cyrilzakka/clinical-trials huggingface dataset:
Influenza Vaccination and COPD Phenotypes

The aim of this study is to determine responses of the immune system to the annual flu vaccination in people with COPD who experience frequent or infrequent exacerbations and healthy participants. We will collect blood and saliva immediately before and one month after flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly antibodies (that provide protection against infection) develop in the blood after vaccination we can provide important new information to help confirm whether those prone to COPD flare ups have weaker immune systems.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 65-85 years with a diagnosis of COPD (according to Global Initiative for Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio \<0.70) and moderate to severe airflow limitation (FEV1 30-80% predicted) who opt to receive the annual influenza vaccine.

We will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine.

Exclusion Criteria:

* Unable/unwilling to provide informed consent
* Any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g egg protein allergy)
* Participation in another clinical trial (use of investigational product or device)
* Not on optimal treatment (COPD patients only)
* Current smokers, exhaled CO \>10 parts per million
* Clinical instability, defined as experiencing a COPD exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic glucocorticosteroids and/or antibiotics and/or hospitalization (COPD only)
* An upper/lower respiratory tract infection e.g. common cold, sinus symptoms, pneumonia, which has not resolved four weeks prior to baseline visit
* Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectases, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease \[e.g. fibrosis, silicosis, sarcoidosis\], active tuberculosis)
* Known alpha-1-antitrypsin deficiency
* Immunological diseases or known infection with Human Immunodeficiency Virus (HIV)
* Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) in the last 5 years
* Currently taking immunosuppressive medications
* Diagnosis of diabetes mellitus
* Severe renal failure (calculated eGFR less than 60 ml/min)
* Liver impairment Child-Pugh B/C and/or active viral hepatitis
* Severe psychiatric or neurological disorders (Parkinson's disease or motor neurone disease)
* Planned donation of human tissue (blood, organs or bone marrow) during the course of the trial
Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry

With this study the investigators want to determine, if a fast identification of germs, causing hospital-acquired infections of the lower respiratory tract, is possible through the use of MCC-IMS technology - a method that allows on time detection and identification of very small amounts of substances in gas samples. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected, cultivated and analyzed by MCC-IMS. The investigators want to determine if MCC-IMS diagnostic could be a faster alternative to conventional microbiological methods. The results of the MCC-IMS analyses therefore will be compared with results of conventional microbiological methods.

In this clinical feasibility study it is to be investigated if MCC-IMS analyses over clinical samples from ventilated critically ill patients could be a fast and secure alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of hospital-acquired pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and cultivated for a short period of time. The headspace over these cultures will be analyzed using MCC-IMS - a technology that allows on time detection and identification of very small amounts of substances in complex and humid gas samples. Conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the MCC-IMS analyses.

Eligibility Criteria:
Inclusion Criteria:

* patient is at the hospital for more than 48 hours
* patient is intubated and mechanically ventilated
* clinical suspicion for an infection of the lower respiratory tract has been raised and decision for microbiological investigation of respiratory aspirate was made

Exclusion Criteria:

* patient is at the hospital for less than 48 hours
* patient has been recruited for another clinical study
* suspicion for an infection with a germ belonging to risk class 3 and 4 according to the german law (BioStoffV and TRBA, e.g. Mycobacterium tuberculosis)
ACL Repair and Multimodal Analgesia

This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.


Eligibility Criteria:
Inclusion Criteria:

* Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:

  * American Society of Anesthesiologists (ASA) physical status 1-3
  * BMI of \< 40 kg/m2
  * Consents to general anesthesia and pre-operative femoral nerve block for case

Exclusion Criteria:

* Any contraindication to a femoral nerve block
* Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
* Peripheral or central nervous system disease
* Renal or hepatic impairment
* History of opioid dependence or current regular narcotic use
* Significant psychiatric disease
* Pregnancy or lactation (by verbal report)
* Seizure Disorder
* History of post-operative nausea and vomiting
* Latex allergy
* Clinically significant cardiac or pulmonary disease
Relapse Prevention With Varenicline

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old
* Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
* Contemplating a smoking cessation attempt in the near future
* Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
* Able to give informed consent

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
* History of attempted suicide or expresses any current suicidal ideation
* Pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Reports desire for immediate treatment of tobacco/nicotine dependence
* Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
The Lifestyle Education About Prediabetes (Leap) Study

This research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes.

Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps are completed and the participants will be randomized to one of two groups: standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version.

In addition to the diet (12 months) participants will be asked to participate in hour-long weekly group classes over zoom. After four months in the program, classes will occur about every month to help participants maintain the new diet. There will also be check-ins and follow-up visits through out the study.


Eligibility Criteria:
Inclusion Criteria:

* overweight, defined as BMI \>= 25 kg/m2 \>= 23 kg/m2 if of Asian descent
* HbA1c between 5.7% - 6.4% verified at baseline
* willingness to participate in group-based sessions
* able to engage in at least light physical activities such as walking
* willingness to follow a prescribed diet, be randomized, self-weight, track diet, and report physical activity minutes
* physician approval to participate

Exclusion Criteria:

* history of type 1 diabetes or type 2 diabetes
* use of anti-obesity medications or participation in another weight loss program or intervention
* use of glucose lowering medications other than metformin
* pregnant or planning to become pregnant during the intervention period
* breastfeeding
* use of oral corticosteroids
* previous bariatric surgery or planning to have bariatric surgery during the study period
* blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia
* any condition for which the study team deems participation to be unsafe or inappropriate
* inability to read, write, or speak English
* inability to provide informed consent
* adherence to a vegan or vegetarian diet
* adherence to a very low-carbohydrate (keto) diet
* difficulty chewing or swallowing
* no influence over what foods are purchased, prepared, and/or served
* above weight limit for DEXA (500 pounds)
* untreated eating disorder or mental health conditions, such as depression with suicidal ideation, bipolar or schizophrenia with psychosis
* use of warfarin
* chronic kidney disease, stage 4 or higher
* use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid), Demadex or Soaanz (torsemide))
* any concerning values in baseline labs (participants will be referred to Primary Care Physician and will be allowed to return for later enrollment if labs are no longer concerning)

  * Triglycerides 600 Milligrams per deciliter (mg/dL) or higher
  * Thyroid stimulating hormone of any abnormal value
  * Potassium of any abnormal value
Reversing Diabetic Peripheral Neuropathy Through Exercise

This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN patients. The investigators will acquire multinuclear-MRI data before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function and peripheral nerve integrity of patients with DPN, and their role in improving DPN symptoms following physical exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 40 and 70
* Clinical diagnosis of Type 2 diabetes
* Clinical diagnosis of DPN
* Have a BMI less than 40 kg/m2 (due to magnet bore restrictions)
* Able to walk unassisted

Exclusion Criteria:

* Serious cardiac pathology or musculoskeletal problems that would limit exercise ability
* MNSI score \< 1
* Current open wound or history of plantar ulcer for the last 3 months
* Partial foot amputations
* Inability to ambulate without assistive device
* Stroke or other central nervous system pathology
* Stage 2 hypertension (resting blood pressure \>160 systolic or \>100 diastolic)
* Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
* Subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment
* Pregnant women and children
Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.

The investigators objectives were developing minidose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined

Exclusion Criteria:

* Subject who has abnormal laboratory test results
Malaria Genetic Surveillance in Cambodia

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia

This is a prospective observational study of patients with clinical Plasmodium falciparum infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.

On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain \~20µl of blood, for a total of \~60µl of blood being collected from each patient for the study.

In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel in the last 2 months. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. This is explained on the patient information sheet. For those who do not want to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>6 months of age
* P. falciparum malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)
* Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study

Exclusion Criteria:

• None
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and longer retention of nicotine in the skin and body.

This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.

Eligibility Criteria:
Inclusion Criteria:

* Adult nonsmoker
* Aged 18-50
* Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument
* Healthy on the basis of medical history
* Systolic blood pressure \<150
* Diastolic blood pressure \<100
* C-reactive protein \<3.1 mg/ml
* Liver function (AST and ALT) in normal ranges
* kidney function (BUN) in normal ranges
* LDL\<131
* Blood glucose \<110
* Not exposed to tobacco SHS.

Exclusion Criteria:

* Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18 instrument.
* Positive SARS-CoV-2 antibody test
* Age 18 \< or \> 50
* Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.
* Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications
* Systolic blood pressure greater than or equal to 150
* Diastolic blood pressure greater than or equal to 100
* Blood glucose greater than or equal to 110
* LDL greater than or equal to130
* Pregnancy or breastfeeding (by urine hCG and/or history)
* Alcohol or illicit drug dependence within the past 5 years
* BMI \> 35 and \< 18
* Current illicit drug use (by history or urine test)
* More than 1 pack year smoking history
* Ever a daily marijuana smoker
* Smoked anything within the last 3 months
* Unable to hold allergy or other OTC medicines
* Occupational exposure to smoke, dusts OR fumes
* Concurrent participation in another clinical trial
* Unable to communicate in English
* No social security number
Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer
* treatment including a chemotherapy
* in complete remission
* last treatment in the last 9 months before inclusion
* signed consent

Exclusion Criteria:

* metastatic disease
* relapse
* women enable to have physical activity
* heart disease or any pathology preventing physical activity
Prevalence of Chronic Venous Disease in General Population

This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.

The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.

Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Eligibility Criteria:
Inclusion Criteria:

* residents living in the rural settlement where study will be conducted
* both female and male
* age 10 years and more
* agree to participate
* signed infromed consent

Exclusion Criteria:

* age 9 years and less
* not signed informed consent
Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)

The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.

The investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. This project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. This pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to National Institutes of Health (NIH).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 25
* Polycystic Ovary Syndrome criteria of both oligomenorrhea (\<9 menses per year) and androgen excess \[clinical hirsutism (Ferriman-Gallway score \>8 or severe acne) or elevated testosterone\].
* Taking no medications for the treatment of insulin resistance.

Exclusion Criteria:

* Diagnosis of Cushing's syndrome
* Untreated hypo/hyperthyroidism
* Elevated prolactin
* Congenital adrenal hyperplasia
* Renal insufficiency (creatinine \> 1.5)
* Diabetes
* Medications that can significantly affect endothelial function
* Pregnancy
* Breast Feeding
* Taking oral contraceptives
* Currently smoking
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients

One-lung ventilation, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the restrictive ventilatory effects of obesity, these patients often show a decreased functional residual capacity and decreased expiratory reserve volume, leading to an overall decreased tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt shunting. There are few studies on the one lung ventilation in obese patients about this prolonged inspiratory time ventilatory method. We plan to investigate the effect of this ventilation method in obese patients during one lung ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Above 40 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. Obesity (BMI \>25 kg/ m2 )
4. thoracic surgical procedure

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. reduced pulmonary diffusion capacity \< 80%