cyrilzakka/clinical-trials huggingface dataset:
Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching.

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years;
* Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location;
* Non-smoking;
* Read and sign the Statement of Informed Consent.

Exclusion Criteria:

* Compromised medical history;
* Severe or chronic periodontitis;
* Extreme caries sensitivity;
* Heavy bruxism;
* Under orthodontic treatment;
* Poor oral hygiene;
* Smokers.
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes

Primary Objective:

To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).

Secondary Objective:

To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases

The study duration will be displayed in 2 parts as follow:

Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization

Eligibility Criteria:
Inclusion criteria:

1. Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
2. Glycosylated hemoglobin ≤9.0%
3. Patient showing a percentage of error at refill equal or below 20%
4. Patient undergoing NaOH rinse procedure of at least 10 minutes period with or without flush Or Patient being re-implanted with a new pump (first fill with insulin)
5. Signed informed consent form prior to enrolment

Exclusion criteria:

1. Pump life time \> 6 years
2. Pump battery voltage \< 2.6 volts
3. Pregnancy or childbearing potential without a medically approved form of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Osteopathic Approach in Inflammatory Bowel Diseases

Crohn's disease (CD) and ulcerative colitis are bowel disease (IBS) with an autoimmune component believed to affect approximately 1 in 140 Canadians. Despite this high prevalence, more than 30% patients with IBD have to live with recurrent gastrointestinal symptoms that is poorly relieved by allopathic medicine. Numerous studies have shown that the quality of life of individuals with IBS is lower than that of the general population. Since visceral manipulations have been shown to be effective in reducing the main discomforts associated with IBS during clinical interventions, it seems likely that it may provide similar relief to patients with IBD. To our best knowledge, no study has evaluated the impact of osteopathic manual therapy on neuro-immuno-vascular modulation of intestine to reduce IBS symptoms.

The aim of this study is to assess the relevance of an osteopathic approach addressing the brain-intestine axis in order to improve symptomatology in subject suffering from IBD by modulating inflammation and vagal tone.

For this study, 10 to 12 participant (18 to 65 years) with Inflammatory Bowel Disease (in remission state) will be recruited to receiving visceral osteopathic therapy. Participant will received four standardized osteopathic session of 45 minutes (1 session every 7 days: week 0, 1, 2 and 3) and a follow up visit at week 4. The osteopathic protocol will specifically address the gut-to-brain neuro-immuno-vascular axis.

Global quality of life and severity of IBS-like symptoms will be a assess at week 0, 2 and 4 using three standardized questionnaires. Gut permeability and intestinal inflammation will be assessed at week 0 and 4 by measuring Zonulin (pre-Haptoglobin 2), Histamine and Diamine Oxidase (DO) levels respectively. Vagal tone at the beginning and at the end of each osteopathic session will be evaluate using heart rate variability (HRV) measurements.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with inflammatory bowel disease (IBD) in remission state;
* Subjects must suffer form recurrent digestive symptoms fulfilling the Rome III criteria;
* Subjects' eating habits should be stable prior to the study.

Exclusion Criteria:

* Concomitant diagnosis of celiac disease or multiple food intolerance;
* Concomitant diagnosis of rheumatologic disease;
* Obesity (BMI ≥ 30);
* Concomitant diagnosis of severe depression or severe anxiety;
* Unstable thyroid or kidney condition;
* Subjects on antidepressant, anti-inflammatory (steroids) or analgesic (paracetamol, aspirin) will be excluded from the study;
* Smokers, patients with problematic alcohol consumption or consuming drugs will be excluded from the study;
* High performance athletes will be excluded from the study.
FMRI Accelerated TMS Depression

This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
* DSM-IV diagnosis of MDD

Exclusion Criteria:

* Unable to speak English.
* Contraindicated for MRI.
* Any current or recent untreated medical, neurological, or psychiatric conditions
* Metal implant devices in the head, heart, or neck.
* History of brain surgery.
* History of cortisol medication use or electroconvulsive therapy.
* Comorbidity with other psychiatric/neurological illnesses or personality disorders
* History of myocardial infarction or arrhythmia, bradycardia.
* Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
* Individuals suffering from frequent/severe headaches.
* Moderate to severe alcohol or substance use disorder.
* Pregnancy
Evaluation of Functional Rehabilitation in Patients Undergoing Physiotherapy After Total Hip Arthroplasty

This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor performance and testing the quality of life of patients undergoing THA surgery, to improve rehabilitation strategies for this population.

The Total Hip Arthroplasty (THA) is a surgical procedure which has been used for more than half a century in the treatment of hip joint diseases.

The Physiotherapy is an important component in the care of patients undergoing THA.

In order to reduce the length of hospitalization after THA, to promote functional independence and to monitor clinical events during hospitalization and up to the 30th postoperative day, the Hip Surgery Group (HSG) of the Department of Orthopedics and Traumatology Department of Orthopedics and Traumatology of Hospital de Clinicas de Porto Alegre (HCPA) has developed a global, multidisciplinary Assistance Protocol of the HSG with outpatient consultations and scheduled home visits for patients that have undergone THA at HCPA.

The team which developed the Assistance Protocol of the HSG consists of orthopedic doctors and anesthesiologists, nurses and social workers.

The insertion of the Physiotherapist in the THA Assistance Protocol is of great importance owing to the professional skills of that professional in the areas of prevention and rehabilitation, working with the multidisciplinary team in functional evaluation and in physical therapy of patients that underwent THA.

The monitoring of the physiotherapist is essential to establish a functional diagnosis, aiming pain relief, promoting the early functional rehabilitation, the reintegration of the patients in their daily activities and offering a better quality of life through reintegration into social life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for THA.

Exclusion Criteria:

* Patients who refuse to participate in this study.
* Patients who live outside the city of Porto Alegre, due to difficulties for visits and the protocol monitoring.
* Patients with femoral neck fracture, due to the impossibility of evaluation.
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients

The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%. Treatment with chemotherapy can improve efficacy, but still the median progression-free survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median overall survival is less than one year. There is a urgent need for tools for predicting the efficacy of the treatment. The current trial aims at investigating the biomarker potential of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by gemcitabine and nab-paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years up to 80 years
* Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
* Locally advanced (primarily unresectable) and/or metastatic disease.
* Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
* ECOG/WHO performance status ≤2
* Absolute neutrophil count (ANC) \>1.5 x 109 /L and platelet count \>100 x 109/L
* Total bilirubin \< 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT \< 2 x ULN. If liver metastases are present, patients can be included if total bilirubin \< 5× ULN or AST/ALT \<10× ULN. Dose reductions of paclitaxel will be performed when bilirubin \>2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
* Serum creatinin \< 1,5 ULN / calculated creatine clearance \> 60 ml/min.
* Written informed consent

Exclusion Criteria:

* Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
* Prior medical treatment for advanced pancreatic cancer
* Confirmed brain metastasis.
* Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
* Treatment with any other investigational drug more than 30 days prior to study entry.
* Allergy to anyone of the included drugs.
* Female patient breast feeding or pregnancy
* Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.
Apply the (MyTransition) App In Transition

Moving from child care to adult care is a hard time for patients and their families. Parents of children with chronic conditions say they need more support around the time of changing care. Care providers say they do not have the tools to provide smooth transitions or help their patients manage their own health. This study is to see if a smart-phone-based app (named MyTransition) can improve healthcare transition experiences and health outcomes for youth, compared to usual care.

Transition to adult care is an unavoidable and challenging period for patients and their families, and comes with adverse outcomes in experience of care, population health, and costs. Parents of children with chronic conditions report a greater need for support around the time of healthcare transition. Providers report neither having the tools nor appropriate resources to foster smooth transitions for patients and their families. We hypothesize that an app-based transition toolkit (named MyTransition) designed to support youth moving from child to adult care can improve their experiences and lead to better health. The main objective of this study is to collect information to design a large multi-centre randomized control trial to assess implementation of the MyTransition app including recruitment, completion of follow-up, and scale-ability of the intervention. The secondary objective is to assess the feasibility and potential effect of the MyTransition app-based transition toolkit for improving health of youth (quality of life), healthcare transition experience, and achievement of health and life goals.

Eligibility Criteria:
Inclusion Criteria:

* Attending participating clinic at McMaster Children's Hospital
* Diagnosed with chronic health condition
* Must be able to utilize the intervention tool
* Must be able to read and understand English

Exclusion Criteria:

* Dependence on caregivers in areas of daily functioning, self-care and/or communication
* Inability to lead or provide own care
* Enrolled in a potentially confounding trial
The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

The investigator would like to investigate the impact of theta-burst stimulation over posterior superior temporal sulcus in children and adolescents with autism spectrum disorder


Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

Exclusion Criteria:

* current and past systemic disease
* current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
* current and past brain injuries
* intelligence \< 70
* seizure history
* pregnant
Intraumbilical Misoprostol in Retained Placenta

Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.

Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .

Eligibility Criteria:
Inclusion Criteria:

* women having singleton pregnancy
* 28 weeks of gestation or more delivered vaginally
* prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour

Exclusion Criteria:

* Who refused to participate in the trial
* Multiple pregnancies
* Previous Caesarean Section
* Haemodynamically unstable
* Severe anaemia (haemoglobin less than 8gm/dl)
* Chorioamnionitis
Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)

This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.


Eligibility Criteria:
Inclusion criteria:

1. Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
2. Up to 3 lines of prior chemo therapy, with treatment free interval of \>6 months
3. Platinum based chemotherapy in the immediately preceding line.
4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
5. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Exclusion criteria:

1. Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
2. More than 2 lines of prior therapies that contained angiogenesis inhibitor.
3. Patients for whom surgery is planned, e.g. interval debulking surgery.
4. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
5. Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
6. Laboratory values indicating an increased risk for adverse events.
7. Significant cardiovascular diseases.
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years old.
* Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.
* Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.
* Measurable disease per RECIST v. 1.1 criteria.
* ECOG performance status 0 or 1.

Exclusion Criteria:

* Radiation therapy within 14 days of C1D1.
* Investigational drug use within 28 days of C1D1.
* Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Eligibility Criteria:
Inclusion Criteria:

* Meets RELIEF Registry criteria for inclusion
* Primary complaint of persistent or recurrent low back pain, with or without leg pain
* Signed a valid, IRB/EC-approved informed consent form

Exclusion Criteria:

* Meets any RELIEF Registry criteria for exclusion
Treatment of Severe Influenza A Infection

Each year, influenza A infection caused great mortality and morbidity, especially among the elderly and individuals with chronic illness. Many of these patients are 'late presenters' who are admitted to hospital a few days after symptoms onset and have developed complications secondary to immunodysregulation. Antiviral treatment with the neuraminidase inhibitor is of limited usage for patients who presented to the hospital 48 hours after symptom onset. Apart from ventilatory and extracorporeal membrane oxygenation support, treatment options for these patients are limited. Recent animal study has demonstrated that combinations of an antiviral agent with a COX-II inhibitor can reduce mortality in mice infected with influenza virus. The investigators therefore propose to enrol patients with severe influenza A infection requiring hospitalization and oxygen support on a randomized controlled trial with celecoxib.

The aim of this double blind randomized controlled trial is to compare the clinical efficacy and safety of celecoxib combined with neuraminidase inhibitors in patients with severe influenza A infection. The hypothesis of this study is that treatment of severe influenza A infection with celecoxib will reduce mortality. The primary outcome to be assessed will be the 28-days mortality rate from hospitalization. The secondary outcomes to be assessed will be safety of the treatment, duration of intensive care, duration of ventilatory and oxygen support, the viral load and cytokine change.

Eligibility Criteria:
Inclusion Criteria:

1) Male or female patients ≥18 years 2) Written informed consent by patient or next-of kin (if patient is too ill to consent) 3) Presumptive diagnosis of influenza A satisfying both clinical and laboratory criteria. The laboratory criteria are defined as at least one RT-PCR positive for influenza A (H1N1, H3N2, H5N1 and H7N9) from respiratory clinical specimens including nasopharyngeal samples and endotracheal aspirates. The clinical criteria are defined as hospitalization with fever or one of the symptoms suggestive of influenza infection including sore throat, rhinorrhea, cough or shortness of breath 2) Desaturation to \<90% in room air by pulse oximetry and required oxygen supplement 3) Within 7 days of onset of symptoms. Patients have to fulfil all the aforementioned criteria.

Exclusion Criteria:

1) Age \<18 years. 2) A known hypersensitivity to celecoxib, oseltamivir or zanamivir 3) Unable to obtain informed consents 4) Influenza A infection diagnosed beyond 7 days from symptom onset 5) Patients receiving other antiviral treatment (apart from oseltamivir or zanamivir), N-acetylcystiene, statins and tradition Chinese medicine during the current admission 6) Patients with renal impairment of creatinine clearance \< 30mL/min