cyrilzakka/clinical-trials huggingface dataset:
Effect of Propofol-Dexmedetomidine on Cerebral Oxygenation and Metabolism During Brain Tumor Resection

Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and intra-cranial pressure (ICP) were least with sevoflurane.

Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.

The well known pharmacodynamic advantages of intravenous anesthetics may give this group of drugs superior cerebral effects when compared with inhalation anesthetics.

The aim of this study is to evaluate the cerebral haemodaynamics and global cerebral oxygenation as well as the systemic haemodaynamic changes using dexmedetomidine, propofol and fentanyl as total intravenous anaesthestics (TIVA) in comparison with sevoflurane - fentanyl anesthesia in brain tumor resection.

Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.

* Induction: propofol, 1.5 - 2 mg/kg.
* Muscle Relaxants: atracurium, 0.5 mg/kg with induction and 0.1 mg/kg/20min. for maintenance.
* Cannulation: Arterial cannula: under complete aseptic conditions 20G cannula was inserted into the radial artery of non dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2%.

Central venous catheter: A suitable central venous catheter will be inserted into Rt subclavian vein under complete aseptic technique, its correct position will be confirmed with chest X-Ray.

Jugular bulb catheterization: Under strict sterile technique the right internal jugular vein will be cannulated in a retrograde technique with confirmation of the catheter tip position using X-Ray (C- arm). Puncture site will be at the level of cricoid cartilage behind the anterior border of the sternocleido-mastoid muscle.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status III or IV.
* Patients scheduled for elective brain tumor resection

Exclusion Criteria:

* Morbid obese patients.
* Severe or uncompensated cardiovascular diseases.
* Severe or uncompensated renal diseases.
* Severe or uncompensated hepatic diseases.
* Severe or uncompensated endocrinal diseases.
* Pregnancy.
* Postpartum or lactating females.
* Allergy to one of the agents used.
* Severely altered consciousness level.
* Sitting position during surgery.
* Prone position during surgery,
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (PNH) in China.

This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with PNH in China who previously have not been treated with complement inhibitors. Approximately 25 eligible participants in China will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adult C5 inhibitor naïve PNH patients (age\>=18), which is confirmed by flow cytometry evaluation
* Must be vaccinated against N meningitidis

Exclusion Criteria:

* Meningitidis infection or unresolved meningococcal disease
* Significant bone marrow failure
* Other significant systemic diseases that might have impact on efficacy and safety assessment
Oral LAT8881 in Neuropathic Pain

This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain.

This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain. After a one week baseline period, subjects entered into the study will be randomised to receive Investigational Medicinal Product (IMP) (LAT8881 or placebo) twice daily for four weeks.

The first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week. Subjects will not take any IMP over these three weeks.

After the second baseline period, subjects will cross over to receive the second treatment (either LAT8881 or placebo, whichever treatment was not received in the first treatment period) twice daily for four weeks.

The pharmacokinetics (PK) of LAT8881 will be investigated in 15 subjects (PK subjects) at selected Australian sites.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash OR
2. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:

   1. symmetrical, bilateral pain in the lower extremities for at least 3 months and
   2. diabetes under control for at least 3 months prior to randomisation, as indicated by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable dose of insulin or oral diabetic medication for 3 months prior to screening, and
   3. no change in diabetic medication planned for the duration of the study
3. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:

   1. painDETECT questionnaire (PD-Q) and
   2. Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)

8. An average daily pain score on the numeric pain rating scale (NPRS) of at least 4 and no more than 8 in the last five diary entries before randomisation

Exclusion Criteria:

1. Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
2. Subjects with both DPN and PHN
Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations

OBJECTIVES:

I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.

PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (no prior treatment vs prior surgical treatment) and geographic area.

Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total of up to 4 injections.

After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of macrocystic lymphangioma of the head and/or neck Cystic spaces at least 2.0 mL confirmed by radiographic imaging (MRI or CT) Mixed lymphangiomas (macrocystic and microcystic disease) allowed if macrocystic component comprises at least 50% of the total disease burden
* No mixed hemangioma-lymphangioma lesions
* At least 6 months since prior surgery for lymphangioma

--Patient Characteristics--

* Hematopoietic: No clinically significant hematologic disease No hemodynamic instability
* Hepatic: No clinically significant hepatic disorder
* Renal: No clinically significant renal disease No personal or family history of post-streptococcal glomerulonephritis
* Cardiovascular: No personal or family history of rheumatic heart disease
* Pulmonary: No respiratory failure

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No history of allergy to penicillin
* No concurrent temperature of 100.5 degrees or greater
* No active upper respiratory infection
* No personal or family history of obsessive-compulsive or tic disorders
* No personal or family history of PANDA (pediatric autoimmune neuro- psychiatric disorder associated with streptococcal infections)
* No history of hypersensitivity to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)
* No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)
STAND Community Trial

The proposed study evaluates the effectiveness of a family-based psychosocial treatment program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process. STAND consists of ten 50-minute sessions delivered by therapists with community-typical levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms and indices of academic and family impairment. In the proposed study, 300 adolescents with ADHD who present for treatment at one of four community mental health agencies in Miami-Dade County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will receive a comprehensive treatment manual, three-day training, and weekly supervision from a project psychologist. Participants will be screened by research staff in the community setting and enrolled on a rolling basis over 30 months. Participants will be assessed at baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures will be obtained for treatment outcome (family and academic impairment), treatment mediators (executive functioning, parent academic involvement, parent-teen communication, parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient, practitioner, service delivery, and organization characteristics). Additional consumer perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence, treatment fidelity, need for additional treatment, attendance, therapist attitude toward treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16% Non-Hispanic White) that is historically underrepresented in research, but ideal for evaluating therapy effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* IQ of at least 70
* Enrollment in sixth through twelfth grade

Exclusion Criteria:

* history of autism spectrum disorder
* not attending a Miami-Dade County Public School
* a primary presenting problem other than ADHD, requiring immediate treatment of a different domain
ADenoVirus Initiative Study in Epidemiology in Germany

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Germany. The planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
* Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
* No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

* Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
* Previous enrolment in the present study.
* Any direct involvement with the study conduct at site or any family link with study site staff.
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of UC is based on:

  * Clinical history
  * Characteristic endoscopic findings
  * Histopathology results from biopsies
* Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
* Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.
* If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.

Exclusion Criteria:

1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.
2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
3. Severe UC, defined as total Mayo score \>10.
4. Not currently in an active phase or flare, defined as a total Mayo score \<4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.
5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
6. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).

   NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.
7. Evidence or history of toxic megacolon or bowel resection.
Clinical Evaluation of Two Different Attachment System

Edentulous patients commonly experience a deterioration in the quality of life; both in terms of oral and general health. Studies demonstrated that conventional dentures do not adequately restore masticatory function nor quality of life. In contrast, implant-supported overdentures are considered the standard of care for edentulous patients as they offer a more stable prosthesis that ultimately results in improved oral function and patient satisfaction.

Precision attachments such as studs, magnets, telescopic crowns or a bars are commonly used for implant supported overdentures. Implant overdentures supported by stud attachments gained popularity for the rehabilitation of edentulous patients as they are self-aligning, offer dual retention and compensate for divergence between implants up to angles of 40 degrees.

However, it has been documented that the stud attachment system (Locators) requires a high frequency of maintenance, particularly with regard to the replacement of the matrix.

In order to overcome some of these limitations of existing attachment systems, a newer system was developed consisting of a matrix made of polyetheretherketone (PEEK) instead of a polymeric material. This system has an amorphous diamond like carbon-based abutment coating (ADLC) and it was claimed to be more resistant to wear.

Clinically and in vitro, no comparative studies have been performed addressing wear and retention of the traditional stud attachment and the newer ADLC attachment.

Thus, the aim of the present study is to clinically and in vitro evaluate the ADLC and study attachment system.


Eligibility Criteria:
Inclusion Criteria:

* Fully edentulous patients encountering problems (functional, aesthetics) with existing dentures in the upper and lower jaw or patients seeking for implant-supported prostheses
* Adequate bone in the anterior mandible for the placement of implants (Regular diameter implant with a minimal length of 10mm) in the canine region
* Written informed consent
* Ability to understand the procedure and to answer a questionnaire.

Exclusion Criteria:

* Impaired cognitive function and/or manual dexterity
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Unable to attend follow-up examinations
* Known or suspected non-compliance, drug or alcohol abuse
* Presence of any uncontrolled systematic disease that could compromise implant surgery and implant long-term performance
* History of radiotherapy in the head and neck region
* Heavy smoker (\>10 cig. /day
* Any potential allergies or hypersensitivity to chemical ingredients of material used

  * Bruxism
  * Presence of bone metabolic disorders (e.g. osteoporosis)
  * Pregnant or lactating women
Tailoring of Vaccine-Focused Messages: Moral Foundations

This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.

Vaccination of young children helps protect this population against a variety of diseases. Children are especially at risk for contraction of and complications from diseases due to their vulnerable immune systems. New evidence-based messages are needed to maintain and increase vaccination uptake among this group. An emphasis on different values is related to decisions parents make about vaccines. The purpose of this study is to develop, implement, and evaluate messages that focus on different aspects of values to impact vaccination attitudes among parents of young children.

Parents emphasize different moral foundations when deciding whether or not to vaccinate children. Based on this research, a messaging intervention with parents of children who are 12 years of age or younger will be conducted. These messages will aid in assessment of how different moral foundations impact attitudes towards vaccination and intent to vaccinate.

This study tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one child ≤ 12 years of age
* Reside in the United States

Exclusion Criteria:

* Have previously participated in this study
A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment
* Born at full term of pregnancy (Gestational age ≥37 weeks)
* Body weight ≥ 3.2 kg at the time of screening
* Born to HIV negative mother
* The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
* Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)

Exclusion Criteria:

* Previously received any polio vaccines (OPV or IPV)
* History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
* History of bleeding disorder contraindicating intramuscular injection.
* Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
* Receipt of immunoglobulin or blood-derived product since birth
* History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
* Known or suspected immune disorder, or received immunosuppressive therapy
* History of poliomyelitis
* History of any neurological disorders or seizures
* Known or suspected febrile, acute or progressive illness
* Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
* Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
* Infants whose families are planning to leave the area of the study site before the end of the study period
* Infants who is considered unsuitable for the clinical study by the investigator
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.

This is a randomized, parallel, 6 month period study.

Eligibility Criteria:
Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
2. Pain VAS ≥4
3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
4. PUF score ≥ 13
5. cystoscopic record within 2 years
6. Hunner ulcer lesion in cystoscopic finding

Exclusion Criteria:

1. Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
2. Patients who are pregnancy or, childbearing age without no contraception
3. Patients with voided volume \<40 or, \> 400ml
4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
6. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, prostate cancer
   * Recurrent cystitis
   * anatomical disorder
7. Patients had prior surgery (eq, bladder augmentation, cystectomy
8. Patients with neurologic disorder
9. Patients with indwelling catheter or intermittent self-catheterization
10. Patients with psychologic problem