cyrilzakka/clinical-trials huggingface dataset:
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).


Eligibility Criteria:
Inclusion Criteria:

* Study participant must be ≥2 to \<18 years of age inclusive, at the time of signing the informed consent/assent according to local regulation
* Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) at Screening that includes a record confirming the presence of MG specific autoantibodies to acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Screening
* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IVa at Screening
* Study participant has received existing conventional treatment(s) for gMG (eg, pyridostigmine, corticosteroids, and/or immune suppressants) prior to Screening
* Study participant has had an unsatisfactory clinical response or worsening of gMG symptoms and is in need of additional therapy (for example, plasma exchange (PEX) or treatment with intravenous immunoglobulin (IVIg))

Exclusion Criteria:

* Study participant with severe weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Screening or Baseline
* Study participant has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP) or other anti-neonatal-Fc receptor (FcRn) medications
* Study participant with any active or untreated thymoma
* Study participant has a history of thymectomy within 6 months prior to Screening
* Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP
* Study participant has received a live vaccination within 4 weeks prior to Baseline or intends to have a live vaccination during the course of the study
EMLA Topical Anesthetic During Scaling and Root Planing

Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.

Objective: The aim of this study was to compare the effect of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine (EMLA®) with injectable 2% lidocaine, topical benzocaine, and 2% placebo for reducing pain during subgingival scaling and root planing (SRP) procedures.

Methods: Thirty-two patients were enrolled in this split-mouth, double-blind randomized clinical trial. Patients were randomized to a sequence of four anesthetics: 25 mg/g lidocaine and 25 mg/g of 5% prilocaine (EMLA®), injectable 2% lidocaine, topical 2% benzocaine, or placebo. Pain and discomfort were measured using a Visual Analogue Scale (VAS) and Verbal Scale (VS). Patient satisfaction with anesthesia was also determined at the end of each treatment session.

Eligibility Criteria:
Inclusion Criteria:

* eligible individuals for the study were selected from those requiring SRP with at least 2 experimental teeth in four of the six sextants.
* each experimental teeth had to present ≥ 1 site with probing depth ≥ 5 mm associated with BP after treatment of gingivitis (without marginal bleeding).
* furthermore, individual should present ≥ 18 years-old, have not ever done periodontal treatment and be able to understand Verbal Scale (VS) and Visual Analog Scale (VAS).

Exclusion criteria:

* patients that related allergy history or sensitivity reaction to any used amide or ester anesthetics form,
* who received anesthesia or sedation 12 hours before SRP,
* who presented ulcerated lesions or abscesses in the oral cavity,
* who presented oral pathologies with immediate surgical,
* who had prior abuse alcohol history, pregnant women,
* who presented uncontrolled hypertension or
* who had participated in a clinical trial of investigational drug before four months from the beginning of this study.
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses

Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.

Primary Objective

1. To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not.
2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue.

Secondary objective

1. To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 95
* Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital.
* Has voluntarily provided signed informed consent to participate and HIPAA authorization for the release of personal health information
* Willing and able to complete patient-reported outcome questionnaires
* Willing to have extra cores taken for research during the standard-of-care biopsy procedure
* Willing to allow surgical specimens to be used for research
* Willing to undergo a blood draw to evaluate for circulating tumor DNA

Exclusion Criteria

* Has staging information indicating locally advanced or metastatic disease.
* Presence of transplant kidney
* Unwilling or unable to complete informed consent
* Previous biopsy of small renal mass.
Low Dose Magnesium Sulphate

This clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of postoperative analgesia, degree of sedation mean arterial blood pressure and HR will be recorded intraoperative and Participants will be asked to rate the pain at the first, second, fourth, sixth and 24th postoperative hour using the VAS score.

* Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
* Sedation score: the degree of sedation will be assessed using the Ramsy sedation score

This prospective, randomized controlled clinical trial aims to establish the effect of magnesium sulphate during nasal surgery regarding deliberate hypotension, postoperative analgesia and sedation with minimal side effects.

this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anaesthesia.

patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list.

Group (P): Patients will receive propranolol 1-2 mg. Group (PM): Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg.

* ABP and HR are continuously monitored and will be recorded before the start of anaesthesia (T1), after intubation (T2), at skin incision (T3), at manipulation of nasal bones (T4), at extubation (T5), before discharge to PACU (T6), and after 30 min in PACU.
* Surgical duration (time from skin incision till skin closure).
* Extubation time (from the end of anaesthesia to extubation)
* Modified Alderete score will be assessed and recorded every 5 minutes until discharge. Patients will be discharged upon achieving an Aldrete score of ≥ 9.
* The time to discharge will be recorded.
* VAS score for pain:
* Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
* Sedation score: the degree of sedation will be assessed using the Ramsy sedation score where all be recorded

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anesthesia
* ASA I or II
* Duration of surgery will be 1-2 hours

Exclusion Criteria:

* Hypertension,
* Myasthenia gravis or other muscular disease,
* Impaired kidney or liver functions,
* History of drug or alcohol abuse,
* History of antidepressant and calcium channel blocker use,
* Mental retardation and hysterical patients.
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product as measured by increases in FEV1.

A single center, open label, single dose study to demonstrate the pharmacodynamic bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate or albuterol sulfate/ipratropium in adult patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines characterized by progressive airflow limitation associated with abnormal inflammatory response of the lungs to noxious particles or gases primarily caused by cigarette smoking.
* Have an established COPD clinical history, symptomatic with dyspnea, chronic cough, chronic sputum production or wheezing. At Visit 1, FEV1/FVC ratio must be less than 0.70 or at least 10% less than the FEV1/FVC ratio determined by the predicted normal value. FEV1 must be less than 70% of the predicted normal value and greater than 25% of the predicted normal value.
* Must be using one or more inhaled bronchodilators for treatment of COPD at the time of Visit 1.
* Current or former smokers, with a history of at least 10 pack-years of cigarette smoking. Number of pack-years = (number of cigarettes per day/20) X (number of years smoked).
* Willing, and in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol.

Exclusion Criteria:

* Current diagnosis of other respiratory disorder(s) including, but not limited to: alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis; sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or pulmonary thromboembolic disease. Patients with concomitant COPD and asthma will be allowed to participate.
* Diagnosis of non-respiratory disorder(s) that are currently affecting lung function, as determined by he principal investigator including, but not limited to: congestive heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia; lupus; rheumatoid arthritis; or liver cirrhosis.
* Unable to abstain from protocol defined prohibited medications during the screening and testing period.
* Unable to withhold short acting bronchodilators for 6 hours prior to spirometry testing at the study visit.
* Unable to perform acceptable or repeatable spirometry or comply with other study procedures.
* Known allergic reaction to albuterol sulfate or ipratropium bromide.
* Diagnosis of cancer that is not presumed to be in remission or cured.
* Active alcohol or drug abuse.
* Pregnant or lactating women. Pregnancy confirmed by a positive hCG test.
* Treatment with another investigational study drug in another clinical study within the last 30 days or five half-lives, whichever is longer.
Investigation of the Effectiveness of Core Stabilization Training in Patients With Subacromial Impingement Syndrome

Subacromial Impingement Syndrome (SSS) is one of the most common shoulder problems. The core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stabilization affects both trunk control and the quality of extremity movements depending on the kinetic chain in the body. The improvement in core stabilization balances the load transfer between the trunk and the extremities and reduces the asymmetry between the extremities. Core stabilization training should be included in rehabilitation programs as core stabilization is adversely affected in patients with CNS. For this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with CNS on pain, range of motion, upper extremity function and core stability.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with subacromial impingement syndrome,
* Being between the ages of 18-65,
* Not having received medical treatment,
* Not having received a shoulder-related physiotherapy program in the last 1 year,
* Not having undergone any shoulder-related surgery,
* Being able to read and understand Turkish

Exclusion Criteria:

* Neurological deficits of the upper extremity and the presence of another orthopedic disease, rheumatic and congenital disease other than CNS
* Presence of mental problems,
* To have received corticosteroid treatment in the last year,
* Having cardiovascular and systemic diseases that prevent work,
* Pregnancy,
* Those with communication problems
Alteration of Stool Microbiota in Preterm Infants With Anemia

This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

Necrotizing enterocolitis (NEC) is a leading cause of death in preterm infants, yet the disease mechanism is not well understood. Among the factors that have been studied are the change in stool microbiota (dysbiosis), severe anemia, and transfusion. Studies suggest that dysbiosis occurs in neonates with NEC. Large studies and meta-analyses have shown a predominance of Gammaproteobacteria, a decrease in Firmicutes, and decreased bacterial diversity in stool from infants with NEC. Studies do not support a relationship between transfusions and NEC since there are conflicting findings on this topic. There is a suggestion, however, that severe anemia may be associated with NEC though this requires further study.

No studies have been done evaluating the relationship between anemia and change in stool microbiota, or blood transfusion and change in stool microbiota. This study aims to primarily evaluate the relationship between anemia and stool microbiota, and secondarily evaluate the relationship between transfusion and stool microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 32 weeks gestation at birth
* Age at enrollment between 7 days and less than/equal to 30 days
* Minimum 100 mL/kg/day enteral feeds

Exclusion Criteria:

* Development of necrotizing enterocolitis (NEC) prior to enrollment
* Prior surgery
* Major congenital anomalies
* Oxygen requirement with FiO2 (fraction of inspired oxygen) \>50% (at time of enrollment)
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.

This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors.

This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year.

Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours.
3. Written, informed consent by patient or surrogate
4. Ability to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

1. Secondary ICH due to trauma, vascular malformation, or tumor
2. Life expectancy \< 1 year
3. eGFR \<45
4. Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment
5. Known hypersensitivity to spironolactone
6. Upper arm greater than 17 inches in circumference
7. Pregnancy, planned pregnancy, or breastfeeding
8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
9. Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization
10. Systolic BP \<120 mmHg at the time of randomization
11. Any condition which, in the judgement of the investigator, increases the risk to the patient
12. History of Addison's disease
A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.

This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.

Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.

Eligibility Criteria:
Inclusion Criteria: Patients selected for the study will be those undergoing ERCP who are at high risk for development of post-ERCP pancreatitis

* patients expected to undergo a sphincterotomy
* patients with suspected sphincter of oddi dysfunction
* patients with a known history in the past of post-ERCP pancreatitis
* patients less than 60 years of age

Exclusion Criteria:

* active pancreatitis
* if they are pregnant
* known adverse reaction to aprepitant
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence

A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
* Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
* Subject was in good health in the opinion of the investigator
* Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
* Subject was minimum of 18 years and maximum of 65 years of age

Exclusion Criteria:

- Subject had any of the contraindications for the InterStim system or InterStim II system
Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering

60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.

Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.

Eligibility Criteria:
Inclusion Criteria:

* single missing posterior tooth with two adjacent posterior teeth
* no acute conservative or paradontal treatment need except for the teeth to be treated in the study
* sufficient oral hygiene

Exclusion Criteria:

* known allergies to components
* bruxism
* missing antagonist tooth
* pregnancy or lactation
* missing written consent
* patients which are not expected to be compliant
* severe systemic diseases
* untreated carious lesions
* untreated parodontitis