cyrilzakka/clinical-trials huggingface dataset:
EP Intravenous Anesthesia in Hysteroscopy

Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.

Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. For hysteroscopic surgery using bipolar resectoscopes, hysteroscopic morcellators or shavers, it is considered efficient and safe to be performed under general anaesthesia, such as intravenous anesthesia. Propofol is one of the most commonly used intravenous anesthetics in clinic, however high dose propofol bring some potential clinical safety hazards, reducing respiratory rate and tidal volume, causing apnea or hypoxemia, and leading to hypoxia especially for obese and elderly patients. Propofol combined with etomidate as an improved scheme of intravenous anesthesia has been proved to have advantages in gastroendoscopy.In this study, the patients undergoing elective hysteroscopic surgery will be randomly assigned to two groups of intravenous anesthesia: Etomidate combined with propofol of 1:2 ratio (EP) versus Propofol (P). The sedation degree, respiratory related events (hypoxia, asphyxia incidence and maintenance time) and hemodynamic events，integrated pulmonary index (IPI) of the two groups will be evaluated to explore the feasibility and safety of the clinical application of EP mixture in hysteroscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective hysteroscopic surgery;
* intravenous anesthesia;
* normal reading and understanding ability
* volunteer to participate

Exclusion Criteria:

* serious complications such as heart failure, liver failure, pulmonary dysfunction, renal failure, etc.
* predictable difficult airway
* high risk of reflux aspiration
* allergy to propofol or etomidate
* already participated in other clinical trials within three months before admission
* unwilling to cooperate
Regulation of Brain Glucose Metabolism in Type 1 Diabetes

This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.

This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.

Eligibility Criteria:
Inclusion Criteria:

T1DM subjects with:

* a history of severe hypoglycemia and/or hypoglycemia unawareness or
* a history of severe hypoglycemia with a blood glucose \<54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
* at least 2 values \<54mg/dl during 2 weeks of CGMS testing during the week prior to study.

Exclusion Criteria:

* Age \< 18 years or \>55 years.
* Body weight \>85 kg at screening visit
* BMI \> 30 (female) and \>30 (male) kg/m2.
* Untreated proliferative retinopathy
* carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity
A Study to Evaluate Strategies for Teaching Effective Use of Diagnostic Tests

A recent Institute of Medicine monograph brought attention to high rates of diagnostic error and called for better educational efforts to improve diagnostic accuracy.1 Educational methods, however, are rarely tested and some educational efforts may be ineffective and wasteful.2 In this study, we plan to examine whether explicit instruction on diagnostic methods will have an effect on diagnostic accuracy of 2nd-year medical students and internal medicine residents.

Research has shown that expert diagnosticians use a two-step process to confirm a diagnosis: hypothesis generation to generate diagnostic possibilities, followed by hypothesis verification to confirm the most likely diagnostic possibility.3-5 The first step appears to be non-analytical, related to pattern recognition. The second step could be calculated using analytical reasoning, however, physicians rarely make an overt calculation of conditional probabilities. Instead, experienced clinicians typically use an implicit habit or heuristic called "anchoring and adjusting" to incorporate diagnostic testing information into their thinking.6,7 Cognitive psychologists have postulated that anchoring and adjusting provides a way that probability estimates can be updated based on additional new evidence. Most of the discussion in the literature focuses on how this heuristic can lead to biased thinking because of base-rate neglect or anchoring.6 Very little discussion is on how this heuristic could be improved to yield more accurate probability estimates and whether proper use of the heuristic could be taught.

The degree to which a diagnostic test should lead to an adjustment of a probability estimate depends on the operating characteristics of a test, that is, the sensitivity and specificity. Likelihood ratios, once understood, are easier to incorporate into one's thinking, and thus could be used to calibrate the anchoring and adjusting heuristic.7

In this randomized trial, we tested whether explicit conceptual instruction on Bayesian reasoning and likelihood ratios would improve Bayesian updating, compared with a second intervention where we provided multiple (27) examples of clinical problem solving. The third arm provided minimal teaching about diagnosis, but no explicit teaching or examples.

Eligibility Criteria:
Inclusion Criteria:

* Medical Student at McMaster University or Eastern Virginia Medical School
* Completed 18 months of coursework
Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice.

The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia will be enrolled.

Patients can be treated with any market released catheter for ablation and diagnostic examination. The decision to perform the ablation will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. The study has been designed to describe the Italian clinical practice in relation to the ablation approach of different kind of arrhythmias. In particular, the investigators will analyze the percentage of acute and long-term success in clinical practice, predictors of arrhythmias recurrence and they will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for ablation procedure of atrial and ventricular arrhythmia;
* Patients who are able to sign an authorization to use and disclose health information and capable of providing informed consent.
* Patients who are willing and capable to attend scheduled follow-up visits at the clinical investigational center for at least 12 months

Exclusion Criteria:

* Patients who are currently enrolled in another clinical study that would directly interfere with the clinical practice of the investigational center
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer

This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
3. No prior systemic treatment for ES-SCLC
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5. Measurable disease, as defined by RECIST v1.1
6. Adequate hematologic and end organ function

Exclusion Criteria:

1. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
2. Active, known or suspected autoimmune disease
3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
4. Positive test result for human immunodeficiency virus (HIV)
5. Active hepatitis B or hepatitis C
6. Significant cardiovascular disease
Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
* periodontitis Stage III or IV
* BMI between 20 and 29 kg/m2
* free diet
* presence of at least 20 teeth

Exclusion Criteria:

* Systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
* dietary allergies
* use of antibiotics or probiotics during the previous 30 days
* pregnancy or breast feeding
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)

The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children).

Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.


Eligibility Criteria:
Inclusion Criteria:

children with or without a diagnosis of ASD between 18 to 71 months of age

Exclusion Criteria:

native language is not English born premature (\< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD) has a history of photosensitive epileptic seizures
A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

This study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.

Typically, health care providers receive inaccurate patient self- reports. This pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-EEG monitoring to serve as a comparison "gold standard." More explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. In the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

-Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.

Exclusion Criteria:

* Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
* Patients who are unable to provide consent.
* Patients who have developmental delay.
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 to \< 18 years at day 1.
* Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield, 2014\]) that has been present for at least 12 months before signing of informed consent
* Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
* Eczema Area and Severity Index (EASI) score ≥ 12
* vIGA-AD score ≥ 3
* ≥ 10% BSA of AD involvement at day 1 pre-enrollment

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Oral or topical janus kinase inhibitors
* Treatment with any of the following agents within 1 week before day 1 pre-enrollment:

  * Topical PDE4 inhibitors
  * Other topical immunosuppressive agents (not including TCS/TCI)
  * Combination topical agents containing a high- or super-high potency corticosteroid
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
* Treated with room temperature stable NovoSeven®
The Effect of Instrument- Assisted Soft Tissue Mobilization on Upper Crossed Syndrome

This study will be a randomized controlled trial conducted to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. A sample size of 52 will be randomly allocated to two group ,(26 participants in each group), by using computer-generated random number list Control group will recieve conventional physical therapy in form of stretching and strengthening and experimental group will recieve firstly myofascial release with IASTM then applying the same conventional physical therapy of control group . Both groups will recieve 3 sessions per week for 4 weeks .

Upper crossed syndrome is characterized by the altered activation of specific muscles and postural deviations of the head, neck, and shoulders. Alterations in muscle activation include tightness of suboccipital and short erector spinae muscles of the neck, levator scapulae (LS), and upper trapezius (UT) muscles on the dorsal side crossed by tightness of pectoralis major (PM) and minor, sternocleidomastoid (SCM), and scalene muscles on the ventral side, and weakness of deep neck flexors (DNF) on the ventral side crossed by weakness of rhomboids, serratus anterior (SA), and middle and lower trapezius (LT) muscles on the dorsal side .

Because of UCS described as muscle imbalance pattern which located within the cervical and thoracic spine region. These imbalances have been shown to produce elevation and forward movement of the shoulders, winging of the scapula, and a forward extension of the head. These changes lead to overstress of the cervical cranial junction and shoulders, which can cause neck and/or jaw pain, headaches, and shoulder problems .

In this syndrome, the increased activity of accessory muscles of respiration disturbs the breathing, and the temporomandibular joint (TMJ) may develop osteoarthritis, resulting in chronic neck pain .

For the available literature, with the lack of evidence supporting about the effects of using myofascial release with IASTM on UCS patients. So the aim of this study was to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in UCS patients.

Eligibility Criteria:
Inclusion Criteria:

- 1-Age ranged from 18 to 45 years . 2- All participants had intensity of neck pain on VAS (4-8) (moderate cases) . 3 - All participants had mechanical neck pain and FHP (craniovertebral angle CVA \< 49) CVA of \< 49) ..

4- All participants had kyphosis angle ≥45°.

Exclusion Criteria:

* 1- Malignancy. 2- Fractures of the cervical spine. 3- Cervical radiculopathy or myelopathy. 4- Vascular syndromes such as vertebrobasilar insufficiency. 5- Rheumatoid arthritis. 6- Neck or upper back surgery. 7- Taking anticoagulants. 8- Local infection.
Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.


Eligibility Criteria:
Main inclusion criteria:

* Out-patients
* Written informed consent
* History of atopic disease
* History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
* Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
* Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
* FEV1 ≥ 70% predicted
* Hyperreactivity to AMP (PC20FEV1 \< 25 mg/ml)
* Good health with the exception of asthma
* Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Main exclusion criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
* Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
* Immunotherapy within one month prior to B0 and/or during the entire study duration
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18-85 years
2. Fitzpatrick skin type I-VI
3. Has visible skin laxity in the treatment region or has a scar
4. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
5. Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
6. Subject must be able to read, understand and sign Informed Consent Form in English
7. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
2. Any type of prior cosmetic treatment to the target area at physicians' discretion
3. History of malignant tumors in the target area.
4. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
5. Pregnant and/or breastfeeding (Applicable to females only)
6. Having an infection, dermatitis or a rash in the treatment area.
7. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
8. Suffering from coagulation disorders or taking prescription anticoagulation medications.
9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
10. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
11. History of vitiligo, eczema, or psoriasis.
12. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
13. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
14. Current smoker or history of smoking within 6 months of study participation.
15. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study