cyrilzakka/clinical-trials huggingface dataset:
Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

This is a prospective randomized cross over study of healthy volunteers comparing end-tidal oxygen concentration among subjects undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas.

Noninvasive positive pressure ventilation with the addition of a nasal cannula is a useful technique to pre-oxygenate and provide apneic oxygenation in hypoxic patients undergoing emergency airway management. This study aims to evaluate preoxygenation by quantifying end-tidal oxygen (etO2) concentration resulting from nasal cannula placement underneath a noninvasive positive pressure ventilation (NIPPV) mask. This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. End-tidal oxygen concentration will be measured by an oxygen sensor following three minutes of NIPPV with and without the addition of a nasal cannula, with each subject serving as his or her own control.

Eligibility Criteria:
Inclusion Criteria:

* Any healthy volunteer aged 18-65 years.

Exclusion Criteria:

* Previous inability to tolerate noninvasive positive pressure ventilation with addition of a nasal cannula.
* Known underlying cardiac or pulmonary disease.
* Active respiratory infections.
Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock

Traumatic disruption of iliofemoral arterial segment is often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral lower extremity, as well as with high mortality.

The investigators describe a bypass technique. It can provide adequate blood supply to the lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a low risk procedure for salvage of the extremity and even patient's life.

Patients were selected on the basis of the following: (1) closed injuries to the lower abdomen and/or pelvis; (2) serious hemorrhagic shock; (3) loss of blood supply to the ipsilateral lower extremity; (4) high-risk emergency artery reconstruction.

The instruments used to measure sensibility of the foot were the Semmes-Weinstein (SW) monofilament test 24 and the static two-point discrimination (2PD) test 25. The weight-bearing area of the first metatarsal head and the dorsum of the first metatarsal head were assessed. Active range of motion (ROM) of the hip, knee, and ankle joints was measured with a goniometer. The muscle strength was test using Medical Research Council (MRC) Scale. The cold intolerance of the leg was measured using the self-administered Cold Intolerance Severity Score (CISS) questionnaire 26. The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100) corresponding to mild, moderate, severe, and extreme severity, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. closed injuries to the lower abdomen and/or pelvis;
2. serious hemorrhagic shock;
3. loss of blood supply to the ipsilateral lower extremity;
4. high-risk emergency artery reconstruction.

Exclusion Criteria:

1. bleeding can be easily control through an open wound;
2. mild shock without life threatening conditions;
3. good blood supply to the ipsilateral lower extremity;
4. low-risk emergency artery reconstruction.
Study to Investigate Daily Symptom Variability, Symptom Effects on Morning Activities of Chronic Obstructive Disease

The primary objective of this non-interventional study is to evaluate daily symptom variability in COPD patients. The secondary objectives are; to evaluate effects of COPD symptoms on the morning activities of patients, to determine therapeutic expectations of patients and physicians in COPD, to determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations, to define COPD patient profiles about the below-mentioned issues: Demographic characteristics, Disease characteristics, Concomitant diseases and implemented drug treatments. All patients, who apply to the study physicians and fulfill all patient selection criteria during patient enrolment period, will be included. Patients, who provide all of the following measures will be included in the study: To apply to a physician for outpatient treatment for any reason, Age over 45 years, being diagnosed with COPD, being a smoker or used to be a smoker once (\> 10 package years), to give consent for the use of their medical data. The patients that exhibit the following exclusion criteria will be excluded from the study: COPD exacerbations still on-going or experienced in the last 3 months (Exacerbation is defined as worsening of COPD symptoms leading to antibiotic and/or short-term oral steroid treatment and/or hospitalization or admission to the emergency unit.); Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis; Participation in an interventional clinical trial at present and Enrollment in this study once. In this study, patients will be recorded at their visit to the physician and there will be no follow-up thereafter.


Eligibility Criteria:
Inclusion Criteria:

* To apply to a physician for outpatient treatment for any reason; being diagnosed with COPD
* being a smoker or used to be a smoker once (\> 10 package years)
* to give consent for the use of their medical data

Exclusion Criteria:

* COPD exacerbations still on-going or experienced in the last 3 months
* Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis
* Participation in an interventional clinical trial at present and Enrollment in this study once
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)

In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}).

Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of ART, after excluding those subjects treated with tenofovir.

BMD will decrease most significantly in HIV-positive subjects with the highest levels of cumulative viremia.

HIV-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines.

Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare sample and fracture association with the use of varying ART medications among dual-eligible persons in Medicare and Medicaid datasets.

Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest duration of ART exposure.


Eligibility Criteria:
Inclusion Criteria:

* treatment naïve patients seen in the 1917 Clinic between January 1, 2000 and May 1, 2010
* currently under care at the time of the initiation of the study (\>1 clinic visit in the past 12 months)

Exclusion Criteria:

* history of chronic renal failure (estimated GFR \<30ml/min)
* known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta)
* multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen)
* treatment with oral glucocorticoids and anticonvulsants
Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma

RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic effect may boost the immune system to help the body create a better immune response to vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir together in improving immune response to vaccines in patients with complete remission following a bone marrow transplant for Hodgkin lymphoma.

PRIMARY OBJECTIVES: I. Compare TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups. SECONDARY OBJECTIVES: I. Compare post-vaccination anti-rabies antibody titers between treatment groups. II. Compare post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups. III. Compare post-vaccination anti-rabies ELISPOT reaction between treatment groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral lopinavir and oral ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive no therapy. All patients then receive a neo-antigen rabies vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects who are in complete remission at Day +100 after a bone marrow transplant for Hodgkins Lymphoma
* Normal AST or ALT, serum creatinine and 12-lead electrocardiogram within the previous 6 months
* Females of childbearing potential must have negative beta-HCG (urine or plasma) within the last month and agree to effective contraception during the course of the study
* Willingness and ability to give informed consent
* Willingness and ability to take pills twice a day for 28 days

Exclusion Criteria:

* Known HIV positive
* Screening ALT or AST greater than 3X upper limit of normal
* Baseline QTc greater than 500 msec
* Current treatment with immunosuppressive agent (systemic glucocorticoid, cyclosporine, mycophenolate, azathioprine, sirolimus, Rituximab, infliximab, adalimumab)
* Current treatment with any of the following: cisapride, ergot derivatives, amiodarone, quinidine, terfenadine, astemizole, rifampin/rifabutin, carbamazepine, phenobarbital, sildenafil, St. John's wort, azithromycin, carbamazepine, HIV anti-virals, methadone, pimozide, phenytoin, sedative hypnotics (midazolam, triazolam), HMG-CoA reductase inhibitors (lovastatin, simvastatin, atorvastatin)
* Active malignancy requiring chemotherapy or radiation
* Baseline creatinine of \> 2.0
* Active infection requiring systemic anti-infective agent (excluding prophylactic antibiotics)
* Hypersensitivity to processed bovine gelatin, chicken protein, neomycin, amphotericin B or chlortetracycline
* Subject must not be on medications that interact with the metabolism of protease inhibitors
Accuracy Study for Enhanced Meter Feature

This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to obtain the enhanced meter feature.


Eligibility Criteria:
Inclusion Criteria:

* Type I or type II diabetes inclusive of the following populations:

  1. Mixed insulin therapies
  2. Basal insulin therapies
  3. Continuous subcutaneous insulin infusion therapies
  4. Multiple daily injection therapies
  5. Non-insulin diabetic treatments (oral and injectable)
  6. Life style (exercise and diet) diabetes management
  7. New diagnosis of diabetes
* Non diabetics
* Able to speak and read English proficiently
* Subjects must be willing to:

  1. once a month, perform a 7 point blood glucose profile over the course of one day
  2. perform fasting blood glucose tests every day
  3. complete baseline and follow-up questionnaires
  4. consent to baseline HbA1c assays

Exclusion Criteria:

* Pregnant
* Hct \<20 or \>60
* Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
* Homeless
* Incarcerated
* Mentally ill
* Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
* Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
Probiotic Supplement as Treatment for Students With ADHD

Subjects will answer the following questionnaire and tests:

* Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)
* Demographic Questionnaire - composed by the researchers
* Family Eating Habits Questionnaire (FEAHQ-33)
* Food Frequency Questionnaire (FFQ)
* Test MOXO

The subjects will take the study product for six months.

After six months the subject will fill once again all the questionnaires.

Computerized performance test MOXO - the test has been developed in Israel by Neurotech Company. The test's goal is to assess and define a participant's performance according to the four indices of Attention Deficit Hyperactivity Disorder: Attention, Hyperactivity, Impulsivity, and Timing with adjustment for age.

Subjects will answer the following questionnaire and tests:

* Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)
* Demographic Questionnaire - composed by the researchers
* Family Eating Habits Questionnaire (FEAHQ-33)
* Food Frequency Questionnaire (FFQ)
* Test MOXO

The subjects will take the study product for six months.

After six months the subject will fill once again all the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Students registered in the college's Support Center for Students with Learning Disabilities and who have been diagnosed by a computerized didactic assessment -MATAL - as well as an attention diagnosis by a psychiatrist or a neurologist,
* Students who are not treated by medication or alternative treatment,
* Students who are not due to complete their education at Tel Hai College during the study period,
* Students who have signed on an informed consent form,
* No dairy intolerance (student can consume milk without any adverse effects),
* No soy allergy,
* Not currently taking any antibiotics or probiotics,
* Not pregnant or planning to become pregnant during the study period,
* Not been diagnosed with any of the following:

  * Cancer
  * HIV/AIDS
  * Crohn's disease
  * Ulcerative colitis
  * Immune compromised illness
  * Other serious illness

Exclusion Criteria:

* Students treated by any type of treatment for Attention Deficit Hyperactivity Disorder,
* Students who have not been assessed by MATAL and a psychiatrist,
* Students who take antibiotics.
One-Year Trajectory of Cognitive Changes in Patients With Late-life Depression in the Short Term

The purpose of this study was to investigate the one-year trajectory of cognitive change in elderly patients with depression, to explore the transfer characteristics and transfer rules of various states of cognitive impairment in patients, to predict the relevant risk factors of cognitive decline, and to find possible influencing factors affecting state change, so as to provide a theoretical basis and reference for subsequent targeted intervention research on geriatric depression.

The 1-year prospective longitudinal study involved 400(prospective)subjects who met criteria for geriatric depression,the whole cognitive function was assessed by mini-mental state examination(MMSE),Montreal cognitive assessment scale-MOCA)and subjective cognitive decline scale(SCD-9).Cognitive function was monitored at 6 and 12 months.GAIN factors related to cognitive function(e.g.,age,gender,education,cognitive function,anxiety level,sleep,social support,resilience,social networks,etc.).By studying the longitudinal changes of cognitive function in the elderly patients with depression,a time-discrete and state-discrete multistate Markov model was constructed,namely,state 1(normal cognitive， NC),state 2(subjective cognitive decline， SCD),State 3(mild cognitive decline，MCI) and State 4(Alzheimer's disease，AD).In-depth analysis of some factors and indicators on the impact of the transfer between the states, the transfer between the states estimated probability.

Eligibility Criteria:
Inclusion Criteria:

1. meeting the criteria for major depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2. age at first onset ≥60 years
3. Informed consent

Exclusion Criteria:

1. Relevant past history affecting cognitive function: various types of stroke, traumatic brain injury, severe brain atrophy, mental abnormalities
2. Perennial alcohol addiction, or long-term use of various drugs that affect mental state
3. Survival time of malignant tumors and tumors
4. Patients with language, vision, and hearing impairments
To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers

The purpose of this study is to assess how the body changes the blood level of single dose of valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation under fasting condition in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female subjects age 18 to 45 years of age (inclusive)
* In good health
* Female subjects either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
* Body mass index within the range of 18.5 to 28 kg/m2 and weigh at least 45 kg

Exclusion Criteria:

* Smokers
* Use prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements, potassium supplements) within 2 weeks prior to dosing. Paracetamol is acceptable
* Participation in any clinical investigation within 4 weeks prior to dosing
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
* Significant illness within 2 weeks prior to dosing.
* History of clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated).
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
* Known hypersensitivity or severe reaction to valsartan or similar drugs
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within the 6 months prior to dosing

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments

Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.


Eligibility Criteria:
Inclusion criteria:

* Patient over 18 years old
* Patient treated for periodontitis between 01/01/2012 and 07/31/2021
* Patient whose medical and periodontal file contains all the elements necessary for data analysis
* Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* Patient without periodontitis
* Patient smoking more than 10 cigarettes / day
* Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment
* Impossibility of giving the subject informed information
* Subject under safeguard of justice
* Subject under guardianship or guardianship
Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).

This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. Category C clinical trial, medical devices. The study will be performed in Switzerland.

SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.

SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue.

The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months.

The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (\> 5 mm gap) in whom surgical repair may not allow direct suture.

Eligibility Criteria:
Inclusion Criteria:

* male \& female patients between 18 and 65 years of age
* a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint
* single lesion per finger
* nerve defect of \>5mm
* nerve treatment initiated within 24 months after nerve injury
* signed informed consent

Exclusion Criteria:

* disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy
* an additional injury that could compromise nerve regeneration
* clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult
* previous conditions of the hand that could affect the healing of the actual nerve injury
* complete amputation injury
* extensive crush injury
* grossly contaminated wound
* receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment
* known to be HIV positive
* known pregnant and lactating females
* participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation
* uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation
* absence of a healthy opposite finger
* suspected allergy to silk
* need of emergency surgery (within 24 hours from injury)