cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients

Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. This time, newly developed ketogenic drink contain beefsteak mint.

The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<70%)
* Poor nutritional status (PG-SGA grade C)
Comparison of Scoring Systems for Bleeding in Open Cardiac Surgery Patients

Seven different scoring systems used for prediction of perioperative bleeding were compared regarding patients operated for elective open cardiac surgery in the investigator's study.

Collected data of 500 consecutive patients, operated for elective open cardiac surgery were analyzed retrospectively. Seven different scoring systems were used to predict the probability of bleeding, including TRACK, PAPWORTH, WILL-BLEED, CRUSADE, ACTION, TRUST and ACTA-PORT. The scores are calculated for each of these systems by using their own parameters, and classified into four risk groups as very low, low, moderate and high. Then, these risk groups were compared with patients identified in two groups regarding the use of perioeprative erythrocyte suspension (ES) transfusions or not, as ES positive and ES negative.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with 18 years of age or older,
2. Patients operated for elective open cardiac surgery.

Exclusion Criteria:

1. Patients with incomplete data,
2. Patients with an age less than 18 years,
3. Patients operated for emergent surgical procedures.
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)

Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients

This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who complete a Phase 4 trial (812P401). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 24 months).

Eligibility Criteria:
Inclusion Criteria:

1. Completion of a previous blinded study of SPN-812 for the treatment of ADHD.
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least ≥5th percentile for age and sex if 4 to 5 years old, at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.
4. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent obtained from the subject if appropriate; written informed consent obtained from the subject if he/she is 18 years old.
5. Females of Childbearing Potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study:

   1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
   2. surgically sterile male partner
   3. simultaneous use of male condom and diaphragm with spermicide
   4. established hormonal contraceptive

Exclusion Criteria:

1. Current diagnosis of significant systemic disease or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the subject is free of episodes currently and for the last six months.
2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).
3. Body Mass Index (BMI) greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).
4. Pregnancy, breastfeeding, or refusal to practice contraception during the study for female subjects of childbearing potential (FOCP).
5. Current substance or alcohol use.
6. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years old
* Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.

Exclusion Criteria:

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma
Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions

The objective of this study is to demonstrate the cognitive enhancement effect and safety of Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 65 years old
* Global Deterioration Scale score (GDS) of 2
* High school or higher levels of education.

Exclusion Criteria:

* Current pregnancy or breast-feeding
* Evidence of neurologic or medical conditions
* Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV)
* Mini-mental status examination score of 24 or less
* Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
* Intelligence quotient less than 70
* Contraindications to magnetic resonance imaging (MRI)
* Use of psychotropics in last 3 months
* Use of oral contraceptive medication
* Participation in other clinical trials during the study period that might affect the outcome of the present study
* Allergic adverse reactions to mushrooms
Assessment of Blood Glucose Monitoring Systems

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male or female subjects with type 1 or type 2 diabetes or healthy subjects
* For BG adjustment people with type 1 diabetes

Exclusion Criteria:

* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
* For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
* Legal incompetence or limited legal competence
* Age \< 18 years
* Dependency from the sponsor or the clinical investigator
* Mental incapacity or language barriers precluding adequate compliance with the study procedures
The Medacta International SMS Post-Marketing Surveillance Study

This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
* Scheduled for a primary total hip replacement.

Exclusion Criteria:

* Active infection
* Pregnancy
* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
* Grossly distorted anatomy (surgeon's discretion)
* Osteomalacia where uncemented implant fixation is contraindicated
* Active rheumatoid arthritis.
* Osteoporosis
* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
* Muscular atrophy or neuromuscular disease
* Allergy to implant material
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule \[LFC\]) in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.

Key Exclusion Criteria:

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History of procedures that could alter absorption of orally administered drugs.
* Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
* Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
* Participation in a clinical study within 30 days prior to study drug administration.
* Clinically significant laboratory abnormalities at Screening or Day -1.
Orthostatic Hypotension in Children With Acute Febrile Illness

Objective:to determent if children suffering from acute febrile illness has higher rate of orthostatic hypotension compared with children with no febrile illness. Design: a prospective cohort study. Subjects: children aged 4-18 year with fever (temperature \> 38.) for up to 48 hours, presenting to the pediatric emergency department. Interventions: All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing.

Orthosatic hypotension describes a condition in which the autonomic nervous system fails to maintain a stable blood pressure in the face of postural change. Children presenting to the pediatric ED with fever often describe symptom like syncope, lightheadedness, dizziness, pallor, fatigue and weakness. These symptom may result from orthostatism related to acute febrile illness. We assume that fever may be associated with autonomic changes (e.g. vasodilatation) that can cause orthostatism. Objective:

to determent if children suffering from acute febrile illness has higher rate of orthostatic hypotension compared with children with no febrile illness. Design: a prospective cohort study. Subjects: children aged 4-18 year with fever (temperature \> 38.) for up to 48 hours, presenting to the pediatric emergency department. Interventions: All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing. Data analysis: The proportion of children with orthostatic hypotension in febrile and non febrile patients will be compared using χ2 test. The changes in blood pressure in both groups will be compared using the Student t test.

Assumption: We assumed that the incidence of orthostatism is higher among children with fever, because fever can cause orthostatism. Significance: Orthostatism can cause syncope which is a potentially dangerous symptom (e.g. head trauma). Syncope accounts for 1-3% of hospital admissions in US. The incidence in youths is estimated at about 15%) Patients presenting to the ED with syncope may undergo numerous and expensive work up with low diagnostic yield. -understanding that fever itself can cause orthostatism and syncope may help us with precaution and diagnosis.

Key word: orthostatism, fever children, emergency medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age: 4-18 year of age.
* Oral temperature \> 38.0
* Duration of fever 6-48 hours

Exclusion Criteria:

* Treatment with medications that may cause orthostatism.
* Vomiting or/and diarrhea (more than twice/day).
* Suspected CNS infection.
* Chronic diseases
* Unable to give an informed consent
Retention of Peek and Bre.Flex Materials Maxillary Bilateral Bounded Removable Partial Dentures

Evaluation of the retention of upper removable partial denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).

The assessor is responsible for all clinical procedure that will be conducted in this study during all the visits:

Panoramic radiograph and periapical radiographs will be made on the prospected abutment teeth to evaluate the crown-root ratio, the apical condition of the abutment and their alveolar bone support.

The preliminary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts. Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the interarch distance and occlusal plane.

Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats will be prepared opposing to the edentulous area.

Final impression will be taken by elastomeric impression material. The impression will be poured into type IV dental stone in order to obtain master cast. The master cast will be surveyed. The proposed design will be as follows: metal framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention. The denture base will be tried in with acrylic teeth in patient's mouth. After that, the denture base of the partial denture will be processed incorporation with the metal framework into the two different materials to be evaluated. The first group will receive the partial denture in which the metal framework incorporated with the denture base fabricated from PEEK material. The second group will receive the partial denture in which the metal framework incorporated with the denture base material fabricated from BRE-FLEX

Eligibility Criteria:
Inclusion Criteria:

* All patients must have Kennedy class III modification I upper partially edentulous ridges.
* The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
* Male or female patient with age range (45-55) and in good medical condition
* All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
* Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
* Free from any tempro-mandibular joint disorder.
* The patients have good oral hygiene and low caries index.

Exclusion Criteria:

* Patients having abnormal habits as bruxism or clenching
* Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
* Teeth with compromised bone support.
* Patient with xerostomia or excessive salivation.
* Patient with abnormal tongue behavior and/or size.
Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function

Aims: 1. To evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (Audiometry and tympanometry, vHIT, VEMP, ENG) ; 2. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function


Eligibility Criteria:
Inclusion Criteria:

* Females and males, Age: ≥ 18 years old
* Patients diagnosed Head and Neck cancers, not treated previously
* Planned for radiation therapy in which the inner ear will be radiated

Exclusion Criteria:

* Patients who were previously diagnosed with a vestibular disorder
* Previous middle or inner ear anomaly
* Failure to complete the whole course of radiation therapy
* More than one course of radiation therapy
* Patients treated with concurrent ototoxic chemotherapy
* Pregnant women
* Patients who will not sign an informed consent form
* Helpless or incompetent patients
Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis

To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.

Low back pain (LBP) is a very common health problem which results in negative impact in daily life and burden especially in elderly. The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%. Among the etiologies of low back pain, lumbar spinal stenosis is frequently encountered by physicians. In a large observational study, the prevalence of lumbar spinal stenosis was 23.6% in the general population and higher in patients more than 60 years-old. If untreated, the symptoms may persist in 70% of the patients over the 48-month observation period. On the other hand, previous studies have shown that surgery is more effective in pain relief, neurological symptoms and further functional status, however, conservative treatment still had favorable effect in patients with milder symptoms.

The role of spinal manipulation has been discussed in previous study which compared the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disc herniation. According to this study, the pain, disability and life quality of both groups in 12-week period had no significant difference that chiropractic spinal manipulative treatment could be considered as a primary treatment. However, comparison among the effect of spinal manipulation, physical therapy, and surgery has not been conducted before. Therefore, the purpose of this study is to compare the effect of spinal manipulation, physical therapy, and surgery in the treatment of lumbar spinal stenosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 to 80 age years old
2. Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS\>=4)
3. Symptom duration is more than three months
4. The diagnosis is proved by MRI

Exclusion Criteria:

1. Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
2. Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
3. Concomitant serious medical conditions
4. History of spinal surgery before
5. Severe osteoporosis or instability of the lumbar spine
Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery

In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.

It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries.

The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy.

Patients will be divided into two groups:

Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.

Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
* BMI \<35 kg / m2

Exclusion Criteria:

* Emergent surgeries, redo cases, minimally invasive procedures
* Patients who do not want to participate
* Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
* Hypersensitivity or history of allergies to local anesthetics
* Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
* LVEF \<30
* Patients with psychiatric disorders
* Pregnancy or breastfeeding
* Presence of hematological disease
* Patients with alcohol-drug addiction
* Patients who use daily opioids for any reason