cyrilzakka/clinical-trials huggingface dataset:
Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy

The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. There is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.

This study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping.

Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil anesthesia group (R)

Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2, body temperature

Patient seletion

* inclusion criteria

  * American Society of Anesthesiologist (ASA) physical status 1-3
  * 18 \~ 70 years
  * patient who agree with informed concent
* exclusion criteria

  * ASA physical status \> 4
  * preoperative SpO2 \< 97%
  * patient who has other neurologic disease not related to carotid endarterectomy

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1-3
* 18 \~ 70 years
* patient who agree with informed consent

Exclusion Criteria:

* ASA physical status \> 4
* preoperative SpO2 \< 97%
* patient who has other neurologic disease not related to carotid endarterectomy
Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder

The aim of the study is to determine the effects of usage of augmented reality for Restricted and repetitive behavior and executive function of children with autism spectrum disorder

Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.

Exclusion Criteria:

* Sensory issues and patients on medication
Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia

This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of classical TN or idiopathic TN according to criteria of The International Classification of Headache Disorders 3rd edition.
2. Age between 18 and 85 years.
3. Subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an average intensity of 4 to 10, inclusive, on the 11-point NRS (0 = no pain; 10 = maximum pain imaginable) during the last 4 weeks to enter the baseline phase.
4. During baseline phase subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an intensity of an average 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the last month to enter the treatment phase (to be randomized).
5. Fluency in Danish.

Exclusion Criteria:

1. Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
2. Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
3. Ongoing and unstable severe psychiatric disease.
4. Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
5. Change of TN treatment or treatment dose within two weeks prior to the baseline visit.
6. Previous treatment with BTX-A for facial pain.
7. Loading treatment within 4 weeks with phenytoin or sodium valproate.
8. Female subjects either pregnant, breastfeeding or with planned conception within the study period.
9. Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study.
10. Known allergy to any component of BTX-A.
11. Infection at the proposed injection site.
12. Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.
13. Known comprised respiratory function.
14. Member of investigational site staff or relative of the investigator.
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531

The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjects


Eligibility Criteria:
Inclusion criteria:

* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
* history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment

The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.

This study will attempt to:

* stop or slow the growth of disease
* gain information about prostate cancer
* evaluate the effectiveness and side effects of the study drug

* Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).
* Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.
* Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.
* After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.
* After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.
* During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the prostate
* Previous treatment with either radical prostatectomy or radiation therapy
* Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart
* Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value
* ECOG performance status 0-1
* ANC \> 1,500/mm3
* Platelet counts \> 100,000/mm3
* SGOT and/or SGPT may be up to 2.5 x ULN

Exclusion Criteria:

* Documented local recurrence of prostate cancer or documented metastatic disease
* History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin
* Medical condition requiring the use of concommitant corticosteroids
* Active infection
* Significant cardiac disease, angina pectoris or myocardial infarction within six months
* Prior chemotherapy including estramustine, suramin
* Active thrombophlebitis or history of thromboembolic events in the six months preceding study treatment
* Clinically significant neuropathy
* Elevated bilirubin above ULN
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery

The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring CABG or valve repair/replacement surgery.
2. Patient must be able to provide informed consent.

Exclusion Criteria:

1. Patients less than 18 or over 85 years of age.
2. Patients less than 50kg or greater than 120kg.
3. Patients currently with endocrine disorders, excluding diabetes.
4. Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
5. Patients currently receiving thyroid replacement therapy.
6. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
7. Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
8. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
9. Patients currently in atrial fibrillation.
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height \[m\])2
* Males must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
* Any major surgery within 6 weeks of study treatment administration

Other protocol-defined inclusion/exclusion criteria apply
Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age \<18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject to approval by the sponsor).
* Inability to swallow crizotinib capsules, adult patients of whom must either have a feeding tube in place or have completed clinical evaluation of dysphagia without any reversible causes identified.
* At least 12 months of age (patients \<12 months of age will be evaluated on a case by case basis and discussed with the sponsor).

Exclusion Criteria:

* Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
* Adult patients who have been previously treated with crizotinib.
Physiologic Effects of CPAP After Vascular Surgery

This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Open or endovascular surgery on the abdominal aorta
* Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
* Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)

Exclusion Criteria:

* Prolonged post-operative invasive ventilation
* Invasive or non-invasive ventilation or oxygen therapy in the last month
* ASA class IV or V
* Emergency procedures
* Pneumothorax or active pulmonary infection
* Any contraindication to CPAP
* Prolonged bed rest
* Patient refusal to participate or to receive preventive CPAP
Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

The general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (SD). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. Successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving voice symptoms in SD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
* Diagnosis is made by a voice disorder specialist.

Exclusion Criteria:

* Regular intake of benzodiazepines
* Cognitive impairment: score \< 27 on Mini-mental state examination
* Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis
Effect of a Dietary Supplement on Quality of Life

The purpose of this research study is to evaluate the effect of a combination of 3 food components to improve the quality of life in people who have trouble sleeping. Ten subjects with insomnia will drink 2 ounces of the supplement or a placebo for 1 week and after a 2 weeks washout period, will take the treatment they did not take the first week. Questionnaires to evaluate quality of life, and a sleep study will be done before and after each treatment week.

Each participant will be in the study for about 1 month. The questionnaires consist of Chubon Quality of Life Rating, the Multi-dimensional Fatigue Inventory, Insomnia Severity Index, the Epworth Sleepiness, Pittsburgh Sleep Quality Index. Subjects will be screened with a medical questionnaire, vital signs, height, weight, oximetry to identify sleep apnea, a CBC and chemistry panel and the Insomnia severity Index. Weight, vital signs, adverse event questioning, dispensing and collection of test material will be done at each visit. During each treatment week subjects will wear an actigraph, keep a sleep diary and at the beginning and end of each treatment week subjects will have a polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, and a buffy coat will be archived.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women \>50 years of age
* Usual bedtime between 9pm and midnight
* Insomnia for \>6months by ICSD-2 criteria
* Insomnia Severity Index score \>10 and Sleep-onset latency or Waking after sleep onset \>30 minutes

Exclusion Criteria:

* Have diabetes mellitus
* Taking chronic medication not on a stable dose for \>1month
* Taking sedating or hypnotic medications
* Have a sleep disorder other than insomnia (like sleep apnea) Adults unable to consent Prisoners Pregnant women Individuals not yet adults
Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments

Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.

A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study.

In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment.

The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method.

A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate.

Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-8 years
* Children who need at least two restorative dental treatments of the mandibular first primary molar

Exclusion Criteria:

* Chronic systemic illnesses
* Dental experience
* Mental disorders
* Invasive medical treatments
* Hospitalization
* Oral health problems with a painful history
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
* Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 OR via the compassionate use programme prior to marketing authorization.
* Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Prescribed bosutinib as part of an interventional clinical trial programme.
* Initiated on bosutinib less than 3 months prior to data collection taking place.
Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced or metastatic pleural mesothelioma;
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
5. Adequate haematological, renal and liver function.

Exclusion Criteria:

1. Primary mesothelioma of peritoneum, pericardium and testes
2. Active, untreated central nervous system (CNS) metastasis.
3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
4. Known active autoimmune diseases.
5. Presence of other uncontrolled serious medical conditions.
Comparative Study Between Outcome of ICT Drainage and VATS in Management of Second Stage Empyema

The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema.

It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.


Eligibility Criteria:
Inclusion Criteria:

* Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis

Exclusion Criteria:

* Empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.