cyrilzakka/clinical-trials huggingface dataset:
CONDOR Impact of Dental Practice-Based Research Network

The purpose of this study was to study the use of a Core Questionnaire that included several questions from each PBRN (DPBRN, PEARL, PRECEDENT - collectively know as CONDOR) that had been extracted from questionnaires previously administered as part of their initial research program activities. This protocol was the first administration of this core questionnaire with the purpose of assessing dental practice changes that may have occured since the earlier administration of the individual questions with the separate networks.It also collected baseline data for others.

The three dental PBRNs had a unique opportunity to measure the impact of research participation on potential changes in practice base of the research protocol. We were able to examine the effect of participation in research in general to the acceptance of research findings from other studies and the effect of association with but not participation in a research network.

Eligibility Criteria:
Inclusion Criteria:

* DPBRN dentists and hygienists who had completed a DPBRN Enrollment questionnaire and for whom DPBRN had a current active address and who were currently licensed to practice
* reported on the Enrollment Questionnaire they were a general dentist, pediatric dentist, or dental hygienist, or reported doing at least some restorative dentistry procedures
* practiced in one of the five DPBRN regions (AL/MS, FL/GA, MN\< PDA, or SK)
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection

Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.


Eligibility Criteria:
Inclusion Criteria:

* 18 through 65 years of age, inclusive
* Patients mono-infected with HBV and currently on HBV treatment for at least 2 years with either the nucleos(t)ide tenofovir (TDF) or entecavir (ENT)
* HBV DNA \< lower limit of quantification (LLOQ) (eg, HBV deoxyribonucleic acid (DNA) \< 20 IU/mL using the Roche COBAS TaqMan assay) within 6 last months
* Signed, written Independent Ethics Committee (IEC)-approved informed consent

Exclusion Criteria:

* Patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of ≥ 10.5 kPa or Fibrosure® / FibroTest ® score of ≥ 0.48 with either test result within past 2 years.
Measurement of Lung Water by Transpulmonary Thermodilution in Lung Transplanted Patients

Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation


Eligibility Criteria:
Inclusion Criteria:

* double-lung transplanted patients

Exclusion Criteria:

* none
Role of MRI in Diagnosis of Postpartum Neurological Disorders

Role of MRI in diagnosis of postpartum neurological disorders


Eligibility Criteria:
Inclusion Criteria:

1. Female gender.
2. Age more than 18 years old.
3. Patients presented with neurological complaint in 3 months following childbirth.

Exclusion Criteria:

1. Male gender.
2. Female younger than 18 years old
3. Contraindication to perform MRI examination. These include:- Cardiac pacemaker.- Metallic aneurysm clips.
Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery?

The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.

How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.

Eligibility Criteria:
Inclusion Criteria:

All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.

Exclusion Criteria:

Patients were excluded if radiography revealed lumbar instability (motion of \>3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
* Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
* Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months
* Recent history of fever or underlying medical problems
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery

Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).


Eligibility Criteria:
Inclusion Criteria:

* written consent

Exclusion Criteria:

* no written consent
Falls in Stroke Patients After Hospital Discharge: Prevalence and Risk Factors

The purposes of this study are: (1) to investigate the incidence and causes of falls of stroke patients residing in Taipei City and Taipei county after their discharge from the National Taiwan University Hospital, (2) to investigate the relationship between clinical manifestations of stroke patients before their hospital discharge and their incidence of falls after hospital discharge, and (3) to identify the risk factors for stroke patients who frequently fall after hospital discharge.

Falls are one of the most common accidents among stroke patients. Stroke patients are more prone to falls than community-dwelling older adults because of their cumulative risk factors of falls such as cognitive impairment and motor dysfunction. Recent studies on falls in Taiwan have primarily focused on falls of community-dwelling older adults. Research focused on falls among stroke patients in Taiwan, however, is scarce. Studies reported by researchers in other countries have only investigated the incidence and causes of falls of patients staying in medical institutions up to three months post-stroke. Therefore, the incidence and immediate causes of falls remain unknown for post-hospital discharge stroke patients during their sub-acute and chronic stages. In addition, whether falls of stroke patients after hospital discharge could be predicted by their clinical manifestations during hospital stay also requires further investigation.

Eligibility Criteria:
Inclusion Criteria:

* between 40 and 75 years old
* first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke)
* ever received rehabilitation therapies at National Taiwan University Hospital
* being willing to take the clinical assessments
* residents of Taipei City or Taipei County

Exclusion Criteria:

* having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter
* having other neurological diseases(ex. Parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke
A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization

We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.

Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients
* Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem)
* Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart)

Exclusion Criteria:

* Died prior to receive the controlled antibiotic
The Prolonged Use of Topiramate for Preventing Migraine Headaches

The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

Previous studies have shown that topiramate is effective in preventing migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. The dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients randomized to receive topiramate will remain on that dose. The comparison phase of the study is a 26-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Established history of migraine for at least one year;
* Migraine meets HIS (International Headache Society) criteria
* An average of at least 4 monthly migraine days during the 3 months preceding trial entry
* Capable of keeping trial records; Exclusion Criteria:
* Patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry)
* Patient had failed (lack of efficacy) more than two adequate previous regimens of migraine prophylactic medications
* Patient had a history of severe drug allergy or hypersensitivity
* Patient overused analgesics, opiates, ergots and/or triptans
* Patient had been using topiramate regularly
Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area

Background : The supplementary motor area is the most common/preferential brain location of LGG. This area plays an important role in many motor and cognitive functions such as motor initiation, bimanual coordination and executive functions. Many studies describe the supplementary motor area syndrome resulting from lesions in this area. News managements for LGGs consisting in intraoperative mapping in awake patients reduce significantly neurological disorders and increase also the overall survival . However, the literature does not provide data concerning motor and cognitive functions in a long term and their consequences in the quality of life of patients.

Objective : The aim of our research project is to identify whether there are some motor or neurocognitive deficit in the short and the long term in a population of patients who have medical story of LGG resection in the supplementary motor area.

Patients and Methods : 20 patients who have medical story of LGG in the supplementary motor area and 20 patients who have medical story of LGG resection in other locations are recruited. Firstly, patients have to complete a self-assessment questionnaire about their quality of life, sent by regular mail or e-mail. Then, patients are admitted on the same day as their follow up visit and underwent motor and neurocognitive screening tests ( "Bilan des 400 points", Tests of Attentional Performances) for an hour. The investigators will analyse data and compare between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have a history of low-grade diffuse glioma resection
* Visiting the University Hospital for a follow-up neurosurgical consultation
* Underwent awake surgery

Exclusion Criteria:

* Presence of cognitive disorders that do not allow the proposed test battery to be performed
* Under guardianship or curatorship
* Opposition to the participation to the research
Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)

The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Signed the Patient Informed Consent Form (ICF)
3. Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
4. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

1. Previous surgical or catheter ablation for atrial fibrillation
2. Current condition of continuous AF \> 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
3. Any carotid stenting or endarterectomy
4. Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
5. LA size \> 55 mm
6. LVEF \<40%
7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
8. Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
9. Uncontrolled heart failure or NYHA function class III and IV
10. MI within the past 2 months
11. Any cardiac surgery (i.e. CABG) within the past 2 months
12. Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
13. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
14. Documented thromboembolic event (including TIA) within the past 12 months
15. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
16. Active illness or active systemic infection or sepsis
17. Unstable angina
18. History of blood clotting or bleeding abnormalities
19. Contraindication to anticoagulation (eg, heparin or warfarin)
20. Life expectancy less than 12 months
21. Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
22. Presence of a condition that precludes vascular access
23. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
24. Currently enrolled in another device, biologics, or drug study
25. Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 50-90 years of age;
* diagnosis of probable Alzheimer Disease, with symptoms \>=1 year prior to screening;
* meets DSM-IV criteria for Alzheimer-type dementia;
* stabilised on approved medications for treatment of Alzheimer Disease for \>=4 months prior to baseline.

Exclusion Criteria:

* active major depressive disorder, or a history of bipolar disorder;
* history of schizophrenia;
* concurrent participation in a non-pharmacological trial with a key objective of improving cognition;
* prior randomisation in any R1450 trial.
Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.

The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. The current community standard of care often withholds pharmacotherapy for depression in substance abusing adolescents, since it is often assumed that their depressions may remit with SUD treatment alone. However, this is an untested hypothesis in adolescents and one that we propose to test in the current study.

Eligibility Criteria:
Inclusion Criteria:

* Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.

Exclusion Criteria:

* History of or current psychosis, history of psychotic depression, bipolar disorder I or II, family history of first degree relative with bipolar I, lifetime history of non-substance induced Mania/Hypomania
* Unstable chronic or serious medical illness
* Currently pregnant
* Take psychotrophic medication, past 2 months: medication or treatment for depression, clinically significant laboratory abnormality
Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion

The intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability .

Inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . The failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (LARCs) . Increasing acceptability and use of LARC methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy

The aim of this study is to This study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion .

Research question:

Which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during IUD insertion ? Research Hypothesis In this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to IUD insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.

Eligibility Criteria:
Inclusion Criteria:

-Multiparous women in 3rd to 5th day of menstrual cycle 2- Women who were 6 weeks postpartum or if recently pregnant. 3- Accept to participate and provide consent

Exclusion Criteria:

* • A contraindication for IUD use such as a gynecological malignancy , sexually transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.

  * Suspicion of pregnancy .
  * Allergy to lidocaine or ibuprofen .
  * Copper allergy .
  * Any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis , and submucous myoma.
  * A psychological or neurological disorder associated with altered pain sensation.
  * MIRENA insertion.
  * Nulliparity.
  * History of failed intrauterine device insertion (uterine perforation, acute expulsion).
The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain

Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.

44 patients participating in the study were divided three groups. The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the home exercise group were instructed to perform stabilization exercise. The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. Assessments were repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must be pain at least 3 months
* Must be visual analog scale rating 3 or more

Exclusion Criteria:

* History of any lumbar spine surgery
* Severe/progressive scoliosis
* Spinal stenosis
* Spondylolisthesis
* Cancer
* Diabetes
* Metabolic syndrome
* History of exercise programs or yoga at least 12 weeks before the onset of study