cyrilzakka/clinical-trials huggingface dataset:
Elastography Ultrasound in Localized Scleroderma (Morphea) Study

Localized scleroderma (LS) is a skin disease that can cause complications such as disfigurement and limitation of mobility. Treatment for LS should be initiated early in the disease, as late-stage scleroderma does not respond well to treatment. Objective tools for diagnosis and follow-up of treatment for LS are not available clinically and are urgently needed. A new non-invasive ultrasound technique called "elastography" measures stiffness of tissues and holds potential for providing objective measures for follow-up of treatment of LS in children and adolescents. The team plans to conduct a multicenter study in North America to determine whether elastography ultrasound can show changes in skin stiffness for a period of 9 to 12 months after initiation of treatment for LS. This novel technology may add information to the existing imperfect clinical tools, thus improving the way therapy is offered to patients with LS.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma (LS) confirmed by a pediatric rheumatologist or dermatologist.
* Presents with one active or inactive lesion, using the contralateral site for comparison at each visit, as long as the same lesion is evaluated at each time point. OR Presents with more than one lesion as far as both lesions are active or inactive.
* Able to cooperate with clinical and US evaluation, and the parent or guardian is able to fill out interim patient history form.

Exclusion Criteria:

* Patients with other co-morbidities (e.g. systemic sclerosis, juvenile idiopathic arthritis, other systemic diseases).
* Patients who present with one active and one inactive lesion.
* Patients with lesions located in the face or head.
Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions

This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions of CDNF. All patients will have at least the port explanted.

A patients participation in the study will last for up to 4 years and will include up to nine visits:

* Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit)
* Pre-surgery / explantation surgery / post-surgery (3 visits)
* Safety (4 visits)
* DAT-PET (Dopamine Transporter - Positron Emission Tomography) examination (1 visit)
* End-of-study visit (1 visit)

Study examinations and assessments:

* Physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (BMI), neurological exam
* ECG (electrocardiography) and blood and urine tests
* Pregnancy tests for women of childbearing age
* Completion of a patient diary to record mobility and time asleep
* Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type movement recording device
* Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health.
* Magnetic resonance imaging (MRI)
* Positron emission tomography scans (PET)
* Skin condition over any remaining implanted subcutaneous portion of the device.
* Skin healing after port / device removal.

For more information: https://treater.eu/clinical-study/

Eligibility Criteria:
Inclusion Criteria:

1. Completion of visit 4 (implantation of DDS) within main study HP-CD-CL-2002.
2. Patients who:

   * Discontinued main study after visit 4 of main study or discontinued extension study.
   * Received 6 doses in main study but didn't participate in extension study.
   * Received 12 doses including extension study.
3. Provision of informed consent.

Exclusion Criteria:

* None
Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.


Eligibility Criteria:
Inclusion Criteria:

* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
* Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.
* The patients' age between 18 \~90 years old.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients allergic to Thymosin α1;
* Lactating women and pregnant women;
* Patients with mental diseases, drug and alcohol dependence;
* Refuse to participate in this study and refuse to sign the informed consent.
Study of Fibrinogen Metabolism During Severe Trauma and Burns

To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.

In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.

Eligibility Criteria:
Inclusion Criteria:

* 20% total body surface area burn or more
* severe trauma with injury severity score greater than 10
* between ages of 18 and 65 years

Exclusion Criteria:

* history of blood clotting disorder
* history of liver disease such as cirrhosis or hepatitis
* pregnant or nursing
* allergic to iodine, shellfish or dye used in X-Rays
* taking long term medications for blood clotting usch as Coumadin or Plavix
* prisoners
* receiving total parenteral nutrition
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects

Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive
* Age 18-64 years
* Able to give informed consent
* Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Due to commence antiretroviral therapy by treating clinician

Exclusion Criteria:

* - Previous major intestinal surgery/inflammatory bowel conditions
* Infective diarrhoea in the last 3 months
* BMI\<18.5
* Currently pregnant OR planning to conceive during the study period
* Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months
Probiotics for Inflammation in Pediatric Chronic Pain

To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.

The purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (Lactobascillus Plantarum, Lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) Explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female biological sex
2. 13-17 years of age
3. Body Mass Index ≥85th percentile for sex and age

Exclusion Criteria:

1. Probiotic (or prebiotic) supplement use or antibiotic use within the past month
2. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
3. Patients who have had a poor response to blood draw or immunizations in the past
4. Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications)
5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
6. Use of illicit drugs
7. Females who are pregnant or lactating
Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder

Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family.

Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders.

We have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders.

We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of Sensory intergration disorder (SID) compared with healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* children 7-36 months of age with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria .
* children 7-36 months of age with feeding disorders based on Chatoor criteria.
* children 7-36 months of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.

Exclusion Criteria:

Children with

* Chronic medical conditions.
* Congenital abnormalities.
* Significant developmental delay.
Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia

A sigle-center, randomized controlled trial will be do to investigate the effects of esomol on heart rate, clinical parameters, mortality, and safety in septic shock patients with tachycardia at different stages, compared with patients who received conventional therapy.

The incidence of septic shock complicated with tachycardia is high and the prognosis is poor. Enough attention should be paid to and appropriate treatment should be given. High heart rate and high cardiac output are beneficial compensatory reactions of sepsis and septic shock. However, excessive sympathetic activation and high heart rate also have adverse effects on the cardiovascular system. Sustained tachycardia is harmful to patients with sepsis and septic shock and needs to be controlled. At present, it is widely used in the treatment of cardiovascular diseases and β Receptor blockers have the functions of preventing and reversing sympathetic effects, anti arrhythmia, anti-inflammatory and balancing myocardial oxygen supply and demand. Therefore, they are recommended to control arrhythmias in patients with septic shock. The 2014 guidelines for sepsis / septic shock in China suggest that if cardiac output is not low and the heart rate is fast after adequate fluid resuscitation, short acting drugs（β Receptor blockers）can be considered. However, there are some differences in the current clinical research results, and it suggests that the timing of treatment may affect the hemodynamic results and clinical outcomes of patients.

Therefore, this study intends to intervene with esmolol in patients with septic shock and tachycardia at different stages, and compare the hemodynamic parameters, clinical outcome, prognosis and adverse reactions with the conventional treatment group, in order to explore the appropriate time of esmolol in the treatment of patients with septic shock and tachycardia.

Eligibility Criteria:
Inclusion Criteria:

" ≥ 18 years old; " New septic shock within 24 hours, meeting the diagnostic criteria in 2012; " Septic shock lasts for more than 6 hours, and after fluid optimization using dynamic parameters, vasoactive drugs are still needed to maintain blood pressure; " the heart rate is greater than 100 beats / min for ≥ 1 hour，not caused by agitation, fever, and other factors; " informed consents are signed.

Exclusion Criteria:

" Shock caused by sepsis; " Septic cardiomyopathy or decreased myocardial contractility, requiring the use of positive inotropic drugs or significant cardiac insufficiency, such as CI ≤ 2.2l/min m2, PAWP\>18mmHg, EF\<40%; " Severe bronchial asthma or COPD; " Pregnant or lactating women; " Sinus bradycardia, degree II and degree III heart block; " β-receptor blockers were used before enrollment or have the history of sinus tachycardia; " Severe valvular heart disease; " Allergic to esmolol; " Tachycardia due to elevated body temperature, agitation, insufficient capacity and other reasons; " Have participated in other clinical studies.
(Pakistan Diabetes Prevention Program PDPP)

The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the prevention of type 2 diabetes. Approximately 20,000 people From four communities will be screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those found to be at increased risk will be given an oral glucose tolerance test. People who, after the oral glucose tolerance test, are identified as having prediabetes or normal but with risk factors such as raised BMI and/or history of hypertension will have the opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention. This consists of culturally adjusted preventive strategies focusing on diet and physical activity in real-life settings. Another important aspect of this trial will be to assess the impact of urban planning on the prevalence of obesity and diabetes.

The aim of this study is to translate the life style intervention project to prevent diabetes into real life settings in Karachi, Pakistan, home to one sixth of the world's population.

Eligibility Criteria:
Inclusion Criteria:

-Adult men and women between 30-64 years of age

Exclusion Criteria:

* Diagnosed type 1 or type 2 diabetes
* Pregnancy or presence of chronic disease rendering survival for three years unlikely
* Any psychological or physical disability to interfere with participation in the study
* Ischemic heart disease
Myocardial Damage and Music Study

MYDA-MUSIC study is a randomized, double blind (operator and analyst) study performed in San Filippo Neri Hospital, Roma, Italy and in Di Venere Hospital, Bari, Italy. The planned study duration is 12 months. The objectives are to assess the effects of heart-rate-variability based music on the incidence and magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable patients. 443 patients with chronic stable angina scheduled for a coronary angiography and possible ad hoc angioplasty will be randomized to receive music or dumb earphones.


Eligibility Criteria:
Inclusion Criteria:

* Chronic stable angina scheduled to undergo a coronary angiography and ad-hoc angioplasty

Exclusion Criteria:

* Abnormal c-TnI level before angiography
* Participation in other clinical studies
* Patients with pacemakers or defibrillators
* High rate atrial fibrillation (baseline heart rate \>99 bpm) at enrolment
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
* Subjects must have acne on their face.
* Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
* Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
* Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
* Subjects must be able to complete the study and to comply with study instructions.

Exclusion Criteria:

* Subjects who are pregnant, trying to become pregnant, or breast-feeding.
* Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
* History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
* Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
* Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
* Other exclusion criteria may apply.
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial

platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year

intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration

Eligibility Criteria:
Inclusion Criteria:

* deep carious lesion- no sign of irreversible pulpitis

Exclusion Criteria:

* old age- periapical lesion-
Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery

This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.

Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.

To address this problem of consistency and protocol adherence, a clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.

A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery with a SVV \<13% with a reduced total amount of fluid administered without any difference in postoperative complications. Therefore the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard of care actually in the department) versus an Assisted fluid management approach (using the AFM mode) on the incidence of minor postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients in the operating room scheduled for a major abdominal \& orthopedic surgery requiring a cardiac output monitoring (EV1000).
* Written informed consent received before surgery.

Exclusion Criteria:

* Minor Patients.
* No french speaking.
* Atrial fibrillation or severe arythmia.