cyrilzakka/clinical-trials huggingface dataset:
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.

* Patients will receive thalidomide orally once daily continuously unless they experience significant side effects. Temodar is given orally once a day for one week, followed by a one week break period. This one week on/one week off schedule will continue for the duration of treatment unless there are significant side effects.
* After eight weeks (2 cycles) a CT scan will be performed to see how the treatment has affected the patient's tumor. Patients will continue taking the study drug unless there is evidence of tumor growth.
* Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects. If there are no side effects during the first two months, the blood tests may decrease in frequency to every two weeks.
* Immediately after the patient has completed the study they will be evaluated by physical exam, blood work, and a CT scan. The follow-up will consist of clinic visits and phone calls every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
* Prior treatment with chemoembolization or cryotherapy is allowed
* Radiotherapy is allowed if completed more than 4 weeks prior to study.
* Measurable disease as defined by RECIST criteria
* Age greater than or equal to 18 years.
* ECOG performance status of less than or equal to 2
* ANC \>1,500/mm3
* Platelet Count \> 100,000/mm3
* Hemoglobin \> 9 g/dl
* Serum creatinine \< 1.5 x ULN
* Total bilirubin \< 2 x ULN
* SGOT and SGPT \< 2 x ULN
* Alkaline phosphatase \< 2 x ULN
* Life expectancy of greater than 12 weeks

Exclusion Criteria:

* Clinically symptomatic central nervous system metastases or carcinomatous meningitis
* Myocardial infarction in past 6 months
* Major surgery in past two weeks
* Uncontrolled serious medical or psychiatric illness
* Insufficient recovery from all active toxicities of prior therapies
* Active nonmalignant systemic disease
* Frequent vomiting or medical condition that could interfere with oral medication intake
* Known HIV positivity or AIDS-related illness
* Pregnant or nursing women
To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B orc.
* Treatment for drug or alcohol dependence.
Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)

Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
* Patients with type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled.
* The patients' age of 18 years or older.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients allergic to Ulinastatin;
* Lactating women and pregnant women;
* Patients with mental diseases;
* Refuse to participate in this study and refuse to sign the informed consent.
Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

Introduction: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT), offers an alternative non-surgical method, which can putatively resolve OSA by combined maxilla-mandibular correction, and addressing craniofacial deficiencies.

The aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a more favorable upper airway, which might result in a reduction in the severity of OSA.

Protocol: Adults who underwent an overnight sleep study and were diagnosed by a sleep specialist physician will be potential subjects for the current study. The BQ and EES will be recorded pre- and post- BOAT treatment. Subjects with mild to moderate OSA will have 2 months follow up visits and a final overnight sleep study to measure apnea-hypopnea index (AHI). The subjects will be asked to wear the appliance for 10-12 hours/day and at night. Findings will be analyzed statistically using paired t-tests.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of mild to moderate OSA with good oral hygiene
* Intolerant to CPAP therapy
* Having enough number of maxillary and mandibular teeth to retain the removable device.

Exclusion Criteria:

* Patients who are unable to attend regular appointments and unable to consent.
* Patients with severe OSA who met the inclusion criteria
Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab

Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)

OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).

The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.

Exclusion Criteria:

* Patients that were not considered by the Institution's heart team as eligible
Median and Paramedian Approach in Spinal Anesthesia

Spinal anesthesia (SA) is frequently used as anesthesia in many surgeries such as lower abdominal, inguinal, urogenital, rectal and lower extremities.

Conventional median approach (MA) is preferred more frequently, although MA or paramedian approach (PA) is used in SA. Especially in geriatric patients due to degenerative changes Although we are told that degenerative changes are less affected in PA during SA in the geriatric age group, few studies have been conducted on the subject and we aimed to evaluate the superiority of the two methods.

In our study, 100 cases were planned to be evaluated prospectively. Patients scheduled for surgery under spinal anesthesia will undergo routine spinal preparation. After routine motorization, patients will be treated with MA or PA.

MA will be performed in a conventional manner and PA will be performed by adding 1 cm lateral and 1 cm caudal from the planned vertebral space to 10-15 degree medial and cephal.

If one of the patients with MA or PA fails, despite three attempts, the other method will be tried by another specialist. If the procedure fails or there are not enough blocks, a different anesthesia method will be applied.

The data of the patients included in the study were evaluated by a different researcher other than the SA physician; demographic data of the cases, type of operation, MA or PA in SA and the number of repeated attempts / trials for the procedure will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 70 years
* elective surgery under spinal anesthesia
* those who agreed to participate in the study
* Those with American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

* who use opioid or other non-steroidal anti-inflammatory drugs regularly
* who are allergic to a drug used in the study
* had contraindications for spinal anesthesia,
* drug addiction
* obese patients (Body Mass Index ≥ 35)
* migraine and chronic headache
* Spinal anesthesia can not be performed in more than 3 trials, but passed to the general anesthesia
* those who do not agree to participate in the study
In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers

The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of the screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥ 18 and ≤ 50 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Hypersensitivity to pramipexole or to other dopamine agonists
* Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on in-house trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial
Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

HBV infection is a dynamic process with complex interactions between virus replication and the host's immune response. The appearance of anti-HBs after HBV infection generally indicates recovery and immunity to HBV1 infection. However, there are several published studies that describe the coexistence of the marker of chronic infection (HBsAg +) and the marker of functional cure (HBsAc +). There are contradictory studies on whether the coexistence of HBsAg/HBsAc implies a different clinical course.


Eligibility Criteria:
Inclusion Criteria:

* all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.

Exclusion Criteria:

* Hepatitis C or HIV Co-infection
Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.

This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of VNS therapy using validated and bespoke self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.

Failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. Vagus Nerve Stimulation (VNS) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. However, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post VNS device implantation in the UK are limited. The current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) in subjects with drug resistant epilepsy

Eligibility Criteria:
Inclusion Criteria:

Living subjects who meet all of the following criteria will be considered for enrolment:

* Clinical diagnosis of drug resistant epilepsy
* Subjects who have had their first VNS device (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead).
* For SenTiva® and Aspire SR®, AutoStim was first activated within 1 month of implantation.
* For SenTiva®, scheduled dosing mode was activated within 1 month of implantation.
* Subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. These subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. Subjects under 7 years will be included in the study with consent from their parent/carer. For adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the Mental Capacity Act 2005.
* Adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to VNS device implantation.

Exclusion Criteria:

* Subjects whose medical records are not available for review.
* Deceased subjects.
Role of Dynamic Movement Intervention in Children with Spastic Diplegia

The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.


Eligibility Criteria:
Inclusion criteria:

* Age ranged from 4-7 years.
* They can walk alone short distance and climb stairs holding on rail (Grade I \& II according to GMFCS).
* They can understand and execute instructions.
* They will be medically stable.
* Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.

Exclusion criteria:

* Visual impairment (visual loss- cataract- myopia- hyperopia).
* Hearing impairment (deafness)
* Cognitive problem.
* Uncontrolled Convulsions.
* Orthopedic surgery for the affected lower limbs within one year.
* Botulinum toxin injection within the last 6 months or within the study period.
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

to evaluate the effect of subcutaneous irrigation on wound complications

Cesarean section is the most common abdominal operation performed worldwide. As with every other surgical procedure, it is sometimes accompanied by surgical complications. Wound complications are encountered in approximately 5% of women that undergo CS and include haematomas, seromas and infection. To evaluate the effects and benefits of subcutaneous irrigation during cesarean section we decide to conduct this randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40, undergoing cesarean section

Exclusion Criteria:

* patients with systemical disease, body mass index\>30
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine

Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. However, many patients who treated with glargine still have poor blood glucose control because of insufficient insulin dose or improper oral medication. This study aims to investigate the optimal treatment scheme in order to improve the blood control in these patients. Continuous Glucose Monitoring System (CGMS) will be used to assess the blood glucose control at baseline and the moment when the patients achieved standard. Oral medications will be standardized first, and insulin doses will be adjusted according to blood glucose values obtained by self-monitoring. Glycemic control will be considered as reaching target of glucose if the fasting capillary blood glucose is less than 6.1 mmol/L. The maximum period of blood glucose adjustment will be 1 months. Oral medication, the type and dosage of insulin, exercise status, insulin injection skill evaluation, islet function, duration of diabetes, complications and insulin antibodies will be recorded in detail at baseline, reaching target of glucose standard and 3 months after reaching target of glucose.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
3. Patients had relatively constant diet and exercise in 2 month before the study.
4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/L

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
2. Patients with severe infectious diseases;
3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Assessment of Validity of Depth by PocketCPR as Sites of Smartphone on Arm

For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most important teaching point. However, the tool to feedback depth of chest compression like Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to be used widely. In these days, smartphone free application can measure depth of chest compression in real-time. This study assess the validity of depth of chest compression by smartphone application, PocketCPR, as three sites of smartphone on arm or hand.

1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band

To analyze the difference between Skill Reporter manikin and PocketCPR application, the investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.


Eligibility Criteria:
Inclusion Criteria:

* Chest compressor with Basic Life Support certification
* Physician, Nurse, Emergency medical technician with more than 3 years clinical experience

Exclusion Criteria:

* Person who cannot practice normal chest compression with any reason
The "Notijoves" Randomised Controlled

Background:

Increase of sexually transmitted infections (STIs) as well as increased use of new information and communication technologies (ICTs) among young people in Catalonia triggers the idea of designing a mobile phone application to promote partner notification.

Objective:

Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification.

Methods:

This is a multicentre randomised controlled trial with a proportional stratification of the sample by centre and random allocation of participants to the three arms of the study (simple web based intervention, game web based intervention and control). This study is conducted by midwives, gynaecologists and physicians in the sexual and reproductive areas of the primary health care centres.

The study population is: 1- All youngsters 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia). 2- All partners of those diagnosed with the previous STIs, independently of their state of infection.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia).
* All partners of those diagnosed with the previous STIs, independently of their state of infection.

Exclusion Criteria:

* Already participated in the study within its length