cyrilzakka/clinical-trials huggingface dataset:
Infliximab Top-down in Pediatric Crohn

The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Sample size: We will include 100 (2 x 50) patients. With these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05; nQuery Advisor).

Study design: an international open-label randomised controlled trial Study population: Children (age 3-17 yrs) with new-onset, untreated, CD with moderate-to-severe disease activity Intervention: Patients will be randomised to either top-down IFX treatment or conventional step-up treatment.

Treatment arm 1: Top-down IFX treatment will consist of a total of 5 IFX infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral azathioprine (AZA) 2-3 mg/kg once daily. AZA therapy will continue after the last IFX infusion to maintain remission.

Treatment arm 2: Step-up treatment will consist of standard induction treatment by oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop. Prednisolone will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.

Main study parameters/endpoints: Clinical remission at 52 weeks without need for additional IBD related therapy or surgery. Secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth and adverse events.

Eligibility Criteria:
Inclusion Criteria:

Children (age 3-17 years, both male and female) with new-onset, untreated CD with moderate-to-severe disease activity assessed by a wPCDAI \>40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria.

Exclusion Criteria:

Patients with the following characteristics will be excluded: immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, active perianal fistulas, severe co-morbidity, severe infection such as sepsis or opportunistic infections, positive stool culture, positive Clostridium difficile assay, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy, those already started with CD specific therapy.
Parenting With Anxiety: Helping Anxious Parents Raise Confident Children

This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.

The study is an online course (derived from an existing evidence-based face-to-face workshop designed and evaluated by the C.I) which aims to reduce symptoms of anxiety in the children of anxious parents. It is a learning tool to help parents to understand the basic processes involved in children's anxiety, to develop a calm, consistent, behaviour management style and to learn skills for responding to difficult emotion in their children.

The whole study takes place online, allowing the participants to sign up, run through some brief eligibility questions, read the study information and provide consent.

Once enrolled in the study, there is a series of baseline questionnaires. The participant also has the option to nominate someone who also knows their child well (e.g. a co-parent, a family member or close friend) to participate in the study with them and to complete a small number of questionnaires. This will help to give us a broader, more objective picture of the child, but is an optional part of the study. 48 hours later (to allow time for the participants to contact the co-respondent if they choose) the index participant will be randomised to one of two groups: either the intervention (the online course), or the control group where they do not receive the intervention.

Those in the intervention will be randomised to receive 8 out of 9 modules of the course, with a suggested time frame of one or two modules a week, each module taking about 30 minutes, with some home-practice tasks in-between.

Both the intervention group and the control group participants will be contacted again after 6 months to complete a set of follow-up questionnaires (similar to those completed at baseline). Depending on when each participant joins the trial, they may be contacted a third time towards the end of the life of the study, to complete another set of questionnaires,9-21 months after their first.

Eligibility Criteria:
Inclusion Criteria:

* Be a parent (any gender, adoptive/biological/step/foster/grandparent) aged 16+, of a child aged 2 to 11 years (inclusive). The index parent must have at least 50 days' contact with the index child per year and confirm that they see enough of the child to report on the child's current anxiety level.
* Index parent must be a UK resident.
* Self-report subjectively substantial levels of current or lifetime anxiety.
* Able to commit to completion of measures at (up to) three time points even if allocated to the control arm.

Exclusion Criteria:

* N/A
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors

The primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly GS-4224) and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of evixapodlin in participants with advanced solid tumors.

This was a planned Phase 1/2 study. However, Phase 2 was not conducted because the study was closed due to sponsor decision prior to opening the dose expansion cohort and hence, RP2D analysis was not performed.

Eligibility Criteria:
Key Inclusion Criteria:

* Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
* Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
* Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
* Adequate organ function.

Key Exclusion Criteria:

* History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
* Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
* Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
* History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)

The aim of this study is to examine whether voice acoustic properties has an influence on sleep apnea. Sleep apnea syndrome is defined as a sudden stop of more than ten seconds multiple times during sleep. The syndrome is common especially among men and occurs in 2%-4% of the population aged 30-60. The syndrome diagnosis is performed by an ENT (Ear, Nose and Throat) physician. The diagnosis is based on evaluation of anatomical structures in the sound path (nose and throat, jaw, pharynx and oral cavity) and a Polysomnography (PSG) test which quantifies the number and duration of breathing pauses during night sleep and additional parameters that monitor sleep. The syndrome has many negative consequences for those who suffer from it, including fatigue , lack of concentration, hypertension, diabetes ,heart disease, stroke and even death. Therefore, early diagnosis is important.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older men who meet the criteria for disorders such as apnea.
* 18 years old men and older who meet the criteria of snores based on screening questionnaires.
* 18 years old men and older who don't suffer from disorders such as apnea and do not suffer from snoring.

Exclusion Criteria:

* Smoking Patients or smoked in the past.
* Having neurological disorders.
* Having swallowing trouble.
* Having Respiratory problems.
* Having Neuroendocrine problems.
* Having Voice disorders.
* Patients who were previously head or/and neck operated
Intraocular Lens (IOL) Calculation Improvement

Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.


Eligibility Criteria:
Inclusion Criteria:

* older 18
* clear cornea
* cataract
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.

OBJECTIVES:

* Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.

OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.

* Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
* Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
* Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.

Patients are followed every 3 months for 2 years, then every 6 months.

PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer
* No evidence of residual disease after surgery
* Tumor located above peritoneal reflection
* No distant metastases

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGPT less than 2 times upper limit of normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No serious cardiac ischemia

Other:

* Adequate metabolic functions
* No prior neoplasm
* No prior/concurrent illness
* No insulin-dependent diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy for the current cancer

Chemotherapy

* No prior chemotherapy for the current cancer

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy for the current cancer

Surgery

* Not specified
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial

The goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. We hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. Participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. After admission, (parents of) participating children will fill out questionnaires. We will compare the two groups on their hospitalization duration and recovery.

In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?


Eligibility Criteria:
Inclusion Criteria:

* 6 weeks to 12 years of age (corrected age for children with gestational age \< 37 weeks)
* hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, as diagnosed by the treating physician. Viral wheeze can only be diagnosed below the age of 6 years.
* requiring supplemental oxygen as per usual care (SpO2 \<92% or for treating symptoms of respiratory distress as determined by the treating physician

As respiratory distress in children with an asthma attack is mainly driven by hypoxia, they are at risk of undertreatment in the acute phase of the attack. Therefore, children aged 6-12 years of age with an asthma attack are excluded from this study.

Exclusion Criteria:

* children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency)
* children born \<32 weeks gestational age
* children already included in other studies, which potentially interfere with this study
* children (of parents) without a stable internet connection needed for answering questionnaires
* children previously included in the current study
* considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
Zink and Bone Strength

Zink and bone strength

blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women with osteoarthrosis or femoral neck-fracture i one hip

Exclusion Criteria:

pathology or prosthesis in contralateral hip
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).


Eligibility Criteria:
Inclusion Criteria:

* Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
* Good general health
* Signed informed consent

Exclusion Criteria:

* History of any treatment in the neck or chin area
* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems
A Deep Learning Method to Predict Difficult Laryngoscopy Using Cervical Spine X-ray Image

An unanticipated difficult laryngoscopy is associated with serious airway-related complications. The investigators developed a deep learning-based model that predicts a difficult laryngoscopy (Cormack-Lehane grade 3-4) from a cervical spine lateral X-ray using data from 14,135 patients undergoing thyroid surgery. This model showed excellent predictive performance, which was higher than that of other deep learning architectures. In this study, the investigators prospectively validate the model for predicting a difficult laryngoscopy and compare predictive power with clinical airway evaluation.

Predicting a difficulty of a laryngoscopy is important for patient safety, as an unanticipated difficult laryngoscopy is associated with serious airway-related complications, such as brain damage, cardiopulmonary arrest, or death. Although clinical predictors, such as the modified Mallampati classification, thyromental distance, inter-incisor gap, and the upper lip bite test, are used for airway evaluation in clinical practice, these indicators have low sensitivity and large inter-assessor variability and require patient cooperation.

The investigators developed a deep learning-based model that predicts a difficult laryngoscopy from a cervical spine lateral X-ray using data from 14,135 patients undergoing thyroid surgery. And this study is under submission.

This deep learning model showed the highest performance in predicting difficult laryngoscopy compared to other deep learning models (VGG-Net, ResNet, Xception, ResNext, DenseNet, and SENet) with a sensitivity of 95.6%, a specificity of 91.2%, and an area under ROC curve (AUROC) of 0.972.

However, as the model was a retrospective design using existing medical records, the presence or absence of cricoid pressure to obtain the optimal laryngoscopy was not evaluated, and not compared with airway evaluations.

In this study, the investigators prospectively validate the model for predicting a difficult laryngoscopy and compare predictive power with clinical airway evaluation. If this study prospective confirm our results, this approach can be helpful in improving patient safety and preventing airway-related complications through objective and accurate airway evaluation.

Eligibility Criteria:
Inclusion Criteria:

* elective thyroid surgery under general anesthesia

Exclusion Criteria:

* age \< 18 years
* no C-spine lateral X-ray image obtained within 3 months before surgery
* Patient who safety is not guaranteed when using a direct laryngoscope. (poor dental condition, risk of neck extension)
* Patients who not cooperate with the physical examination for airway evaluation
Induction of Cytokines in Human Monocytes by SARS-CoV in Adults and Children

Severe acute respiratory syndrome (SARS) is a new emerging infectious disease. Its pathogen is a newly discovered coronavirus (SARS-CoV). The clinical course can be classified to 3 stages: viral replication phase, hyperimmune reactive phase, and pulmonary destruction phase. Human monocyte plays a critical role in the initiation of immune response in defending the intracellular pathogens (eg viruses). Monocytes can engulf viruses and present the viral antigens in the major histocompatibility (MHC) molecule to the cell surface to initiate T lymphocyte response. Monocytes also secrete various cytokines to modulate immune response. SARS-CoV is a mutant of animal virus to cause human disease and is able to cause unusual severe respiratory illness. It is suggested the unusual severe disease is due to the intense immune reaction.

The investigators will harvest human monocytes from healthy adult and children blood donors. Monocytes would be cultured and infected by SARS-CoV. The change of viral load is monitored after infection. Cytokines secreted by monocytes after infection are also measured. The difference of monocyte cytokine secretion is compared between adults and children. The study is to verify the SARS-CoV infectivity of human monocytes and prove the unusual severity caused by SARS-CoV is related to viral-induced dysregulation of cytokine responses. The results may also clarify why adults tend to have a more severe illness compared with children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 20 to 50 years old
* Healthy children aged 2 to 5 years old
Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes \>2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.


Eligibility Criteria:
Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure \>50 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* excessive erythrocytosis
* other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* regular use of medication that affects control of breathing
* heavy smoking