cyrilzakka/clinical-trials huggingface dataset:
Effect of Aerobic Exercises on Static & Dynamic Balance

To determine the effect of aerobic exercises on static \& dynamic balance of children in Down syndrome. When a person has Down syndrome, they have an extra chromosome. In the body, chromosomes are discrete collections of genes. They control how a baby's body develops and works both throughout pregnancy and after birth. A newborn typically has 46 chromosomes. Down syndrome is a genetic disorder that affects physical and developmental growth and can cause minor to severe issues. Mental impairment, unusual facial features, an increased risk of cardiac defects, and digestive issues that can range in severity from mild to severe are all symptoms associated with the syndrome.

This will be a randomized controlled trial. Total sample size of 20 will be divided into control and experimental groups. Control group will be given with the standard physical therapy intervention as a baseline treatment while experimental group will be given with the aerobic exercise along with baseline treatment. Pediatric balance test and the six-minute walk test will be used before and after the intervention. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.

Eligibility Criteria:
Inclusion Criteria:

* Children with medical diagnosis of DS
* Children with mild (IQ 50-70) to moderate (IQ 35-40) mental retardation
* Age 5-12 Years
* Children who were able to stand and walk

Exclusion Criteria:

* Recent injury to lower extremities
* History of or ongoing vestibular neuritis
* Use of Walking Aids
Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 3 months and 5 years
* Children admitted to a pediatric ward

Exclusion Criteria:

* Children with chronic diseases of the respiratory , gastrointestinal , renal system;
* Children with malformations of the cardiovascular system ;
* Children with immune deficiencies ;
* Infants born preterm ( gestational age \< 37 weeks ) ;
* Children with congenital metabolic diseases ;
* Children Who received probiotics before enrollment ( up to 7 days before hospitalization)
Pharmacokinetics of Intranasal Ketorolac in Children

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.

The intranasal (IN) route of administering medications is an effective means of delivering analgesics to children in a painless and minimally distressing manner, especially in comparison to traditional means of intravenous (IV) or intramuscular (IM) administration, which require a painful and distressing needle stick.

Ketorolac is an analgesic that is commonly administered to children, and can be given by the IN route, in addition to the IV and IM routes. However, the pharmacokinetics of intranasal ketorolac when administered in children has only been described in a limited fashion. The administration of IN ketorolac in children, using the proprietary SPRIX device, which atomizes a fixed amount of ketorolac, produces serum concentrations of ketorolac that are associated with analgesia. However, the concentrations of ketorolac achieved using a mucosal atomization device (MAD) has not yet been evaluated in children presenting to the emergency department. The MAD is a plastic device that attaches to the top of a syringe (see figure). The MAD is much more commonly used for atomizing medications; allows a variable dosage to be administered; and has been shown to be a means of effectively delivering other analgesics and sedatives intranasally.

The purpose of this study is to assess the pharmacokinetics of IN ketorolac when using a MAD to deliver the medication in children presenting to the emergency department. We will determine the maximum serum concentration achieved (Cmax), time to maximum serum concentration achieved (Tmax), and bioavailability (compared to IV ketorolac) when ketorolac is administered intranasally using a MAD.

Eligibility Criteria:
Inclusion Criteria:

* Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.

Exclusion Criteria:

* Known allergy to ketorolac
* Contraindication to receiving ketorolac
* Receiving any NSAID within the past 6 hours
* Presence of an intranasal obstruction that cannot be readily cleared using suction or nose-blowing
* Inability to speak English or Spanish
* Critical illness
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension

This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to standard of care. This observational study collected clinical data and biologic specimens from patients who were treated for portopulmonary hypertension (PoPH), with a goal of achieving hemodynamic parameters appropriate for orthotopic liver transplantation candidacy, including mean pulmonary arterial pressure (mPAP) less than 35 mmHg and pulmonary vascular resistance (PVR) less than 3 Wood-units (WU) at Week 24 in patients with severe PoPH.

Treprostinil is approved as a continuous subcutaneous (SC) or intravenous (IV) infusion by the FDA for the treatment of WHO group I PAH with New York Heart Association (NYHA) Functional Class II, III or IV symptomatology. To date, treprostinil has not been studied in the setting of PoPH; however, it is commonly prescribed in this setting. This was an observational, open-label, multicenter study which documented the safety and efficacy profile of this agent in PoPH to facilitate orthotopic liver transplantation (OLT).

Eligibility Criteria:
Inclusion Criteria:

* Patients must:

  1. Had portal hypertension.
  2. Be otherwise suitable candidates for OLT.
  3. Had severe pulmonary arterial hypertension (PAH) defined as a resting mean pulmonary arterial pressure (mPAP) \>35 mmHg and pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) by right heart catheterization (RHC) performed as part of standard of care evaluation within 90 days of enrollment.
  4. Treprostinil therapy must be recommended by the treating physician per standard of care.
  5. Be NYHA Functional Class II, III, or IV.
  6. Had pulmonary capillary wedge (PCW) pressure ≤18 mmHg and transpulmonary gradient (TPG) ≥15 mmHg.

Exclusion Criteria:

* Patients must not:

  1. Had received any any investigational therapy as part of a clinical trial for any indication within 30 days prior to enrollment.
  2. Had a change in dose of treatment for PAH (bosentan \[Tracleer\], ambrisentan \[Letairis\], tadalafil \[Adcirca\], or sildenafil \[Revatio\]), within 30 days prior to enrollment. That is, subjects may have been treated with any of these agents provided the dose was stable for at least 30 days prior to enrollment.
  3. Had renal failure requiring hemodialysis.
Objective Measurements of the Opacification of the Lens After Vitrectomy

Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
* Bilateral phakic patient

Exclusion Criteria:

* Vitrectomy combined with cataract surgery
* Pregnant or breastfeeding woman
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants

Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former conflict regions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The treatment program Formation, Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior. Addressing trauma-related mental disorders as well as emotions related to aggression by means of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled violence.

The investigators want to provide evidence, that FORNET is an effective and efficient module to assist soldiers after deployment in Somalia and/or male and female ex-combatants who fought in the civil war in Burundi. In addition the investigators aim to explore how traumatic incidences and maltreatment during childhood may influence treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale,
* High degree of appetitive aggression,
* Violent behavior during the past three months

Exclusion Criteria:

* Current use of mind altering drugs,
* Psychotic symptoms
Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Population

A questionnaire that can measure disease severity from the patients perspective in patients with pectus excavatum already exists in English (Pectus Excavatum Evaluation Questionnaire; PEEQ). This questionnaire was recently translated into Dutch. Before this Dutch version can be used, it needs to be tested by a number of patients.

Data will be collected at three moments:

1. Preoperatively: The PEEQ will be completed on paper during the outpatient clinic visit.
2. Postoperatively: The PEEQ will be completed electronically 2 months post-surgery.
3. Test-retest reliability: The PEEQ will be administered electronically at least two weeks after a previous assessment.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be pectus excavatum patients aged 12 to 18 years old who are scheduled for a Nuss procedure. Parents or legal guardians will also be invited to complete the parent section of the PEEQ.

Exclusion Criteria:

* Exclusion criteria will be the inability of the patient or their parent/guardian to complete the corresponding section of the questionnaire due to language barriers.
The Effect of Tranexamic Acid for Total Hip Arthroplasty

The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

Eligibility Criteria:
Inclusion Criteria:

* ASA 2-3
* 18-75 age
* total hip arthroplasty surgery
* regional anesthesia

Exclusion Criteria:

* allergies to drug
* liver and kidney failure
* ischemic heart disease
* coagulopathy
Efficacy and Tolerability of Xalatan in Patients

Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

* Efficacy data not collected or analyzed
* Safety and tolerability of Xalatan assessed NA

Eligibility Criteria:
Inclusion Criteria:

* Patient with ocular hypertension at least 22mg Hg
* Patient must be over 18 years old

Exclusion Criteria:

* None listed in the protocol
Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed).
2. ECOG score ≤ 2, expected survival ≥ 3 months.
3. Histology or cytology confirmed as breast cancer.
4. Prior to trastuzumab and endocrine therapy and progression/recurrence.
5. At least one RECIST 1.1 defined measurable lesions.
6. Normal function of major organs.

Exclusion Criteria:

1. pregnant or lactating women
2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy.
3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline).
4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.)
5. Patients with central nervous system disorders or mental disorders
6. Bone metastasis lesions only, no other measurable lesions.
7. Hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg) without ideal control.
8. Uncontrolled heart disease.
9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome.
10. Uncontrolled rain metastasis.
Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI

The overarching goal of this study is to develop PET/MR techniques to accurately detect nodal metastases for surgical planning and assessment of treatment response.

Patients (n = 30) with head and neck cancer who are scheduled for node dissection surgery are eligible. Enrolled subjects will undergo one research PET/MR scan at the Center for Biomedical Imaging (660 First Avenue) within one week prior to the planned surgery. During the dissection, the locations of removed lymph nodes will be noted in terms of conventional neck lymph node levels. PET/MR data will be used for development of a combined kinetic model analysis of PET and MRI data (Aim 1). The final PET/MR findings will be compared with pathological evaluation results in order to assess the accuracy of PET/MR for detection of nodal metastases (Aim 2).

Eligibility Criteria:
Inclusion Criteria:

Patients with head and neck cancer who are scheduled for node dissection surgeries at NYU Langone Medical Center or Bellevue hospital are eligible.

Exclusion Criteria:

Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.

* Electrical implants such as cardiac pacemakers or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
* Ferromagnetic objects such as jewelry or metal clips in clothing
* Claustrophobia
* History of seizures
* Diabetes In addition, patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
Study of an Investigational Glucose Meter System

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* Type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Pregnancy
* Hemophilia or any other bleeding disorder
* Previously participated in a study using the G3 system
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
* A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
* Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients

A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control.

There is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events.

The COPE trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who are required a combination therapy with sitting systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
* Outpatients aged over 40 years and less than 85 years (inclusive), regardless of sex.
* Previously untreated patients or patients who are on other therapy, which can be converted to 4mg of benidipine.
* Patients who can be treated with benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.

Exclusion Criteria:

* Seated systolic blood pressure ≥ 200 mmHg or seated diastolic blood pressure ≥ 120 mmHg.
* Secondary hypertension.
* Type I diabetes mellitus or type 2 diabetes on insulin treatment.
* History of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study.
* Heart failure (New York Heart Association \[NYHA\] functional classification II, III or IV).
* Chronic atrial fibrillation or atrial flutter.
* Congenital heart disease or a history of rheumatic heart disease.
* Severe peripheral arterial disease (Fontaine Class II, III or IV).
* Serious liver dysfunction (AST or ALT ≥100 IU / l).
* Serious renal dysfunction (serum creatinine ≥ 2mg/dl).
* History of malignancy 5 years prior to study entry.
* Pregnancy.
* Compliance rate \< 70% assessed by a patient interview.
* Known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.
* Other serious illness or significant abnormalities that the investigator judges inappropriate for the study