cyrilzakka/clinical-trials huggingface dataset:
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* maxillary sinus disease
* chronic sinusitis

Exclusion Criteria:

* fungal disease
* Samter's triad
* hemophilia
* prior sinus surgery
Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development

The goal of this observational study is to compare the brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).

The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.

Eligibility Criteria:
Case group:

Inclusion Criteria:

1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
2. Ages 2-17 years;
3. Parents/caregivers understand the content of the study and agree to participate in.

Exclusion Criteria:

1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
2. Children with brain injuries, specific chronic or congenital diseases.
3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
4. Children cannot receive the head MRI examination.

Control group:

Inclusion Criteria:

1. Healthy children age between 2 to 17 years.
2. Children without the family history of ASD or other neurodevelopmental/mental diseases.
3. Parents/caregivers understand the content of the study and agree to participate in.

Exclusion Criteria:

1. Children with brain injuries, specific chronic or congenital diseases.
2. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
3. Children cannot receive the head MRI examination.
N-Acetylcysteine Protection Against Radiation Induced Cellular Damage

Catheter ablation procedures (CAPs) are first line treatment for a great variety of cardiac arrhythmias. CAPs require X-Ray imaging; consequently, CAPs cause ionizing radiation (IR) exposure for patients. Exposure to IR, even at low-doses, increases individual risk of developing cancer. IR cause DNA damage directly and, mostly, indirectly by formation of cellular free radicals. Furthermore different response to IR results from inherited variants in genes involved in DNA damage repair. N-acetylcysteine (NAC) is an aminoacid that can directly neutralize free radicals and increase antioxidant systems. Our preliminary data suggest that IR exposure in patients undergoing CAP deranges the oxidative stress status and the pre-procedure intravenous administration of NAC could decrease such abnormality.

CARAPACE is a prospective, randomized, single-blinded, parallel-arm monocenter study. Eligible patients undergoing CAP at the Arrhythmology Unit of Centro Cardiologico Monzino will be enrolled.

The hypothesis driving our study, based on published literature and our preliminary data, is that administration of antioxidant agents, before cardiac procedures involving IR exposure, might prevent IR harmful effects on human tissues in terms of reduction of systemic oxidative stress status and, in parallel, of oxidative DNA damage.

The antioxidant agent tested in our study is NAC. NAC is a well-tolerated and safe medication and it has antioxidant properties is based on three main mechanisms: 1) direct antioxidant effect, 2) glutathione (GSH) precursor action, and 3) its activity in breaking thiolated proteins.

Another hypothesis to be tested is whether genes involved in DNA damage repair could explain the great variability in patient radiosensitivity to IR exposure and whether these genes could affect NAC protective/healing effects.

Eligibility Criteria:
Inclusion Criteria:

* Patient's age \>18 years.
* Negative hCG pregnancy test (if appropriate).
* Indication to perform CAP guided by fluoroscopy (IR imaging).
* Ability and willingness to give informed consent and to comply with protocol.

Exclusion Criteria:

* Any contraindication to CAP (such as, pregnancy and breastfeeding).
* Hypersensitivity to the active substance or to any of the excipients.
* Enrollment in another study that may interfere with CARAPACE study.
* Administration of an experimental drug within 30 days or 5 half-lives of the investigational drug.
* Chronic kidney disease (serum creatinine \>1.5 mg/dl).
* Acute/Chronic inflammatory disease.
* Antioxidant drugs intake over the previous 2 weeks.
* History of radiotherapy or chemotherapy in the last year.
* Any documented condition that, in PI's motivated judgement, makes the patient a poor candidate for the study.
* Computed tomography and/or coronary angiography within 5 days prior to baseline analysis.
Therapeutic Options for Treatment of Burning Mouth Syndrome

Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. The purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, B-vitamin injections and informative treatment only.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed with burning mouth syndrome and excluded local and systemic causes

Exclusion Criteria:

* patients who have received treatment for burning mouth earlier
* patients with local or systemic causes of burning mouth
Natural History Study in Patients with PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa

The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.

Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase.

Hereditary retinal diseases such as retinitis pigmentosa are rare genetic diagnoses of the retina with chronic lifelong progression, often leading to blindness. Progression varies greatly between individuals. PDE6A, PDE6B and RHO related retinitis pigmentosa phenotypes are typical retinal dystrophies with early onset of rod dysfunctions and a rather slow progression of the cone dysfunction with progression to complete blindness in later adulthood.

Classical gene therapy could improve the function of the rods if successful, although the changes may only be very small and need to be measured using sensitive methods. In contrast, neuroprotective therapeutic approaches could slow down these slow processes even further, which would be extremely difficult to prove as clinical efficacy in a future clinical trial with very individual courses.

In order to have clinical examination methods in the future that can prove the safety and efficacy of neuroprotective approaches, very sensitive examination methods are needed whose test variability is also known. In addition, a neuroprotective treatment method can positively influence the metabolic state of the retina, which, in contrast to slowing down a slow degeneration process, would be a demonstrable effect if the metabolism of the retina can be examined in a clinically relevant way.

For these reasons, the investigators will focus on the above-mentioned genotypes of retinitis pigmentosa in a non-interventional study in order to collect and correlate structural, functional and metabolic examinations of the retina.

Eligibility Criteria:
Inclusion Criteria:

* Age: from 5 years of age
* Patient with PDE6A, PDE6B, and RHO-based retinitis pigmentosa
* Patient and/or legal representatives are willing and able to give written informed consent

Exclusion Criteria:

* severe general disease, that would make longer examinations not possible
Halliwick Concept on Motor Functions in Spastic CP

This randomized controlled trial will investigate the effect of hydrotherapy (halliwick concept) on motor functions in children with spastic cerebral palsy (CP). Minimum of 30 Spastic CP children will be recruited for this study. Children will be randomly assigned into control group who will receive conventional selected exercise treatment or study group who will receive the same conventional program in addition to underwater exercise program. Motor function will be evaluated at baseline and after 3 months of treatment. No potential harms are expected during this study.


Eligibility Criteria:
Inclusion Criteria:

* Children from both sexes diagnosed with spastic CP according to a pediatrician
* The degree of spasticity will be determined as grade two or less according to modified Ashworth scale
* Their age will range from five to nine years
* Intelligence quotient score \> 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales
* No severe psychosocial or behavioral problems, such high aggression or risk of self-harm.

Exclusion Criteria:

* Initiation of oral antispastic medication
* botulinum toxin injections or surgery performed less than 90 days before enrollment
* severe visual or auditory impairment
* uncontrollable epilepsy (defined as the occurrence of seizures despite the use of at least one antiepileptic drug)
* open wounds
* children with a psychiatric disorder
* cognitive disorders evaluated by the pediatric evaluation of disability inventory
* uncontrolled epilepsy
* active infection
* severe cardiopulmonary disorders.
Ketone Supplementation in Individuals With PTSD

The purpose of this study is to determine if a 6-week period of ketone salt supplementation affects physiological, emotional, cognitive, and/or behavioral health markers in individuals with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PTSD

Exclusion Criteria:

* Pregnant, younger than 18 or older than 65
Participation of Breast Milk Feeding Mothers in Research

To assess concerns and barriers for measuring milk intake of breast fed infants using the remote food photography method and SmartIntake smartphone application. These data will 1) provide support for further development of the Infant RFPM and 2) provide important preliminary data in a National Institutes of Health grant application being developed and assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study population.

Study participation will be the completion of an anonymous, online survey powered by HIPAA compliant REDCap database. The survey will be made available to potential participants through the internet. The survey will take approximately five minutes to complete. The expected duration of recruitment and completion of the study is six months.

Eligibility Criteria:
Inclusion Criteria:

* Any individual may take the survey.

Exclusion Criteria:

* None
The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium

Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions during anesthesia might increase in the coming years. Neuromuscular blockers (curare like substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle relaxation and immobility during surgery. Rocuronium is one of the most widely used neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate the effect of neuromuscular blocking agents. In the study the investigators want to evaluate the effect of intravenous lidocaine during the operation on the time course of the rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions (lidocaine has been shown also to improve intubation conditions) and safety.


Eligibility Criteria:
Inclusion Criteria:

* Adult, age ≥18 to 60 years, male or female.
* American Society of Anesthesiology \[ASA\] status I or II.
* Patient is able to read and understand the information sheet and to sign and date the consent form.
* Patient scheduled of elective surgery lasting longer than 120 min without need for continuous curarisation.
* Surgery without application of local anesthetics (epidurals, wound-infiltration).
* If the patient is female and of childbearing potential, she must have a negative pregnancy test.

Exclusion Criteria:

* A history of allergy or hypersensitivity to rocuronium or lidocaine
* Neuromuscular disease
* Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics \[aminoglycosides\] and anticonvulsants \[phenytoine\])
* Electrolyte abnormalities (for instance, hypermagnesemia)
* Hepatic or renal insufficiency
* Patients with epileptic disease
* Patients with a body mass index \<19 or \>28 kg m2
* Pregnant or breastfeeding women
* Expected difficult intubation or mask ventilation
* Atrioventricular heart block II or III -
Use of Banana Leaf Dressing on Donor Site Wounds

Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing harvesting of skin graft one or both thigh
* Surgery under general anesthesia
* Given informed consent and has accomplished a written inform consent

Exclusion Criteria:

* Patient with uncontrolled medical condition such as diabetes or hypertension
* Pregnant females
* Patients in whom legs or back was used as donor site
* Surgery under regional anesthesia
* Refused inclusion into the study
* Patients who had previous skin harvesting on the area of the study
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.


Eligibility Criteria:
Inclusion Criteria:

* With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
* Must demonstrate response to beta 2 agonist by Reversing;
* Must demonstrate ability to use DPI;
* Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Additional Criteria

Exclusion Criteria:

* Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
* Upper respiratory tract infections
* Asthma exacerbations;
* Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
* Use of prohibited drugs or failure to observe the drug washout restrictions;
* Having been on other clinical drug/device studies in the last 30 days;
* Other Criteria
GLP-1 and Microvascular Function in Type 2 Diabetes

Some gut hormones, called incretins, stimulate insulin production in order to control sugar levels but also activate brain centres and signal to stop eating. Current administration of incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the skin) injection and has been routinely available for diabetic patients for more than 4 years. It is an effective treatment for the lowering of blood glucose with an average weight loss of about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that incretins based treatments may also have beneficial effects on blood vessel function. However, it is not known whether this effect is by direct action on the blood vessel independent of an improvement of latent inflammation which is typically associated with weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this study is to determine whether the incretin-based diabetes treatment with the GLP-1 (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It will determine whether the improvement in blood vessel function is independent of the effect of weight loss and changes in inflammation. This by the study of vascular function before and after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1) participants randomized to hypo-caloric diet to achieve a similar weight loss than with Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive assessment of blood vessel function, body fat distribution and metabolic profile at baseline and at the end of the treatment phase will be combined with assessments of inflammation markers in blood and in fat tissue biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes and an HbA1C between 7-8.5% on a stable dose of sulphonylurea and/or metformin

Exclusion Criteria:

* use of insulin
* corticosteroids
* contraceptives, tamoxifen
* methotrexate
* DPP-IV inhibitors
* pregnancy
* lactation
* endocrine disorders
* acute MI or cerebrovascular disease
* Raynaud's disease or connective tissue disease
* current or previous history of malignancy
* subjects treated with ergotamine derivatives
* unstable blood pressure for the last 3 months
* current treatment with warfarin
* subjects on any anti-inflammatory or anti-platelet agents
* history of any bleeding disorders and GI bleeds.
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
2. Detectable metastases by bone scan, CT-scan, or MRI.
3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
4. Suitable venous access for blood sampling

Exclusion Criteria:

1. Prior treatment with any anti-prolactin receptor antibody
2. Major surgery within 28 days before study treatment
3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
4. Prior anaphylactic or other severe infusion reaction to antibody formulations

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery

This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.

Cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. Despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. Although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. This study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy.

The study will be conducted retrospectively by reviewing archive records. Patients operated for cholecystectomy will be included. Patients that open surgical method used from start will be excluded from study. Age, comorbidities (ASA score), laboratory findings (leukocyte count and CRP), imaging findings (abdominal ultrasound, CT, or MRI), history of previous abdominal surgery, history of ERCP, and history of pancreatitis will be evaluated. Laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 95 years old.
* Operated for gallbladder disease (Cholecystectomy)
* Surgery must started with laparoscopic approach

Exclusion Criteria:

* Open surgery from the start
* Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)