cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥12 to \<18 years of age at time of screening visit
* Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
* IGA ≥3 at screening and baseline visit
* EASI ≥16 at the screening and baseline visit
* Baseline Pruritus NRS average score for maximum itch intensity ≥4
* ≥10% BSA of AD involvement at the screening and baseline visits
* With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable

Exclusion Criteria:

* Participation in a prior dupilumab clinical study
* Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
* Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
* Body weight \<30 kg at baseline
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
* Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
* History of malignancy before the baseline visit
* Diagnosed active endoparasitic infections or at high risk of these infections
* Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug

Other protocol-defined inclusion/exclusion criteria may apply
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, age 18 years or older at screening.
* Relapsed or refractory CD22-positive ALL.
* Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
* Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
* Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.
* ECOG performance status 0-2.
* Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
* Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
* Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
the Effects of Air Pollution on Respiratory Diseases in Children

The investigators expect to reveal the association between air pollution and childhood respiratory diseases through a multi-center observational study, and summarize the relationship between air pollution and childhood respiratory diseases.

The investigators will collect the data of outpatient and emergency children in Beijing Children's hospital and other participating hospitals due to respiratory diseases from 2010 to 2021, , collect clinical data and basic information, obtain air pollution data and meteorological monitoring data and perform data processing and statistical analysis,，then analyzes the impact of air pollution on children's respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* All children participating in this clinical study must meet all of the following criteria:

  1. Age: 0-18 years old, male and female
  2. Consultation for respiratory diseases
  3. Visit time is between 2010-2021
  4. Provide complete personally identifiable information and medical information

Exclusion Criteria:

* All children with any of the following conditions must be excluded from this study:

  1. children who visit hospital don't for respiratory diseases
  2. children participating in this clinical study don't provide complete personally identifiable information and medical information
  3. Visit time is not between 2010-2021.
Mitochondria and Chronic Kidney Disease

The overarching goal of this study is to determine the role of chronic kidney disease and the activation of the kallikrein-kinin system during hemodialysis on the development of mitochondrial dysfunction; the investigators will measure mitochondrial function using the gold standard method, 31-phosphorus magnetic resonance spectroscopy.

The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial dysfunction in patients undergoing hemodialysis. The investigators will first perform a randomized, placebo-controlled, double-blind, cross-over study measuring the effect of Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have been on maintenance hemodialysis for at least 6 months

Exclusion Criteria:

* History of functional transplant less than 6 months prior to study
* Use of immunosuppressive drugs within 1 month prior to study
* History of active connective tissue disease
* History of acute infectious disease within one month prior to study
* AIDS (HIV seropositivity is not an exclusion criteria)
* History of myocardial infarction or cerebrovascular event within 3 months
* Advanced liver disease
* Gastrointestinal dysfunction requiring parental nutrition
* Active malignancy excluding basal cell carcinoma of the skin
* Ejection fraction less than 30%
* Anticipated live donor kidney transplant
* Pregnancy, breast-feeding or child-bearing potential
* History of poor adherence to hemodialysis or medical regimen
* Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies that are contraindicated in magnetic resonance imaging.
* Inability to provide consent
Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.

During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Provided written informed consent.
* Have a reported history of dry eye
* Have a history of use or desire to use eye drops for dry eye symptoms
* Have corrected visual acuity greater than or equal to +0.7 in both eyes

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
* Have any planned ocular and/or lid surgeries over the study period.
* Have an uncontrolled systemic disease.
* Be a woman who is pregnant, nursing or planning a pregnancy.
* Be a woman of childbearing potential who is not using an acceptable means of birth control
* Have a known allergy and/or sensitivity to the test article or its components.
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Have used an investigational drug or device within 30 days of Visit 1
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.
* Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:

  * PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL);
  * Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease
  * Bone disease progression defined by two or more new lesions on bone scan

Exclusion Criteria:

* Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.
* History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).
* Patients who previously received treatment with Enzalutamide.
* Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8.
* Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery

Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mediastinotomy for cardiac surgical procedures

Exclusion Criteria:

Patients with:

* Allergies to skin adhesives
* Known keloid formation
* Prior sternotomies
* Conditions making them not candidates for vicryl skin closure
Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

This study will be a double blind randomized, controlled, parallel, study. A total of1 00 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into two groups by closed envelop method,

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients will be included.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
* Patients fit for anesthesia and surgery.

Exclusion Criteria:

* - Patients with BMI \>55 kg/m2.
* Patients with previous procedures for the treatment of obesity.
* Pregnant females and lactating women.
* Patients with psychological or psychiatric disease
* Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
* Patients who experienced vomiting within 24 hours before surgery.
* Patients with history of alcohol or drug abuse.
* Patients with hypersensitivity or contraindications to any of the drugs used in this study.
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve

The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.

The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.

The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.

Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.

Eligibility Criteria:
Inclusion Criteria:

* All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.

Exclusion Criteria:

Common:

* Do not attempt resuscitation (DNAR) orders
* Blunt, penetrating, or burn-related injury
* Patients with exsanguinations
* Known prisoners
* Known pregnancy
* Non-ROC EMS agency/provider

For Analyzing Late versus Early

* EMS-witnessed arrests
* Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)

For ITD:

* Tracheostomy present
* CPR performed with the mechanical compression "Autopulse" device.
Longitudinal Evaluation and Real-world Evidence of NT201

This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Planning treatment with incobotulinumtoxinA.

Exclusion Criteria:

* Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
* Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
* Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
* Any infection and/or inflammation at the planned injection points.
* Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points.

The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission.

This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).
* Patients with active disease defined as a Harvey-Bradshaw index \>4 and/or a C-reactive protein concentration \>5 mg/l.
* Informed consent.

Exclusion Criteria:

* Patients with ulcerative colitis.
* Patients treated in placebo controlled trials.
* Patients unwilling to participate or withdrawing informed consent for this study.
Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.

Balance impairment after stroke is significantly correlated with fall risk. To improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. Each exercise step will take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. The changes in balance performance and fall efficacy will be measured and compared within and between groups.

Eligibility Criteria:
Inclusion Criteria:

* First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
* Both sexes
* Age above 20
* Good cognition (Mini Mental State Examination Scale ≥24)
* Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
* Impaired balance (BBS \<41)

Exclusion Criteria:

* Recurrent stroke
* Associated with other neurological conditions (such as Parkinson's disease, Epilepsy, meningitis)
* Deficits of somatic sensation involving the paretic limb (Fugl-Meyer Assessment - sesation\< 1)
* Lower extremity weight bearing pain (Fugl-Meyer Assessment- pain \<1)
* Low back pain (VAS ≥ 3)
* Severe visual deficits which cannot be corrected by lens or glasses
* Symptomatic vestibular disorders (Paroxysmal postural vertigo)
* Associated serious cardiac disorder
Effect of Propranolol on Preventing Posttraumatic Stress Disorder

This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.

Posttraumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will assess the effect of post-trauma propranolol on reducing the incidence and severity of PTSD. The study will also evaluate propranolol's effectiveness as a preventive measure against subsequent PTSD symptoms.

Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event. Baseline psychometric and psychobiologic measurements will be collected. Within 6 hours following the traumatic event, participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propranolol or placebo twice daily. A 9-day medication tapering will follow. Participants will undergo psychophysiologic, psychodiagnostic, and psychometric testing for PTSD 1 and 3 months following the traumatic event.

Eligibility Criteria:
Inclusion Criteria:

* Experienced an acute psychological traumatic event
* Heart rate of 80 beats per minute (bpm) or greater
* Understands English

Exclusion Criteria:

* Traumatic event that occurred more than four hours before arrival to emergency department
* Physical injury that may affect safe participation (e.g., head injury)
* Systolic blood pressure less than 100 mm Hg
* Medical or surgical condition that poses a risk of shock
* Medical condition that may affect the safe administration of propranolol
* Previous adverse reaction to, or non-compliance with, a beta-blocker
* Current use of medication that may react badly with propranolol
* Elevated saliva alcohol level
* Presence of salivary opiates, marijuana, cocaine, or amphetamines
* Pregnant or breastfeeding
* Traumatic event reflecting ongoing victimization
* Psychiatric condition that may affect safe participation
* Unwilling or unable to commute to Boston for research visits
* Attending physician in emergency department does not advise participation