cyrilzakka/clinical-trials huggingface dataset:
Feasibility of an Augmented Two-Day Step Test and Causal Modeling for Post-Exertional Symptom Exacerbation in Post Covid-19 Syndrome

This study aims to evaluate exercise capacity and identify causes of Post-Exertional Symptom Exacerbation (PESE) in individuals with Long COVID. The investigators will compare the effectiveness of the Two-Day 6-Minute Incremental Step Test (6MIST) and the Cardiopulmonary Exercise Test (CPET) in detecting PESE. Additionally, the investigators will assess metabolism, mitochondrial function, autonomic symptoms, psychological factors, and physical activity. Participants will complete both the Two-Day 6MIST and the Two-Day CPET, with a one-month gap between them. Each test is performed on two consecutive days to assess the delayed symptom response. The subjective symptoms of PESE will also be measured through questionnaires. To explore potential causes of PESE, the investigators will measure metabolism using indirect calorimetry, bioelectrical impedance analysis and food diaries, mitochondrial dysfunction with NIRS technology, autonomic symptoms using the COMPASS-31 questionnaire, psychological factors with questionnaires and physical activity levels using an activity tracker. This study will determine if the Two-Day Step Test (6MIST) is a feasible alternative to the two-day CPET for measuring PESE and will help uncover underlying mechanisms contributing to symptom exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Long COVID patients following the World Health Organization (WHO) criteria: "the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation"
* Previously active as described in the WHO recommendations for physical activity (minimal 150 minutes/week of moderate intensity aerobic physical activity OR minimal 75 minutes of vigorous intensity activity/week OR an equivalent combination of moderate- and vigorous-intensity activity throughout the week)
* Patient suffers from PESE as defined by the DePaul Symptom Questionnaire PEM (Post-Exertional Malaise) subscale
* Able to understand and sign written informed consent in Dutch, French or English

Exclusion Criteria:

* Any pre-existing conditions or new medical diagnosis that can alternatively explain the current symptoms
* Being unable to perform a cycle ergometer test as decided upon by the medical study team members
* Suffering from Chronic Obstructive Pulmonary Disease (COPD) GOLD classification category 2,3 or 4 (by the Global Initiative for Chronic Obstructive Lung Disease)
* Allergies to medical adhesive bandages
* Skin conditions aggravated by sunlight including Porphyria
* Participation in other interventional trials
* Mitochondrial diseases
* Pregnancy
* Lactation
A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice

The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
* The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study.
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.
* Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
* Previous participation in this study. Participation is defined as signed informed consent.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Previous treatment with Ryzodeg®.
A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.

The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.


Eligibility Criteria:
Inclusion:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* Over the age of 18 and took their AFPT within the past 1 month.

Exclusion:

* Previous diagnosis of diabetes
* Pregnant or nursing
Lidocaine Infusions for Chronic Pain in Children

This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.

Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with a chronic pain condition (\> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective.
2. American Society of Anesthesiologists class 1 or 2
3. Age 8-18 years
4. Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires
5. Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)

Exclusion Criteria:

1. History of seizures
2. Known liver or renal disease
3. Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)
4. Allergy or sensitivity to lidocaine or other local anesthetic
5. Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)
6. Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges
7. Pregnancy

Withdrawal Criteria

1. Patient or parent/guardian request
2. Refusal to have intravenous access and serum levels drawn
3. Inability to complete pain scores on the questionnaires (paper or electronic) at the first infusion and weekly for 2 weeks and at one month following infusion
4. Baseline free carnitine concentration \< 26 micromoles/L or total carnitine \< 32 micromoles/L (reference values from SickKids Department of Pediatric Laboratory Medicine "Guide to Laboratory Services")
A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus. The prevalence rate is approaching towards a peak throughout the world including Bangladesh. The current intervention used in peripheral neuropathy does not bring satisfactory result. Recent trial shows that L-carnitine is effective and safe in DPN. So it is expected that L-carnitine may produce better effect in compared to other medicine used previously for alleviation of DPN.

: Diabetic peripheral neuropathy is one of the common complication of chronic diabetes mellitus, with a 30-50 % prevalence. Progressive development of pain, numbness in toes or feet and sensory motor disorders affects the patient's quality of life. The epidemic spread of the disease has raised concern among physicians and researchers. A variety of agents or medicines with potential effect have been studied to control development of peripheral neuropathy. The existing management are yet unsatisfactory. Recent studies have suggested that L-carnitine is potential to alleviate symptoms in patents with diabetic neuropathy. Previous trial also indicated the efficacy and safety of L-carnitine on diabetic neuropathy. This limitations have led to search for an effective and tolerable option by placebo controlled trial.The present study is an attempt to investigate the effects of carnitine on pain and symptom improvement of diabetic peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

i. Clinically diagnosed diabetic patients who had been on stable antidiabetic therapy for 1 year ii.Age: 18 years to 70 years iii. Patients HbA1c level \<10

Exclusion Criteria:

i. Patient who are suffering from other causes of peripheral neuropathy for example chemotherapy and HIV patient, rheumatoid arthritis, SLE, alcololism, vitamin B12 deficiency etc ii. Lactating and pregnant women iii. Patients taking anticonvulsants, antidepressants, opoioids and other neuropathic pain medication agents
Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult

Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.


Eligibility Criteria:
Inclusion Criteria:

* using smartphone
* alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test

Exclusion Criteria:

* COPD
* active pulmonary TUBERCULOSIS
* Acute exacerbation within 4weeks
* severe psychological disorder
* severe systemic disease; severe LC, ESRD ...
* MALIGNANCY
High Tone Power Therapy for Hemiparetic Cerebral Palsy Children

Balance reactions and postural control are inadequate in children with CP which affect their daily living activities. So, different treatment modalities have been used to improve balance for cerebral palsy children. Recently, High tone power therapy is a new quantum leap in the field of electro therapy that can be used to stimulate nerves and muscles, so this randomized controlled study will be conducted to investigate the effect of high tone power therapy on balance and quality of life in hemiparetic cerebral palsy children.


Eligibility Criteria:
Inclusion criteria:

* Age ranged from 6 to 8 years.
* Height not less than one meter.
* Their spasticity will range from 1 to 1+ according to the Modified Ashworth Scale.
* Children have normal flexibility of the lower back muscles as adequate flexibility with normal muscle length is essential for proper joint function and efficient movement.
* Exclusion criteria:
* Children will not follow instructions.
* Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
* Tightness of the hip flexors.
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.

The literature includes studies that investigate the relationship of pneumoperitoneum and different positions with intracranial pressure during laparoscopy. Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation. Ultrasound guided measurement of the optic nerve sheath diameter as a non-invasive method will be used for measurement. The investigators believe reverse Trendelenburg position before pneumoperitoneum may prevent undesired sudden increases in intracranial pressure.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopic cholecystectomy operation
* Age between 18-65
* ASA I-II
* BMI ≤ 35

Exclusion Criteria:

* Ophthalmologic disease and optic nerve pathology
* Increased intracranial pressure
* History of cerebrovascular disease
Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis

It is aimed to compare in the early period the clinical and ultrasonographic findings in terms of the effectiveness of ultrasound-guided subacromial bursa injection with corticosteroid and ultrasound-guided lavage, which are the treatment options available in the literature for patients with calcific tendinitis who do not respond to conservative treatment.

Calcific tendinitis is a disease that occurs with the precipitation of hydroxyapatite crystals on tendons and shoulder region is the most involved. In the shoulder region, calcific tendinitis can involve all rotator cuff tendons, most commonly the supraspinatus. It may progress with pain and functional limitation. The pain can increase with movement or can occur at rest and sleep. The prevalence of calcific tendinitis is between 2.7% and 20% in the general population. The most common age group is between 30 and 60. It can negatively affect the family and social life of the person and cause loss of workforce.

Especially in the treatment of patients with calcific tendinitis unresponsive to conservative treatment, ultrasound-guided corticosteroid injection in subacromial bursa and ultrasound-guided lavage are frequently used treatment options. However, there are very few studies in the literature comparing these two treatment methods as randomized controlled trials.

In this study, it is aimed to compare the effectiveness of ultrasound guided subacromial bursa injection and ultrasound guided lavage procedures on pain scores, functional scales, disability scales, direct radiography findings and ultrasonographic imaging findings.

Eligibility Criteria:
Inclusion Criteria:

* Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment
* Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging
* Cases between the ages of 18-75 whose informed consent was obtained for participation in the study

Exclusion Criteria:

* Cases with radiculopathy ipsilateral to the affected shoulder
* Cases with active inflammatory arthropathy of the affected shoulder
* Cases with previous shoulder surgery
* Cases with a history of humeral head, scapula, and clavicle fractures
* Cases with neurological deficit affecting the upper extremity
* Cases with uncontrolled diabetes mellitus and uncontrolled hypertension, uncompensated congestive heart failure, chronic renal failure, chronic liver disease, tumor and/or vascular disease, inflammatory and/or infectious diseases, currently active psychiatric disease
* Cases with a history of subacromial bursa injection, calcific lavage or shoulder joint injection in the last 3 months
* Cases with a history of allergic reaction to the substance to be applied as local anesthetic
* Pregnancy or lactation
* Anticoagulant or antiagregant (antiplatelet) medication use that may interfere with the injection procedure.
Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Need for therapy in patients with relapsed/refractory patients
* Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:

  * follicular lymphoma
  * mantle cell lymphoma
  * lymphoplasmacytic lymphoma
  * nodal or splenic marginal zone lymphoma
  * measurable disease
  * lymphoma specific therapy in the last four weeks
  * WHO performance grade 0, 1 or 2

Exclusion Criteria

* Patients suitable for high dose therapy
* Transformation in high grade lymphoma
* Leukocytes \< 1,5/nl or platelets \< 100/nl (except due to lymphoma)
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

This study aims to investigate the effect of mixed of herbs and spices on gene expression of pathways associated with glucose homeostasis, oxidative stress, inflammation and its interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* BMI 23-33 kg/m2
* Must be able to accept spices
* Agreed and signed informed consent

Exclusion Criteria:

* Below 18 years old
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuss
* Vegetarian or vegan
* Having food allergies
* Stressed by venous blood sampling or previous experience of being difficult to be cannulated
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding
Azelaic Acid Versus Hydroquinone in Melasma

The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.

Eligibility Criteria:
Inclusion Criteria:

* must have stable moderate-severe epidermal or mixed melasma involving the face
* all races
* males and females
* persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months

Exclusion Criteria:

* if the person has only dermal melasma
* pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
* a known allergy or sensitivity ot azelaic acid or hydroquinone
* the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
* starting or stopping hormonal medication within 3 months
* chemical peels, microdermabrasion, or laser treatment within 6 months
* worsening or improving melasma
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:

A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

The current clinical trial is designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections a)which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria

* Proven or probable invasive fungal infections according to EORTC/MSG criteria.
* IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.
* Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria

* Concurrent progressive neurological disease (except if due to invasive fungal infection)
* Use of medications that are known to interact with azoles and that may lead to life-threatening side to effects.
* Prior enrollment in this study.
* Subjects with a life expectancy of less than 72 hours.