cyrilzakka/clinical-trials huggingface dataset:
Iron Status and Hypoxic Pulmonary Vascular Responses

On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise and that lowering iron by giving a drug that binds iron, magnifies this response. This is potentially a clinically important observation since iron-deficient people may be at increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due to lung disease or residence at high altitude; furthermore if this were true then intravenous iron could be an important treatment in this patient group in the event of hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor' or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood pressure through the lungs.

This study will answer the question (1) do iron-deficient volunteers have a greater rise in PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete? The purpose of this study is not to test the safety or clinical efficacy of iron which is already known.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Men and women aged 18 years or older and generally in good health
* Detectable tricuspid regurgitation on echocardiography during both normoxia and hypoxia enabling measurement of pulmonary arterial pressure
* For iron-deficient volunteers: ferritin ≤15microg/L and transferrin saturation \<16%
* For iron-replete volunteers: ferritin ≥20microg/L and transferrin saturation ≥20%

Exclusion Criteria:

* Haemoglobin \<8.0g/dl
* Haemoglobinopathy
* Iron overload defined as ferritin \>300microg/L
* Hypoxia at rest or on walking (SaO2 \<94%) or significant comorbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension, uncontrolled asthma or chronic obstructive pulmonary disease
* Exposure to high altitude (\>2,500m) within the previous six weeks or air travel \>4 hours within the previous week
* Iron supplementation or blood transfusion within the previous 6 weeks
* Pregnancy or breast feeding
Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)

ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.

Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.

The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression

Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
2. 21 to 80 years of age inclusive.
3. VC greater or equal to 75% of predicted at screening and baseline.
4. Onset of weakness within 3 years prior to enrollment.
5. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
6. Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.
7. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Exclusion criteria

1. Requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day.
2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline \> 50 mg/d, trazodone and sertraline \> 100 mg/d, citalogram \> 20 mg/d or paroxetine \> 30 mg/d.
6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
7. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
8. History of renal disease.
9. History of liver disease.
10. Current pregnancy or lactation.
11. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
12. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
13. VC \< 75% of predicted.
14. Receipt of any investigational drug within the past 30 days.
15. Women with the potential to become pregnant who are not practicing effective birth control.
Twice Weekly Steroids and Exercise as Therapy for DMD

The study team will determine the potential of low dose twice weekly prednisone and whether exercise training can synergize to delay disease progression and improve muscle strength/physical function in boys with Duchenne muscular dystrophy (DMD). Current standard of care (daily prednisone) is associated with adverse side effects. Evidence from DMD mouse models suggest that weekly dosing provides same efficacy without side effects. Appropriate exercise may also benefit but this area has not been adequately explored.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DMD confirmed by 1) clinical history with features before the age of five, 2) physical examination, 3) elevated serum creatine kinase level and 4) absence of dystrophin expression, as determined by immunostain or Western blot (\<2%) and/or DNA confirmation of dystrophin mutation.
* Age 5.0 to 9 years: a lower age limit of 5.0 years is selected as children younger than that are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 9 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age.
* Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs.
* Aim 1 only: GC-naïve at baseline (and prior 6 months)
* Aim 2 only: on stable daily GC regimen for 6 months prior to baseline

Exclusion Criteria:

* Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
* Presence of unstable medical problems, significant concomitant illness including cardiomyopathy or cardiac conduction abnormalities
* Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
* Presence of a secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
* Presence of an unstable medical condition (e.g. uncontrolled seizure disorder)
* Behavioral problems causing an inability to cooperate during testing or understand exercise instruction
* Participation in other forms of drug or gene therapy during the period of the study
Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments

Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.

On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via "Google Meet" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Agreeing to exercise once a week for 8 weeks
* Being between the ages of 18-65
* Playing a string instrument in Bursa Regional State Symphony Orchestra / Bursa Uludağ University State Conservatory / Bursa Uludağ University Faculty of Education Fine Arts Education Department, Department of Music Education / Ege University State Conservatory of Turkish Music
* Main instrument being a stringed instrument (violin, viola, cello, double bass)
* Playing an instrument for more than 5 years
* Having a musculoskeletal problem related to playing an instrument or performance

Exclusion Criteria:

* Having a musculoskeletal problem that is not related to playing an instrument or performance
* Playing the instrument less than 15 hours per week
* Having had a corticosteroid injection within 6 weeks
* Having used anti-inflammatory or gabapentin within 3 weeks
* Having had any surgical operation that would prevent exercise in the last 6 months
* Having any diagnosed neurological and/or orthopedic problem that would prevent exercise in the last 6 months
* Having a diagnosed psychiatric problem
* Maximum subcutaneous fat thickness more than 12 mm
Repellents as Added Control Measure to Long Lasting Insecticidal Nets

The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these control methods tackle only indoor and night biting vectors. The proportion of transmission occurring outdoors and before sleeping hours or so-called "residual transmission" is steadily increasing and may compromise the effort towards malaria elimination.

The purpose of this study is to raise evidence on the effectiveness of mass use of topical repellents in addition to LLINs in controlling malaria infections.

A multidisciplinary approach will be used to collect information on the most important factors that contribute to the successful reduction of "residual malaria transmission". In a first objective the epidemiological efficacy of repellents on prevalence of malaria carriers and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross sectional random sample of 65 people will be drawn at the beginning and the end of the malaria season to obtain an estimate of the malaria prevalence. The second objective will handle the entomological efficacy and persistence of the topical repellent on malaria vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will be studied in a third objective.


Eligibility Criteria:
Inclusion Criteria:

* All household members volunteering from selected communities

Exclusion Criteria:

* Infants less than 2 years
Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.

Sensory disorders in patients with multiple sclerosis are among the most common symptoms encountered.

A functional impairment based on sensory disorders of the hand. The hand is a sensory organ that transmits the cerebral cortex protopathic sensitive information, proprioceptive or epicritiques. The view-hand association plays an important role in the understanding of the environment. Its exploratory use remains an essential and voluntary basis. The process of recognition of the object passes through manipulation, but operates instantaneously. The brain is able to do a quick summary of the information it receives to determine the nature of the manipulated object. The exploration takes a posteriori, the brain can then determine the details component object (texture, shape, composition, temperature and weight).

Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its use as a neuromodulator of pain. The gate control theory has led to the development of TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers increases the control exerted on spinal level, thereby inhibiting the action of afferent fibers of small caliber related to nociception. This stimulation strengthens the blocking of "gate" at the corresponding cell bodies of spinothalamic tract and reduces the transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic inhibition depends on the area and stimulated.

The objective of this study is to improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing remitting MS defined according to Poser criteria \[9\] and McDonald \[5\].
* Age ≥ 18 years, male or female sex
* Patients with sensory disorders interesting hands, evidenced by clinical examination objective.
* Patients with an EDSS between 2 and 4 with functional sensitivity parameter ≥ 2.
* Patients affiliated to a social security scheme.
* Patients signed informed consent for the study.

Exclusion Criteria:

* Patients with other central or peripheral disorders may affect the sensitivity of the hand.
* Patients with allodynia in the study area
* Patients with a motor and / or deficit cerebellar ataxia of the upper limbs.
* Patients treated with psychotropic or antiepileptic drugs.
* Patients for whom a flare occurred affecting the sensitivity of the hand, within 30 days before enrollment.
* Patients holders of an active implantable medical device.
* Pregnant women and vulnerable patient population.
A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes

Backgrounds \& Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed that a higher prevalence of poor metabolizers in Chinese population might affect the diagnostic accuracy of a PPI test.

Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole 80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.

As described above

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with symptoms suggesting GERD will be enrolled from gastroenterology outpatient clinics in our academic institute. The typical GERD symptom was defined as heartburn and/or regurgitation at least 3 episodes per week in recent 3 months.

Exclusion Criteria:

* Those who were under maintenance PPI treatment, have a medical contraindication to PPI therapy, report a history of peptic ulcer disease or gastrointestinal surgery, malignancy proven by endoscopy, or unwilling or unable to provide informed consent.
An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated.

This study will also provide another mechanism for reporting adverse events related to study drug safety.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
* Currently tolerating treatment in the parent protocol.
* Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
* Have at least stable disease, as determined by the investigator.
* Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.

Exclusion Criteria:

* Has been permanently discontinued from study treatment in the parent study for any reason.
* Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
Effects of Black Tea Intake on Serum Lipids

A diet-controlled clinical trial which attempts to provide estimates of the effect of black tea consumption on serum lipids under tightly controlled conditions, including a controlled diet. Mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7 mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a 15-week, double blind, randomized crossover trial, during which they consumed a controlled low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* between 45-65 years old
* mildly hypercholesterolemic (total cholesterol levels between 4.9 and 6.7 mmol/L, 190 and 260 mg/dl)
* high-density lipoprotein cholesterol (HDL-C) between 0.9 and 1.6 mmol/L (35 and 65 mg/dl)
* triglyceride (TG) concentrations below 6.8 mmol/L (600 mg/dl)
* habitually consumed a typical American diet with low dietary flavonoid intake (\<4 one-half cup servings of fruits and vegetables/day) and low intake (\<1 serving/day) of soy-rich foods, nuts, herbs, and spices (besides salt and pepper)
* aspartate aminotransferase (AST) between 0 and 55 mg/L
* creatinine between 70.7 and 150.3 mmol/L (0.8 and 1.7 mg/dl)
* glucose between 3.3 and 6.4 mmol/L (60 and 115 mg/dl)

Exclusion Criteria:

* current smoker
* usage of high amounts of antioxidant vitamin supplements (\>3 times the Recommended Dietary Allowance (RDA) of vitamins E, C, and selenium, or \>10 mg/day of beta carotene)
* had been diagnosed with diabetes, coagulation disorders, chronic pulmonary disease, current active malignancy, renal disease requiring dialysis, malabsorption, or gastrointestinal disorders, or had a history of cardiovascular disease.
* antihypertensive, immunosuppressive, cholesterol lowering, or anticoagulant medications
* consuming \>3 servings of alcohol daily
* Pre-menopausal (women)
Clinical Application of Methylene Blue for Treatment of Covid-19 Patients

The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Leucomethylene Blue (reduced form of MB, colorless) may be applied for the treatment of COVID-19 according to the scientific evidences.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed case of Covid-19 (by RT-PCR, HRCT)
2. Admission to Intensive Care Unit
3. Need for intubation and mechanical ventilation (PaO2/FiO2 \< 100-200)
4. Written informed consent

Exclusion Criteria:

1. Pregnancy and breastfeeding
2. History of G6PDH deficiency
3. Preadmission anticoagulation
4. Severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2)
5. Medical records of cirrhosis
6. Active chronic hepatitis
7. Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit
8. Patients with history of allergic reaction or significant sensitivity to Methylene blue
9. Treatment with immunosuppressive agents
10. Use of other investigational drugs in the moment of inclusion
Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema

To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.

* Ranibizumab can be a safe treatment for diabetic macular edema regarding maintenance of retinal ganglion cell function after repeated intravitreal injections.
* To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
* The primary endpoint for the study will be the changes in full-field and focal macular photopic negative response (PhRN) amplitude (in µV) over time, from baseline to month 12.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, older than 18 years, who have signed an informed consent.
* Patients with Type 1 or Type 2 diabetes mellitus and prior diagnosis of diabetic macular edema (DME), who had not undergone any previous treatment, either pharmacological or laser photocoagulation.
* Patients with visual impairment due to DME whom, in the opinion of the investigator, would benefit from treating with IVR.

Exclusion Criteria:

* Known hypersensitivity to ranibizumab or any of its components.
* Previous participation in any clinical studies of investigational drugs within 1 month
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
* Pregnant or nursing (lactating) women.
* Inability to comply with study or follow-up procedures.