cyrilzakka/clinical-trials huggingface dataset:
Using e-Nose Technology to Identify Early Lung Cancer

The purpose of this study is to test the ability of a new technology called breathprinting, or electronic nose (e-nose), to detect early-stage lung cancer. Additionally, researchers also want to see if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-85
* Single, monolateral nodule of at least 50% solid composition visible on chest CT scan (with or without contrast) suspicious for lung cancer.
* MSK radiologist report or read suggestive (i.e. at least 50% certainty) of suspected primary lung cancer (in accordance with the level of certainty criteria set forth by MSKCC Radiology)

  o Patients with biopsy-proven early stage, primary lung cancer that meets staging requirements, do not need to also have a radiology report meeting inclusion criteria
* Negative test for COVID-19 performed locally or at MSK, done as part of standard of care testing (i.e. only when required by specific institutional policy) prior to biopsy or surgical procedure
* Eligible for fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis (i.e., does not have comorbidities precluding these).
* Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study

  o Patient must agree to undergo fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis prior to e-nose collectionNote: Biopsy-proven patients that meet eligible staging criteria who are not further surgical candidates will be collected prior to next step in standard of care treatment
* Patients with biopsy-proven clinical stage I lung cancer are eligible if the biopsy is done within 6 weeks of the consent date

Exclusion Criteria:

* Age \<21 and \>85 years at first outpatient visit.
* Multiple ipsilateral or bilateral nodules reported on chest CT scan and/or concurrent as suspicious for lung cancer (note: nodules deemed indeterminate, inflammatory, etc. will not exclude a patient from participating in this study) semisolid GGOs.
* Lung nodule of interest is less than 50% solid in composition
* Per MSK radiologist report or read, the lung nodule of interest is "less likely" or "unlikely" (i.e. less than 50% certainty) to be neoplastic (in accordance with the level of certainty criteria set forth by MSKCC Radiology)
* Any previous history of lung cancer
* History of any non-lung cancer(s) that is currently being treated (note: prior history of completely treated non-lung cancer from any time will be eligible)
* Metastatic lung cancer disease seen on chest CT or PET scan at hilar/mediastinal nodes or contralateral lung or extrathoracic sites.
* Previous medical history of a lung biopsy/surgical procedure for cancer diagnosis (note: patients who underwent a lung biopsy over three years ago that showed negative for lung cancer and patients who underwent a lung biopsy confirming stage I lung cancer within the past 6 weeks will be eligible)
Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects

This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.

A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 18 and 27 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results
The Effect of Hypnosis on Periodontal Treatment

Treatment of periodontal diseases relies on the mechanical removal of microbial dental plaque, calculus, and necrotic cementum from root surfaces in both supra- and subgingival areas to control inflammation in periodontal tissues. As in all dental treatments, dental phobia and dental anxiety are common challenges in initial periodontal therapy. Hypnosis is among the traditional non-pharmacological behavior management techniques used to manage stress and improve pain tolerance. It is known that hypnosis is effective in anxiety control in dentistry. The use of salivary levels of inflammatory mediators released during the disease is a valid method for assessing the progression of periodontal disease and healing after treatment. In this study, the effect of hypnosis on healing in patients undergoing Phase I periodontal therapy will be evaluated by comparing the mean differences in cytokine levels between case and control groups


Eligibility Criteria:
Inclusion Criteria:

Being between the ages of 20-65 Not having any systemic disease Having chronic periodontal disease Having the ability to understand the study and answer questions

Exclusion Criteria:

Having any systemic disease Being under 20 or over 65 Not having any periodontal disease
Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients

Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Accepting research
* Being a relative of a palliative care patient
* Ability to communicate adequately

Exclusion Criteria:

* The patient's relative has a disability (such as vision, speech and hearing) that prevents them from communicating.
* No psychiatric problems
Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.

The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.

Eligibility Criteria:
Inclusion Criteria:

1. Orthodontic patients (both genders)
2. Age range (14-24)
3. Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
4. Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
5. Cases requiring maximum anchorage during anterior segment retraction.
6. Cases with minimal crowding (2-3) mm

Exclusion Criteria:

1. Patients suffering from any systemic diseases interfering with tooth movement.
2. Patients with extracted or missing permanent teeth. (except for third molars).
3. Patients with badly decayed teeth.
4. Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc....).
5. Patients with previous orthodontic treatment
Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.

This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults. This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients. Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed, including inhibitor development, thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC agglutination. Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia B
* Less than 5 years of age
* In the investigator's judgment, the patient and/or caregiver will be compliant to study procedures

Exclusion Criteria:

* A currently detectable FIX inhibitor. A family history of inhibitors will not exclude the patient.
* Impaired liver function
* Impaired renal function
Studying Innate Immune Responses in Infants With Bronchiolitis

This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.

Respiratory syncytial virus (RSV) causes a spectrum of illness in healthy infants, ranging from asymptomatic infection to life threatening bronchiolitis with respiratory failure. The reasons for the differences in clinical presentation remain unknown. Interferons are natural antiviral factors and components of the innate immune response, which play a role in limiting viral replication.

We postulate that differences in clinical severity of RSV infection may be due to innate immune differences in the production of type I and III interferons (innate interferons). To test this hypothesis, we will recruit infants with mild, moderate and severe RSV bronchiolitis and compare production of innate interferons in blood and respiratory samples, using quantitative and functional analysis. We will determine whether interferon responses differ across a spectrum of clinical severity, and will relate them to viral load.

To establish whether defects in interferon production persist in those infants with severe infection, we will retest them following recovery and measure interferon responses after challenge with live RSV. Demonstrating a persisting defect may suggest a genetically determined defect requiring further investigation. Identification of the mechanisms of severe disease in patients without known risk-factors could lead to targeted therapy to prevent or treat severe disease.

Eligibility Criteria:
Inclusion Criteria:

* Bronchiolitis
* Infant

Exclusion Criteria:

* Age over 1 year
* Underlying chronic lung disease, prematurity, congenital heart disease
PET Imaging of Subjects Using 124I-PU-AD

This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.

This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.

Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.

After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.

Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:

   Cancer:
   1. Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.
   2. Cancer histology confirmed by pathology.
   3. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).

   Alzheimer's:
   1. Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria.
   2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
2. Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.

Exclusion Criteria:

1. Subject has unacceptable pre-study organ function during screening defined as:

   1. Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
   2. AST/ALT \>2.5 x ULN
   3. Albumin \< 2 g/dl
   4. GGT \> 2.5 x ULN (IF Alkaline phosphatase \> 2.5 x ULN)
   5. Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min.
2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
3. Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances


Eligibility Criteria:
Inclusion Criteria:

* adolescents aged 12 to 16 benefiting from social security coverage
* in good general health in brushing and taking treatments
* Have FODs
* who consent to the study and whose parents have given their consent
* suitable for orthodontic treatment in view of his oral state

Exclusion Criteria:

* inability to obtain informed consent
* use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month before inclusion
* allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)
* no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion
* medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care)
* physiological, pathological condition, medication or behavior that may have repercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco)
* oral state requiring other priority care (untreated cavities, untreated active periodontitis, progressive recession)
Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-
Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19

Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18;
* Diagnostic COVID-19 by RT-PCR;
* Hospitalisation in resuscitation for the management of complications related to COVID-19
* Implanted ECMO-VV during hospitalisation;
* Patient agreeing to participate in the study

Exclusion Criteria:

* Sujet under guardianship or trusteeship
* Sujet under safeguard of justice
Simplified Insulin Protocol Using Lantus in Elderly

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years or older
* Diagnosis of diabetes mellitus Type II
* At least 2 (short-acting or mixed) insulin injections per day
* At least 1 episode of hypoglycemia (glucose value \<70) on screening CGM

Exclusion Criteria:

* Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
* Active liver disease (history of cirrhosis or LFT \> 3 times normal)
* On dialysis or with severe renal dysfunction (creatinine clearance \<20 ml/min)
* Malignancy that limits life span to less than 18 months
* Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study
Plyometric and Complex Training in Male Cricket Players

The complex training starts with a high load of resistance training that is succeeded by plyometric training. This combination aims at improving the efficacy of the plyometric training stimulus, thus increasing the neuromuscular response, explosive strength, and power. This response might further be improved by making appropriate variations in the dosage parameters of complex training. Previously available literature reports conflicting evidence, with some studies supporting the effectiveness of complex training for improving power output in sports, whereas others contradict this rationale. There is a paucity of research evidence that directly compares the efficacy of plyometric and complex training for the outcomes of physical performance in cricket players.


Eligibility Criteria:
Inclusion Criteria:

* University-level cricket players
* Age of 18 to 26 years
* Playing competitively at least once a month
* Involved in resistance training for at least six months
* Working knowledge of the english language

Exclusion Criteria:

* A history of severe neurological deficit, injury or concussion in the past six months,
* Operative treatment for lower or upper limb in the past six months,
* Current musculoskeletal pain (any level of chronicity)