cyrilzakka/clinical-trials huggingface dataset:
Endodontic Management of Primary Molars

The purpose of this study was to describe the clinical and radiological outcome of root canal treatment with OrthoMTA in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed.

The study included 13 primary mandibular second molars with infected pulp and congenitally missing second premolars in which traditional root canal treatment with gutta-percha was contraindicated. Pulpectomy was performed in each tooth and the canals were filled with OrthoMTA. The clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9, and 12 months. Fractal analysis was used to detect changes in the trabecular bone after the treatment. Repeated measures analysis of variance test and two independent t-tests were used to evaluate the data.

Eligibility Criteria:
Inclusion Criteria:

* Selected to be preserved after an orthodontic consultation
* Absence of permanent tooth germ under second primary molars
* Sensitivity to percussion and palpation, complaints of spontaneous or persistent pain
* Presence of irreversible pulpitis or pulp necrosis, and abscess or fistula, presence of pathological mobility,
* Presence of internal and external pathological root resorption
* Furcal lesions
* Presence of infection exceeding 1/3 of the root
* Pathological loss of substantial bone support
* Loss of periodontal attachment
* Contraindication of traditional root canal treatment

Exclusion Criteria:

* Presence of any systemic disorder
* Presence of any syndrome
* A history or suspicion of allergies
* Age \<7 years,
* Teeth selected to be extracted after an orthodontic consultation
* A score of 1(-) or 2(--) according to the Frankl Behavior Scale
* Parents who refused treatment, children who refused to receive the intended treatment once it was initiated
Effects of TENS on Pain Threshold and Brain Activities in Healthy Adults

The purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.

Transcutaneous electrical nerve stimulation (TENS) is a pain modulation tool which is commonly used clinically. TENS has 2 major modes: "conventional TENS'' and "acupuncture like TENS". Conventional TENS induces a local pain modulation, whereas acupuncture like TENS induces central pain modulation mechanism. The pain threshold at treatment area and outside of area is regarded as local pain modulation and central pain modulation respectively. However, the effect of acupuncture like TENS on pain threshold was remained unclear. TENS also induces cortical activities changed in the central nervous system. Recent Electroencephalography (EEG) studies suggested that TENS induces event-related potential and power spectrum changes, however, the time and frequency bands of EEG changes and its relationship with pain threshold were still unclear. Therefore, the purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.

Eligibility Criteria:
Inclusion Criteria:

* 20\~65 y adults
* No cognitive function problem
* Without taking any type of pain medication or substances that could affect the cognitive functions

Exclusion Criteria:

* Peripheral or central nervous system disease
* Sensory lose
* TENS application is contraindication
* Cardiac pacemaker
* Any type of pain
Preoperative Smoking Cessation in Patients Undergoing Surgery

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient listed for intermediate or high-risk surgery at the Kantonsspital of Lucerne
* Patient undergoing surgery in one of the following departments: Abdominal surgery, thoracic surgery, cardiac surgery, urology, gynaecology, vascular surgery or head and neck surgery
* Date of surgery \>2 weeks after date of listing for surgery or discussion by tumor board
* Current smokers, defined as daily smoking of at least one cigarette, cigar or pipe
* Age over 18 years
* Able to give signed written informed consent

Exclusion Criteria:

* Plastic surgery
* Consumption of illegal drugs
* Alcohol dependency defined as preexisting alcohol related disorders (eg. alcoholic psychosis, Alcohol abuse, Alcohol polyneuropathy, degeneration of nervous system due to alcohol, Alcoholic myopathy, Alcoholic liver disease)
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia
Cognition Following Computer Assisted Total Knee Arthroplasty

A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.

Inclusion criteria

* Primary, cemented knee arthroplasty
* Unilateral or bilateral TKA

Exclusion criteria

* Patient is unable to speak English
* Unable to read and write
* Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
* Patients with history of IV drug abuse
* Previous history of dementia
* Patients on mental status changing medications

Eligibility Criteria:
Inclusion Criteria:

* Primary, cemented knee arthroplasty
* Unilateral or bilateral TKA

Exclusion Criteria:

* Patient is unable to speak English
* Unable to read and write
* Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
* Patients with history of IV drug abuse
* Previous history of dementia
* Patients on mental status changing medications
Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients

The purpose of this study is to determine the pharmacokinetic properties of two different dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with life-threatening illness.

Rationale:

Critically ill patients with trauma or sepsis exhibit a high degree of vitamin C deficiency at ICU admission and vitamin C plasma concentrations decrease even more during the first three days of admission. Vitamin C is a natural anti-oxidant and crucial for endothelial and organ protection

Objective:

To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine.

Study design:

Prospective randomized controlled pharmacokinetic intervention study

Study population:

Adult critically ill patients admitted to the ICU of the VU University Medical Center, Amsterdam, with sepsis or SIRS after major surgery or trauma with a non-neurological sequential organ failure (SOFA) score \>6 and an expected length of ICU stay of \>96 hours.

Intervention (if applicable):

Patients will receive either 2 or 10 gram/day vitamin C intravenously twice daily for two days in bolus or continuous infusion.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis or Systemic Inflammatory Response Syndrome (SIRS) after major surgery or trauma;
* Non-neurological sequential organ failure assessment (SOFA) score \>6;
* Expected length of ICU stay \> 96 hours;
* Written proxy consent by legal representative.

Exclusion Criteria:

* Admission after out of hospital cardiac arrest
* Prior use of supplemental vitamin C in the week before
* Major bleeding
* Pre-existent renal insufficiency defined as an eGFR of \< 30 ml/min/1.73 m2 (stadium 4-5)
* Expected need for renal replacement therapy within 48 hours
* Known glucose 6-phosphate dehydrogenase deficiency
* History of urolithiasis or oxalate nephropathy
* Previous use of prolonged high dose vitamin C supplements
* Hemochromatosis
Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of stomach cancer
* advanced stomach cancer of stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

* prior chemotherapy for stomach cancer in its advanced stage
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients
Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer

RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.

PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.

OBJECTIVES:

Primary

* Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection.

Secondary

* Determine whether acupuncture relieves dry mouth in these patients.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to surgical procedure (selective neck dissection vs modified radical neck dissection vs radical neck dissection) and baseline Constant-Murley score (≤ 35 vs \> 35). Patients are randomized into 1 of 2 treatment arms.

* Arm I: Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
* Arm II: Patients undergo standard of care for 4 weeks. In both arms, treatment continues in the absence of unacceptable toxicity.

The Constant-Murley score is assessed at baseline and then at week 6. Pain medication use is recorded at baseline, during study treatment, and then at week 6. Numerical Rating Scale of pain on activity and xerostomia inventories are completed at baseline and then at weeks 5 and 6.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella)
* Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection
* Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction)
* No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 months since prior radiotherapy
* More than 6 weeks since prior acupuncture
* Concurrent analgesics allowed
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.

Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AA according to established criteria in 2010
2. Age from 14 to 60 years
3. Suffering from AA within six months
4. No serious infection or acute hemorrhage.
5. Left ventricular ejection fraction (LVEF) ≥ 50%
6. No acute infectious diseases.
7. Understanding and willingness to sign a written informed consent document.
8. Eastern Cooperative Oncology Group(ECOG) score of 0-2pionts.

Exclusion Criteria:

- Patients with AA have to be disqualified from this study if any of the following is applicable.

1. Severe aplastic anemia(SAA) with severe infection.
2. Severe aplastic anemia(SAA) with active hemorrhage.
3. Severe heart attack, liver and kidney disease following serious complications
4. Patients with allergic constitution.
5. Pregnancy and lactation.
6. Accompanied by malignant tumors and other clonal disease.
7. Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with ADHD and oppositional symptoms
* ADHD-RS\>=24
* CGI \>=4
* T-score of Opp subscale CPRS-R:L \>=65
* Normal ECG and BP
* \>= 55 lbs
Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and able to understand an informed consent
* Adequate oral hygiene to allow for implant therapy consistent with standards of care.
* Missing a single tooth in the maxillary anterior region
* Presence of adjacent natural teeth

Exclusion Criteria:

* Poor oral hygiene
* Severe parafunctional habits, for example, bruxing and clenching
* Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
* Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
* Pregnant or expecting to be pregnant
* History of drug and alcohol abuse
* History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level \>7%)
* Radiotherapy in the head and neck area,
* On certain medications like bisphosphonates or steroids currently or within the past three months
* Absence of adjacent teeth
* Unwillingness to return for the follow-up examination
* Smokers (more than 20 cigarettes per day). Subjects smoking \<20 cigarettes per day were requested to stop smoking before and after surgery
Serotonin and Motor Plasticity

With this study, the investigators aim to test whether acute administration of selective serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor learning task in comparison to placebo in healthy humans.

Microdialysis findings in animal models provide evidence for a monoaminergic augmentation of motor function. However, this evidence is largely limited to noradrenaline and dopamine, with little evidence to support a similar effect for serotonin. What remains to be tested therefore, is whether acute serotonergic administration induces neural or behavioral changes during motor learning also. Using a sample of 60 female participants (with the possible inclusion of male participants at a later date), the investigators aim to test the effects of a serotonergic challenge on motor learning and plasticity in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* female
* right-handed
* healthy
* has taken oral contraceptives (ovulation inhibitor) continuously for at least 3 months
* has read and agreed to study parameters

Exclusion Criteria:

* tattoos on head or neck
* non-removable metal on or in body
* alcohol abuse
* is currently taking medication
* smokes more than 3 cigarettes per day
* positive drug test
* pregnancy
* plays an instrument professionally
* plays videogames more than 2 hours per week
* is a professional athlete
* suffers from migraines
* has taken part in another study, where motor learning skills and/or medication is a factor, in the last 3 months
* heart rhythm disorders (long QT)
* hypertension
* calcium or magnesium deficiency
* neurological disorders
* chronic metabolic disorders
* liver or kidney diseases
* immunodeficiency
* endocrine disorders
* psychiatric disorders
* tumors
* injuries to the head and brain
Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* BMI ≤35
* Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
* Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks

Exclusion Criteria:

* Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
* Is participating in another clinical study
* Has inflammatory arthritis
* Has knee avascular necrosis
* Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
* Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure
Immune Monitoring on Sipuleucel-T

The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.

The primary objectives of this study are to:

1. Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
2. Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
3. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
4. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Written informed consent obtained
* Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
* No prior systemic chemotherapy for metastatic prostate cancer
* Hemoglobin \> 9 mg/dl

Exclusion Criteria:

* Patients unable to understand the research protocol and/or provide informed consent
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.

Exclusion Criteria:

* Subjects with severe liver impairment
* Subjects who have weakened immune systems
Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age greater than or equal to 18 years with mild to moderate hypertension.
* Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.

Exclusion Criteria:

* Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
* Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.
* Patients with clinically significant elevations in laboratory values at Screening Visit.
* Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
* Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.