cyrilzakka/clinical-trials huggingface dataset:
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.


Eligibility Criteria:
Inclusion Criteria:

Study participant must meet one of the following:

* Study participant completed MG0006 according to the protocol
* Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006

Exclusion Criteria:

* Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP
* Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs
* Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant's ability to participate in this study
Effect of Acute Cardiovascular Disease on Microbiome

Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.

An interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome.

Aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* patient consent
* CCS, ACS or CLI
* angiographical confirmed peripheral or coronary artery disease

Exclusion Criteria:

* pregnancy/lactation period
* current antibiotic treatment or in the past 3 months
* chronic inflammatory bowel disease
* short bowel syndrome
* artificial bowel outlet
* persistent diarrhea or vomiting in the past 3 months
* simultaneous participation in another interfering nutrition study
* active chemo or radiation therapy
Intrapleural Gene Transfer for Pleural Mesothelioma

This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in subjects with pleural mesothelioma.

Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation. Subjects are then followed-up as outpatients for a total of 6 months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is removed once it is not necessary.

Eligibility Criteria:
Inclusion Criteria:

* evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
* evaluable disease
* No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
* Must have a pleural space involved with tumor accessible for pleural catheter insertion
* FEV1\> 1 liter or 40% of predicted value
* Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core

Exclusion Criteria:

* Presence of HIV or Hepatitis B infection
* Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
* Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
* Presence of untreated brain metastases
* Prior bone marrow or stem cell transplants
Pioglitazone Treatment in Polycystic Ovary Syndrome

In this study, the investigators wish to investigate how pioglitazone treatment effects hirsute women. Hirsute women are often overweight and have an increased amount of male sex hormone in their blood. Their blood tests show frequent changes corresponding to the changes seen in diabetic patients.

Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients. Previous studies showed that this drug is able to decrease the level of insulin in blood in hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The drug has only been marketed for few years, and no investigations have been carried out as to the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.

This clinical trial includes 30 strongly hirsute women. The patients are randomized to either placebo or an active drug. The treatment period is 16 weeks. The patients included must be healthy and take no medicine possibly changing the results of the study. The patients must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.

This examination programme will be carried out before start of pioglitazone or placebo treatment and again after 16 weeks of treatment. The examinations require 2½ days of hospitalization.

The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow more hair than normal women. The study will show whether pioglitazone treatment can reduce the amount of male sex hormone in blood and how the level of stress hormone and growth hormone is changed when reducing the amount of insulin in blood.


Eligibility Criteria:
Inclusion Criteria:

* Irregular menses, i.e. cyclus length of \>36 days
* Premenopausal
* Increased fasting insulin \> 50 pmol/l
* Increased free testosterone \> 0.035 nmol/l

Exclusion Criteria:

* Age: \<18 years
* Contraceptive pill within the past 3 months
* Postmenopausal (increased FSH)
* Known diabetes mellitus, endocrine disease or other disease requiring treatment
* Drug use
* Pregnancy
* Planned pregnancy during the treatment period
* Increased liver parameters
Repeatability and Response Study of Absorptive Clearance Scans

The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will determine whether the imaging technique will demonstrate similar results when it is repeated on different days. They will also determine how their results change when subjects utilize several common CF medications.

Cystic Fibrosis (CF) is an autosomal recessive genetic disease, caused by mutations of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) that impairs ion transport at epithelial surfaces. This results in the accumulation of dehydrated secretions in the airways and chronic infection and inflammation in the lungs, leading to significant morbidity and mortality. The investigators understanding of CF pathogenesis has increased substantially and many new targeted therapies are being developed to treat this disease, however, the measurements of clinical efficacy used to evaluate these therapies require long trials to demonstrate an effect. New translational techniques are needed to assess changes in the most basic aspects of the disease and allow for the rapid screening of disease-altering therapies. The investigators have recently developed a novel aerosol-based imaging technique to measure liquid absorption in the airways - a central pathophysiological process related to CFTR dysfunction. The investigators propose that airway liquid hyper-absorption is a key link between cellular defects in ion and fluid transport and progressive airway dysfunction in CF. Thus The investigators technique may provide a measure of disease severity and rapid indication of therapeutic correction in advance of currently available outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* subjects 18 years old or older with a diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms who are clinically stable as determined by a physician co-investigator

Exclusion Criteria:

* one second forced expiratory volume (FEV1) \<50% of predicted
* nursing mother
* positive urine pregnancy test or unwilling to test
* cigarette smoker
* unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
* are intolerant to hypertonic saline (response only)
* are intolerant to any inhaled therapies (response only)
* fail mannitol tolerance testing (response only)
* have a history of excessive (uncontrollable) coughing after an osmotic stimulus (response only)
* have a history of hemoptysis (response only)
Modulation of Brain Oscillations Underlying Working Memory

This study will use novel transcranial alternating current stimulation (tACS) protocols and electroencephalography (EEG) to modulate and measure brain oscillations that underlie working memory. tACS is a noninvasive method used to modulate the timing and patterns of brain rhythms via weak electric currents passed through electrodes on the scalp.

In this study, healthy adult individuals will perform a spatial working memory task as investigators record scalp EEG before and immediately after undergoing transcranial alternating current stimulation (tACS). Each participant will complete four tACS sessions in randomized order: 1) theta-nested gamma tACS applied during active task periods, 2) theta-nested gamma tACS applied during passive (rest) periods, 3) gamma stimulation applied in phase with ongoing theta oscillations, and 4) placebo tACS. The different stimulation protocols will take place on different days. Therefore, participants will be expected to attend 4 in-person study visits at the Martinos Center for Biomedical Imaging in Charlestown, Massachusetts.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Fluent in English.

Exclusion Criteria:

* History of a neurological/psychiatric disorder
* Current use of psychotropic medications
* Current use of substances and drugs that were shown to affect tES (transcranial electrical stimulation) efficacy (dopamine altering drugs, nicotine, NMDA (N-methyl-D-aspartate) antagonists/agonists, sodium/calcium channel blockers, norepinephrine reuptake inhibitors, GABAergic modulators and selective serotonin reuptake inhibitors)
* Contraindications for tACS (e.g., history of seizures, metallic implants in the head or neck, implanted brain stimulators, vagus nerve stimulators, pacemakers, pregnancy)
Posterior Nasal Nerve (PNN) Rhinitis Study

Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those diagnosed with chronic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 22 to 75 years (inclusively)
2. Willing and able to provide informed consent
3. Willing and able to comply with the subject-specific requirements outlined in the study protocol
4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure
5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
7. rTNSS score of greater than or equal to 6
8. Dissatisfaction with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief, as judged by the subject

Exclusion Criteria:

1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
3. Active nasal or sinus infection
4. Moderate to severe ocular allergic symptoms (such as eye tearing \[epiphora\], itching \[pruritus\], or redness \[erythema\])
5. History of significant dry eye
6. History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
8. Known or suspected to be pregnant, or is lactating
9. Participating in another clinical research study
10. Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study
"Comparison of Spirulina Gels for Treating Stage II Grade B Periodontitis"

This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.


Eligibility Criteria:
Inclusion criteria:

* Patients with good systemic health.
* Patients who can maintain good oral hygiene.
* Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·

  * Any systemic disease that affects the periodontium. ·
  * Pregnant, postmenopausal women. ·
  * People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
  * People who use mouth washes regularly ·
  * Participation in other clinical trials.
3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children

Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.

Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.

Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.

During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.

After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.

Data from manometry will be correlated with the success rate of BET.

Eligibility Criteria:
Inclusion Criteria:

* Constipation
* Parental agreement

Exclusion Criteria:

* after surgery on lower gastrointestinal tract
* diagnosis of inflammatory bowel disease
* diagnosis of other disorder that may affect anorectum function
* parental disagreement
Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines

The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:

1. How does the type and dose of exercise affect the treatment of NAFLD?
2. What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?
3. How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?

Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
* Age between 25 and 50 years old
* Use of smartphone
* Fall into category A or B according to the American Heart Association Risk Assessment Criteria

Exclusion Criteria:

* Viral hepatitis
* Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)
* Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs
* Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease
* Liver storage diseases
* Cancer
* Cirrhosis
* Advanced changes in liver ultrasonography evaluations, such as fibrosis
* Presence of other chronic diseases (kidney failure, heart failure, atherosclerotic heart disease, hypertension, arrhythmia disorders)
* BMI greater than 40 kg/m²
* History of surgery or trauma in the last 6 months
* Orthopedic and/or neurological impairment
* Health problems that may hinder participation in the exercise program
* Regular and continuous participation in sports or exercise at least 3 times a week for the past 3 years
* Family history of coronary artery disease (coronary artery disease before the age of 45 in male first-degree relatives and other male relatives, or before the age of 65 in female first-degree relatives and other female relatives)
* Presence of specific symptoms during medical history or physical examination: chest pain radiating to the neck, jaw, or arm, shortness of breath during rest or physical activity, dizziness, fainting, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, palpitations or tachycardia, intermittent claudication, heart murmur, unexplained excessive fatigue
* Fall into category C or D according to the American Heart Association Risk Assessment Criteria
A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.

No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who have received at least one dose of QDENGA vaccine in Malaysia during the study period.
2. Participants or their legally authorized representative (LARs) with a functioning phone number.

Exclusion Criteria:

No exclusion criteria will be applied for this study.
Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant

Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. However, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. Treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. Several technologies and devices are developed around this LED and specially a compact system.

The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with conventional phototherapy (non-LED) and satisfaction of the parents and the professional staff about comfort of this new technology. The newborn infant is placed in a sleeper with the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the blue light. This one is generated by the module LED and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually.

The device is endowed with an hour counter to schedule the time of treatment. The energy illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².


Eligibility Criteria:
Inclusion Criteria:

* Newborn infants ≥ 38 gestation weeks without or with risk factors of severe icterus (G6PD or pyruvate-kinase deficiency, red blood cells membrane defects, hemoglobinopathies, cephalohematoma or significant bruising, decreased breastfeeding)
* newborn at 35 and 38 gestation weeks without risk factor of severe icterus (qs)
* hyperbilirubinemia to deal according to the curves of indication of phototherapy of the APP on 2004
* no opposition of parents

Exclusion Criteria:

* opposition of parents
* newborn infants less than 33 weeks
* newborn infants at 35 or more weeks of gestation with risk factors of severe icterus
* Jaundice in first 12 hours
* Hyperbilirubinemia \> 340 µmol/L whatever is the age