cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis

In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years at the time providing signed informed consent
* At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
* Willing and able to comply with study requirements and visit schedule

Exclusion Criteria:

* Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening
Hyperglycemia in a Coronary Intensive Care Unit

Newly diagnosed hyperglycemia (NDH) and stress hyperglycemia (SH) during acute illness is reported as a non-physiological condition in hospitals. The investigators aim is to determine the rate of NDH and SH among cases admitted to coronary ICU with acute coronary disease and to inquire the relationship of SH with disease severity and functional outcomes such as longevity of ICU stay.

Patients with acute coronary heart disease admitted to the emergency room will be recruited consecutively. Admission plasma glucose (APG) and fasting plasma glucose (FPG); the first morning after admission, measurements will be obtained and each participant will be subjected to capillary glucose measurement (CGM) every six hours within the first day.

Patients will be separated into 4 groups:

GROUP 1: Normoglycemic cases GROUP 2: Newly diagnosed hyperglycemic cases Group 2a: Unrecognized diabetes, hbA1c: \>6.0% Group 2b: Stress hyperglycemia \<6.0%. GROUP 3: Known diabetes Age, gender, co-morbidities on admission, adverse outcomes in hospital, duration of stay in coronary ICU, deaths, drugs, and glucose levels will be all recorded.

Throughout the hospital stay of Group 2 and Group 3, CGMs were performed and treated when necessary (target glucose\<180mg/dl).

Acute Physiology and Chronic Health Evaluation II (APACHE-II); a severity of disease classification system was used for each case.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room

Exclusion Criteria:

* Patients admitted to coronary ICU from other hospital wards
* Patients with any disease that will need drugs that may interfere with blood glucose negatively (mannitol, glucocorticoids, vasopressor agents, etc.)
Cystic Fibrosis (CF) Flow Rates Study

We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* CF
* FEV1 ≥ 30% and \< 90% predicted

Exclusion Criteria:

* Be considered "terminally ill" or listed for lung transplantation
* Have had a lung transplant
* Have had a significant episode of haemoptysis (\>60 ml) in the three months prior to enrolment
* Have had a myocardial infarction in the three months prior to enrolment
* Have had a cerebral vascular accident in the three months prior to enrolment
* Have had major ocular surgery in the three months prior to enrolment
* Have had major abdominal, chest or brain surgery in the three months prior to enrolment
* Have a known cerebral, aortic or abdominal aneurysm
* Be breast feeding or pregnant
* Be using beta blockers
* Have unstable asthma
The Use of Warmed Saline in Vaso-occlusive Episodes

The purpose of this study is to determine if warming the intravenous (IV) fluid given to patients with Sickle Cell Disease who are experiencing painful episodes known as Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV pain medications given, improve pain and improve global comfort.

Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is the primary reason that these patients seek medical care in the acute care setting. This complication arises when blood vessels are obstructed by sickled red blood cells resulting in ischemic injury.

The standard management of these painful episodes comprises the administration of opioid analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These episodes often last five to seven days and many patients require inpatient management for continued administration of intravenous analgesics.

The public health impact of the disease is large as admissions frequently result in school or work absences and can be financially and emotionally taxing.

It is well established that exposure to cold precipitates VOC. For this reason, management of the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain relief. It is conceptually appealing to conjecture that warm fluids might have similar salutary effects on VOC. This conjecture is bolstered by the physiologic effect of temperature on vascular tone. Specifically, it is well established that cold temperatures cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic areas.

Eligibility Criteria:
Inclusion Criteria:

* Vaso-occlusive Episode defined as a pain rating of 3 or above on the Wong-Baker FACES score in a child with an established diagnosis of sickle cell disease (SS, SC or S β Thalassemia)
* 4-21 years of age

Exclusion Criteria:

* fever (temperature greater than 38 degrees Celsius)
* inability to complete FACES pain scale
* evidence of acute chest syndrome clinically or radiographically
* deemed by attending physician to be so ill as to need immediate hospital admission.
TreatPaCS = Treatment for Preschool Age Children Who Stutter

Treatment for preschool age children who stutter: a randomised, multicentre, non-inferiority parallel group pragmatic trial with Mini-KIDS, the social cognitive behaviour therapy and the Lidcombe Program with 249 children

Three treatment approaches for preschool age children who stutter are delivered and %Syllables Stuttered at 18 months post-randomisation of the three arms are compared .

Mini-KIDS is a direct treatment based on principles of stuttering modification, with pseudo-stuttering, that is, deliberate stuttering, as one of the main components. The program for 4-6-year old children consists of four stages: Stage 1 = desensitization, Stage 2 = modification, Stage 3 = identification and Stage 4 = generalization. The program for 2-4-year old children does not include stage 3. Speech therapist and parent(s) are the speech model for the child. They add normal dysfluencies to their speech. Later on in treatment and if necessary, children learn to recognise and alter their stuttering moments.

The social cognitive behaviour therapy contains 5 treatment phases: (1) conditioning speaking activities, (2) cognitive training focused on emotions, (3) cognitive training focused on cognitions, (4) emotional training and (5) skill training (Boey, 2010). This treatment is not directed at the speech of the children, but rather at the cognitive and emotional aspects that surround the stuttering.

The Lidcombe Program (LP) is an operant program that directly provides verbal feedback to the child's stutter-free speech (mainly) and the child's stuttering (occasionally). The program comprises two stages: Stage 1 in which (near) zero levels of stuttering are achieved and Stage 2 in which the achieved (near) zero levels of stuttering are maintained for a long period of time. The LP usually takes between 11 to 23 (60-minute) treatment sessions to achieve the goals of Stage 1, i. e. (near) zero levels of stuttering.

Eligibility Criteria:
Inclusion Criteria:

Preschool age children must

* stutter (identified by the Speech-Language Therapist)
* be aged between 2 - 6.5 years
* have normal hearing reported by the parent(s)
* have, if bilingual, a parent who speaks a language that the SLT understands and speaks to allow clear communication
* have at least one parent agreeing to be intensively involved in treatment and knowing that s/he will implement treatment at home
* have at least one parent who is willing and able to videorecord his/her child regularly

Exclusion Criteria:

- have a syndrome such as Down Syndrome.
Prosthetic Hip Infections: Prospective Study

Data from large prospective cohort studies of prosthetic joint infections are lacking.

Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.

Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population

* all patients who consented to participate in the study with prosthetic hip infections treated by:
* debridement-synovectomy for acute infection or with one-stage or two-stage
* exchange arthroplasty or resection arthroplasty for chronic infection
* antibiotic therapy

Outcome:

* Follow-up: minimum of 2 years
* Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip arthroplasty infection
* Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection
* Antibiotic therapy
* Signed informed consent

Exclusion Criteria:

* Prolonged suppressive antibiotic therapy
* No surgical treatment
Prophylactic Environmental Management of Delirium

Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.

A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.

Eligibility Criteria:
Inclusion Criteria:

* Above 65 years of age and one of the following:
* Age above 70 years.
* Alcoholism
* Cognitive deficit (Mini mental state examination \<24 points)
* Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)

Exclusion Criteria:

* Delirium at admission.
* Admittance to a ward other than general internal medicine.
* Lack of family support.
* Informed consent refusal.
* Hospitalization in a room with more than two beds.
Interprofessional Education of Medical Students Using Medical Simulation

Due to the growing role of medical simulation in the education of medical students and the development of cooperation in interdisciplinary teams in the health care sector, a study was designed to examine the relationship between the competences and resources of students and the role of education through simulation classes based on the development of technical and in cooperation with specialists in these fields. Researchers want to focus on students' levels of stress and anxiety, coping strategies, and self-efficacy. An important element will be the self-assessment of students on the level of their non-technical competences.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary consent to participate in the study
* Declaration of participation in the Interdisciplinary Simulation Circle
* Student status in the field of medicine (6th year) or nursing (3rd year of first-cycle studies) or medical rescue (3rd year)

Exclusion Criteria:

* Completed another course of medical studies
Supportive Periodontal Therapy Under Antiresorptive Therapy

This observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing supportive periodontal therapy (SPT) after completing anti-infectious therapy (AIT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg
* Regular attendance to SPT (no interruption of interval of more than one year)
* Existing radiographs (orthopantomogram or dental status) of up to six months before AIT
* ART-group: patients on antiresorptive medication (underlying diseases: osteoporosis, cancer diseases)
* Understanding of participation in this study and given informed consent

Exclusion Criteria:

* Patients \< 18 years
* Patients who underwent radiation therapy
* Pregnancy
Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division

EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of lung cancer
* enlarged mediastinal or hilar lymph nodes (\>10 mm)

Exclusion Criteria:

-
Pyroxamide in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.

OBJECTIVES:

* Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
* Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
* Describe the pharmacologic behavior of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for resolution of adverse events.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor or hematologic malignancy

  * Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available
* Measurable or clinically evaluable disease

  * Elevated tumor marker is acceptable for evaluable disease
* No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 125,000/mm\^3
* Hemoglobin at least 9.0 g/dL

Hepatic

* Bilirubin normal
* AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* PT no greater than 1.5 times ULN

Renal

* Creatinine normal

Other

* HIV-positive status allowed
* Prior malignancy allowed
* No severe physical or emotional illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent bone marrow growth factors

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* See Disease Characteristics
* At least 4 weeks since prior wide-field radiotherapy and recovered
* At least 2 weeks since prior limited-field radiotherapy and recovered
* Recovered from prior radiotherapy

Surgery

* See Disease Characteristics

Other

* No other concurrent antitumor treatment
Type 1 Diabetes Prediction and Prevention (DIPP) Study

The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.

Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.

Eligibility Criteria:
Inclusion Criteria:

* Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland

Exclusion Criteria:

* Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

Exclusion Criteria:

* Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate
Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue

Evaluate the effect of the photobiomodulation mode of the diode laser on the anaesthetic area and find the best parameter that would accelerate the withdrawal of anaesthesia.

A randomized clinical trial will be performed at the Pedodontics Out Paediatric Clinic at the Facility of Dental Medical for girls. Al Azhar University has twenty patients with upper or lower first primary molars on the right and left sides that need to be treated. Using the split-mouth technique, the mouth will be split in two halves. The first half represents the first group, and the second half represents the second group.

Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser (low-level laser therapy).

Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.

To avoid bias in the 2nd group, the laser will be applied on this side, but in turned-off mode. The type of anaesthesia that will be evaluated is articine hydrochloride 4% with 1:200 epinephrine (vasoconstrictor).

Eligibility Criteria:
Inclusion Criteria:

Parents have to complete the written consent form. Patient who behaved well. Children aged from 6 to 12 years can evaluate soft tissue anaesthesia. Patients that require treatment with bilateral upper or lower first primary molar infiltration under anaesthesia.

Exclusion Criteria:

Patients who are mentally disordered or hand-capped. uncooperative patients.
Strengthening Emotional Regulation: a Group Intervention with Adolescents

The goal of this clinical trial is to determine the initial efficacy of an emotional regulation skills training (ERST) intervention program in a group of adolescents presenting mild symptoms affecting their ability to regulate emotions. For this purpose, a sample of 1st and 2nd-year high school students (ages 14-16) will be recruited, and the intervention will be conducted on the educational institution's premises during school hours. The main questions it aims to answer are:

Does the ERST intervention reduce symptom levels in adolescents with mild emotional dysregulation? Does the ERST intervention improve emotional regulation skills in adolescents? Researchers will compare pre-intervention (T1) and post-intervention (T2) outcomes, as well as follow-up assessments at 3 months, to evaluate changes in symptom levels and emotional dysregulation. Additionally, a blinded teacher assessment will be conducted at T1 and T2 to evaluate symptom levels.

Participants will:

Attend the ERST intervention sessions during school hours. Complete self-report assessments at four time points (T1, T2, and 3-month follow-up).

Be evaluated by a blinded teacher at T1 and T2.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents in their first or second year of high school.
* Must be currently enrolled in school.
* They should be referred for emotional dysregulation issues and require mental health support.
* They must score above the 75th percentile on the total scale of the SDQ screening tool

Exclusion Criteria:

* Adolescents who are regularly receiving psychological treatment