cyrilzakka/clinical-trials huggingface dataset:
Bioaerosol Sampling in Suspected Pulmonary Tuberculosis

Tuberculosis (TB) is transmitted in bioaerosols containing Mycobacterium tuberculosis (Mtb). Mtb-containing bioaerosols are likely related to host infectiousness and central to ongoing TB transmission. No routine diagnostic assay exists to measure Mtb in bioaerosols. Furthermore, published studies of Mtb in bioaerosol samples, have been limited to individuals with sputum-positive pulmonary TB. Currently TB diagnosis is based on clinical symptoms and sputum laboratory findings. However, approximately half of all patients commencing TB treatment are sputum negative resulting in a high proportion of presumptive treatments. We therefore propose to use a sensitive sampling protocol to investigate the prevalence of Mtb-containing bioaerosols in both sputum-positive and sputum-negative TB suspects.

Our pragmatic, parallel-group design is aimed at identifying viable Mtb in bioaerosols produced by individuals attending a TB clinic in Cape Town, South Africa. Bioaerosol sampling will be performed on all eligible individuals presenting with symptoms indicative of TB and repeated at 14 days if initially positive for viable Mtb. Participants will be classified into three distinct groups based on the National TB Control Program (NTBCP) criteria: Group A, TB notification with sputum-based laboratory confirmation; Group B, TB notification with empiric diagnosis; and Group C, individuals not notified. Group C individuals with detectable Mtb bioaerosol will be monitored until resolution of clinical and laboratory status. Collection of bioaerosol specimens will be via two consecutive sampling modalities: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect sampling following passive respiratory activity and environmental sampling. microscopy. Mtb genomes and mycobacterial and host lipids will be detected using droplet digital PCR and mass spectrometry analyses, respectively. The primary objective is to determine the prevalence of Mtb bioaerosols in all TB clinic attendees and in each of the mutually exclusive groups A, B and C. Secondary objectives are to investigate differences in prevalence of Mtb bioaerosol by HIV status, current isoniazid preventive therapy (IPT) use and pre and post initiation of anti-TB chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age over 13 years
* person with suspected TB
* provision of written, informed consent (parental consent and patient assent for those aged under 18yrs)
Immunisation History Survey - a Study to Measure Levels of Immunity to Routine Immunisations

To collect the immunisation history of participants enrolled in a previous vaccine study (REC 09/H0604/107) in order to assess the influence of genetic variation on the level of immunity to routine immunisations.

Children aged 6 month to 13 years were enrolled in a study to compare the immunogenicity and safety of adjuvanted or non-adjuvanted influenza vaccines during the 2009 pandemic influenza season. Nine-hundred and forty-nine children were recruited from 5 UK centres: Oxford, Southampton, Bristol, Exeter, and London

In the previous study, DNA was collected when individuals provided appropriate consent, to explore the genetic determinants of responses to vaccination. Although, study participants consented for their medical records to be reviewed by members of the study team, and for these data as well as anonymised serum samples to be used in future research, routine immunisation histories were not collected before this study closed.

In this study we wish to collect the full vaccination history of participants, as this information will be extremely important in interpreting results. We propose sending a letter to parents/guardians informing them of the study and asking whether they are willing for members of the study team to approach their general practitioner or the child health computer system in order to retrieve these records. Immunisation histories will then be included with other non-identifiable information needed for analysis, and samples unlinked from personal identifiers prior to analysis.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are consent in the original vaccine study (09/H0604/107) with explicit consent for samples to be stored and used in future research as well as consent to this subsequent study

Exclusion Criteria:

* Individuals who do not have explicit consent for samples taken in the original vaccine study (09/H0604/107) to be stored for future research.
* Individuals who have not been consented into this study
Respiration Validation for CPM Device

This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 10 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For the last, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 and who are willing and able to give informed consent
* Willing and able to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device
* Volunteers of any race, any gender
* Range of physiques
* Healthy

Exclusion Criteria:

* Injury or skin disturbance in the area of the test device
* Allergies or sensitivities to silicone/acrylic-based adhesive
* Pregnant
* Currently smokes cigarettes
* Has known respiratory conditions that might prevent them from following the study procedure such as:

  * Flu
  * Pneumonia/bronchitis
  * Shortness of breath/respiratory distress
  * Respiratory or lung surgery
  * Emphysema, COPD, lung disease
* Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function
* Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask)
To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy

This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically proven esophageal squamous cell carcinoma
* Karnofsky performance score(KPS) ≧70
* Concurrent chemoradiotherapy
* Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Patients have good compliance to treatment and follow-up of acceptance
* the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications

Exclusion Criteria:

* Patients with severely bowel function impaired or can not tolerate enteral nutrition
* Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
* Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
* Patients who have distant metastasis
* The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial
Effects of Green Tea Extract on Obese Women With High Level of LDL

Green tea is one of the most popular beverages in the world. It is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese with high LDL level.

Randomized, double-blind, crossover placebo-controlled clinical trial

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years
2. body mass index (BMI) \>= 27 kg/m2
3. fasting low-density-lipoprotein cholesterol (LDL) \>= 130mg/dl and (4) willing to participate in this trial.

Exclusion Criteria:

1. serum alanine transaminase \> 80 U/L
2. serum creatinine \> 1.8 mg/dl
3. breast feeding or pregnancy
4. heart failure, acute myocardial infarction, stroke, heavy injury
5. any other conditions not suitable for trial as evaluated by the physician. -
Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.

Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.

Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.

The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over,
* Patient with glioblastoma treated by radiochemotherapy with temozolomide,
* Patient with suspicion of pseudoprogression between the 1st and 12th month after the end of concomitant chemoradiotherapy,
* Patient receiving a social security scheme,
* Patient for whom informed and written consent to participate has been obtained,

Exclusion Criteria:

* Subject under safeguard of justice (tutelage, curatorship),
* Minor patient,
* Patient without signs of progression MRI (stable disease or good response to treatment according to the RANO 2010 criteria),
* Clinical or radiological progression justifying a change of treatment,
* Patient not able to decide and with refusal of the family entitled to continue research.
* Pregnant woman, breastfeeding or old enough to have children but without effective contraception,
* Contraindication to performing an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia,
* Contraindication to gadolinium according to ANSM 2017 recommendations
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)

This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old) but \< 80 years of age
* Symptomatic PVCs or asymptomatic PVCs with a burden \> 5%
* Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective

Exclusion Criteria:

* Ischemic cardiomyopathy with LVEF \< 40%
* Severe heart failure (New York Heart Association Class III, or IV) or valve disease
* Sustained ventricular tachycardia
* Structural heart disease or myocardial scar
* Pregnancy or nursing
* Patients with known thyroid issues, on renal dialysis.
* Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
* Hypotension due to autonomic dysfunction
* Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
* Patients who have had prior cervical vagotomy
* Patients with skin on the tragus that is broken or cracked
* Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) with Connected Devices

By bringing together the fields of seizure detection and that of Sudden Unexpected Death in Epilepsy (SUDEP), the current project aims at delineating which set of biosensors and related biomarkers would optimally characterize the severity of GTCS and the associated risk of SUDEP.

The main objective is to to evaluate which of the five biosignals considered, being, electrodermal activity (EDA), heart rate (HR), accelerometry (AC), arm-measurement of skin electromyography (EMG), and bed sensing of body movement (BM), or any of their combinations, offers the most accurate detection and quantification of our primary indicator of GTCS-severity, i.e. postictal EEG suppression (PGES).

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 12 years or older, suffering from epilepsy
* Patient undergoing Video-EEG recording
* Patient at risk of presenting a GTCS during Video-EEG monitoring according to one of the following criteria (i) known to suffer from GTCS, or (ii) considered for Antiepileptic drugs (AED) tapering during Video-EEG (GTCS often occur during Video-EEG as a result of AED tapering for promoting the occurrence of seizures).
* Patient willing to participate in the study and signed informed consent, by patient or legal representative when required.

Exclusion Criteria:

* Patients aged less than 12 years old
* Patient not willing to participate in the study, and where informed consent from the patient or the legal representative, when required, cannot be obtained - Patient considered not at risk of presenting a GTCS during Video-EEG because they are not known to suffer GTCS and not candidate to AED tapering during Video-EEG.
Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

The objectives of this study are:

* To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
* To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Years 20-45
* 18 ≤ BMI \< 27kg/m²
* volunteer

Exclusion Criteria:

* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
* Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
* Subject with known for hypersensitivity reaction to amlodipine and valsartan
* Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1.5 ii. Total bilirubin \> Upper normal limit × 1.5 iii. eGFR\< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, \< 3.5mEq/L or \> 5.5mEq/L)
* Positive test results for HBs Ab, HCV Ab, Syphilis regain test
* Drug abuse or continued excessive use of caffeine (caffeine \> five cups/day), severe heavy smoker (cigarette \> 10 cigarettes per day) and alcohol(alcohol\>30g/day)
* Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
* Clinically significant hypotension(SBP \< 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP \< 65mmHg) when screening period
* Participation in any clinical investigation within 60days prior to study medication dosing
* Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing
* Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Hepatic encephalopathy, a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis and 10-50% of patients with transjugular intrahepatic portosystemic shunt.Although the occurrence of episodes of hepatic encephalopathy appears to be unrelated to the cause of cirrhosis,increases in the frequency and severity of such episodes predict an increased risk of death.A small metaanalysis determined that lactulose and lactitol were equally effective in the treatment of HE.Probiotics alter the gut flora resulting in decreased ammonia production and absorption due to decreased intraluminal pH. Also shown to alter the short chain fatty acid production, \& decrease intestinal permeability.Various studies have shown some improvement in either the prevalence of minimal hepatic encephalopathy or results in neuropsychological tests with the use of probiotics.Lactulose and probiotics improves minimal hepatic encephalopathy in cirrhotic patients and it has also been shown that minimal hepatic encephalopathy predisposes the cirrhotic patient to HE.We will assess the effects of lactulose and probiotics for the prevention of recurrence of hepatic encephalopathy (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and previous history of recovery from hepatic encephalopathy

Exclusion Criteria:

* history of taking lactulose in the past 6 weeks.
* alcohol intake during the past 6 weeks or during follow up
* patients on secondary prophylaxis for spontaneous bacterial peritonitis
* previous TIPS or shunt surgery
* significant comorbid illness such as heart, respiratory, or renal failure
* any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
Safety and Efficacy of γδ T Cell Against Gastric Cancer

In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:30-75
2. Karnofsky performance status \>50
3. Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Patients who have a life expectancy of at least 12 weeks
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Known human immunodeficiency virus (HIV) infection.
3. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
4. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
5. Pregnancy