cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 60-125mg/dL glucose level(at screening)
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus


Eligibility Criteria:
Inclusion Criteria:

1. Age 3 to 12 years (inclusive)
2. IXT for distance or constant IXT for distance and either IXT or exophoria for near
3. IXT size of \> 10PD
4. Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12)
5. Visual acuity of no greater than 2 lines between eyes
6. Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye
7. Investigator willing to observe IXT untreated for at least 1 year

Exclusion Criteria:

1. Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year
2. Prior strabismus, intraocular or refractive surgery or botulinium injection
3. Surgery planned within the next year
4. Prematurity (birth weight \< 1500g, gestational age \< 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability
5. Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)

The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.

Exclusion Criteria:

* Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
* Patients who will receive other systemic antifungal agents for the first time in screening period
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain

The aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. It has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* adults between 18 and 60 years old
* nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified
* chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain
* able to read and understand French

Exclusion Criteria:

* History of surgery or major trauma to the spine
* Current use of medication known to impair physical effort and pain perception
* Lumbar scoliosis of more than 20°
* Collagenosis, severe osteoporosis
* Neuromuscular disease
* Malignant tumor
* Non-controlled hypertension
* Infection
* Radiculopathy
* Progressive neurologic defect
* Myelopathy
* Lumbar disc hernia
* Pregnancy
* Active lower body injury and/or severe and disabling pain limiting the capacity to undergo the evaluation.
Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease

Randomized clinical trial focusing on the effect of tailored information on Covid-19 for patients with chronic kidney disease stage 5 on health literacy, anxiety and self-perceived health.

This single-center randomized open clinical trial in persons with chronic kidney disease stage 5 investigates the effect of information about coronavirus targeted at the study population, using study specific information videos followed by a teach-back method. We measure digital, functional, interactive and critical health literacy, fear of coronavirus and self-perceived health at baseline and end-of-study. Patients are followed from May-July 2021 through February 2022 (study period 7-9 months).

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stage 5

Exclusion Criteria:

* Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.
Assessing Models of Exposure Therapy

The objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Therefore, the investigators will be comparing the performance of such clients in a treatment as usual (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The investigators hypothesize that clients will perform significantly better in the ACT-focused ERP session than they will in the TAU-ERP session. More specifically, the investigators hypothesize that clients and an independent rater will report that in the ACT-focused ERP session, clients performed significantly fewer rituals and/or avoidance behaviors, experienced comparable levels of distress, exerted significantly more effort, had significantly less difficulty getting started with the ERP, were significantly less influenced by their uncomfortable thoughts/feelings, were significantly more willing to experience discomfort, were significantly more focused on working towards what is important to the client. The investigators also hypothesize that an independent rater will rate clients as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP session. The investigators also hypothesize that clients will rate the ACT-focused ERP session as significantly more preferable and acceptable than the TAU-ERP session, and that they will report being significantly more willing to do the ACT-focused ERP session again.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.
The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
* Able to speak and read English
* Able to consume food orally
* Willing to consume an alternative Mediterranean diet
* Scheduled to receive treatment with radiation or chemoradiation
* Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
* Able to provide informed consent

Exclusion Criteria:

* Women who are pregnant
* Head and Neck Cancer not the primary diagnosis
* Patients scheduled to receive surgery
* Patients on enteral or parental nutrition
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.


Eligibility Criteria:
Inclusion Criteria:

* Obese adults
* Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
* Medically healthy with no clinically significant results of screening exams

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of glaucoma or increased intraocular pressure
* History of kidney stones
* Cholelithiasis or cholecystitis within 6 months
* Cardiovascular event within 6 months
* Obesity of known genetic or endocrine origin
* Recent weight instability
* Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
* Systolic blood pressure \> 150 or diastolic \> 95 mm Hg
* Positive urine drug or alcohol screen
* Positive serology for HIV, HBV, or HCV
* History of alcoholism or drug abuse
* History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
* Hypersensitivity to study drug or related compounds
* Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
* Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
* Women who are pregnant or lactating
* Hemoglobin \< 12 g/dL
* Use of tobacco or nicotine-containing products within 6 months
Intermittent Vibrational Force During Orthodontic Treatment With Aligners

This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to explore whether the application of intermittent vibratory forces modify RANKL and OPG concentrations in patients undergoing orthodontic treatment with clear aligners. The specific objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among groups according to the application or not of Acceledent® treatment at different time points and frequencies of aligner changes.

Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator of dental movement. The purpose of this study is to determine the effect of intermittent vibrational force application during orthodontic aligner treatment on RANKL and OPG concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical trial will include candidates for malocclusion treatment with aligners, randomly assigned to 3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at 6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner adjustment will also differ among groups and measurement time points. At different time points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor for RANKL and OPG analysis using ELISA kits.

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of treatment of malocclusion with Invisalign® (Align Technology, San Jose, CAL) using at least 14 sets of aligners
* patients with good general health

Exclusion Criteria:

* smoking habit, poor oral hygiene, the presence of periodontal disease or any other chronic or systemic diseases that could affect bone metabolism or inflammation and the previous or current receipt of medications that could influence bone metabolism (e.g., bisphosphonates).
No Reflow Phenomenon Incidence and Predictors

Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described.

Objectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population.

Secondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days.

Methods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Presenting with ST elevation myocardial infarction
* Appropriate for Primary Percutaneous Coronary Intervention

Exclusion Criteria:

* Primary Percutaneous Coronary Intervention not performed eg due to non- flow- limiting coronary artery disease
* Unsuccessful PCI
* Thrombolysis
* Patients who do not survive the procedure to leave the catheterisation laboratory
IMX-150 Cream for Diabetic Neuropathy

The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.


Eligibility Criteria:
Inclusion Criteria:

* Must have sufficient command and understanding of the English language to complete diaries and questionnaires
* If female, may not be pregnant or lactating
* Can be treated on an outpatient basis
* Has a clinical diagnosis of Type-1 or Type II diabetes with: confirmed diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months.
* Must have a hemoglobin A1C value of 11% or less that is stable under treatment
* Agrees to use the test creams as specified for the 4 week period
* Willing to not use any other medications, including investigational medications, to treat pain symptoms of Diabetic Neuropathy while in study.

Exclusion Criteria:

* Currently using any nitrate medications
* Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
* Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
* Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
* Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
* History of migraine, cluster or vascular headaches, chronic pain with greater pain intensity than the pain of diabetic neuropathy or other chronic pain condition within the region of the diabetic peripheral neuropathy
* Amputation of more than one toe per foot
* Neurological disorder or skin condition that may alter local sensation in the feet
* History of unstable medical problem, clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study mediation, interfere with the study evaluations, or interfere with the patient's ability to comply with the study
* History of drug (including cannabinoid) or alcohol abuse within the past year
* Cognitive or language difficulties that would impair completion of the pain assessment tool
* Within the past 3 months, have had either a myocardial infarction, uncontrolled hypotension, or uncontrolled hypertension
* Participated in a study of any investigational drug within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Screening
* Major abdominal, thoracic or vascular surgery within 6 months of the first dose of study medication
* Open lesions in the area where the cream is to be applied
* Fertile patients who are unable or unwilling to comply with the contraceptive requirements during the study period
Causes of FUO in Infants and Children

Definition: fever \< 38˚c for which the cause could not be identified, documented by a health care provider after 3w.evaluation as an outpatient \[or after 1w. evaluation in the hospital\]. Most cases, however, do not have fever alone, but FUO results from atypical presentation of common diseases. On the other hand FUO lasting longer than 6mo is uncommon in children \& suggests granulomatous, autoimmune or auto inflammatory diseases

Fever of unknown origin (FUO) is a relatively common pediatric complaint. The time of FUO generally ranges from 10 to 21 days. Generally the fever should be greater than 38.3 ˚c for at least 10 days with no evident source after initial outpatient or inpatient workup. A broad range of illnesses are known to cause FUO, including infectious, autoimmune and oncologic etiologies. Definitive diagnosis of FUO can be challenging, with many cases resolving spontaneously without a diagnosis. There is currently no standardized diagnostic approach for working up FUO. The general direction of the workup often depends on the patient's presentation, symptoms, and environmental exposures. It is generally accepted that a complete history and physical examination as well as basic laboratory tests, and empiric antibiotic therapy are initial steps in the workup of FUO. With no advanced resources available, radiographs such as chest X-rays and abdominal ultrasonography as well as simple tests e.g. ESR are commonly performed looking for infectious and malignant sources of FUO. If the diagnosis is still obscure laboratory tests for auto immune antibodies or specific infectious agents, are additional logical steps if the diagnosis remains in question.

Unlike adult studies, the categorical distribution of diagnosis of the causes of FUO in pediatrics has not changed in recent decades (Nield\&Kamat , 2018) \[1\]. Additional studies are needed to improve the recognition of causes of prolonged fever in children.

So that FUO is not a single specific medical disorder but may be a potential manifestation of several diseases and disorders. The initial approach to FUO is suggested to be determination of the causes of prolonged fever in each of the body systems, as suggested by the presenting complaint. For instance in the respiratory system in developing countries tuberculosis (TB) must be searched for in the first place. Similarly Protein Energy Malnutrition (PEM), and vitamin D deficiency rickets must be also thought of as a cause of recurrent / chronic chest infection leading to FUO. In the gastrointestinal system persistant/ recurrent diarrhea must be searched for. In the developing countries, urinary tract infection, typhoid fever and viral hepatitis constitute other hidden causes of FUO. Collagen diseases, auto inflammatory diseases as well as immune deficiency diseases and auto immune disorders must be searched for as causes of FUO.

Eligibility Criteria:
Inclusion Criteria:

* All FUO cases admitted to AUCH during one year of the study.

Exclusion Criteria:

* cases of HIV
Ofatumumab in AQP4-IgG Seropositive NMOSD

This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating disorder that affects mainly adult patients. It is associated with a pathological B cell-mediated humoral immune response against the aquaporin-4 (AQP4) water channel. Monoclonal antibodies against CD20 have been shown to be effective for prevention of relapses in patients with NMOSD, and therefore been recommended as first-line therapy for this disorder. Ofatumumab (OFA), a fully humanized anti-CD20 monoclonal antibody, has been approved for multiple sclerosis treatment. However, prospective multicenter studies are needed to determine the efficacy and safety of ofatumumab in treating NMOSD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.
* Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.
* Adults aged ≥18 years old.
* Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).
* Provision of written informed consent to participate in this study.
* Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.
* Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.

Exclusion Criteria:

* Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.
* Pregnant or breastfeeding patients and those with family planning during the study period.
* Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.
* Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.
* Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.
* Active infection at within 4 weeks before baseline.
* Positive for HBV or HCV.
* Evidence of latent or active tuberculosis (TB).
* Have received any live or live-attenuated vaccine within 6 weeks before baseline.
* History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.
* History of severe allergic reactions to biological agents.
* Inability to provide written informed consent.
Healthful Diets and Risk of Hearing Loss

To prospectively examine the relations between adherence scores for three healthful dietary patterns, the Alternate Mediterranean diet (AMED), the Dietary Approaches to Stop Hypertension (DASH), and the Alternative Healthy Eating Index (AHEI-2010), and risk of hearing loss in the Nurses' Health Study II.


Eligibility Criteria:
Inclusion Criteria:

* The investigators limited the study to women who provided information on their hearing on the 2009 or 2013 questionnaire.

Exclusion Criteria:

* The investigators excluded those who did not provide responses to the hearing questions on either questionnaire, reported a hearing problem that began before baseline for the current analysis (1991) or did not report date of onset, or reported cancer other than non-melanoma skin cancer. The investigators also excluded women who did not complete the baseline diet questionnaire and who had missing diet information for each subsequent time period.