cyrilzakka/clinical-trials huggingface dataset:
Pre-oxygenation Methods in Bariatric Patients

The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen.

The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of apnoea.

General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length of time from administration of these medications to when the breathing tube is placed, when the patient is not breathing and the airway is not secured. This time is known as apnoea time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels, within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction of anaesthesia as part of a process known as pre-oxygenation. There are different ways of delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the lungs to give the anaesthetist more time to place the breathing tube. With good pre-oxygenation, apnoea times of up to 7 minutes are possible.

Apnoea time is a potentially hazardous period during induction of anaesthesia and it is particularly so in patients with severe obesity. On the one hand, obesity makes the upper airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by abdominal contents compressing the base of the lungs reduces the amount of oxygen available within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective method of pre-oxygenating bariatric patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Undergoing general anaesthesia .
* Between the ages of 18 and 80 years.
* Body mass index (BMI) greater than 40 Kgm-2.

Exclusion Criteria:

* Unable to give informed consent.
* Significant cardiac history which is defined as current angina, myocardial infarction \<12 months before the date of the procedure.
* Significant peripheral vascular disease defined as claudication on minimal exertion or Ankle-Brachial index of \<0.7, a stroke or a transient ischaemic attack \<12 months before the procedure.
* Presence of significant heart-valve disease or congestive heart failure.
* Significant lower respiratory disease including brittle asthma; chronic obstructive pulmonary disease (GOLD stages 3 or 4).
* Strong predictors of both difficult intubation and difficult facemask ventilation on anaesthetic airway assessment.
* Patient with American Society of Anesthesiologists (ASA) grade of 4 for any reason.
Using the Hierarchical Cluster Method for Foot Deformities

The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.

Aim and Introduction: Due to individual anthropometric differences, there are many different types of foot posture Foot posture variations affect lower extremity structure, alignment and biomechanical characteristics. Particularly in younger people, performing critical biomechanical measurements in the lower extremity and foot is extremely important to the detection of, and early intervention in, orthopedic problems that these individuals will encounter in their later life. In the literature, attempts at analysis of the evaluations realized so far have been made by univariate analysis. Considering the relationship between variation and variables, these methods result in loss of information. The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.

Methods: The study is carried out on 2nd and 3rd year university students in the physiotherapy and rehabilitation department taking a kinesiology course. The analyses are performed at the Biruni University Physiotherapy and Rehabilitation laboratory. Patients with musculoskeletal system pathomechanics which could prevent standing and walking are not included in the study. After demographic characteristics are recorded, Q, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles are measured with a goniometer. The height from the ground of the navicula are calculated by caliper, using the Navicular drop test. Metatarsal width are also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests are performed under weight-bearing and non-weight-bearing conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy university students.
* Must be able to walk independently.

Exclusion Criteria:

* Students with chronic sprains.
* Students who had undergone lower extremity surgery within the last year.
* Students who use assistive walking devices.
Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.

Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.

Eligibility Criteria:
Inclusion Criteria:

* child aged 2-7 years
* ASA I or II
* scheduled for abdominal surgery
* with average weight, height, normal serum albumin

Exclusion Criteria:

* patients with allergy to the study drug
* patients with significant organ dysfunction
* patients with cardiac arrhythmia
* patients with congenital heart disease
* use of psychotropic medication and mental retardation.
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years old Expected survival \> 12 months Baseline ECOG Performance Status rating 0-1 Naïve to chemotherapy or hormonal treatments Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically Locally advance breast cancer of stage IIb-IIIc No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin) Patients have measurable lesions (according to RECIST v1.1 criteria) Intention to cooperate with baseline puncture and neoadjuvant therapy No advanced metastasis or metastasis involving brain or liver Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L No coagulation abnormality Normal heart function, with normal ECG and LVEF ≥ 55% Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration No coagulation abnormality Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.

Exclusion Criteria:

* Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials) Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment Peripheral neuropathy \>1 degree caused by any reason History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg); Breast cancer during lactation or pregnancy Unwillingly to receive baseline puncture or neoadjuvant therapy Mental illness or incompliance to treatment caused by other reasons Known history of severe hypersusceptibility to any agents used in the treatment protocol Patients received major surgery or suffered from severe trauma within 2 months of first administration Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial Known to be infected with human immunodeficiency virus (HIV) Other circumstances considered to be inappropriate to be enrolled by researchers
Cognitive Multi-sensory Rehabilitation on Upper Limb Function and Fatigue in Stroke

This interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. The main question is:

• Does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of study group CMR and traditional physical therapy and control group traditional physical Therapy rehabilitation. CMR 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.

About 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. Further, post-stroke fatigue affects up to 92% of post-stroke patients. Post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. Post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery.

Preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. Cognitive Multisensory Rehabilitation (CMR) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. Cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. Because CMR integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 65 years.
* 6-18 months after ischemic stroke
* living in the community (i.e., not in a long-term care home).
* medically stable.
* normal score in the Montreal Cognitive Assessment (MoCA: 25 to 30, maximum score = 30).
* Spasticity of upper limb muscles ranged from (grade 1:2) according to the Modified Ashworth scale.

Exclusion Criteria:

* severe spasticity (Modified Ashworth Scale score of 4)
* any medical condition that hinders full participation,
* another neurological diagnosis beyond stroke including cognitive impairment, or
* upper extremity pain \> 4/10 on the Numeric Pain Rating Scale (maximum 10/10).
Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease

The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.

Twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fMRI). Scanning will be done while subjects perform a verbal learning task. Ten subjects will be scanned before and after the two week training. Another ten will be scanned twice at a two week interval before beginning the cognitive training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)

Exclusion Criteria:

* Neurologic disorder other than Alzheimer's disease
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis

The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.

Secondary objectives:

* To study the evolution of passive glenohumeral range of motion
* To study the evolution of the global range of passive and active motion for each method used
* To evaluate functional recovery (DASH)
* To evaluate the impact on quality of life (SF36)
* To study the difference in visual analog scale scores for pain during physical therapy sessions
* Compare the two methods/groups after three months.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI

Exclusion Criteria:

* The patient is pregnant or breastfeeding
* Any emergency situation
* Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)
Comparability of Bispectral Index and NeuroSENSE in Aged Patients

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 74 years

Exclusion Criteria:

* pace-maker
Heart Rate Variability in Extracorporeal Membrane Oxygenation (ECMO) Patients

National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.

Inclusion criteria:Adults patients (aged older than 18 years; less than 90 years old) used ECMO for cardiopulmonary support

Exclusion criteria:

1. Patients used illicit drugs
2. Patients received heart transplantation
3. Patients have the history of arrhythmia

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (aged \> 18 years; less than 90 years old) used ECMO for cardiopulmonary support

Exclusion Criteria:

* Patients used illicit drugs
* Patients received heart transplantation
* Patients have the history of arrhythmia
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer

This observational study evaluates if drug response testing can be performed within 7 days and analyzes the value of ex-vivo drug screening for hematological malignancies as a biomarker to predict outcome, clinical course and response to treatment.

Targeted treatments have revolutionized care of individual diseases. While a new generation of targeted drugs is emerging in leukemia and lymphoma it remains clinical reality that most genetic information is not used for therapeutic stratification. This is in part based on the shortcomings of traditional biomarker discovery within clinical trials, where throughput is limited in both, drug number and sample size. If it were possible to map the variable pathway dependencies and drug sensitivity patterns in individual patients it is likely to become an asset to identify genotype-phenotype associations, understand the underlying complexities of molecular networks and further precision medicine stratification.

To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure pathway sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a hematological malignancy: patients with leukemia, myeloma or lymphoma (e.g. ALL, AML, CLL, T-PLL, MCL, MM) who are in need of treatment and are willing to donate sufficient tumor material for ex-vivo drug sensitivity testing.
2. The treating physician needs to indicate treatment.
3. Measurable disease burden according to criteria as mention in section 3.
4. Treatment must be scheduled and the patient must be eligible for the planed treatment as judged by the treating physician.
5. Availability of 5x10e7 cells from peripheral blood draws, bone marrow aspirations or lymph node biopsies.
6. Patient's written informed consent present.
7. Ability to understand the nature of the trial and the trial related procedures and to comply with them.

Exclusion Criteria:

1. Any condition, which precludes initiation of treatment (e.g. breast feeding, pregnancy, infections, etc.) as judged by the treating physician.
2. Any coexisting medical or psychological condition that would preclude participation in the required study procedures, as judged by the treating physician.
3. No systemic cancer treatment except for cytoreductive pretreatment within 1 week of enrollment.
Psychological Preparation Prior to Bariatric Surgery

Is it feasible to perform a randomized controlled trial to assess whether or not psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to the investigators patients?

This is a feasibility study, assessing how possible it would be to perform a randomized controlled trial to see if preoperative psychological or mental health problems impacts on length of stay, short and long term health outcomes, weight loss, and if preoperative counseling has any effect.

Eligibility Criteria:
Inclusion Criteria:

* New referrals to the Sheffield Teaching Hospital Bariatric service

Exclusion Criteria:

* Non-English speakers
* Patients that are not fit for bariatric surgery
* Patients that have already seen the bariatric psychologist
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

This study is designed to determine whether symptom burden differs by time to infusion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Diagnosis of multiple sclerosis (revised 2017 criteria)
* EDSS 0-7
* Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for \>12 months as part of their clinical care
* Individual must be able to provide consent, read/write/comprehend English Language

Exclusion Criteria:

* Clinical relapse within 3 months of first on-study infusion
* Cognitive impairment limiting the ability to consent or fill out the electronic survey
* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
* Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
* Active substance abuse disorder
* Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection)
* Chemotherapy use within 6 months of first study infusion
* Prior treatment with alemtuzumab within 12 months of first study infusion
* Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion