cyrilzakka/clinical-trials huggingface dataset:
COMORAL® the Oral Irrigation Unit Clinical Trial

This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited.

To establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday.

Subjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.

This is a randomized, open-labeled, single-centered clinical study to evaluate COMORAL® the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. The purpose of this clinical study is to evaluate the safety and effectiveness of COMORAL® the oral irrigation unit in preventing gingivitis and plaque formation in adult patients.

42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.

After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.

Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.

Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less
* Those with 3 or more natural teeth in each quartile
* Those who can voluntarily sign the consent form

Exclusion Criteria:

* Existing dental caries
* Existing periodontitis
* Other oral diseases
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* A total body weight \>25 kg (55 lbs).
* Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
* Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.

Exclusion Criteria:

* Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
* Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
* Ongoing use of another drug for treating overactive bladder
* Uncontrolled narrow angle glaucoma, urinary or gastric retention
The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System

There are many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system.

The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.

The sympathetic and parasympathetic divisions of the autonomic nervous system affect the function of many organs, glands, and involuntary muscles in the body. The sympathetic and parasympathetic nervous systems often play opposing roles in the body, one is suppressed when the other increases activity. With the beginning of exercise or sports activity, sympathetic activity in the body increases and after a certain period reaches a plateau value at maximum activity. With the end of sports activity, the suppressed parasympathetic activity increases, and the sympathetic system returns to its resting state over time.

Low sympathetic activity and/or high parasympathetic activity and low heart rate before training or exercise can be considered as performance indicators. It also indicates that recovery from the previous training or exercise is adequate. Parasympathetic system activation continues for up to 48 hours after exercise. If the exercise is intense and persistent, parasympathetic system activity can last up to 72 hours. In addition, due to the increase in anaerobic respiratory rate during exercise, there may be decreases in parasympathetic reactivation.

Transcutaneous vagus nerve stimulation (VNS) can affect cardiovascular parameters both at rest and during exercise. VNS improves autonomic modulation and positively reduces pain and fatigue associated with cycling exercise. On the other hand, VNS is particularly useful in reducing pain and fatigue during and after competition.

Slow breathing modulates the activity of the vagus nerve. Controlled breathing exercises (CBE) directly affect the respiratory rate, which can lead to faster physiological and psychological calming effects by increasing vagal tone during slow expiration. CBE increase heart rate variability in healthy participants.

The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a moderate level of physical activity according to the International Physical Activity Scale
* No orthopedic obstacle to exertion
* Being male

Exclusion Criteria:

* Having any active or chronic disease
* Having cooperation problems
* Using regular medication for any chronic condition within the last year
* Being a smoker
* Having had heart surgery
* Having had surgery on the respiratory system
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.


Eligibility Criteria:
Inclusion Criteria:

* Age between 0 - \<19 years
* Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies)
* Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology
* Planned central venous access device insertion of \>90 days
* Written consent signed according to local law and regulations
* Parents/guardians or patient are willing and able to comply with the trial procedure

Exclusion Criteria:

* A previous central venous access device removed \< 12 months ago.
* Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks.
* Primary immunological disorder
* Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.
* Documented bacteremia in the period from 24h before catheter insertion until inclusion
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes and optimize future treatment goals

Eligibility Criteria:
Inclusion Criteria:

* 1) Be able to sign written informed consent.
* 2) Age range from 18 to 75 years old, regardless of gender.
* 3) Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression.
* 4) After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases.
* 5) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
* 6) The expected survival period is ≥ 6 months.
* 7)No other surgical contraindications

Exclusion Criteria:

* 1) Primary tumors of the spine or multiple tumors of the body, with\>3 metastatic organs and\>5 metastatic sites.
* 2) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
* 3) Severe heart, lung, liver, kidney or other diseases affecting the surgery.
* 4) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
* 5) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
* 6) Infectious diseases.
* 7) Refuse to follow up or participate.
* 8) The researchers determine that the patients are not suitable for enrollment this clinical trail.
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy

Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated. Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children. Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP. However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training. Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance. Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development. Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP. The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy diagnosis
* Children with level I or II according to Gross Motor Classification System

Exclusion Criteria:

* Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
* Severe convulsions that can not be controlled by drugs
* Congenital malformation accompanying cerebral palsy
Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Eligibility Criteria:
Inclusion Criteria:

* Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
* Measurable disease
* Good performance status
* Adequate bone marrow reserve, hepatic, pulmonary and renal functions

Exclusion Criteria:

* Serious concomitant systemic disorder
* Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
* Pregnancy/breast-feeding
* Significant weight loss over the previous 6 weeks before study entry
* Inability or unwillingness to take vitamin supplementation and corticosteroids
Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months since diagnosis
* Insulin naive subjects
* OAD treatment for at least 4 months with max. two OAD treatments
* Body mass index below 30.0 kg/m2
* HbA1c between 7.0-11.0%

Exclusion Criteria:

* OAD treatment with three or more OADs
* Secondary diabetes
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
* Uncontrolled hypertension
* Known or suspected allergy to trial product or related products
Structural and Molecular Neuroplasticity in Migraine

The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.

To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-45 years of age
* Between 1-14 migraine attacks per month or healthy

Exclusion Criteria:

* Cannot be taking daily migraine medication
* Healthy subjects cannot be taking hormonal birth control pills or other medication
* Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

The purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo chemotherapy

This study is designed as a randomised, double-blind, active-controlled, parallel-group study to be conducted in approximately 80 sites.

Approximately 340 male or female patients aged 18 or older suffering from hematologic malignancies (de novo patients or relapsing patients) at intermediate to high risk of TLS and scheduled for receiving the first cycle of cytotoxic chemotherapy, regardless of the line of treatment, will be randomized in this study. Eligible patients (as per screening visit) will be randomly allocated in a 1:1 ratio to Febuxostat or Allopurinol. The double-blind treatment period starts two days prior to the planned beginning of chemotherapy and continues for 7 to 9 consecutive days, according to Investigator judgment and on the basis of the actual duration of chemotherapy regimen administered to the patient. Along the study treatment, uric acid levels, creatinine levels, Laboratory TLS/Clinical TLS and Adverse Events represent the major clinical findings to be monitored on a daily basis. Overall the study encompasses 10 to 11 planned visits at site, including screening, randomisation, on treatment and final follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of TLS (according to the TLS risk stratification, Cairo M et al, British Journal of Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
* Life expectancy \> 1 month

Exclusion Criteria:

* Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations
* Patients with sUA levels ≥ 10 mg/dL at randomization
* Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization
* Patients with severe renal and/or hepatic insufficiency
* Patients with diagnosis of LTLS or CTLS at randomization
Sunshine 2 Study for Women With Diabetes

This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible to participate will be randomly assigned to either a weekly dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active comparator of 5,000 international units of vitamin D3 for six months. Participants will complete approximately four in-person study visits and several telephone visits throughout the six month trial period, where the researchers will assess depressive symptoms, diabetes self-management, and systolic blood pressure.

The primary aim of this study is to determine the effect of vitamin D supplementation on depressive symptoms, self-management, and systolic blood pressure compared to placebo. The hypothesis is that women receiving vitamin D supplementation will report fewer depressive symptoms, increased diabetes self- management mediated by depression improvement, and will have a lower systolic blood pressure compared to those taking placebo at three and six months follow-up.

The secondary aim is to explore the mechanistic effect of vitamin D supplementation on inflammatory biomarkers and their association with depression. Here, the hypothesis is that women receiving vitamin D supplementation will have a decrease in inflammatory biomarkers which will be associated with fewer depressive symptoms compared to those taking placebo at three and six months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women age 21 and older
* Objective evidence of depressive symptoms at the screening and baseline visits
* Diagnosis of type 2 diabetes currently being treated by a healthcare provider
* Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)

Exclusion Criteria:

* Current alcohol or substance use disorder
* Any unstable or severe psychiatric disease including diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, or other psychotic disorder
* Severe complications of diabetes, such as blindness and/or amputation
* Any malabsorption disorder, such as Crohn's disease and/or celiac sprue
* Elevated serum calcium level deemed significant by the Principal Investigator
* Use of 1,000 or more international units daily vitamin D 60 days before enrollment and unwillingness to discontinue vitamin D supplementation 30 days before enrollment.
* Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks prior to enrollment.
* Participants who are pregnant, nursing, or planning to become pregnant during the study.
* Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG) or diastolic blood pressure (DBP) greater than 100 mmHG.
* Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed clinically significant by the Principal Investigator