cyrilzakka/clinical-trials huggingface dataset:
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo

This study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments will be administered for 7 days. Disease activity for the Target Lesion will be evaluated using the Skin Infection Rating Scale (SIRS) Score.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 2 years of age or older
* Clinical diagnosis of primary impetigo (bullous or non bullous)
* Minimum diameter of Target Lesion to be one centimeter measured either as length or width.
* Presence of at least one and no more than ten lesions per subject at the time of screening
* The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age.
* Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4

Exclusion Criteria:

* Presence of other active skin diseases at or near the Target Lesion area to be treated
* A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
* Signs and symptoms of another current infection requiring antibiotic treatment
* Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject
* History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease
* Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp
* Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary
* Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug)
* Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment
* Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions).
* Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo
A Phase 2 Study of YA-101 in Patients with Multiple System Atrophy

This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.

The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the process of the clinical trial and give informed consent for the participation of the study.
2. Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
3. Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
4. Able to take oral medications.
5. Able to ambulate without the assistance of another person.

Exclusion Criteria:

1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
2. Evidence of renal impairment or hepatic impairment.
3. Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
4. Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
5. Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate

This study will involve the use of therapeutic hypothermia. This prospective cohort pilot study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. The study hypothesis is that magnesium sulfate will significantly increase the rate of cooling.

This study will involve the use of therapeutic hypothermia, an accepted medical treatment recommended for comatose post resuscitation patients by the International Liaison Committee on Resuscitation (ILCOR), the American Heart Association (AHA), and the European Resuscitation Council. This prospective cohort pilot study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. 14 patients will be prospectively randomized to receive either magnesium sulfate or normal saline (placebo) in this study.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
* Estimated or known age \> 18 years.
* Intubation, ventilation and placement of esophageal temperature probe.
* Persistent neurologic dysfunction i.e. comatose upon enrollment \[GCS ≤ 8\].

Exclusion Criteria:

* Height greater than 188 cm.
* Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
* Core temperature less than 35°C after ROSC (as measured in the esophagus).
* Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
* Known pregnancy.
* Known terminal illness that preceded the arrest.
* Known enrollment in another study of a device, drug, or biologic.
* Major trauma or other co-morbidity requiring urgent surgery.
* \> 4 hours since return of spontaneous circulation.
* Severe coagulopathy (with active bleeding).
* Hemodynamic instability despite vasopressors (SBP \< 90 mmHg or MAP \< 60 mmHg for \> 30 minutes after ROSC and before enrollment).
* Bradycardia (HR\<60/min)
* Allergy against MgSO4
* AV-block
* Myasthenia gravis
* Known terminal renal insufficiency (creatinine-clearance \< 20ml/min)
* Severe myocardial dysfunction (EF\<25%)
* Chronic digitalis therapy
Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Eligibility Criteria:
Inclusion Criteria:

* Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
* Medically fit children (ASA I, II).
* Children mentally capable of communication.
* Children aged 6-11 years.
* First dental visit.
* Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.

Exclusion Criteria:

* Children with a behavioral management problem.
* Children with known allergy to local anesthetic agents.
* Parental refusal for participation
Gingivitis and Periodontitis as a Risk Factor for Stroke

Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.

Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases.

These diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography.

Exclusion Criteria:

* Not willing to participate
* Neurological complications other than stroke
Survey on QUality of Life In myeloDisplasia (SQUID)

The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation

In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary MDS
* At least one cytopenia according to International Prognostic Score System (IPSS) criteria (Hb \< 10 g/dL
* Absolute neutrophils count (a type of white cell that fights against infection) \< 1.800/µL
* platelets (irregularly shaped cells found in blood that help prevent bleeding) \< 100.000/µL)
* Willing and able, based on investigator's judgment, to fill in QoL questionnaires

Exclusion Criteria:

* Refractory anemia with excess blasts (tumor cells located in the marrow \> 20%)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) \>3
* History of cerebrovascular disease with cognitive outcomes
* Psychiatric diseases or senile or vascular dementia
* Positive anamnesis for another clinically active tumor or when treatment has been stopped since less than 5 years
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects

Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
* Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
* Non-smoker or not smoking for at least 12 months
* Be first generation Japanese (For Group 1 only), defined as:

  1. Born in Japan
  2. Has 2 Japanese biological parents and 4 Japanese biological grandparents
  3. Has lived outside of Japan for less than 5 years
  4. Has made no significant changes in lifestyle, including diet, since leaving Japan

Exclusion Criteria:

* Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
* Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
* Has a history of drug or alcohol abuse
* Has previously received calmangafodipir or mangafodipir
* Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
South Texas Early Prevention Studies PreK

The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.

The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit of randomization, intervention, and analysis. The study was designed for two years of intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring 2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped prematurely and only results from the first three periods will be presented.

The two school districts where the study was conducted are located along the Texas-Mexico border in the county of Hidalgo. These school districts were selected because of the high poverty and health risk-factors levels.25 The preschools have two grade levels with children 3 and 4 years of age. The present study targeted preschools with children 4 years of age. Demographics of the two school districts were similar, 99% Hispanic, 92% economically disadvantaged, and 42% identified as English as a second language.

Eligibility Criteria:
Inclusion Criteria:

* PreK children
* Enrolled in PSJA and La Joya ISDs

Exclusion Criteria:

* na
Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor

The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).

The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
2. Willing and able to provide informed consent and follow the study protocol
3. Clinically indicated planned restoration of normal rhythm

Exclusion Criteria:

1. Unable to provide informed consent
2. Unable to follow the study protocol
3. Women who are pregnant
4. Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl

Exclusion Criteria:

* Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
* Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
* Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug;
* Women who are pregnant or breastfeeding;
* Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
* Known hypersensitivity to any component of the study drug
Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.

The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
* Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
* No contra-indications according to the local marketing authorization

Exclusion Criteria:

* Previously treated with Radium-223 for any reason
* Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.

In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.

To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.

Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

Eligibility Criteria:
Inclusion Criteria:

* Caucasians above 20 and below 45 years of age
* Normal glucose tolerance as assessed by the WHO criteria
* First degree relative and at least 1 second degree relative with type 2 diabetes
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT/ASAT \> 2 times normal value)
* Kidney disease (S-creatinin \> 130uM and/or albuminuria)
* Heart disease (NYHA II, III or IV)
* Treatment with medicine that cannot be paused
* Pregnancy of breast feeding