cyrilzakka/clinical-trials huggingface dataset:
Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.


Eligibility Criteria:
Inclusion Criteria:

* subject has a confirmed diagnosis of cystic fibrosis
* detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
* informed consent of the patients or parents
* subject is older than 7 years
* subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
* women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol

Exclusion Criteria:

* subject has a critical condition defined as: FEV1 \< 30% and / or SaO2 \< 93% without O2-substitution; need of O2-substitution
* subject had an ENT surgery within 3 months prior to study
* subject shows signs of nasal bleeding
* subject has an ear drum perforation
* subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug.
* subject is unlikely to comply with the procedures scheduled in the protocol
* subject has a known allergic reaction to the medication
* subject is pregnant or breastfeeding
* subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
* systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
* if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study.
* progressed renal insufficiency
* severe damage of the N. acusticus
* dizziness (potential damage of. N. vestibularis)
A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis

The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL) when administered intradermally by the Mantoux technique to patients in the acute phase of treatment against active TB. The secondary objectives are to assess the immune response of two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).

This clinical trial is a single centre phase Ib open dose adjustment study with respect to the dose of C-Tb combined with a double blind randomised, split-body comparison of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (each patient receives the unpreserved version in one arm and the preserved version in the other arm).

Eligibility Criteria:
Inclusion Criteria:

The patient:

1. Has signed an informed consent
2. Is willing and likely to comply with the trial procedures
3. Has been diagnosed with active TB and has been in treatment ≤ 60 days at the time of inclusion

   * has 1 documented positive sputum smear microscopy result
   * has positive culture
   * has a positive PCR result for tuberculosis
   * has a compatible clinical picture of TB with the intention to treat
4. Has a positive T-spot assay or a QuantiFERON®-TB Gold In Tube test
5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

The patient:

1. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. BCG, MMR, yellow fever, oral typhoid vaccines)
3. Has a known congenital or acquired immune deficiency
4. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
5. Is infected with HIV
6. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
7. Has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access
8. Is actively participating in another clinical trial
9. Is pregnant according to urine pregnancy test at inclusion
10. Has a condition which in the opinion of the investigator is not suitable for participation in the study
Mechanisms of Weight Loss With SGLT2 Inhibition

The purpose of this study is to investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese.

Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.

The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. BMI 25-45 kg/m2
3. Hemoglobin A1C \> 6.5% but \< 9%
4. Normal renal function (GFR \> 60)
5. Age 18-75

Exclusion Criteria:

1. Type 1 diabetes
2. History of recurrent UTI or mycotic genital infections
3. Treatment with insulin or a GLP1 agent
4. Pregnant or breastfeeding
Bright Light Therapy for Weight Loss

The study investigates whether bright artificial light adds to hypocaloric diet to lose weight in obese subjects.

The study is aimed to check a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvay, 2002, unpublished). Subjects: aged 20-65 y, BMI \> 30, non-seasonal (SPAQ score \<8, no seasonal problem), in good general health, with regular sleep from 22:00-1:00 to 6:00-9:00. Study season: November-April. Placebo-controlled, single-blind, crossover. At least 1 mo between two arms; at similar phase of menstrual cycle (if present). If could not complete at the first year, the second arm is to be done the next winter. Intervention: Lightbox (4300 lux) - during one arm, deactivated ioniser - during another arm (sequential alternation upon entering the study) for 3 weeks each morning (at least 18 days) starting between 6:00-9:00. Seating distance (from the face to the device) is 41 cm, duration - 30 min. Diet: a target amount of kcal per day is calculated based on age, weight and gender (WHO), e.g. for a woman 40 y ang 80 kg it is 1502 kcal per day. Food content - is also as recommended by WHO. Food distribution over day - usual for the particular test subject but constant over sessions. Food diary is completed daily and subjects calculate kcal themselves based on a Table of kcal. Outcomes: Weight is measured during a visit to doctor a day before and day after the 3-week session, and also at home every week. Motivation and Expectation are rated by 3-point scales in a Diary, at the beginning of each session. Mood, activity and appetite are self-estimated using a VAS-like 10-points scale every week. At the end of each arm the "Easiness of dieting" scale and Adverse event(s) are completed. In the diary, there are also columns for sleep on and off times, intervention time, duration and distance, number of kcal. A target number of subjects to complete the study is 40.

Eligibility Criteria:
Inclusion Criteria:

* age 20-65 y
* BMI \> 30
* non-seasonal (SPAQ score \<8, no seasonal problem)
* good general health; if there is a serious chronic disease - then compensated, with a constant dose of medication(s)
* regular sleep from 22:00-1:00 to 6:00-9:00
* a wish to participate and complete the study

Exclusion Criteria:

* any acute disease during the past month
* transmeridian travel \>3 time zones over the past month
* a use of medication(s) which influence body weight - during the last 2 months
A Study of Stimulant Medications Infusion Through Midline Catheters Based on Real-world Data

Based on the previous research, this study intends to explore the outcome of trans-MC infusion of stimulant drugs when the MC tip is located in the subclavian vein/chest wall segment axillary vein, especially to analyze the relationship between drug dose, infusion days and catheter-related complications, so as to provide a basis for the clinical application of MC infusion stimulant drugs, provide evidence for the revision of infusion practice guidelines, and ensure the safety of patients' infusion. Reduce the occurrence of adverse events, provide a basis for further expanding the clinical application scope of MC, reduce unnecessary peripherally inserted central venous catheters (PICC) and central venous catheters (CVC) and other central venous catheters, and reduce medical costs.

Midline catheters were inserted by hospital nurses in each center, and patients with MC catheters were included in order, and baseline data of patients were extracted from medical records, including patients' age, gender, education level, body mass index, occupation, admission diagnosis, thrombosis history, major surgery trauma history, chronic medical history, catheterization history and related examination indicators. At the same time, researchers authorized by the principal investigators of each center and uniformly trained researchers will collect data and record the puncture situation during catheterization: including catheter, puncture method, puncture location, puncture arm, puncture site, punctured blood vessel and vascular diameter, number of puncture needles, catheter brand, catheter model, catheter insertion length, catheter exposed length, catheter tip position; During the catheter indwelling period, the catheter function and complications were collected until extubation, and the reasons for extubation, transcatheter blood collection, and vascular intima were recorded, and the patient's transcatheter drug information was extracted from the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old.
* In patients with conventional indwelling single-chamber three-way valve MC, the catheter tip is located in the axillary vein or subclavian vein of the chest wall segment.

Exclusion Criteria:

* Those who have been placed with a central venous catheter during MC insertion.
* Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterates, etc.
Prediction of Duration of Mechanical Ventilation in ARDS

The investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in several published cohorts (NCT00736892, NCT022288949, NCT02836444, NCT03145974), aimed to characterize the best early scenario during the first three days of diagnosis to predict duration of mechanical ventilation in the intensive care unit (ICU) using supervised machine learning (ML) approaches.

The acute respiratory distress syndrome (ARDS) is an important cause of morbidity, mortality, and costs in intensive care units (ICUs) worldwide. Most ARDS patients require mechanical ventilation (MV). Few studies have investigated the prediction of MV duration of ARDS.

For model description and testing, the investigators will extract data from he first three ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,000 mechanically ventilated patients enrolled in several observational cohorts in Spain, coordinated by the principal investigator (JV), and funded by the Instituto de Salud Carlos III (ISCIII). The investigators will follow the TRIPOD guidelines and machine learning techniques will be implemented \[Random Forest (RF), eXtreme Gradient Boosting (XGBoost), and Logistic regression analysis) for the development and accuracy of prediction models. Disease progression will be tracked along those 3 ICU days to assess lung severity according to Berlin criteria. For external validation, the investigators will use 303 patients enrolled in a contemporary observational study (NCT03145974). The investigators will evaluate the accuracy of prediction models by calculation several statistics, such as sensitivity, specificity, positive predictive value, negative value for each model. The investigators will select the best early prediction model with data captured on the 1st, 2nd, or 3rd day.

Eligibility Criteria:
Inclusion Criteria:

* Berlin criteria for moderate to severe acute respiratory distress syndrome

Exclusion Criteria:

* Postoperative patients ventilated \<24h
* brain death patients
Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.

Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria

* Maternal age 20-35 years old.
* Singleton pregnancy between 16 - 24 weeks
* Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study

Exclusion criteris

* Extremes of reproductive age (less than 20 years old or more than 35 years old).
* Patients with multiple pregnancies.
* Anemia not linked to iron deficiency.
* Allergy to iron derivatives.
* Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
* Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
* Any obstetric complicating factors like pregnancy induced hypertension (PIH).
* Patients with history of chronic blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age 20-35 years old.
* Singleton pregnancy between 16 - 24 weeks.
* Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.

Exclusion Criteria:

* Extremes of reproductive age (less than 20 years old or more than 35 years old).
* Patients with multiple pregnancies.
* Anemia not linked to iron deficiency.
* Allergy to iron derivatives.
* Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
* Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
* Any obstetric complicating factors like pregnancy induced hypertension.
* Patients with history of chronic blood loss.
Open-Label Treatment Extension of Protocol MNTX 302

This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.


Eligibility Criteria:
Inclusion Criteria:

1. Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
2. Negative pregnancy test
3. Stable vital signs

Exclusion Criteria:

1. Women who are pregnant and/or nursing
2. Received any investigational product, other than MNTX, in the past 30 days
3. Evidence of fecal impaction
4. Clinically significant active diverticular disease
Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics was often considered as one of main causes for this hypotension. However, the studies on this topic have been lacking. Dynamic preload indices are more suitable than static preload indices to predict the effect of preload changes. And, recently, passive leg raising test showed successful results to predict fluid responsiveness in patient with spontaneous ventilation.

The investigators hypothesized that hypotension after induction of anesthesia is caused by decrease of preload by anesthetics and passive leg raising test could predict this hypotension. In this study, the investigators will try to evaluate whether passive leg raising induced hemodynamic changes could predict hypotension during anesthesia induction.

In this randomized controlled clinical trial, the investigators hypothesized that passive leg raising induced changes in hemodynamic parameters could predict the hypotension during anesthesia induction. To evaluate this, before anesthesia, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min). Hemodynamic profiles planned to be measured are mean arterial pressure, heart rate, cardiac index, stoke volume and stroke volume variation. After this, the occurrence of hypotension (systolic blood pressure \< 90mmHg or mean arterial pressure decrease \> 30% of baseline) will be recorded during the time from anesthesia induction to surgical skin incision. Hypotension will be treated by a standardized method. If heart rate (HR) is less than 70 beats/min, 5mg of ephedrine will be administered and if HR is greater than 70 beats/min, 30 mcg of phenylephrine will be administered. This will repeated until hypotension subsided. Refractory hypotension will be defined as continuous hypotension despite the total infused dose of ephedrine \> 0.5 mg/kg or phenylephrine \> 4 mcg/kg. The ability to predict hypotension and refractory hypotension during anesthesia induction by passive leg raising test will be evaluated by receiver operating characteristic curve analysis.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective cardiac surgery

Exclusion Criteria:

* arrhythmias
* documented peripheral artery disease
* severe pulmonary disease
* heart failure
* unstable angina
* preoperative use of inotropics or mechanical assist device
* use of angiotensin converting enzyme inhibitors
* expected intubation difficulty or gastric reflux disease
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.

This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).

Eligibility Criteria:
INCLUSION CRITERIA:

1. Males or Females, 45 - 80 years of age
2. Confirmed coronary artery disease defined as one of the following:

   * Post-acute coronary syndrome or myocardial infarction or
   * Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or
   * Angiographically documented lesion occluding ≥70% of a coronary vessel

   And at high risk as defined as one or more of the following:
   * Elevated hsCRP (high-sensitivity C-reactive protein)
   * Diabetes mellitus
   * History of carotid artery disease and/or peripheral artery disease
   * Thrombo-embolic transient ischemic attack or stroke \>1 year prior to screening
3. All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.

EXCLUSION CRITERIA

1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
2. History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion
3. Clinically significant hematological, hepatic or renal abnormalities
4. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
5. Recent significant (as determined by the investigator) cardiovascular events