cyrilzakka/clinical-trials huggingface dataset:
Expiratory Muscle Training in Stroke

Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases.

As a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. Stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. Although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. Considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. From this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.

Eligibility Criteria:
Inclusion Criteria:

* Mini mental score is 24 or higher
* 55 years of age or higher
* Currently not taking respiratory muscle training
* Fonseca Questionnaire score is 20 or higher
* Onset of stroke is between 3 months and 5 years

Exclusion Criteria:

* Developed dysphagia caused by other diseases rather than stroke
* Repetitive stroke story
* Cancer in head and neck region
* Abdominal or thoracic surgery story
* Existence of neurodegenerative disease
A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
* Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

* Subjects with type 1 diabetes
* Subjects who are or have previously been on liraglutide
* Subjects who have previously been enrolled in the study
* Subjects who are participating in another clinical trial
* Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease

The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.

A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2221) will examine the effects of 4 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein \[CRP\]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for inclusion if they meet the following inclusion criteria:

* Men and women \> 18 years of age
* Written informed consent from the subject
* Stable CAD
* Stable medical condition, will be compliant and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subjects must NOT meet any of the following exclusion criteria:
* Planned CABG
* Hospitalization for acute coronary syndrome if troponin level is \>0.1 ng/mL in the preceding 6 weeks
* Hospitalization for ST-segment acute myocardial infarction (STEMI) in the preceding 12 weeks
* Subjects with chronic inflammatory disease (e.g., RA), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
* hs-CRP \>15 mg/L repeated on at least 2 occasions \>24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)
* Acute or chronic heart failure as defined by the NYHA classification as functional Class III or Class IV
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes

The study objectives are:

1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
3. To examine the mechanisms underlying the exercise-related changes in cardiovascular function.

The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.

Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.

Eligibility Criteria:
Inclusion Criteria for type 2 diabetes :

* Diagnosis of type 2 diabetes
* Sedentary or minimally physically active for at least the prior 1 year
* Able to give consent

Inclusion criteria for healthy control group:

* Sedentary or minimally physically active for at least the prior 1 year
* Able to give consent

Exclusion Criteria:

* History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
* History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
* Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
* History of renal impairment
* History of gout or hyperuricemia
* History of hepatic disease or infection with hepatitis B, C
* History of seizures, or other relevant on-going or recurrent illness
* Recent (within 3 months) or recurrent hospitalizations
* Use of tobacco products
* \>5 % weight change in the prior 6 months.
* Current intake of medications that may affect study results
* Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
* Pregnancy (positive urine pregnancy test) or lactation
* For the healthy control group, history of diabetes.
Outdoor Allergen Exposure, Sensitivity, and Acute Asthma

To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma and to produce forecasting models to predict days of high concentration.

Asthma is a growing problem, and outdoor allergens play a role in exacerbation of many cases. A clearer understanding of this role and its magnitude, and a means of controlling the effects of outdoor allergen exposures is needed. We propose Poisson time-series and conditional panel studies to test these hypotheses: 1) The incidence of acute asthma attacks, as measured by urgent care inhalation treatments and hospitalizations for asthma, has a dose-dependent relationship with exposure to specific outdoor allergens; 2) Specific sensitization to outdoor allergens is a risk factor for having an acute attack; and 3) Exposure conditions that lead to acute asthma attacks can be forecast, creating an opportunity to reduce asthma morbidity and mortality ny targeting pretreatment and/or exposure controls.

Eligibility Criteria:
Must be a member of the Fallon HMO and be treated for acute asthma exacerbation.
Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit

Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium).

Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. \>20 mg/l for endocarditis) and avoiding overdose.

Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced.

The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Patients with documented Gram-positive infection sensitive to teicoplanin;
* Patients who have received at least 4 doses of teicoplanin on a three-weekly schedule, as monotherapy or associated with other antibiotics

Exclusion Criteria:

* Hospitalized patients
* Patients who have received less than 4 doses of teicoplanin for any cause.
Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy

The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.

Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.

Postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.

Different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.

According to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.

The analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.

Adequate postoperative pain relief can enhance recovery and increase patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 40-65 years old
* Patients with ASA clinical status I/II
* Patients eligible for abdominal hysterectomy
* Oncological surgery

Exclusion Criteria:

* Body mass index (BMI) ≥ 40/kg / m2
* Previous abdominal surgery (except cesarean section)
* Severe cardiovascular, renal, and hepatic dysfunction
* Contraindications to spinal anesthesia
* Neuromuscular diseases
* Inappropriate for spinal anesthesia
* Patient refusal
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
* Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
* No clinically relevant findings on the physical examination at Screening

Exclusion Criteria:

* History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Modified Swiss Narcolepsy Scale total score \< 0 at screening or history of narcolepsy or cataplexy
Cell Phone Application for Vision Assessment

The purpose of this study is to evaluate how visual acuity assessed with Peek Acuity (a cell phone application to check visual acuity) among preschool and school-aged children 3 to less than18 years of age (1) compares to the standard visual acuity exam in the ophthalmology clinic and (2) performs as a screening test for ocular abnormalities that warrant referral for an eye exam.

Current recommendations suggest that children begin visual acuity screening as early as possible with most children capable at 3 years old though some may not be able to cooperate until 4 years of age. While visual acuity screening is standard in schools and pediatric clinics, the specificity of the exams has been questioned. A number of community screening exams rely on outdated and flawed methods that may not accurately access the vision of all children. Because many children who fail these vision screenings are referred to ophthalmology clinics without a true visual acuity deficit, a more accurate but accessible, cost effective, and feasible vision screening exam is necessary. One solution is a smart phone application designed to assess visual acuity, called Peek Acuity. The application is available for android operating system and can be downloaded as a free beta from the Google Play Store. A short tutorial walks users through the application. The application displays a single letter "E" in 4 positions, 0, 90, 180, and 270 degrees (rolling "E") that does not require English comprehension. Patients are instructed to point in the direction of the arms of the "E." The examiner records the responses by swiping the screen in the direction the patient points. The application uses responses to calculate visual acuity and typical exams can be completed within 2 minutes.

In one study, Peek Acuity visual assessments have been shown to be comparable to that determined by the ophthalmology clinic in patients aged 55 years and older. This study also found that the Peek Acuity is efficient, with an average exam time of 77 seconds compared to 82 seconds using the standard Snellen eye chart.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to provide consent
* 3 to less than 18 years of age

Exclusion Criteria:

* Unable or unwilling to give consent
* Over 18 years of age
* Less than 3 years of age
Removal of Dermal Exposure to Phthalate Ester by Hand Washing

The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand, the investigators compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by hand washing with soap and water vs. water only. In two three-day N-of-1 trials, residual DEHP was measured in a single female adult who washed exposed hands with soap-and-water or water-only. Subsequently, a crossover study was performed by randomly assigning another 28 subjects equally to wash with soap-and-water or with water-only, and then each one received the other treatment 24 hrs later.

Three studies, consisting of two N-of-1 trials and one crossover study, were used to compare the effect of handwashing with soap and water (intervention) and handwashing with water only (placebo) on phthalate removal from hands. The soap was plain soap, consisting of vegetable oil and sodium hydroxide. First, the investigators recruited one healthy female aged 25 yrs to participate in two N-of-1 trials. In each trial, her hands would be exposed to DEHP and then be treated with either soap intervention or placebo for three times over the course of three days. The first trial started on 15 May 2013. On day one, after the subject prewashed her hands, she allowed her hands to be exposed to a designated amount of DEHP. She then washed them with water only and rinsed them sequentially in three separate polyethylene (PE) bags, each containing 200 mL water to collect DEHP residue. One hour later, the same protocol was followed, except the exposed hands were treated with soap and water instead of water only (Figure 1a). The water rinsing in three separate bags remained the same. The pairs of studies were repeated on two subsequent days (16 and 17 May).

In the second N-of-1 trial, which was also performed over three days (22-24 May), the protocol using the same subject remained the same for all three days, except that the subject underwent intervention first then placebo. The water rinsing remained the same.

A randomized 2 × 2 crossover study was subsequently conducted between June and September 2013. The investigators assigned one group of 7 females and 7 males to perform handwashing with soap and water (intervention) and another group of 7 females and 7 males to perform handwashing with water only (placebo). Briefly, on the first day, the two groups washed their DEHP exposed hands using either soap and water or water only and then rinsed them in a PE bag with 200 mL water to collect DEHP. After 24 hrs, the experiment was crossed-over with the same two groups receiving the opposite treatments.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult over age of 18 years
* BMI\>18

Exclusion Criteria:

* diagnosis of any type of cancers, dermatitis, asthma
* cut, abrasion, and trauma on hands
* BMI \<18
Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)

Facioscapulohumeral Dystrophy is a Autosomal dominant inherited dystrophy with the prevalence of 1:20,000 and it is the third most common dystrophy after the dystrophinopathies and myotonic dystrophy. The symptoms including: Pain, facial weakness, scapular fixator, humeral, truncal, pelvic girdle and lower-extremity weakness, High frequency hearing loss, Retinal telangiectasia . The existing treatments are not effective so, cell therapy is a new hope to improve patients' quality of life. Therefore, We design this clinical trial to evaluate the safety and feasibility of stem cell transplantation.

In this study, we select 15 patients with FSHD based on eligibility criteria. All the patients underwent physical examination, laboratory evaluations, EMG-NCV, muscle sonography and muscle MRI. Then, a sample of patient's muscle is taken from Biceps Femoralis to isolate and culture of MDSC. The AD-MSC is prepared from Royan Adipose Tissue Bank. The patient is admitted in general hospital, and the cell suspensions are injected into biceps, triceps and trapezoids muscles by neurologists. After transplantation, the patients will be under observation for 5 hours and will be discharged if no side effect happen. All the patients will be followed at 1,2,4,6 and 12 months after cell injection.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-50
2. Both gender
3. Weakness of face muscle
4. FSHD phenotype positive
5. Genetic Test confirmation for FSHD

Exclusion Criteria:

1. Co - morbidities: Heart \& respiratory diseases,malignancy, rheumatologic disorders
2. Progressive form of disease
3. Not able to sign the consent
Pentax Airway Scope (AWS) Intubation

This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.

100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.

Eligibility Criteria:
Inclusion Criteria:

* subject is at least 18 years old
* BMI between 30 and 50
* scheduled for elective surgery requiring orotracheal intubation

Exclusion Criteria:

* a known difficult airway
* loose teeth
* subject pregnancy
* rapid sequence induction required
* subject is unable to give consent
* anesthesiologist considered use of the Pentax AWS to be contraindicated
* special endotracheal tube (ETT) is needed for the case.