain lithium concentrations-including whole brain, voxel-wise, parcellation, mean, and region-of-interest approaches-and clinical lithium response.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or above,
2. a clinical diagnosis of bipolar disorder type I or type II ,
3. having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and
4. provided written informed consent.

Exclusion Criteria:

1. insufficient comprehension of the Dutch language,
2. unable to provide informed consent,
3. drug or alcohol abuse over a period of two weeks prior to study participation, and
4. meeting any exclusion criterium for MR imaging.
Influence of Direction of Movement While Walking

The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of walking training - walk forwards and backwards, with closed and open eyes.

In the third minute of training walking a significant increase in blood flow velocity was recorded, both in right and left middle cerebral arteries. It was observed in the left artery during all forms of training. In the right artery it occurred only during three forms of difficult training, and was preceded by significant decrease in blood flow in the first minute of the gait with eyes closed. The output values of the rate of blood flow in both right and left middle cerebral arteries became progressively reduced in the successive stages of gait. Pressure and pulse rates did not correlate with the variables of blood flow velocity in middle cerebral arteries.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without brain disease

Exclusion Criteria:

* brain disease and walking disfunctions
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

* sign written informed consent form
* age ≥ 18 years, ≤69 years
* ECOG status: 0\~2
* pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
* negative peritoneal cytology
* underwent curative distal gastrectomy with D2 lymph node dissection
* no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
* adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria:

* be enrolled in other clinical trials
* underwent prior antitumor treatment
* allergic reaction to S-1 or oxaliplatin
* abnormal GI tract function
* female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
* other situation to be judged not adaptive to the study by investigators
A Phase I Study of XH-S004 in Healthy Volunteers

This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.


Eligibility Criteria:
Inclusive criteria:

1. Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening.
2. Male body weight no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 26.0 kg/m2 (both inclusive).
3. Medically healthy without no clinically significant abnormalities on the basis of inquiry, vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests (hematology, serum chemistry, coagulation function and urinalysis, etc,) , and chest X-ray, etc,.
4. Participants must be able to understand the procedures and methods of this study, and voluntarily take part in this study, and communicate well with investigators, and comply with requirements throughout the study, and sign the informed consent form (ICF).
5. Subjects must guarantee and agree to take effective contraceptive methods (example, condom and intrauterine device) other than oral medication from 14 days prior to signing ICF to 30 days after last dose, and have no plan to donate sperm and ovum during the study.

Exclusive criteria:

1. Pregnant or lactating woman, or woman with a positive pregnancy test.
2. Participants who are suspected or confirmed to be allergic to any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
3. Participants with a medical history or a presence of significant cardiovascular, pulmonary, endocrine, urinary/reproductive, gastrointestinal, dermatologic, immunologic, hematological, neurological, psychiatric and infectious diseases or abnormalities; Or any acute, chronic disease or physiological condition that could interfere with the study results.
Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study

In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up).

During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU.

The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
* APACHE II score ≥ 12 ≤ 29
* Unrecognized dementia diagnosis

Exclusion Criteria:

* Delirium at randomization (Positive CAM-ICU score)
* Participation in scientific projects which include patient interviews
* Not Speak and understand Danish
An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.

The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM.

The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC).

This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ≥ 18 years of age;
2. Has a diagnosis of type 2 diabetes mellitus (T2DM)
3. Participants with:

   * newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
   * inadequate glycemic control on previously prescribed any oral antidiabetic drug.
4. VIPIDIA® is prescribed according to the approved label for the Russian Federation.
5. The participant's physician decides to prescribe VIPIDIA®:

   * as monotherapy or
   * as a part of combination therapy.
6. The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.

Exclusion Criteria:

1. Contraindications of respective approved Russian summary of product characteristics (SmPC);
2. In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;
3. Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.
4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Glioblastoma Psychosocial Support Program

The goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.

The specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. The investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. The investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.

Eligibility Criteria:
For patients:

Inclusion Criteria:

* Patients who self-report a diagnosis of glioblastoma
* Age \>18 years
* English Speaking

Exclusion Criteria:

* Lacks capacity for interview or is unable to provide informed consent
* Visual or hearing impairments or severe behavioral problems that preclude participation
* Too sick to participate

For caregivers:

Inclusion Criteria:

* Age \>18 years
* English Speaking

Exclusion Criteria:

* Lacks capacity for interview or is unable to provide informed consent
* Visual or hearing impairments or severe behavioral problems that preclude participation
* Too sick to participate
Dietary Nitrate and Physiological Aging

The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity, and blood pressure responsiveness to a variety of physiological stressors in older healthy adults. We will also examine the effect of dietary nitrate supplementation on measures of central artery stiffness and aortic blood pressure in older adults. Lastly, we will also recruit a group of young subjects in order to help characterize the age-related changes associated with the physiological outcome measures of the present study.

1 in 3 adults in the U.S. have hypertension which is known to increase the risk of heart disease and stroke. Blood pressure regulation is mediated by many factors including but not limited to metabolic factors, pressure/stretch sensing receptors located in the aorta and carotid arteries, endothelial cell function, and kidney function (via water and sodium absorption/excretion). It has been shown that many of these regulatory mechanisms are altered and/or become dysfunctional with aging. Specifically older adults commonly demonstrate a decreased sensitivity in pressure receptors and/or endothelial dysfunction. Additionally with aging, there is an increase in sympathetic nervous system activity and arterial stiffness which can contribute to higher blood pressure. The important vasodilator, nitric oxide (NO), has been implicated as a key signaling molecule involved in several of the mechanisms in blood pressure regulation outlined above. A decreased NO production or bioavailability is thought to contribute to several of the physiologic changes that come with aging. Therefore, the overall aim of this study is to use a randomized, double-blind crossover, placebo controlled study to examine the effects of acute dietary nitrate supplementation (to boost bioavailable NO) on various parameters of blood pressure regulation and responsiveness in normal healthy older adults. Our main hypothesis is that 4 weeks of dietary nitrate supplementation will decrease the blood pressure responses in older adults in response to a variety of physiological stressors.

Eligibility Criteria:
Two separate age groups were included.

Inclusion Criteria:

* Healthy young adults 18-35 years of age (comparison group)
* Healthy older adults 60-85 years of age (intervention group)

Exclusion Criteria:

* Hypertension, hyperlipidemia, current smoker or smoker within the last year, heart disease, diabetes, Chronic obstructive pulmonary disease, asthma, sleep apnea, Raynaud's disease, body mass index (BMI) \> 30 kg/m2, allergy medication, clinical depression, autonomic disorders and other conditions or medications that might normally alter cardiovascular function, exercise tolerance, and/or blood pressure responses.
Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery

To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.

As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.

Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.

The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.

In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.

Eligibility Criteria:
Inclusion Criteria:

* Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy

Exclusion Criteria:

* Inability to sign Informed Consent
Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.

clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.

Resin composite materials have been rapidly developed in the latest few years. Direct resin composite restorations become the golden standard for restoring intracoronal cavities. While for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic restorations in most situations being more esthetic and conservative with lower cost (Rocca \& Krejci, 2007).

Indirect resin composite onlays usually are lab processed in two appointments but it can be made in one appointment through CAD/CAM technology or by flexible model technique (semidirect technique).

These restorations offer more control on the proximal contacts and the anatomic form over the direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses are decreased and become limited to the width of the luting space. Annual failure rate (AFR) of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).

One of the advancement in resin composite technology is the evolution of short fiber reinforced resin composite (SFRC) material that allows making a direct onlay restoration possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).

This material is made to be used as a dentine substitute in the high stress-bearing areas. It is covered by a conventional resin composite filling to act as the enamel replacement this combination gives us a kind of biomimetic restoration.

Eligibility Criteria:
Inclusion Criteria

1. Pulp asymptomatic vital carious upper or lower molars.
2. Proximal complex carious cavities involving one or two weak cusps.
3. Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
4. Presence of favorable occlusion.
5. Healthy volunteers

Exclusion Criteria:

1. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
2. Deep subgingival cavity margins.
3. Possible future prosthodontic restoration of teeth.
4. Severe periodontal problems.
5. Medically compromised patients.