cyrilzakka/clinical-trials huggingface dataset:
Augmented Reality Medical Simulation

In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.


Eligibility Criteria:
Inclusion Criteria:

* Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
* 18 years and older

Exclusion Criteria:

* Have a history of severe motion sickness
* Currently have nausea
* History of seizures
* Are clinically unstable
* Currently using corrective glasses (not compatible with AR headset)
Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma

The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main inclusion criteria:

* History of persistent bronchial asthma

Main exclusion criteria:

* Hypersensitive to compounds of Alvesco
* Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, 450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

Eligibility Criteria:
Inclusion Criteria:

* evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
* on hormone replacement therapy
* postmenopausal
* increased risk of developing breast cancer based on personal or family history
* never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
* women who have a high risk of breast cancer
* older than 18 years

Exclusion Criteria:

* no anticoagulants
* no marked breast tenderness
* not pregnant or within twelve months of breast feeding/childbirth
Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.

Fluid deresuscitation has been shown to have favourable outcomes in the management of the critically ill patient. Whilst diuretic medications have previously been the mainstay of achieving this deresuscitation, the metabolic and biochemical complications associated with their use can limit their application. Mechanical ultrafiltration is another means of achieving fluid deresuscitation and has theoretical benefits over the use of intravenous diuretics. It allows a more titratable process, without the potential metabolic complications. The use of ultrafiltration has been limited by the requirement of wide bore central venous access. The SCUFFD study is a means of assessing whether ultrafiltration with regional anticoagulation can be achieved through standard central or peripheral venous access.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Evidence of fluid overload (greater than trace amount of peripheral oedema in \>1 site, pulmonary oedema on chest radiograph, or positive fluid balance equivalent to \>5% body weight)
* Clinician intention to target a negative fluid balance
* Expected to remain in a critical care setting beyond the next calendar day

Exclusion Criteria:

Anticipated unavailability of suitable vascular access

* Lack of commitment to full support
* Receiving or imminently planned to receive renal replacement therapy
* Hyponatraemia (Sodium \<130mmol/L)
* Hypernatraemia (Sodium \>150mmol/L)
* Significant metabolic alkalosis (Bicarbonate\>30 and pH\>7.5)
* Significant metabolic acidosis (HCO3- \<18 mmol/l and pH \< 7.30)
* Uncorrected hypokalaemia (Potassium \<3.0mmol/L)
* Liver failure (Child-Pugh Grade B or above)
* Shock (any of: lactate \>3mmol/L, extensive skin mottling, central capillary refill time\>3 seconds, more than 1 vasoactive agent in use, noradrenaline dose \>0.2 mcg/kg/min, use of dobutamine, adrenaline, milrinone, enoximone or levosimendan)
* Receiving any systemic anticoagulation other than for routine venous thromboembolism prophylaxis, or dual antiplatelet therapy
* Prisoner
* Known pregnancy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants

A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.

This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers.

The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index 18.5 to 32.0 kg/m2, inclusive.
* Negative for current SARS-CoV-2 infection by rapid antigen test on Day -1.
* Is seropositive to N and/or S SARS-CoV-2 antigens at Screening.
* For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception.
* Is able and willing to provide written informed consent.
* NOTE: Other protocol defined inclusion/exclusion criteria apply

Exclusion Criteria:

* Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
* Is pregnant, breastfeeding, or seeking pregnancy while on study.
* Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured.
* Has had any symptoms of acute respiratory illness (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.
* Has evidence of active infection with HIV, HBV, or HCV.
* Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.
* Had major surgery within 30 days prior to study drug dosing or planned surgeries within 12 months after planned study drug dosing.
* Received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to Screening or planned administration of any investigational drug or biologic during the study period.
* Received immunoglobulin or blood products within 6 months prior to Screening.
* Previously received a mAb within 6 months or 5 half-lives (whichever is longer) prior to Screening.
* NOTE: Other protocol defined inclusion/exclusion criteria apply
Adolescent Mite Allergy Safety Evaluation

This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.

The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.

The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female subjects aged ≥12 to ≤17 years
* A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
* Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
* Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication
* The subject must be willing and able to comply with trial protocol and adhere to IMP treatment

Main Exclusion Criteria:

* A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
* Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1
* Ongoing treatment with any allergy immunotherapy product at screening
* Severe chronic oral inflammation
* A diagnosis or history of eosinophilic oesophagitis
* Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration
* Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial
* Sexually active female of childbearing potential without medically accepted contraceptive method
Action Observation Treatment in Parkinson's Patients

The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease patients on Hoehn and Yahr 3-4

Exclusion Criteria:

* Mini-Mental State Examination \< 24
* Fluent aphasic patients
* Apraxia
* Neglect
* major neuropsychiatric disorders
The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients

Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

Objectives 1.To evaluate and comparison of BCR-ABL p210 mRNA transcripts (%IS unit) results from two detection kit ; Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) VS QXDx™ BCR-ABL %IS Kit (Bio-Rad) in chronic myeloid leukemia (CML) patients Secondary objective 2.To be used as a standard inspection method of the Hematology laboratory at Siriraj Hospital Inclusion criteria

1. Leftover RNA samples from CML patients were recruited from the Hematology Laboratory Division of Hematology Department of Medicine Faculty of Medicine, Siriraj Hospital Mahidol University, after TKI treatment and regular follow-ups or newly diagnosed.
2. All samples were successively tested by QXDx™ BCR-ABL %IS Kit (Bio-Rad) which used Droplet Digital PCR (ddPCR) technique.

Exclusion criteria

1.In adequate or poor-quality specimen

Eligibility Criteria:
Inclusion Criteria:

* Leftover RNA samples from CML patients were recruited from the Hematology Laboratory Division of Hematology Department of Medicine Faculty of Medicine, Siriraj Hospital Mahidol University, after TKI treatment and regular follow-ups or newly diagnosed.
* All samples were successively tested by QXDx BCR-ABL %IS Kit (Bio-Rad) which used Droplet Digital PCR (ddPCR) technique.

Exclusion Criteria:

* In adequate or poor-quality specimen
Atrial Fibrillation Research Database

All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin, phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in real world settings will be recorded in this register. Within this register a characterization of patients and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation
* Indication for oral anticoagulant treatment

Exclusion Criteria:

* Missing Informed Consent Form
* Missing Contact Informations for Follow up
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).

This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018.

All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage.
* Confirmed ALK gene rearrangement by any validated test.
* Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record.
* Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020.

Exclusion Criteria:

-Participating on any clinical trials of which final results has not yet been reported during the study period.
Impact of Diverticular Disease on the Detection of Colon Adenomas

Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* age \>= 18 years

Exclusion Criteria:

* pregnant women
* patients denying written consent
* indication for colonoscopy: familial adenomatous polypose
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: previously known colon polyp/adenoma/carcinoma
* history of colon surgery
* contraindication for resection of polyps
* American Society of Anesthesiologists (ASA) class IV, V or VI
Pilot Study of Colon Cancer Screening Tests

Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.


Eligibility Criteria:
Inclusion Criteria:

* All individuals age 50 to 70 years

Exclusion Criteria:

* Unable to give informed consent
* History of colorectal cancer
* History of adenomatous polyp
* History of inflammatory bowel disease
* Prior participation in FOBT screening
* Prior refusal to participate in FOBT screening
* Flexible sigmoidoscopy within the previous 3 years
* Virtual colonoscopy within the previous 3 years
* Optical colonoscopy within the previous 3 years
* Severe of terminal illness that would preclude benefit from colon cancer screening
Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome compared to conventional stimulation treatment. There is high inter- and intra person variability in ovarian response and fertility outcome parameters after stimulation treatment and little is known about explanatory variables herefore.

Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin which has been widely asssociated with reproductive outcome and subfertility. Therefore, in this study we aim to investigate the influence of preconception nutrition and folic acid use on ovarian response after mild/conventional stimulation treatment and to identify biomarkers in the follicular fluid which can indicate oocyte quality and other fertility outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center

Exclusion Criteria:

* Prior oocyte donation
* Endometriosis
* Hydrosalpinx
* MESA/PESA
* Age \>37
* BMI \<18 or \>29kg/m2
* Menstrual cycle disruptions
* Indication for Intra Cytoplasmic Sperm Injection (ICSI)
* Prior IVF treatment without embryo transplant
* History of recurrent abortion
* Abnormal karyotype of male/female
* Uterine abnormalities
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one evaluable or measurable lesion per RECIST 1.1
3. Male or female subject at least 18 years old and no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
6. Be able to provide archived or fresh tumor tissues-

Exclusion Criteria:

1. Previous exposure to any anti-CD73 monoclonal antibody
2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
3. Unstable central nervous system netastases
4. Known active autoimmune disease or inflammatory disease
5. Known active infectious disease
6. Other uncontrolled systematic disease that may increase the risk of participating the study-
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women

To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters obtained previously during the course of the initai study involving the effect of transdermal estrogen on bone turnover in postmenopausal osteoporotic women.


Eligibility Criteria:
Post-menopausal osteoporotic women