cyrilzakka/clinical-trials huggingface dataset:
Gustatory Function Following Radiotherapy to the Head and Neck

The aim of this study is to assess the effect of RT or chemo-RT on chemosensory gustatory function in patients with HNC. By using detailed dosimetric data derived from the RT planning system, we will be able to calculate mean radiation doses to important structures including the anterior and posterior tongue, oral cavity, parotid and submandibular salivary glands, and correlate them with both qualitative and quantitative data for dysgeusia.

This study aims to collect data from patients with HNC undergoing RT or chemo-RT to correlate quantitative chemosensory gustatory function with

* Detailed dosimetric data for critical structures relevant to perception of taste
* Fungiform papillae density (FPD)
* Use of concurrent platinum based therapy
* Patient reported taste loss using The Taste and Smell Survey (TSS) \[14\]
* Patient reported toxicity and overall QOL using University Washington Quality of Life Revised Version 4 (UW-QOL v4) \[15\].
* Clinician reported acute and late toxicity using NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4) \[16\] and Scale of Subjective Total Taste Acuity (STTA) \[17\].
* Weight (as a surrogate of nutritional status).

This study hopes to demonstrate a dose dependent relationship for loss of taste and to develop a dose constraint for preservation of taste. In turn this will serve as a platform for further research to optimise the technical delivery of radiation either in the form of optimised IMRT or through the use of intensity modulated proton therapy (IMPT).

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Undergoing unilateral or bilateral RT or concurrent chemo-RT to the head and neck - region using either a conformal or IMRT planning technique or
* No restrictions on tumour sub-site
* No restriction on tumour histology
* No restrictions on radiotherapy dose and fractionation
* For entry into the cross-sectional cohort; patients 12 months post completion of unilateral or bilateral RT or concurrent chemo-RT to the head and neck region using either a conformal or IMRT planning technique.

Exclusion Criteria:

* Patients with pre-existing olfactory or gustatory disorders either self-reported or through objective taste function testing.
* Patients with radiological or clinical involvement of following nerves

  * facial nerve
  * chorda tympani
  * glossopharyngeal nerve
  * lingual nerve
  * greater petrosal nerve
  * geniculate ganglion
* Patients who have undergone a total or partial glossectomy
99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC

To evaluate the safety, dosimetry and efficacy of 99mTc/68Ga labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01 and 68Ga-NM-01) in the diagnostic imaging PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new clinical method of non-invasive PD-L1 expression detection in NSCLC using 99mTc/68Ga labeled anti-PD-L1 sdAb.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
* Male or female, aged 18-75 years old
* Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
* AST, ALT, BUN, Cr not more than double the normal values
* Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases

Exclusion Criteria:

* Severe infection
* Unable to provide biopsy sample for testing PD-L1 expression level
* Patients with pacemakers
* Pregnant and lactating women
* Investigators professional decision that the subject should not participate in this clinical study
Insecticidal School Uniforms for Dengue Prevention in Thailand

This is a randomised controlled trial that will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. A double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.


Eligibility Criteria:
Inclusion Criteria:

* pupils in participating schools

Exclusion Criteria:

* skin sensitivity, exema
Assessment of Thigh Muscle After a Stretching Program

The purpose of this study is to establish, through ultrasound, measurements of the thigh muscles (Biceps Femoris and Vastus Lateralis)and the chronic effects of a static stretching program on the muscle-tendon unit these muscles.


Eligibility Criteria:
Inclusion Criteria:

* physically active male volunteers
* soldiers of the Army School of Physical Education of Rio de Janeiro, Brazil
* young men

Exclusion Criteria:

* any musculoskeletal disorder in the lower limbs
* neurological or cardiovascular disease experienced previous to or reported during the study.
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
2. Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:

   • Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.

   Or:

   • Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
4. Patients must have received prior platinum containing treatment.
5. WHO performance status of 0-1

Exclusion Criteria:

1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
3. Prior treatment with an HSP90 inhibitor
Validating Cardiac MRI Biomarkers and Genotype-Phenotype Correlations for DMD

This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better understand the health of the heart and changes in heart health over time in boys with DMD.

Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical drug trials for boys with DMD.

Consequently, the first objective is to identify and characterize several cardiac MRI biomarkers for boys with DMD.

The second objective is to use their well-characterized cardiac MRI biomarkers and define their sensitivity for detecting early cardiac involvement. The final objective is to use these validated cardiac MRI biomarkers to better understand the genotype-phenotype correlation in boys with DMD, which to date remain tenuous. The investigators propose a pilot study to explore cardiac genotype-phenotype correlations in boys with DMD and outlier phenotypes using approaches they have pioneered for skeletal muscle.

Eligibility Criteria:
Inclusion Criteria:

* Healthy boys or pediatric patients with DMD age 7 to 21
* Able \& willing to complete an approximately 75-minute (or less) MRI exam without sedation or mechanical ventilation
* Drug regimen (if applicable) stable for at least 3 months prior to participation

Exclusion Criteria:

* Renal insufficiency (GFR\<40 mL/min/m2)
* Non-MRI compatible implants (e.g. neurostimulator, pacemaker, implanted cardioverter defibrillator)
* Claustrophobia that prevents an MRI exam
* Known allergy to MRI contrast agents
* Serum potassium level of \>5.0 mmol/L
* Signs and symptoms of heart failure
Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .


Eligibility Criteria:
Inclusion Criteria:

* AECC definition of acute respiratory distress syndrome
* Early acute respiratory distress syndrome (within 72 h of diagnosis)
* PF ratio \< 200 at PEEP ≥ 8 cmH2O

Exclusion Criteria:

* Imminent death
* Contraindication to corticosteroid treatment
* Already on more than 0.5 mg/kg of methylprednisolone or its equivalent
* Evidence of uncontrolled infection
* Refusal of managing physician to participate in the study
Improving Faculty's Ability to Speak Up to Others in the Operating Room

Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions of others within the team can have direct, immediate, and preventive effect on adverse outcomes. However, little is known about the hurdles and enablers of this behavior in healthcare, especially within the operating room setting.

Objective

1. Determine if an educational workshop would improve speaking-up behaviors of practicing anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the self-reported hurdles and enablers for speaking-up in those situations encountered.

Design Randomized controlled experiment of an educational workshop intervention on communication behaviors in a simulated case. Qualitative analysis of debriefing conversations following the simulated case.

Setting Established academic simulation center

Participants Seventy-one practicing anesthesiologists from four academic medical centers and one community hospital

Intervention Fifty minute educational workshop on speaking-up that included rationale, conversational techniques, a rubric for speaking-up, and role-play.

Main Outcomes and Measures

1. Observed communication in a simulated case that included a surgeon falling asleep during surgery, inappropriate activation of a speakerphone by a nurse, and an incorrect treatment order by a colleague in response to a venous air embolism. 2. Transcribed conversation during a structured debriefing, analyzed for hurdles and enablers.

Eligibility Criteria:
Inclusion Criteria:

* Attending Anesthesiologist

Exclusion Criteria:

* Prior exposure to test case
Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial

This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)

Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls.

We have a three group randomized controlled design. Migraine patients from the headache outpatient clinic will randomly be assigned to get two different cover stories via a flyer with study information and through the physician from the outpatient clinic: 50% of patients will receive the information that they will take part to investigate migraine (by watching the visual stimulus (roller coaster video)). The other 50% will receive the information that they will take part as healthy controls for a headache unrelated study (by watching the visual stimulus (roller coaster video)). Sex and age matched healthy controls will take part in the same experiment and get no additional information but that we investigate the perception of a visual stimulus (roller coaster video). The protocol for the intervention is standardized and identical for all participants.

Migraine patients will be randomly given the priming information and therefore their group allocation. Physicians will allocate by pulling from a randomized equally sized stock of flyers (of which 50% inform for healthy controls and 50% for migraine patients).

Migraine Patients for both migraine groups will be recruited and diagnosed by a neurologist from the UKE headache outpatient clinic. Healthy controls will be recruited via an internet platform for job advertisement. Participants will be paid 10€ for participation. Participants must be at least 18 years old and have signed the informed consent. They are excluded if they have 1. History of any neurological disease, 2. Self-report of diagnosis of vestibular disease, 3. History of trauma or pathology of the cervical spine (e.g., whiplash associated disorder), 4. Pregnancy, 5. Other relevant musculoskeletal, systemic or psychiatric disease.

Eligibility Criteria:
Inclusion Criteria:

* migraine patients following ICHD-3 criteria
* headache free controls

Exclusion Criteria:

* any other headache or pain disorder
* known somatic or psychiatric disorder
* pregnacy or breast feeding
* known vestibular disorder or whiplash injury
Static Stretching Exercises and Ultrasound Elastography Evaluation

The aim of thid study was to compare two methods applied to increase the flexibility of the hamstring muscles and objectively evaluate changes in muscle stiffness using the two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young individuals with hamstring shortness were divided into two groups by simple randomization. The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive static stretching exercises to the second group. Hamstring flexibility was evaluated with the sit-and-reach test, and muscle stiffness with the 2D SWE method.


Eligibility Criteria:
Inclusion Criteria:

* Having a limitation of more than 25° in the active knee extension test
* Only engaged in recreational sports during the study period

Inclusion Criteria:

* Having a history of lower extremity injury within the last two years
* Not volunteering to participate in the study.
Biopsychosocial Factors' Influence on Shoulder Pain

The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability. Previous studies have suggested that specific genes influence pain perception. Other studies have suggested that specific psychological factors influence pain perception. We plan to investigate both of these factors to see if they contribute to the development of chronic shoulder pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* chronic shoulder pain and disability

Exclusion Criteria:

* none
Non-technical Skills of Emergency Physicians in a Virtual Emergency Department

The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care.

The ability to manage multiple patients and anticipate the risk of error related to task interruptions or disruptions has been identified among relevant non-technical skills (NTS) for practicing emergency medicine. However, the link between these skills and the quality of care has not been quantified. NTS are usually analyzed by qualitative methods such as interviews, direct observations, or questionnaires that have low performance according to the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation).

The investigators have created and validated an experimental model of a virtual, authentic and realistic Emergency Department (ED). The platform has been modelled in a "Second Life" environment. The NTS of emergency physicians will be assessed and recorded during simulated care of multiple virtual patients. The NTS association with ED length of stay and disposition decision will be analyzed. This study will be an internal pilot study and will include 30 emergency physicians who practice emergency medicine for at least two years.

Sessions will be performed in the Toulouse Institute of Health Care Simulation, Toulouse University Hospital. They will be composed of three stages: briefing (30 minutes), simulated practice (3 hours), and debriefing with an explicit interview (30 minutes). Two researchers and a computer technician will supervise the sessions. The data will be obtained by analyzing the video recorded during the simulated practice and the interview.

Eligibility Criteria:
Inclusion Criteria:

* Active emergency physicians working in an ED of the French Midi-Pyrenees region
* Two years of practice in emergency medicine or more
* Volunteer to participate in the study

Exclusion Criteria:

* Emergency physician working in another setting than ED, outside the Midi-Pyrenees region, or practicing emergency medicine for less than 2 years.
Neutrino Regimen for Treatment-experienced HCV GT1 Patients

This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or greater than 18 years, with chronic genotype 1b infection;
2. HCV RNA equal to or greater than 10,000 IU/mL at Screening;
3. Cirrhosis determination;
4. Subjects who are treatment-experienced;
5. Screening laboratory values within defined thresholds;
6. Use of highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

1. HIV or chronic hepatitis B virus (HBV) infection;
2. Contraindications for PEG or RBV therapy;
3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
6. Chronic use of systemic immunosuppressive agents;
7. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Effectiveness of Virtual Reality Training in Amblyopia

The goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: SJ-JRS2021) in the treatment of mild to moderate amblyopia in children. The main questions it aims to answer are:

* Whether virtual reality training is more effective than occlusion therapy
* Safety of virtual reality training in amblyopia treatment If participants have refractive problems, correct the refraction first and wear corrective glasses. The experimental group will be treated using visual function training therapy software (model: SJ-JRS2021). The control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. Researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age 4-7 years old (including 4 and 7 years old), both sexes;
* Monocular amblyopia was diagnosed;
* The corrected visual acuity of amblyopia is between 0.2 (inclusive) and 0.6, and the binocular visual difference is more than 2 lines;
* The guardian of the subject can understand the purpose of the trial and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination

Exclusion Criteria:

* The subject has tumor, heart disease, hypertension and epilepsy;
* The subject has an implanted electronic device, such as a pacemaker;
* The subject has suffered from mental illness;
* Subject suffers from vertigo, fear of heights or brain trauma;
* The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time;
* The subject has strabismus or congenital cataract, congenital ptosis, trauma and other ocular organic lesions and related surgical history;
* Subject has had any form of treatment for amblyopia other than refractive correction and covering treatment.
* Other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.
Effects of Meditation

This research is being done to learn about the effects of doing meditation (sitting quietly and concentrating) on people's ability to pay attention and be relaxed.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-55
* currently enrolled in methadone maintenance program

Exclusion Criteria:

* history of: a severe medical or psychiatric condition (except substance abuse; e.g., schizophrenia); brain trauma affecting cognitive functioning
* prior experience with meditation