cyrilzakka/clinical-trials huggingface dataset:
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery

Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. The aim of this study is to introduce a novel modification of the intraoral inverted L ramus osteotomy (ILRO) to overcome these limitations in mandibular setback surgery. preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Inferior alveolar nerve function was regained perfectly one year post-operatively. This procedure introduces a robust alternative to the BSSO osteotomy in some cases of mandibular setback surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* patients with skeletal class III malocclusion.
* Patients with thin mandibular rami with minimal medullary bone.
* Patients with inferior alveolar nerve proximity to the buccal cortex.
* Patients with lateral bending of the inferior mandibular border at molar angle region.
* Patients with high mandibular foramen.

Exclusion Criteria:

* Patients with previous extensive jaw surgery.
* mandibular pathological lesions.
* Patients with temporomandibular joint dysfunction.
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .

This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Provision of archived tumor tissue sample and mandatory tissue biopsy
* Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease
* Life expectancy ≥12 weeks
* Patients must have measurable disease and at least 1 lesion not previously irradiated
* World Health Organization (WHO) performance status of 0 or 1

Exclusion Criteria:

* Mixed small cell and NSCLC histology
* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma

Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the same time. This study is a multicenter prospective study. Participants including healthy control,HCC, liver cirrhosis, hepatitis and benign tumor-like lesions are consecutively recruited into the cohort. All the blood samples are collected before any treatments and will be tested in single center in order to decrease bias.

GALAD score including age, sex, PIVKA-II(DCP), Alpha-fetoprotein (AFP) and alpha-fetoprotein L3 (AFP-L3), is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. While increasing studies showed the diagnostic accuracy of AFP-L3 was not as good as that of AFP or PIVKA-II, and AFP-L3 was not significant in the multivariable model. Thus, a model with better diagnostic accuracy and more suitable for Chinese patients is needed. Here, based on a multi-locus blood-based assay targeting circulating tumor DNA methylation, we aim to develop a novel diagnostic model--GAMAD (gender, age, methylation, AFP and DCP) and validate its performance among HCC patients and those at high risk of developing HCC,such as liver cirrhosis, hepatitis patients. This is a multicenter, observational, prospective study. After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Establishing Diagnosis according to the European Association for the Study of Liver(EASL) criteria
* High risk group of developing HCC including liver cirrhosis and hepatitis under the confirmed diagnosis
* Able to provide sufficient and qualified blood samples for study tests
* No prior or undergoing cancer treatment (local or systematic)
* Able to provide a written informed consent

Exclusion Criteria:

* Obstructive jaundice patients
* Medical history of taking warfarin
* With other known malignant tumors or multiple primary tumors
* Patients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigator
* During pregnancy or lactation
* Recipient of blood transfusion within 3 months prior to study blood draw
* Insufficient qualified blood sample for study test
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck

This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, recurrent or metastatic SCCHN not curable by local therapy
* No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior of given as part of multimodal treatment for locally advanced disease)
* Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
* At least one radiographically measurable lesion
* HPV test results available (positive and negative eligible)
* ECOG Performance status of 0 or 1
* Adequate end organ function
* Positive PD-L1 expression level (CPS ≥ 1%)

Exclusion Criteria:

* Disease suitable for local therapy administered with curative intent
* Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN
* Radiation or other non-systemic therapy within 2 weeks of first dose of study drug
* Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug
Tau Imaging in Young Onset Dementia

The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of \[18F\]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of \[18F\]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be 45 - 70 years of age
2. MMSE \> 10 at screening visit.
3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
4. Participants must be willing and able to comply with scheduled visits and imaging procedures.
5. A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
6. Participants must identify a study partner who is willing to accompany the patient to study visits

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
2. Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
3. QTc \> 450 msec on screening ECG.
4. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).
The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion

A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet \< 0 mm.
2. Concave profile with normal lower facial height (clinically and radiographically).
3. Good oral health free from caries and periodontal problems at the start of treatment.

Exclusion Criteria:

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with vertical growth pattern or backward mandibular rotation tendency.
3. Patients with gross facial asymmetry.
4. Patients with cleft lip and palate and/or craniofacial syndrome
5. Patients with bad oral habit.
6. Active periodontal disease.
7. Previous history of TMJ signs or symptoms
The Genetics of Cardiomyopathy and Heart Failure

The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.

The purpose of this research study is to explore the causes and inheritances of cardiomyopathies. Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure. The underlying genetics of cardiomyopathies are poorly understood. This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies. This information will be used to identify inheritance patterns within families with cardiomyopathies. In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy. Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of cardiomyopathy
* Family members of individuals with a diagnosis of cardiomyopathy
* Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy

Exclusion Criteria:

* Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to cardiomyopathy
Effects of Osteopathic Manipulative Therapy on Arrhythmias

The study focuses on patients who have already been diagnosed with an arrhythmia. This is a randomized control trial that will use measurements from the implanted devices to quantify changes in the number of cardiac events experienced. Subjects will present to the Long Island Heart Rhythm Clinic (LIHRC) at the New York Institute of Technology (NYIT) Academic Health Care Center for their scheduled appointment with Dr. Cohen. These patients are generally coming in for their electrophysiology cardiology checkup, postsurgical visit, or consultation concerning their cardiac health. Once confirmed the patients meet the inclusion criteria, they will be informed about this proposed study and asked if they would like to participate. They will then be consented and randomized according to the randomization procedure outlined below.

Once enrolled, the patients will complete the study as outlined in the procedures below. They will have a baseline EKG taken, and then proceed to either Osteopathic manipulative medicine (OMM) treatment or control somatic dysfunction (SD) evaluation. The investigators will then analyze the CareLink data, or the web-based management service for the respective device, to quantify the effects the OMM or control SD evaluation had on any arrhythmia events.

All investigators delivering OMM will be neuromuscular medicine/osteopathic manipulative medicine (NMM/OMM) board certified attending physicians and trained in the specific techniques that have been associated with arrhythmia SDs and treatment modalities to have consistency when treating subjects. Subject confidentiality will be maintained throughout the process as delineated in Question 5 of the protocol document.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has an implanted device connected to CareLink, Merlin, or respective web-based monitoring device, for at least one month
* Subject has documented diagnosis of a controlled arrhythmia
* If subject has been prescribed anticoagulants, the patients has been taking them for at least one month prior to intervention

Exclusion Criteria:

* Subject planning any surgeries, device updates or changes in the next month
* Subject's treatment regimen, including any medications, will be changed in next month
* Subject has contraindications to undergo OMT, which include prior spinal surgery, prior spinal fracture, any acute fractures over regions being treated or open wounds, current infection, or any other medical conditions that would prohibit OMT
* Subject is pregnant
Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.


Eligibility Criteria:
Inclusion Criteria:

* Phototypes: I, II, III and IV
* Integral skin test in the region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of antinflammatory or immune-suppression drugs
* Personal history of atopy
* History of sensibilization or irritation for topic products
* Active cutaneous disease
* Use of new drugs and/or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Fast-track in Minimally Invasive Gynaecology

Objective: Evaluate the effects of a fast-track (FT) protocol on costs and postoperative recovery.

Design: randomized trial

Setting: University Hospitals

Population: 170 women undergoing total laparoscopic hysterectomy for a benign indication

Methods: A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol.

Main outcomes measure: Primary outcome was costs. Secondary outcomes were length of stay, postoperative morbidity and patient satisfaction.

1. Fast-Track protocol:

   Preoperative
   * Anesthetic consultation
   * Proposal of optimization of patient's general health state + family meeting if necessary
   * Hospitalization on day of surgery
   * Solids stopped 6 hours prior to surgery, drinking encouraged up to 2 hours prior to surgery

   During surgery
   * Anti-infectious prophylaxis
   * Anesthesia via IV propofol/remifentanil
   * Anti-nausea prophylaxis
   * Pain control based on limited systemic opioid use

   Postoperative
   * Balanced analgesia for pain control
   * Antithrombotic prophylaxis
   * Early oral refeeding
   * Rapid mobilization
   * Gum chewing
   * Foley catheter removal at the end of surgery
   * Peripheral IV catheter removal 6 hours postoperatively
2. Usual care protocol :

Preoperative

* Anesthetic consultation
* Hospitalization on day of surgery
* Fasting beginning at midnight prior to surgery

During surgery

* Anti-infectious prophylaxis
* Balanced anesthesia via halogen gas
* Anti-nausea medication if needed

Postoperative

* Balanced analgesia for pain control
* Antithrombotic prophylaxis
* Same-day refeeding according to patient's wish
* Same-day mobilization according to patient's wish
* Foley and peripheral IV catheter removal on day 1 postoperatively

Eligibility Criteria:
Inclusion Criteria:

* women undergoing total laparoscopic hysterectomy for a benign indication

Exclusion Criteria:

* the requirement for an additional surgical procedure, such as prolapse repair or urinary incontinence, because a prolonged operative time could compromise early patient discharge and
* the inability to speak French because the patients were required to complete their data collection logbook in French.
Sleep Apnea and Tromboembolic Disease

There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE).

OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.

DESIGN: Case-control study.

METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:

a) medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.

Eligibility Criteria:
Inclusion Criteria:

* Case group:
* Pulmonary embolism diagnosed by CT Pulmonary Angiography.
* Control group:
* randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease

Exclusion Criteria:

* Refusal to sign informed consent.
* Expected survival less than 12 months
* Long-term oxygen therapy
* Hospital admission in the previous two months.
* Familiar thrombophilia
Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

Aseptic abscess syndrome (AA) is a rare entity characterized by the occurrence of deep abscesses with no germ found. Antibiotic therapy is ineffective and they are sensitive to anti-inflammatory treatment with corticosteroids.

Gut microbiota is important for the development of the immune system. In Crohn's disease which is frequently associated with AA syndrome, dysbiosis is found but could also be involved in the immune response at a distance from the gut.

Stool, blood, saliva and urine samples will be taken from the patients included and their controls in the centers where they are followed. These biological samples will be transported to Clermont Ferrand using the same procedure (transporter and dry ice) where the following analyses will be performed: microbiota on stool and saliva, short chain fatty acids on stool and lymphocyte study on blood.

* Included patients will be adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al.
* Controls will be adults without aseptic abscess syndrome living in the same environment as the patients, whether related to the patient or not.

Patients and controls must be able to provide informed consent and be affiliated with the French Social Security system.

Eligibility Criteria:
Inclusion Criteria:

* For cases: adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al:
* Deep abscesses on radiological examination with neutrophilic features proven by pathological analysis of a surgical specimen or biopsy when performed
* Negative blood cultures, negative serological tests for bacteria, including always Yersinia enterocolitica, and, during surgery or aspiration, sterile pus (with standard cultures, BAAR and fungal tests) Failure of antibiotic therapy, when prescribed, after at least 2 weeks for conventional antibiotic therapy and at least 3 months for anti-tuberculosis treatment
* Rapid clinical improvement the day after the prescription of corticosteroids (at least 1/2 mg/kg prednisone or equivalent) followed by radiological improvement after 1 month of corticosteroids, sometimes in association with immunosuppressive treatments.

For controls: adult person living in the same environment as the case to which it is matched. Adult person living in the same household or near the patient.

For cases and controls:

* Ability to provide informed consent.
* Membership in the Social Security system.

Exclusion Criteria:

* Pregnant women. Incapable patients Patients deprived of liberty Antibiotic therapy administered within 6 weeks prior to inclusion.