cyrilzakka/clinical-trials huggingface dataset:
Residual Sample Collection for Respiratory Viral Panel

Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.

The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.

Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

Eligibility Criteria:
Inclusion Criteria:

* Sample from patients exhibiting signs/symptoms of respiratory viral infection
* All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.

Exclusion Criteria:

* Samples that are incorrectly de-identified
A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:

Group A: Subjects with ESRD who are receiving hemodialysis treatment

Group B: Subjects with severe renal impairment

Group C: Subjects with moderate renal impairment

Group D: Subjects with mild renal impairment

Group E: Healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult male or female aged 18 to 79 years, inclusive.
* All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level \>35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject has a BMI \>37 kg/m2.
* Subject has taken any prescribed systemic or topical medication
* Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
* Subject has received an investigational drug within 30 days before dosing.
* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
* Subject has had a clinically significant illness
Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson

The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).

Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.

The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.

Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease, diagnosed for at least 2 years,
* Medical treatment (if any) unchanged in the past 4 weeks at least
* Hoehn \& Yahr score \< 3
* Montreal cognitive assessment (MOCA) score between 20 and 30
* Able to understand the aim and methods of the study and provide signed informed consent-

Exclusion Criteria:

* Atypical parkinsonian syndrome
* Cardiovascular pathology preventing moderate physical exercise
* Orthostatic hypotension
* Any condition (other than PD) interfering with gait
* pregnant or nursing
Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. Honey, another method of soothing cough cannot be used in children \<1 year due to concerns for infantile botulism. A preparation from agave syrup has been created to address the need for an infant cough syrup. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male or female infant who is 2 to \<48 months of age.
* presents with a non-specific acute cough for 7 or fewer days' duration.
* Parents/legal authorized representative reporting at least moderate cough and cold symptoms.
* Parent/legal authorized representative was in the home with the child on the night prior to enrollment and plans to be in the home with the child on the night when study treatment will be administered
* Parent/legal authorized representative who is willing and able to comply with study requirements.

Exclusion Criteria:

* Previous participation in this clinical trial
* Gestational age at birth \<35 weeks.
* Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).
* Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
* History of reactive airways disease, asthma, or chronic lung disease.
* Use of any medication or honey to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment.
* Presence of any significant disease including immunodeficiency, hepatic, renal,cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
* Known allergy to agave nectar or grape flavoring
Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months.

Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of \>= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether the participants have depression (Beck depression questionnaire). Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes
* give consent to the study
* accessibility to the previous and recent test results

Exclusion Criteria:

* acute infection or inflammation lasting more than a week
* acute metabolic decompensation
* unable to attend to the follow-ups
* having non-thyroid endocrine diseases
* active oncologic treatment
Effect of Kava on Anxiety and Stress in Cancer Survivors

This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment. Participants will be randomized to take either kava first or placebo first. Kava 75 mg or placebo will be taken three time daily (TID) for 14 days (Period 1), followed by a washout period of 14-28 days. Thereafter, the participant will take either placebo or kava TID for 14 days (Period 2), whichever he/she did not take in Period 1.


Eligibility Criteria:
Inclusion Criteria:

* Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
* Score of ≥ 5 on the GAD-7 questionnaire, considered to be mild anxiety
* ECOG performance status 0-1
* Normal kidney and liver function within 28 days prior to the first dose of kava or placebo
* Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
* Ability to provide written, informed consent

Exclusion Criteria:

* Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
* Anti-cancer therapy within 28 days prior to registration, and/or during study participation, except for aromatase inhibitors
* Known liver disease such as cirrhosis (any Child-Pugh class), active infectious hepatitis, immune-mediated hepatitis, hemochromatosis, non-alcoholic steatohepatitis (NASH), or Wilson's disease
* Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
* Chronic use of high-intensity statin therapy
* Significant uncontrolled conditions or situations, which in the judgment of the enrolling investigator, could affect safety and/or ability to adhere to study requirements
* Adjustments in anti-depressants and/or anxiolytic medications within 8 weeks prior to study registration
* Known allergy to kava
* Women who are pregnant, intend to become pregnant, or are nursing
* Regular use of alcohol, defined as ≥ 3 times per week, regardless of amount, within 14 days prior to study registration
* Parkinson's disease
* History of or current substance use disorder by self-report
Ultrasound Guided Bilateral Erector Spinae Plane Block in Laparoscopic Cholecystectomy

This study will define the postoperative analgesic effect of ESP block via amount of patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely and rescue analgesics) and compare the control group in patients having laparoscopic Cholecystectomy .

Laparoscopic interventions are considered as minimally invasive procedures. They have both cosmetic and open surgery advantages in terms of surgical stress. Laparoscopic cholecystectomy is the most commonly performed laparoscopic upper abdominal procedure. After this procedure, patients often complain of excessive pain. Non-steroidal anti-inflammatory agents and opioids are used for postoperative analgesia. In addition, in the past decade, in the guideline of ultrasonography, peripheral block types with analgesic activity have been described in laparoscopic cholecystectomies as well as in many operations on the development of regional anesthesia and analgesia techniques. It was reported that transverse abdominis plane (TAP) block provided effective analgesia in these cases in the first ultrasonography guideline of petit triangle region in 2010. Later studies on TAP block activity, drug doses and concentrations in laparoscopic cholecystectomies have been conducted. There are also publications indicating that TAP block has been applied to the subcostal region for more effective analgesia. The ESP block is a new block for the treatment of thoracic neuropathic pain. In the following process; ESP block thoracic and breast surgery, bariatric surgery, and upper abdominal surgeons have also been reported to provide effective postoperative analgesia .

The standard practice for post-operative pain management for laparoscopic cholecystectomy in Maltepe University Hospital consists of routine intravenous analgesic and rescue analgesics and in combination with patient-controlled analgesia (PCA).

Given the importance of providing adequate analgesia in upper abdomen surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, the investigators are proposing a prospective observational study to examine the analgesic efficacy of the ESP block in laparoscopic cholecystectomy as a potential analgesic technique. The investigators are hoping the results of this study will provide framework for future larger comparative studies.

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding diathesis
* Use of any anti-coagulants
* Inability to provide informed consent
* Severe kidney or liver disease
* Inability to operate PCA system
* Patient with psychiatric disorders
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.


Eligibility Criteria:
Inclusion Criteria:

* female participants, age \>/=18 years
* advanced, inflammatory or early stage unilateral invasive breast cancer
* HER2-positive breast cancer
* baseline left ventricular ejection fraction (LVEF) \>/=55%

Exclusion Criteria:

* metastatic disease (Stage IV) or bilateral breast cancer
* previous anticancer therapy or radiotherapy for any malignancy
* other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
* clinically relevant cardiovascular disease
* current chronic treatment with corticosteroids of \>10mg methylprednisolone or equivalent
Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors

The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database.

The Ethics Committee approval has been obtained.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years

Exclusion Criteria:

* Non urgent cholecystectomy
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen

This is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen.

All eligible patients shall apply permitted topical steroid(s) according to standard local practice

For the entire study period, patients should apply Ceradan Cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily.

At the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks.

Retrospective information on other topical treatments used will be collected at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children aged ≥6 months to ≤6 years
* Baseline PEST score of 3- 4
* Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the NESS
* Diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to Investigator's judgement
* Patients who have not visited the dermatologist before (dermatologist-naïve)
* Agree to participate and provide written consent by parent or guardian (and assent if applicable)

Exclusion Criteria:

* History of severe episodes of atopic dermatitis (for example: oozing, crusts)
* Clinical signs of skin infection (viral, bacterial or fungal)
* Grading of \>11 as defined by the Nottingham Eczema Severity Score (NESS) within 3 months prior to study inclusion
* Known reaction or allergy to test drug or excipients or steroids
* History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period
* Patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment
* The patient has been exposed to below therapy within the set timeframe:

  i. Systemic administration of corticosteroid - four weeks; ii. Systemic administration of immunosuppressive drugs - four weeks; iii. UV therapy four weeks
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
* Parents/guardians may be unable to complete the patient diaries or questionnaires
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections

The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.

In the current study, we propose investigating the roles of vitamin D supplementation and of regular gargling to prevent URTI/ILI. Vitamin D may be an important factor in respiratory health. Observational studies have associated low serum 25(OH)D levels with more frequent and more severe respiratory infections. However, evidence is lacking that replacement of vitamin D decreases respiratory infections. Four interventional studies of vitamin D supplementation have noted a reduction in respiratory infections, with an estimated 5-25% reduction, but results were not statistically significant.

In Japanese populations, gargling has been found to significantly reduce the incidence of upper respiratory tract infections by approximately 35% (Satomura et al., 2005). This intervention has not been studied in different populations but may be a useful personal practice to reduce URTI.

We propose a 2X2 factorial, randomized, placebo-controlled trial of vitamin D/placebo and gargling/no gargling to study the effects of vitamin D supplementation and gargling on upper respiratory tract infections in McMaster students. This study will be conducted over two years, during September and October of each study year, to capture the natural peak in rhinovirus activity.

Eligibility Criteria:
Inclusion Criteria:

* Current or part-time student at McMaster University
* 17 year of age or older
* Currently living:

  i. In residence or, ii. Off-campus with at least one student housemate
* Willing and able to sign an informed consent

Exclusion Criteria:

* Students who do not meet the inclusion criteria
* Currently living at home with parents
* History or diagnosis of hypercalcemia
* Diagnosis of parathyroid disorder (hyper or hypo)
* Diagnosis of chronic kidney disease
* Use of anticonvulsants
* Malabsorption syndromes
* Diagnosis of sarcoidosis
* Currently pregnant or planning a pregnancy
* Inability to swallow capsules