cyrilzakka/clinical-trials huggingface dataset:
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \<90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
* Age \> 18
* Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
* Reversibility \>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
* FEV1/Forced Vital Capacity (FVC)\<75%
* Blood Eosinophils (EOS) \>300 cells per mm3
* Exhaled Nitric Oxide (FeNO) \>25 parts per billion (ppb)
* Asthma Control Test (ACT) score \<20

Exclusion Criteria:

* Pregnant, nursing, or unwilling to test for pregnancy
* Current smoker or \>10 pack year smoking history
* Body Mass Index (BMI)\>37
* Respiratory infection in the last 30 days
* Use of antibiotics or oral prednisone in the last 30 days
* Current or previous use of dupilumab
* Current or recent use of anti-IL-5 therapies
* Any other criteria that place the subject at unnecessary risk
* Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
* History of non-skin cell cancer in the last 5 years
* Drug or alcohol addiction in the last 5 years
* Any other uncontrolled disease
Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs

The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Age≥18years old

Exclusion Criteria:

1. Expected life \< 6months
2. Baseline AST/ALT \> 3x upper limit of normal (ULN)
3. Age \<18years old
Pathogenesis of the Cardiometabolic Risk in Youth With Type 1 Diabetes

The purpose of this study is to quantitate hepatic de novo lipogenesis (DNL) in youth with poorly-controlled type 1 diabetes (T1D) (HbA1c \>8.5%), youth with T1D who achieve targeted glycemic control (HbA1c \<7.5%) and lean controls. Hypothesis: Youth with poor glycemic control experience higher fractional hepatic DNL during the fasting and the postprandial states than youth who achieve targeted glycemic control and lean controls.

What is not known, is whether hepatic de novo lipogenesis (DNL) contributes to dyslipidemia in this in patients with type 1 diabetes (T1D). The aim of the study is to test the hypothesis that an enhanced rate of DNL largely contributes to dyslipidemia occurring in youth with poorly-controlled T1D. According to this hypothesis, youth with poorly-regulated T1D experience a state of persistent insulin independent, highly variable fluctuations of glucose, and other sugars, through the glycolytic pathway that result in an enhancement of hepatic DNL and an increased production of triglycerides (TG). Newly-formed TG are packaged into large-VLDL that are secreted into the circulation contributing to an increase in plasma TG. When the TG concentration in the hepatocytes exceeds the ability of the liver to secrete TG, the latter start accumulating leading to hepatic steatosis.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c \>8.5% for the group with poorly controlled diabetes
* HbA1c \<7.5% for the well-controlled patients
* T1D for at least 12 months (T1D groups only)
* Negative pregnancy test (all groups)

Exclusion Criteria:

* Baseline creatinine \>1
* Being on medications affecting glucose concentrations other than insulin
* Positive pregnancy test
* Endocrinopathies
Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort

Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CEE treated with intravenous thrombolysis (IVT) between 2015 and 2020 managed at the CHU de Nîmes or Patients with TIA/stroke with ECC identified on CT between 12/2019 and 04/2023 managed at CHU de Nîmes

Exclusion Criteria:

* Patient's refusal to use his/her data
Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.


Eligibility Criteria:
Inclusion Criteria:

* Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
* Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
* Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
* Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

* Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
* History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
* Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
* History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
* History of angina requiring treatment with nitrates.
* Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.
A Dose-Escalation Study in Participants With Recurrent Malignant Glioma

This is a study of oral LY2157299 as monotherapy and in combination with lomustine in participants with recurrent malignant glioma.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Have histological or cytological evidence of relapsed malignant glioma (such as glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma) for which no treatment of higher priority exists

  * Available baseline tumor specimen is required prior to considering participant to be enrolled. The original diagnostic tumor tissue is sufficient for this inclusion criteria, but where possible, freshly obtained tumor biopsy material may be obtained
  * Measurable disease to allow assessment of tumor response based on radiographic assessment following Macdonald criteria and Response Evaluation Criteria In Solid Tumors (RECIST)
* Have sufficient hepatic, renal, and hematological function
* Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy or other investigational therapy for at least 30 days prior to study enrollment and recovered from the acute effects of therapy
* Able to swallow tablets and capsules
* For females, reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method (including intrauterine or barrier devices) during and for 3 to 6 months after the study
* Male participants must be willing to use contraception during and for 3 to 6 months after the study

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have moderate or severe cardiac disease:

  * Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
  * Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks, ventricular hypertrophy, or recent myocardial infarction)
  * Have major abnormalities documented by echocardiography with Doppler (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction (LVEF) \<50%, evaluation based on the institutional lower limit of normal)
  * Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography \[CT\] scan with contrast)
* Have current acute or chronic leukemia
* Women who are pregnant or lactating
* Have received prior nitrosourea (including lomustine) therapy
Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.

Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish
* Male or female primary solid organ transplant patients 0-21 years of age
* Recipients at least 1 month post-transplant hospital discharge

Exclusion Criteria:

* Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol
* Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires
* Re-transplant recipient
* Multi-organ transplant recipient
Interactive Effects of IV Ethanol and IV Nicotine

There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female;
2. between the ages of 21 and 50 years;
3. medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
4. history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence
5. social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.

Exclusion Criteria:

1. history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
2. regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
3. current abuse of any recreational or prescription drugs (except alcohol);
4. alcohol naïve.
Effects of Yoga Exercise on Participates With Tinnitus

This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (\>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

Tinnitus is the auditory phantom sensation in the absence of external sound stimulation. Tinnitus that persisted more than six months without improvement can be called chronic tinnitus. One report proposed the neurophysiological model of tinnitus. In addition, tinnitus patients suffered from insomnia, irritability, anxiety and/or depression.

Current management of tinnitus is a drug-based treatment and/or nutritional supplementation. Music therapy, hearing aid therapy, and tinnitus retraining therapy (TRT), were also applied for patients with tinnitus. Even though, success rates of various tinnitus treatments were still unsatisfactory till now.

This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (\>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Participates with tinnitus persisted more than 6 months from ear, nose, and throat out-patient department.
2. No drug treatment for their tinnitus in recent 3 months.
3. No respiratory diseases (eg, asthma).
4. Normal cognitive function.
5. Normal language comprehension.

Exclusion Criteria:

1. Pregnant females or menopausal females with hormone replacement therapy.
2. Hypertension
3. Glaucoma.
4. Those who cannot express their opinions or follow orders.
5. Cancer patients.
6. Objective tinnitus.
Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy.
3. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction.

   * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
   * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria:

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.
4. Evidence of distant metastasis beyond the pelvis.
Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

The aim of the present study is to assess before, as well as 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes mellitus and diabetic sensomotoric neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Have type 1 or type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification on ongoing insulin or/and oral antidiabetic therapy with a stable regimen for the previous 3 months
* Male or female subjects aged between 18 and 75 years, inclusive
* Have an HbA1c level ≤ 9.5% without optimizing potential
* mTCNS (modified Toronto Clinical Neuropathy Score) ≥ (above or equal to) 6) OR (a score on the MNSI (Michigan Neuropathy Screening Instrument)questionnaire of ≥4 or a score on the MNSI examination ≥2.5)
* Medical history without major pathology (with the exception of type 2 diabetes) as judged by the investigator, especially no major peripheral artery disease.
* Body mass index (BMI) between 25 and 45kg/m2, both inclusive

Exclusion Criteria:

* Subjects with secondary forms of diabetes such as due to pancreatitis.
* Current or previous treatment (less than 6 months) with benfotiamine, B-vitamins, vitamin B complex, alpha lipoic acid or actovegin.
* Have any contraindications, known allergy, or hypersensitivity to benfotiamine.
* Have any contraindications, known allergy, or hypersensitivity to local anesthetics.
* Neuropathy by other origin than diabetes.
* Other severe pain that might impair the assessment of neuropathic pain.
* Treatment with more than one of following: tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, anticonvulsants, class I antiarrhythmics with Na-channel inhibition (mexiletine, flecainid, propafenon and others) or neuroleptics in patients receiving these drugs for neuropathic pain.
Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade

the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.

Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 age
* unwanted general anaesthesia
* ASA 1-2
* single forearm, arm surgery

Exclusion Criteria:

* major psychiatric problems
* major neurologic deficits
* coagulopathy
* drug allergies
* chronic analgesic used
The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support

Patients receiving mechanical ventilation (MV) support in intensive care units (ICU) may have some negative experiences. The most common of these are problems such as pain, agitation, anxiety, deterioration in comfort, dry mouth, thirst, and inadequacy in communication.

Reiki, one of the energy therapies among the non-pharmacological nursing practices that have become widespread in recent years, is one of the healing therapies that contribute to the protection and promotion of well-being, healthy aging, and the treatment of some health deviations and is applied noninvasively with hands.

In the literature, there are many studies suggesting that Reiki has positive effects on pain, anxiety and stress response (heart rate, blood pressure, respiratory rate) in patients with Reiki. It is known that these studies generally consist of health professionals such as cancer, haemodialysis, patients undergoing laparoscopic or endoscopic procedures, haemodialysis patients or nurses. Studies have shown that Reiki is especially effective in cancer patients, preoperative stress, anxiety, postoperative pain and symptom management in chronic diseases. For Reiki application in the intensive care unit, only a few studies conducted in the neonatal intensive care unit were found.

The study will consist of 40 patients hospitalized in intensive care units of Yalova Training and Research Hospital and who are receiving mechanical ventilation treatment. The sample will consist of patients who receive mechanical ventilation support in the intensive care unit, who are over 18 years of age, who are willing to participate in the study, who do not have neurological and psychiatric diagnoses, who are not due to drug/alcohol etc. intoxication, who are not in the terminal period, who are not sedated, who have a GCS score of 9 and above, who are receiving mechanical ventilation support for more than 48 hours, who are hemodynamically stable (not on high dose inotropic support, etc.), and who have a pain score of 3 and above.

Since there was no previous study similar to our research in the literature, the sample size was calculated as 26 patients in the experimental group and 26 patients in the control group with a large effect size d= 0.8, 5% margin of error (α) and statistical power (1-β) = 0.80 as recommended. To increase the power of the study and assume that there may be losses from the sample group, 30 patients were planned to be included in the study, 30 in the experimental group and 30 in the control group.

Eligibility Criteria:
Inclusion Criteria:

1. over 18 years of age,
2. not have a neurological and psychiatric diagnosis,
3. are not due to drug/alcohol etc. intoxication,
4. are not in the terminal period, who are not sedated,
5. have a GCS score of 9 and above, who receive mechanical ventilation support for more than 48 hours,
6. haemodynamically stable (not on high dose inotrope support, etc.),
7. have a pain score of 3 and above.

Exclusion Criteria:

Patients who do not fulfil the inclusion criteria will be excluded.

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