cyrilzakka/clinical-trials huggingface dataset:
Hypoallergenicity of a Hydrolyzed Protein Infant Formula

Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.

Eligibility Criteria:
Inclusion Criteria:

1. Infants and children aged up to 3 years.
2. Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:

   1. Physician-supervised double-blind oral food challenge; or
   2. Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
   3. Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level \> 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm).
3. Willing to switch to a different hypoallergenic formula
4. On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
5. Expected minimal consumption of 144ml of test product/day during the open challenge.
6. Written informed consent provided by parents/guardians, according to local law.

Exclusion Criteria:

1. Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
2. Diagnosis or known allergy to any of the ingredients in the test product.
3. Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
4. (Twin / triplet) sibling of an infant/child already participating in the study.
5. Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements.
6. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
7. Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.
Corneal Stroma Implantation for the Treatment of Keratoconus

The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.

Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced and completed keratoconus patients
2. Voluntarily signed informed consent
3. No surgery and anesthesia contraindications

Exclusion Criteria:

1. Acute edema of cornea
2. Primary keratoconus patients
3. The patients combined systemic diseases
4. Reject study and follow visit
5. Cannot tolerate surgery or anesthesia
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children

The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.

Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical.

The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims:

1. Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference).
2. Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity).
3. Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life).
4. Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention.

It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.

Eligibility Criteria:
Inclusion Criteria:

* BMI 85th percentile and above, otherwise healthy
* Age between 8-11 years old

Exclusion Criteria:

* Diagnosis of metabolic syndrome
* Diagnosis of type 2 diabetes
* Diagnosis of Mental Retardation
Heart Rate Changes Following the Administration of Sugammadex

This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 0-18 years
* Anesthetic plan includes NMB reversal with sugammadex

Exclusion Criteria:

* Sugammadex not used during the case
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.

Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.

Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.

Eligibility Criteria:
Inclusion Criteria:

* lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.

Exclusion Criteria:

* patients with systemic diseases like cardiovascular disease
* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
* pregnant/lactating females
* tobacco users
* alcoholics
* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
* Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.
A Prospective Real World Study of Rimegepant in the Treatment of Migraine

The goal of this observational study is to test the effectiveness and safety of Rimegepant in the treatment of migraine patients in real world.

The main questions it aims to answer are:

* \[question 1\] the effectiveness and safety of Rimegepant in the acute treatment of migraine
* \[question 2\] the effectiveness and safety of Rimegepant in the long-term treatment of migraine.

  1. Participants will be asked to take Rimegepant when they need to treat or prevent a migraine attack.
  2. Participants will be asked to record the efficacy data at 0.5, 1, 2, 24, 48h post dose and report any AE to evaluate the effectiveness and safety of Rimegepant in the acute treatment of migraine
  3. Participants will be asked to track monthly migraine days and the use of Rimegepant, finish 2 PROs during the follow-ups, report any AE to evaluate the effectiveness and safety of Rimegepant in the long-term treatment of migraine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed as migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, beta version
* Rimegepant is prescribed by the physician for the treatment of patients with migraine.
* Patients signed written informed consent.
* Male and Female subjects ≥ 18 years and older
* Patients is not participated in other concurrent interventional clinical studies.

Exclusion Criteria:

* The patients with severe visual, hearing, language, intelligence, memory, and consciousness disorders, are unable to cooperate with the completion of the questionnaire and follow-up.
* Pregnant patients
* Lactating female patients
* Patients who are highly dependent on medical care.
Coronary Artery Aneurysm Registry

International registry gathering patients with angiographically confirmed coronary aneurysm.

INTRODUCTION AND RATIONALE:

Coronary artery aneurysm is defined as coronary dilatation which exceeds the diameter of normal adjacent segments or the diameter of the patient's largest coronary vessel by 1.5 times. Described by Bourgon, it is an uncommon disease which has been diagnosed with increasing frequency since the advent of coronary angiography. The incidence varies from 1.5% to 5% with male dominance and a predilection for the right coronary artery.

Although several causes have been reported, atherosclerosis accounts for 50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture and vasospasm, causing ischemia, heart failure or arrhythmias. The natural history and prognosis remains obscure, since definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic) or interventional/surgical procedures.

OBJECTIVES.

Taking into account the classical coronary aneurysm definition, the investigators propose:

* ANATOMIC OBJECTIVES.

  * To characterize coronary aneurysms frequency over all cause invasive coronary angiography.
  * To describe anatomy, location and aneurysms features.
  * To assess intracoronary imaging data if available.
  * To describe the natural history, when evolutive chats were available
* CLINICAL OBJECTIVES.

  * Cause for the diagnostic catheterization and aneurysms symptoms, if present.
  * Patient´s clinical features.
  * Long-term outcomes.
* THERAPEUTIC OBJECTIVES.

  * To assess management strategies, conservative, interventional or surgical and its short and long term results.
  * Outcomes regarding management.

DESIGN:

* Retrospective recruitment, prospective follow-up registry.
* Multicentric/international.
* Anonymized.
* Electronic database. Centralized analysis (core) at Hospital Clínico San Carlos.
* Recruitment: 1/january/2002-1/december/2015.

Eligibility Criteria:
Inclusion Criteria (angiographic diagnosis):

* Coronary aneurysm: focal coronary dilatation which exceeds the diameter of normal adjacent segments or the diameter of the patient's largest coronary vessel by 1.5 times.

Exclusion Criteria:

* Patient ´s refusal to participate.
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.


Eligibility Criteria:
Inclusion Criteria:

* History of dry eye syndrome (KCS) for a period of at least 6 months
* Clinical diagnosis of bilateral KCS
* Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
* Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
* Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion Criteria:

* Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
* Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
* Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
* Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
* Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
* Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
* Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
* History of herpes keratitis.
* Corneal transplant
* Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
* Cataract surgery within 3 months prior to the Screening Visit.
An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

Retrospective study to comply with FDA's post-market surveillance order. The purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Patients who have not been revised prior to contact will be asked to submit to a blood draw, clinical exam and MRI.

This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers.

The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.

Eligibility Criteria:
Inclusion Criteria:

* patient meets the sampling plan requirements

Exclusion Criteria:

* patient is contraindicated for MRI
* patient fails to consent for the study
Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China

The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.


Eligibility Criteria:
Inclusion Criteria:

* apparent health;
* Hb concentration\>60 g/L;
* C-reaction protein (CRP)\<10 mg/L;
* parental or guardian approval of participation in all aspects of the study; and
* parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation.

Exclusion Criteria:

* does not match the inclusion criteria
Emergency Ketamine Treatment of Suicidal Ideation

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment

Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Ages 18-65
3. All races and ethnicities
4. Willing and able to provide informed consent
5. A cutoff score of \>3 on the Beck Scale for Suicidal Ideation
6. \>2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria:

1. Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
2. Post-partum state (within 2 months of delivery)
3. Homicide risk as determined by clinical interview
4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:

   1. Any current primary psychotic disorder
   2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
   3. use of any hallucinogen (except cannabis), in the last month
   4. Any dissociative disorder
   5. Pervasive developmental disorder
   6. Cognitive disorder
   7. Cluster A personality disorder
   8. Anorexia nervosa.
5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
6. Any known hypersensitivity or serious adverse effect with ketamine
7. Any clinically-significant medication or condition that would preclude the use of ketamine
Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

The study aims to evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.

The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score \<3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50
* PSA between 2.5 and 4.0ng/ml
* (Eastern Cooperative Oncology Group)ECOG grade: 0-1
* Normal organic function indexes:
* (absolute neutrophil count)ANC ≧1.5×109/L
* (platelet count)PLT ≧100×109/L
* Hb ≧90 g/L
* (total bilirubin)TBIL ≦1.5×ULN
* (aspartate aminotransferase)ALT≦2.5×ULN
* (alanine aminotransferase)AST ≦2.5×ULN
* (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN

Exclusion Criteria:

* Former serum PSA detection
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
* No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

Exclusion Criteria:

* History of liver disease other than NASH
* History or evidence of cirrhosis
* History of pancreatitis
* History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
* History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
* Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack