cyrilzakka/clinical-trials huggingface dataset:
Histological Change of The Dentinal-Pulp Complex and Root Resorption

The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.

Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. The objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first premolar extraction indicated
* Patients with no sistemic diseases
* Healthy premolars with completed root and no trauma or restoration

Exclusion Criteria:

* Sistemics diseased
* Restoration, trauma in first premolars
* root uncompleted
Registry Platform Gastric/Esophageal Cancer (SAPHIR)

The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic esophageal, gastric or gastroesophageal junction cancer, treated in palliative intention in daily routine practice in Germany.

SAPHIR is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic esophageal, gastric or gastroesophageal junction Cancer in Germany. The registry will follow patients for up to two years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to two years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven stage IV (metastatic) ESCC, EAC, GAC or GEJAC
* Planned palliative systemic first-line therapy
* Age \>= 18 years
* Signed informed consent (IC)

  * Patients answering questionnaires: IC before first therapy cycle
  * Patients not answering questionnaires: IC latest 4 weeks after start of first therapy cycle

Exclusion Criteria:

* No systemic therapy for ESCC, EAC, GAC or GEJAC
Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery

It is recognized that a poor glycemic, pre- and intraoperative balance is the source of increase in morbimortality. There was no local protocol at the CHRU Brest regarding the perioperative management of the diabetic patient. This retrospective observational work aims to assess the application of the French recommendations for the perioperative management of diabetes, and compare management before and after the introduction of a protocol based on its recommendations published in 2017 by the SFAR.

The main endpoint is the percentage of patients for whom half of the patients recommendations from the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after protocol and staff training.

Half of the recommandations are implemented for each recommendation evaluated applicable in 29% of patients(n=25) in the before group versus 66.23% (n=52) in the after group (p\<0.05).

This corresponds to an improvement significant of 36.23% for our primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* patients diabetics
* urology or visceral surgery

Exclusion Criteria:

* ambulatory surgery
Hydralazine Valproate for Ovarian Cancer

The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or gemcitabine, however, the results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of chemotherapy.

Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate plus topotecan over placebo plus topotecan upon progression-free survival.

Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase progression-free survival from 6 to 9 months as compared with the same regimen of chemotherapy plus placebo.

Randomized, double-blind phase III trial. A total of 211 patients (alpha 0.5, power 0.8)with cisplatin-resistant recurrent or persistent cancer will be randomized to topotecan + placebo or topotecan + hydralazine + valproate for 6 courses every 4 weeks. Patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d. Both drugs in a slow-release formulation. Experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course.

Eligibility Criteria:
Inclusion Criteria:

* Measurable or evaluable disease(evaluable according to CA125 criteria of GCIG) Cisplatin resistant ovarian cancer
* Persistent or progression to first line platinum-based chemotherapy
* Relapse within 6 months after completing first line platinum-based chemotherapy
* Platinum-sensitive disease who are failed to second line therapy based on platinum.
* Adequate organic function as defined by: hemoglobin \>10 g/L, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 mL/min; total bilirubin \< 1.5 upper normal limit value

Exclusion Criteria:

* History of allergy to hydralazine or valproate;
* Past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician;
* Newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine.
* Previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding.

Other exclusion criteria are uncontrolled systemic disease or infection.
Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery

Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A randomized controlled double blinded MRI study comparing long versus short axis catheter placement. Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 y.
* Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r
* Written and informed concent

Exclusion Criteria:

* Patient uanble to cooperate
* Patients not speaking and understanding Danish or English
* Patiens in immunosuppresive treatment
* Patienter with neuropathys in lower extremities
* Allergies to the in the protocole listes medicines
* A daily opoid intake
* Pregnant women
* Patients not meeting MR-criterias (metal, claustofobia...)
Extracorporeal CO2 Removal in Hypercapnic Patients

Noninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.

During a period of two years (from January 2013 to July 2015) 35 patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated with extracorporeal Co2 removal plus NIV as last resort therapy.

The collected data of these patients will be retrospectively matched with data obtained from 35 historical controls who received conventional treatment with endotracheal intubation. The study will retrospectively compare intubation rate, acid base homeostasis, norepinephrine requirements (in the patients who due to clinical conditions were under norepinephrine before starting extracorporeal Co2 removal ) and coagulation parameters.

Eligibility Criteria:
Inclusion Criteria:

* exacerbation of chronic obstructive pulmonary disease
* failure of non invasive ventilation
* expression of a clear intention not to be intubated

Exclusion Criteria:

* alterations in mental status which do not allow to express a clear intention not to be intubated
* contraindications to anticoagulation
Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease

In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon. Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the clinical response does not correlate consistently with the degree and time of HbF increment, suggesting that HU clinical benefits may involve other mechanisms such as the induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.

Plasmatic proinflammatory molecules (C-reactive protein, orosomucoid, RANTES, IL-6, IL-8, MCP-1, IL-1A, IL-1B, ET-1, IL-4, IL-10, TNFalpha, IFNgamma), hormones from the hypothalami-pituitary-adrenal axis (cortisol, ACTH), and hypothalamic peptids (arginine vasopressin, corticotrophin-releasing hormone) will be measured from SCD children treated or not with HU (20 treated children, 20 untreated children with a history of vaso-occlusive events, 20 asymptomatic children, and 20 healthy African controls).

Eligibility Criteria:
INCLUSION CRITERIA:

1. Homozygous SS sickle cell children, aged \> 3 years, of sub-Saharian Africa extraction, in a steady-state of disease (free of any infectious or vaso-occlusive events for the 4 weeks prior to and 2 weeks after blood sampling, and transfusion-free for 4 months prior to blood sampling), taken no drug except penicillin-V, folate or iron supplementation, hydroxyurea, divided into three groups :

   * children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events
   * untreated children with major vaso-occlusive events
   * children \> 5 year-old without a history of vaso-occlusive events Signed informed consent obtained from the subjects (if possible) and their parents
2. Controls : heterozygous AS parents or siblings of the patients, and AA siblings or healthy African unrelated subjects, aged \> 3 years, taken no drug on the day of blood sampling.

Signed informed consent obtained from the subjects (if possible) and their parents

EXCLUSION CRITERIA:

* Children in a acute-phase of the disease
* Parent's or patient's refusal
* Taking any drug except penicillin-V, folate or iron supplementation, hydroxyurea
* Un-healthy control or taking drug
Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain

Athletic osteitis pubis is a pathologic entity that can cause functional impairment. Scientific evidence have noticed that athletes experiment pain and a decrease on strength. Moreover, this symptomathology can affect daily life and functionality. There is no scientific evidence about the influence of manual therapy (MT) as a single treatment to improve this condition. The investigators decided to conduct a randomized controlled trial to compare the effects of a MT technique with placebo technique.


Eligibility Criteria:
Inclusion Criteria:

* Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.
* Internal rotation ROM limited.
* Positive provocation pain tests.

Exclusion Criteria:

* Pain due to intraarticular hip pathology.
* Hip pain due to inflamatory diseases.
* Previous surgical interventions in hip, pelvis or lumbar spine.
* MRI results or provocation pain tests inconcluyent
Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)

Obesity and metabolic dysfunction-associated steatotic liver disease (MASLD) accelerate the appearance of arterial stiffness due to inflammatory and oxidative stress mechanisms producing increased vascular tone and increasing the risk of cardiovascular disease. This arterial stiffness can be measured through pulse wave velocity (PWV). Obesity and MAFLD have multifactorial components, high fructose diet and sedentary lifestyle are causing the onset of these diseases earlier in life such as in adolescence. L-citrulline, a non-protein amino acid, has shown positive effects on improving nitric oxide synthesis which improves endothelial function, as well as results on the metabolic profile in MASLD. High intensity interval training (HIIT) has also shown benefits on endothelial function improving the metabolic profile of people with obesity and MASLD with the advantage of decreasing the time required to perform the physical activity. A clinical study will be conducted with 45 adolescents (15-19 years old) with MASLD and the participants will be divided into 3 groups to perform HIIT and supplement with citrulline or placebo for 12 weeks.

The investigators hypothesize that citrulline and HIIT have additive effects on endothelial function in people with obesity and MASLD, in addition to improving metabolic, lipid and hepatic steatosis profile. the researcher´s aim is to evaluate the effect of citrulline and HIIT on arterial stiffness assessed by PWV in adolescents with MASLD. For this the investigators will perform a randomized, double-blind clinical study in 45 adolescents with MASLD and obesity, who will be supplemented with 6 g per day with L-citrulline or placebo (Carboxymethylcellulose) and will perform HIIT sessions for 12 weeks. At the beginning and at the end of the intervention, the level of arterial stiffness by means of PWV, body composition, biochemical and metabolic data, as well as the degree of hepatic steatosis will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obesity and metabolic associated-dysfunction steatotic liver disease associated with (MASLD) and with moderate or severe steatosis
* History of physical inactivity
* They should not be under treatment with any dietary supplement or polyvitamins for weight loss at least 6 months before the study.
* They should not be smokers.
* Not have a diagnosis of any chronic degenerative disease
* Adolescents without fracture or musculoskeletal injury
* Patients without surgical procedures at least 1 month prior to the protocol.
* Women who are not pregnant or use oral contraceptives

Exclusion Criteria:

* Participants who do not complete at least 80% of the training sessions.
* Participants who miss 2 consecutive weeks of training.
* Who do not ingest the L-citrulline supplement or placebo.
* Participants who present allergy or intolerance to L-citrulline.
* Participants who present any injury during the intervention period that prevents them from performing the training.
Indirect Measurement of Respiratory Quotient in Coelioscopic Surgery

The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured RQ from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room.

But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic surgery was an exclusion criteria of our pilot study.

However, no study has examined the impact of coelioscopy on the indirect measurement of RQ


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for coelioscopic surgery

Exclusion Criteria:

* Cardiac and thoracic surgery
* Preoperative oxygen therapy
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
* Patients who are using ResMed masks

Exclusion Criteria:

* Patients who are unable to provide written informed consent
* Patients who are unable to comprehend written and spoken English
* Patients who are using Bilevel PAP
* Patients who are pregnant
* Patients who are suffering any of the following:

  * Acute respiratory infection
  * Acute sinusitis, otitis media or perforated eardrum
  * Pneumothorax or pneumomediastinum
  * Recent history of severe epistaxis requiring medical attention
Single-implant Overdentures Retained by the Novaloc Attachment System

The objective of this explanatory mixed methods study is to compare a novel attachment system (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of edentate elders. The investigators will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elders. Participants will be followed for three months with each attachment type; patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with preferred attachment; this latter assessment will enable the observation of attachments' long-term wear and maintenance events.


Eligibility Criteria:
Inclusion Criteria:

* Not have had a tooth extraction within the past six months
* Request implant stabilization of a mandibular conventional complete denture
* Have clinically acceptable maxillary and mandibular complete dentures
* Have adequate bone in the anterior mandible for the placement of a single 3.3 mm wide implant in the midline
* Be able to maintain adequate oral hygiene and clean dentures;
* Present no systemic conditions for which minor oral surgery would be counter-indicated
* Have an adequate understanding of written and spoken English or French;
* Be capable of giving written informed consent

Exclusion Criteria:

* Severe/serious illness that requires frequent hospitalization
* Impaired cognitive function
* Unable to return for evaluations/study recalls
* Have a history of radiation therapy to the orofacial region
* Have specific conditions that may jeopardize the treatment, such as alcoholism or smoking (\>10 cigarettes/day)
* Have acute or chronic symptoms of parafunctional or temporomandibular disorders
* Previous dental implant treatment

Following radiographic exam, investigators will exclude volunteers with bony pathologic lesions, less than 11 mm of minimum vertical mandibular bone height in the midline or width for planned implants, evident endosseous vascular structures or mandibular ridges with remaining alveolar sockets
Proton Therapy for Hodgkin Lymphoma

The purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation.

3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

1. Proton Plan
2. Conventional Plan
3. Intensity Modulated Radiotherapy (IMRT) Plan

The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)

Eligibility Criteria:
Inclusion Criteria:

* Confirmed "classic" Hodgkin lymphoma.
* Completed chemotherapy.

Exclusion Criteria:

* Prior radiotherapy.
* Prior or concurrent cancer other than non-melanomatous skin cancer.
Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome patients meeting 3 of 5 criteria:

  1. waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
  2. triglycerides ≥150 mg/dl;
  3. high-density lipoprotein cholesterol (HDL-C) \<40 mg/dl in men and \<50 mg/dl in women;
  4. blood pressure ≥130/85 mm Hg
  5. fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics)
* Patients requiring secondary ASCD prevention

Exclusion Criteria:

* Patients with less than 5 year survival
* Patients with cancer undergoing therapy or on palliative treatment
* Patients with end stage heart failure