cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Written consents;
* Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
* Healthy obese or overweight subjects with BMI between 27 and 35.

Exclusion Criteria:

* History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
* Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
* History of drug abuse during the three years prior to screening;
* History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
* Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
* More than one lifetime episode of major depression;
* Currently working night shifts at a job;
* On average consumes greater than two cups of coffee or xanthine-containing beverages per day (\>200 mg/day) within the two weeks prior to screening;
* Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
* Aspartate aminotransferase or alanine aminotransferase \>2.5 x ULN;
* Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens

The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.

Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.

SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.

SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management

Eligibility Criteria:
Inclusion Criteria:

* Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
* SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
* Patient were consented to trial.

Exclusion Criteria:

* Chronic disease such as heart disease, liver, renal and severe sepsis
* History of anaphylaxis
* Skin rash
* Pregnancy
Clinical Findings in General Paresis

This is a study of the clinical and neuroimaging of general paresis. The investigators studied six patients with general paresis.

Inclusion Criteria:

* Mental disorders
* positive TPHA in CSF and sera
* HIV-negative serology by ELISA

Exclusion Criteria:

* Negative TPHA in CSF and sera
* No image data

Eligibility Criteria:
Inclusion Criteria:

* EEG MR

Exclusion Criteria:

* Serological test
Potential Role of CD9 and Implication of Motility Process in Pathogenesis of TEL/ALM1-positive ALL Relapses (LAL TEL/ALM1 and CD9).

Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).

1. Assess of the impact of CD9 expression level on motility assays (migration and adhesion) We have initiated motility assays (fibronectin adhesion experiments and CXCL12 chemoattracted migration tests with modified Boyden chamber technique) using the CD9 positive TEL/AML1-positive cell line REH and the CD9 negative cell line RAJI (wild or transfected with CD9 cDNA). Data will be analyzed in combination with blocking antibodies and chemical antagonist according to the level of CD9 (transcript and protein) and of CXCR4. Protein quantifications will be performed by flow cytometry and Western Blot. Interactions will be explored by confocal microscopy and biological pathways by immunoblot.

   Adhesion results will be validated on patient samples of B-ALL.
2. Post-transcriptional regulation of CD9 in TEL/AML1-positive ALL To identify miRNAs that are potentially deregulated in TEL/AML1-positive acute lymphoblastic leukaemia and especially to screen for CD9 -targeted miRNAs, we will use a TaqMan ®MicroRNA Arrays approach allowing the simultaneous measurement of about 760 human miRNA.

Small RNA will be extracted from bone marrow samples of twenty childhood B-ALL to screen miRNAs which are differentially expressed between CD9-positive and CD9-negative ALL and further compared with miRNAs which were predicted to target CD9 in databases. Validation of the selection will be performed by single Q-PCR for selected miRNAs using a novel cohort of ten bone marrow samples. Transfection assays and luciferase assays will be further realized to confirm that the differential miRNAs really target and affect CD9 expression .

Eligibility Criteria:
Inclusion Criteria:

* patients \> 1 year and ≤18 years
* with B-ALL diagnosis
* registered in Rennes for treatment
* written informed consent signed by all patients or their parents or legal guardian

Exclusion Criteria:

* Refusal to participate
* Inherited cytogenetic abnormalities
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile

Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.

Residual refractive errors(myopia 50% and hyperopia 30%) are the main problems at patients after IOL Implantation.

The residual refraction (myopic and hyperopic) after IOL Implantation is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition.

Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK).

Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis.

Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment.

The aim of our study is to investigate the effect of Relex-Smile to treat the residual refraction errors (myopia and hypermetropia) 6 months after IOL Implantation.

Before SMILE, Yag-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE ,there will be a diopter change. In pseudophakic patients with hyperopic astigmatism and residual refraction ,corneal topography-guided intrastromal fresh lenticular implantation should be performed and the lenticule was placed according to the low K value.

At myopic residual refraction(-0.75D till -5.50D) after IOL Implantation The method used at the EYE Hospital Pristina by ReLex-SMILE is safe and effective method, since there is no flap and this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.

At hyperopic residual refraction this study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant(-1.50D) that will be taken from myopic patients to implant on Pseudophakic patients with residual hypermetropia refraction (+1.0D) using VisuMax Femtosecond laser - Smile module surgery

Eligibility Criteria:
Inclusion Criteria:

* residual hypermetropic, myopic refraction on pseudophakic patients
* low visual acuity

Exclusion Criteria:

* active anterior segment pathologic features,
* previous corneal or anterior segment surgery,
* glaucoma,
* retinal detachment
The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children

To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite.

Two groups were treated with clear aligners and labiolingual springs Hawley and the study consisted of 30 patients, 15 patients in each group. Cast analysis and cephalometric analysis were performed at pretreatment and posttreatment. Quality of life was assessed at the end of treatment for both groups.

Eligibility Criteria:
Inclusion Criteria:

1. In the mixed dentition phase, aged between 7-12 years
2. With a dental Class I molar relationship according to Angle's classification
3. ANB within the normal range i.e. (the crossbite will be diagnosed as dental)
4. Exhibiting anterior crossbite (AC) in at least one permanent incisor in the sagittal plane
5. No prior orthodontic treatment for any reason
6. No history of maxillofacial trauma
7. No systemic diseases or syndromes that may interfere with treatment
8. Able to attend regular appointments and cooperate with instructions throughout the treatment process

Exclusion Criteria:

1. Patients with functional anterior crossbite associated with mandibular functional shift
2. Patients with clinically evident retrognathia or prognathia of the maxilla or mandible
3. Patients with severe gingivitis or periodontitis
4. Patients with known allergies to the materials to be used in the treatment
5. Patients with severe dental anomalies (e.g., supernumerary teeth, missing teeth, dental malformations)
6. Patients with serious emotional or psychological issues that may hinder treatment compliance
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
* Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
* BMI within the range of 25 - 45 kg/m2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to IMPs or related products
* Clinically significant concomitant disease or abnormal lab values
* Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Effects of Music on Post-Cesarean Pain, Anxiety, Breastfeeding and Mother Infant Attachment Impact

The physiological effects of music therapy include creating a behavioral change and changing the mood by reducing psychophysiological stress, pain, anxiety and isolation. Music has the ability to create deep relaxation. It is known to have relieving effects on insomnia. In addition, it has been reported that music therapy application before and during birth reduces labor pain and reduces postpartum anxiety and depression levels. The postpartum period, which begins with the birth of the newborn, covers the 6-8 week period that it takes for the changes that occur in the woman's body during pregnancy to return to its pre-pregnancy state. This period is an important transition period in which physical, social and emotional changes occur in mothers. In addition to rapid anatomical and physiological changes, mothers experience a difficult process in which the transition to motherhood is experienced, new roles and responsibilities are assumed, and relationships with their spouses and other family members are reorganized. Although a woman begins to feel the changes that having a baby creates in her daily life during pregnancy, she usually experiences the biggest change after the baby is born. The period when the first emotional bond between the newborn and her family is formed and a sense of trust develops is defined as mother-baby bonding. Many factors affect mother-baby bonding in the postpartum period, which is the most important time when the bond established between the expectant mother and the baby during pregnancy, referred to as prenatal bonding, is strengthened after birth. It is particularly affected by the mother's upbringing, as well as her experiences during pregnancy, birth, puerperium, and the baby's first months. Healthy and early interaction between mother and baby initiates a healthy bonding process.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Being in the third trimester (up to 2 weeks before the planned cesarean delivery date)
* Being primigravida
* Having a single fetus
* Not having a hearing problem
* Voluntarily participating in the study

Exclusion Criteria:

* Having any chronic disease
* Having a risky pregnancy condition (gestational diabetes, gestational hypertension, preeclampsia, etc.)
* Having a psychiatric medical diagnosis and using medication.
Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students

Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents


Eligibility Criteria:
Inclusion Criteria:

* at least 14 years of age;
* non-injecting use of heroin, cocaine or crack cocaine in the last six months;
* test HIV antibody negative;
* agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
* willing to return for visits at 1, 6, and 9 months post-enrollment;
* willing and able to provide informed consent.

Exclusion Criteria:

* history of injection drug use in the previous 3 years;
* pregnant;
Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa

The aim of the RCT is to analyse clinical and histopathological particularities for excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser, CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding, the need for additional electrocoagulation or sutures and patient's postsurgical perception of pain, other postsurgical effects and use of analgesics.


Eligibility Criteria:
Inclusion Criteria:

* Clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa
* Fibrous hyperplasia dimensions 0.5 to 2 cm
* Patient understands and reads the German language
* Written informed consent

Exclusion Criteria:

* Untreated diabetes Typ II
* Severe infectious disease (HIV, hepatitis)
* Severe psychiatric disease
* Immunosuppressive therapy
* Anticoagulation
* Pregnancy; a pregnancy test (Clearblue®) is performed in women of childbearing age
Multisystem Inflammatory Syndrome In Children at Sohag University Hospital

Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives .

Unlike adults, the vast majority of children with COVID-19 have mild symptoms. However, there are children who have significant respiratory disease, and some children may develop a hyper inflammatory response similar to what has been observed in adults with COVID-19. Furthermore, in late April 2020, reports emerged of children with a different clinical syndrome resembling Kawasaki disease (KD) and toxic shock syndrome; these patients frequently had evidence of prior exposure to SARS-CoV-2.

The pathophysiology of MIS-C:

Is unclear ,but it appears to be a consequence of a exacerbated immune system response or maladaptive response of the host .After the virus enters the human cells, the first line of defense against infection should be a quick and well-coordinated immune response ;however, when this mechanism is unregulated and excessive ,hyper inflammation can occur.

Cytokines that play an important role in inducing immunity and immunopathology during infections in excess can cause the clinical syndrome known as cytokine storm. The inflammatory response caused by SARS-CoV-2appears to be the major cause of mortality in infected patients .

The infection of dendritic cells or macrophages by SARS-CoV-2 induces the production of low levels of antiviral cytokines and increases the production of inflammatory cytokines (tumor necrosis factor\[TNF\], interleukin\[IL\]-1, IL-6,and interferon ).


Eligibility Criteria:
Inclusion Criteria:

Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .

1. Fever for ≥3 days.
2. Clinical signs of multi system involvement (at least 2 of the following):

   1. Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)
   2. Hypotension or shock
   3. Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)
   4. Evidence of coagulopathy (prolonged PT or PTT)
   5. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)

4. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).

according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.

Exclusion Criteria:

* Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.
Does Goal Elicitation Improve Patient Perceived Involvement

The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.

This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.

Eligibility Criteria:
Inclusion Criteria:

* New patients visiting the orthopaedic service
* English fluency and literacy

Exclusion Criteria:

* Returning patients
* Children
* Non-English speaking patients
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
* At least 18 years of age
* Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
* One or more measurable disease
* Adequate hematologic (neutrophil count \>= 1500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit (UNL)x2.5, bilirubin level =\< UNLx1.5, alkaline phosphatase =\< UNLx2.5), and renal (creatinine clearance \>= 30mL/min)
* Expected life time more than at least 2 months
* A patients who signed the informed consent prior to the participation in the study

Exclusion Criteria:

* A pregnant or lactating patient
* A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
* A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
* A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
* Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
* Uncontrolled serious infection
* Enrollment in other study within 30 days
* Hemorrhage on baseline radiologic examination
* A patient who refused to sign the informed consent
Study to Assess the Burden of Mild Outcomes (Physician Office Visits) Due to Influenza in the United States

This is a database study to quantify the burden of multiple mild outcomes (i.e., those that result in visits to a physician's office) attributable to influenza in the United States, stratified by age group, geographic region and influenza subtype for selected influenza seasons.

This is a retrospective database study to quantify the burden of multiple mild pre-defined influenza-attributable outcomes of interest, which resulted in physician office visits for persons who were less than 65 years of age, in the United States in the relevant Marketscan Commercial database in the period from July 2000 through April 2009, and October 2010 to May 2011. The corresponding physician office visits for persons 65 years of age and older, with a mild influenza-attributable outcome of interest, in the United States that were recorded in the relevant MarketScan Medicare Supplemental database in the period from July 2006 through April 2009, and October 2010 to May 2011 were also investigated. The period from April 2009 through September 2010 is excluded to avoid the H1N1 pandemic wave.

Eligibility Criteria:
Inclusion Criteria:

• Recorded in a Marketscan database with any of the specified diagnostic codes.

Exclusion Criteria:

• Missing data in any of the following fields: age, diagnosis, region or visit date.