cyrilzakka/clinical-trials huggingface dataset:
A Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush

The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index.


Eligibility Criteria:
Inclusion Criteria:

* give written informed consent prior to study participation and be given a signed copy of their informed consent form
* be at least 18 years of age and typically use a manual toothbrush;
* be in good general health as determined by the investigator/designee based on a review/update of their medical history;
* possess a minimum of 16 natural teeth with facial and lingual scorable surfaces;
* have a Baseline pre-brushing MGI score of at least 1.75;
* have a Baseline pre-brushing RMNPI score of greater than 0.5;
* have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline pre-brushing;
* agree not to participate in any other oral care study for the duration of this study;
* agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study;
* agree to refrain from using any non-study oral hygiene products for the study duration;
* agree to return for all their scheduled visits and to follow all study procedures;
* refrained from brushing their teeth or from performing any other oral hygiene procedures anytime within the 12 hours prior to their morning brushing and agree to follow these same restrictions prior to all visits except (the Week 1 p.m. visit);
* refrained from any oral hygiene, eating, drinking\* (except small sips of water), chewing gum, and tobacco use for at least 3 hours but not more than 6 hours prior to this visit and agree to follow these same restrictions prior to all p.m. visits.

Exclusion Criteria:

* a condition requiring the need for antibiotic premedication prior to dental procedures;
* severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession;
* teeth that are grossly carious, fully crowned, or extensively restored;
* active treatment for the following conditions: periodontitis, cancer, or a seizure disorder;
* report to be nursing or pregnant, or intend to become pregnant any time during the course of this study;
* taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks;
* have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device;
* oral/gum surgery within the previous two months;
* a disease or condition that could possibly interfere with examination/procedures or with the subject's safe completion of this study.
The Brain Changes in Sleep Apnea Study

Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. However, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. The Brain Changes in Sleep Apnea Study will look at the brain health of people with severe sleep apnea both before and after 4 months of treatment with a CPAP machine. Pre- and post-CPAP treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and urine tests, a pulse wave velocity test, and an MRI. Also pre- and post-CPAP treatment, participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for 8 nights to track the duration and quality of their sleep, and wear a device for 1 night of sleep to assess their breathing and blood oxygen levels. It is expected that there will be improvements in participants' brain health after 4 months of CPAP treatment.

Between January 2018 and February 2022, the Brain Changes in Sleep Apnea Study will recruit 80 adults with newly diagnosed severe sleep apnea attending the sleep clinics at Sunnybrook Health Sciences Centre (n=40) or the University of Edinburgh (n=40). Participants will undergo home-based assessment with 3 wearable devices (24 hours of ambulatory blood pressure monitoring, 8 nights of actigraphy to assess sleep duration and fragmentation, and 1 night of finger-probe peripheral arterial tonometry and oximetry to assess cardiorespiratory physiology including sleep apnea), completion of a sleep and health questionnaire, 24-hour collection of urine for assessing sympathetic nervous system activity, blood banking for endothelial biomarkers, cognitive evaluation, pulse wave velocity test, and an MRI of the brain, at 2 time points: 1) after initial polysomnographic diagnosis of sleep apnea but before the initiation of CPAP, and 2) after 4 months of CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed sleep apnea not on CPAP or any other treatment for sleep apnea;
* Apnea hypopnea index \>=15 on diagnostic polysomnogram;
* Oxygen desaturation index \>=10 or O2 saturation in sleep \<90% for \>15 minutes on diagnostic polysomnogram;
* Subjectively sleepy;
* Planning on starting CPAP for sleep apnea.

Exclusion Criteria:

* Known history of stroke, transient ischemic attack, or other CNS disease;
* Unable to safely undergo MRI;
* Use of alpha-blocking agents;
* Persistent non-sinus arrhythmia;
* Severe pulmonary or cardiac diseases including COPD and CHF;
* Waking spO2\<90%;
* History of panic disorder.
Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap

The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.

The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.

The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Immediate or delayed breast reconstruction using the pedicled TRAM-flap
* Older than 18 years of age
* Understand enough Danish to comprehend the given information and to complete the study questionnaire
* Verbal and written informed consent

Exclusion Criteria:

* Current smokers
* Not eligible patients, assessed by surgeon
* High level of co-morbidity, assessed by surgeon or anesthesiologist
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
* Subjects who have been positive for CCR4
* Subjects who received one or more chemotherapy regimens
* Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
* Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
* Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
* Subjects who have a performance status of 0 to 2
* Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
* Subjects who are negative for anti-HCV antibody
* Subjects who have normal function of the major organs
* Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

* Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
* Subjects who are known carriers of HIV
* Subjects who have active multiple cancer
* Subjects who have a history of allergic reactions to therapeutic antibodies
* Subjects requiring continuous systemic treatment with steroid
* Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study
* Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m\^2.
* Serum bicarbonate 12 - 20 mEq/L.
* On maximum tolerated dose of ACE inhibitor and/or ARB.

Exclusion Criteria:

* Acute metabolic acidosis.
* Anticipated dialysis or kidney transplant within 6 months.
* Recent acute kidney injury.
Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.

Following medical history and clinical examination the children which are scheduled for treatment with suspected pulpary involved primary teeth will be selected. During the regular treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is performed the blood that is flowing out of the pulp will be collected and stored until analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will be obtained in follow up appointments if the child will remain in regular treatments in our clinic.


Eligibility Criteria:
Inclusion Criteria:

- Pulpal involved primary teeth with a vital pulp of which a certain amount of blood can be obtained.

Exclusion Criteria:

* systemic disease
* pulp necrosis
* permanent teeth
Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum

The purpose of this study is to identify possible links between conditions for carrying out a blood patch (BP) to treat accidental post dural puncture acute headache (PDPH) in the early post partum period and occurrence of chronic headaches at 1 and 6 months.

It is established that accidental dural puncture promotes the onset of chronic headaches in 25 to 60% of cases but the risk factors for the occurrence of this event are not known.

To identify those risk factors, the investigators will analyze the initial conditions of the accidental breach, the initial manifestations of the PDPH, the methods of carrying out the BP and the patient data.

In this study, the investigators will evaluate (phone questionnaire and score) incidence of chronic headaches at 1 month and 6 months after the realization of a blood patch, incidence of chronic low back pain, impact on daily life, incidence of late recurrences of PDPH, incidence of early and distant complications

In case of failure of effectiveness of the first blood patch, the investigators will search for associated factors: patient data, mode of delivery, initial PDPH, conditions for carrying out the BP.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old,
* Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward,
* Collection of non-opposition after oral and written information,

Exclusion Criteria:

* Patient under curatorship or guardianship
* Not speaking/understanding French
* BP performed in another indication
* Benefiting from the AME (state medical aid)
ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC;
* Histologically confirmed adenocarcinoma;
* EGFR-wildtype NSCLC;
* Provision of blood (plasma) sample for ctDNA testing;
* Patient must be able to comply with the protocol;
* Provision of blood (plasma) sample for ctDNA testing;

Exclusion Criteria:

* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
* Histologically confirmed small cell lung cancer or other metastatic tumors;
* Patient with no histologic or cytological diagnosis;
Outcome of Proximal Femur Replacement at a Tertiary Care Hospital

This is a retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement

retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement will be conducted All patients that fall in the selection criteria from 2009 to 2018 will be included as part of this study will be selected Patients are identified using medical record numbers. A questionnaire containing questions on demographics of the patients which includes their age, sex and co morbids. Furthermore, the cause of fracture, time from the fracture to presentation in the emergency room, time from the presentation to ER to the time patient was in the operating room would be noted. Duration of the surgery.

The weight bearing status in the ward and follow-up would be noted. Functionality of the patient; which is that how much patients are able to carry their normal daily routine work would also be noted from the medical records.

Collected data will be analysed using Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL, USA). Results will be recorded as frequencies, means, Standard Deviation (SD) and p-values while statistical tests will be applied for comparative reasons. For all purposes a p-value of 0.05 will be considered as the level of significance.

Eligibility Criteria:
Inclusion Criteria:

* All patients, regardless of race, gender, age and co-morbids, who were treated with proximal femur fracture with any of the following variables:

Poor bone quality Bone loss Severe communition Multiple comorbids Failed hip surgery Pathological fractures

Exclusion Criteria:

* The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record.
Bicuspid Echocardiac Study Team（BEST）

The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.


Eligibility Criteria:
Inclusion Criteria:

* Ultrasound or other imaging tests to diagnose patients with BAV

Exclusion Criteria:

* Patients with TAV or/and have significant aortic valve calcification
* Those deemed unsuitable for enrollment by clinicians (e.g., end-stage patients, mentally ill patients, non-cooperating patients, etc.)
* Those who do not agree to be included
To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout


Eligibility Criteria:
Inclusion Criteria:

* Subject has a body mass index ≥18.0 and ≤32 kg/m2;
* Screening sUA value ≥480μmol/L;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr\>ULN；
* History of kidney stones or screening kidney stones by B-ultrasound;
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
* ALT or AST \> 1.5 x ULN
* Unstable angina, history of symptomatic arrhythmia, or heart failure
* HbAlc\>8%
* eGFR\<60ml/min/1.73m2
* Investigational drug within 3 months of study dosing
Building Lipedema Research Resources

Lipedema is a disease marked by subcutaneous adipose tissue accumulation in the lower extremities of females that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity, although it's estimated to affect a high 11% of women. Clinical diagnosis of lipedema requires specialized training not widely available at most major medical centers, and there remains a substantial need for objective tools to distinguish lipedema from obesity. There is a critical need to define specific molecular markers of disease in circulation or at the tissue-level. The purpose of this study is to create, manage, and characterize an innovative lipedema biorepository. The goal of the biorepository will be to better understand disease mechanisms of lipedema and to define specific molecular markers of disease in circulation or at the tissue-level. The long-term purpose of our studies are to help with prevention and early management of lipedema.


Eligibility Criteria:
Inclusion Criteria:

* Participants with or without lipedema
* Age range = 18-80 years
* Participants with lipedema have a formal diagnosis by a physician using criteria in Appendix A of protocol
* Female

Exclusion Criteria: Volunteers in the lipedema or control group will be excluded with the following:

* Pregnant or breast-feeding
* Taking any anticoagulation or antiplatelet therapy other than aspirin (up to 100 mg daily)
* Active infection anywhere in the body, or open wound on the lower-extremities or at locations for ultrasound, bioimpedance, and tissue dielectric measurements
* Battery-operated device implanted that cannot be removed for ultrasound, DXA scan, bioimpedance, and tissue dielectric measurements
* Primary lymphedema
* Uncontrolled diabetes, renal disease, thyroid disease, or hypertension
* Hormone dysregulation or another significant clinical condition affecting hormone status as confirmed by clinical co-investigators
* Bone metastases
* Contrast imaging scan in the previous 7 days
* Nuclear medicine scan in previous 3 days
* Lumbar spine fusion
* Weigh more than 500 lb (226.8 kg)

Also excluded are subjects incapable of giving informed written consent:

* Subjects who have an inability to communicate with the researcher for any reason
* Subjects who are non-English speaking who cannot communicate through a translator, or if a translator is not available
* Subjects who cannot adhere to the experimental protocols for any reason
* Subjects who have limited mental ability to give informed consent due to mental disability, confusion, or psychiatric disorders
* Prisoners
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery

The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age
* Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation

Exclusion Criteria:

* Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
* Patients cannot have a history of hypersensitivity to any component of FID 112903.
* Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.
* Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.
* Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.
* Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure \>25 millimeters mercury in either eye.
* Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.


Eligibility Criteria:
Inclusion Criteria:

* All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.

Exclusion Criteria:

* Not applicable